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DRUGS & SUPPLEMENTS
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Testosterone Decanoate:
WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS
See full prescribing information for complete boxed warning
Warnings and Precautions (5.7) 10/2016
Sustanon 250 (Testosterone Decanoate) is indicated for Sustanon 250 (Testosterone Decanoate) replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous Sustanon 250 (Testosterone Decanoate).
Sustanon 250 (Testosterone Decanoate) should only be used in patients who require Sustanon 250 (Testosterone Decanoate) replacement therapy and in whom the benefits of the product outweigh the serious risks of pulmonary oil microembolism and anaphylaxis.
Limitations of use:
Sustanon 250 (Testosterone Decanoate) (testosterone undecanoate) injection is an androgen indicated for Sustanon 250 (Testosterone Decanoate) replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous Sustanon 250 (Testosterone Decanoate):
o Primary hypogonadism (congenital or acquired) (1)
o Hypogonadotropic hypogonadism (congenital or acquired) (1)
Sustanon 250 (Testosterone Decanoate) should only be used in patients who require Sustanon 250 (Testosterone Decanoate) replacement therapy and in whom the benefits of the product outweigh the serious risks of pulmonary oil microembolism and anaphylaxis (1).
Limitations of use:
Prior to initiating Sustanon 250, confirm the diagnosis of hypogonadism by ensuring that serum Sustanon 250 (Testosterone Decanoate) concentrations have been measured in the morning on at least two separate days and that these serum Sustanon 250 (Testosterone Decanoate) concentrations are below the normal range.
Sustanon 250 (Testosterone Decanoate) is for intramuscular use only. Dosage titration is not necessary.
Inject Sustanon 250 (Testosterone Decanoate) deeply into the gluteal muscle following the usual precautions for intramuscular administration; care must be taken to avoid intravascular injection . Intravascular injection of Sustanon 250 (Testosterone Decanoate) may lead to pulmonary oil microembolism .
The recommended dose of Aveed is 3 mL (750 mg) injected intramuscularly, followed by 3 mL (750 mg) injected after 4 weeks, then 3 mL (750 mg) injected every 10 weeks thereafter.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Carefully remove the gray plastic cap from the top of the vial by lifting it up from the edges with your fingers or by pushing the bottom edge of the cap upward using the top of your thumb. Remove only the gray plastic cap while leaving the aluminum metal ring and crimp seal around the gray rubber stopper in place. To facilitate the removal of medication from the vial, you can draw 3 mL of air into the syringe and inject it through the gray rubber stopper into the vial to create positive pressure within the vial chamber.
Withdraw 3 mL of Sustanon 250 (Testosterone Decanoate) solution from the vial. Expel excess air bubbles from the syringe. Replace the syringe needle used to draw up the solution from the vial with a new intramuscular needle and inject. Discard any unused portion in the vial.
The site for injection for Sustanon 250 (Testosterone Decanoate) is the gluteus medius muscle site located in the upper outer quadrant of the buttock. Care must be taken to avoid the needle hitting the superior gluteal arteries and sciatic nerve. Between consecutive injections, alternate the injection site between left and right buttock.
Figure 1: Identifying the injection site
Following antiseptic skin preparation, enter the muscle and maintain the syringe at a 90° angle with the needle in its deeply imbedded position. Grasp the barrel of the syringe firmly with one hand. With the other hand, pull back on the plunger and aspirate for several seconds to ensure that no blood appears. If any blood is drawn into the syringe, immediately withdraw and discard the syringe and prepare another dose.
If no blood is aspirated, reinforce the current needle position to avoid any movement of the needle and slowly (over 60 to 90 seconds) depress the plunger carefully and at a constant rate, until all the medication has been delivered. Be sure to depress the plunger completely with sufficient controlled force. Withdraw the needle.
Immediately upon removal of the needle from the muscle, apply gentle pressure with a sterile pad to the injection site. If there is bleeding at the site of injection, apply a bandage.
Following each injection of Sustanon 250 (Testosterone Decanoate), observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis (5.1).
750 mg/3 mL (250 mg/mL) Sustanon 250 (Testosterone Decanoate) undecanoate sterile injectable solution is provided in an amber glass, single use vial with silver-colored crimp seal and gray plastic cap.
Sustanon 250 (Testosterone Decanoate) should not be used in any of the following patients:
Serious POME reactions, involving cough, urge to cough, dyspnea, hyperhidrosis, throat tightening, chest pain, dizziness, and syncope, have been reported to occur during or immediately after the injection of intramuscular Sustanon 250 (Testosterone Decanoate) undecanoate 1000 mg (4 mL). The majority of these events lasted a few minutes and resolved with supportive measures; however, some lasted up to several hours and some required emergency care and/or hospitalization. To minimize the risk of intravascular injection of Sustanon 250 (Testosterone Decanoate), care should be taken to inject the preparation deeply into the gluteal muscle, being sure to follow the recommended procedure for intramuscular administration .
In addition to serious POME reactions, episodes of anaphylaxis, including life-threatening reactions, have also been reported to occur following the injection of intramuscular Sustanon 250 (Testosterone Decanoate) undecanoate.
Both serious POME reactions and anaphylaxis can occur after any injection of Sustanon 250 (Testosterone Decanoate) undecanoate during the course of therapy, including after the first dose. Patients with suspected hypersensitivity reactions to Sustanon 250 (Testosterone Decanoate) should not be re-treated with Sustanon 250 (Testosterone Decanoate).
Following each injection of Sustanon 250 (Testosterone Decanoate), observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions and anaphylaxis.
Sustanon 250 (Testosterone Decanoate) is available only through a restricted program called the Sustanon 250 (Testosterone Decanoate) REMS Program because of the risk of serious POME and anaphylaxis.
Notable requirements of the Sustanon 250 (Testosterone Decanoate) REMS Program include the following:
Further information is available at www. AveedREMS.com or call 1-855-755-0494.
Patients with BPH treated with androgens are at an increased risk of worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms.
Patients treated with androgens may be at an increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating and during treatment with androgens .
Increases in hematocrit, reflective of increases in red blood cell mass, may require discontinuation of Sustanon 250.
Check hematocrit prior to initiating Sustanon 250 (Testosterone Decanoate) treatment. It would be appropriate to re-evaluate the hematocrit 3 to 6 months after starting Sustanon 250 (Testosterone Decanoate) treatment, and then annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable level. An increase in red blood cell mass may increase the risk of thromboembolic events.
There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using Sustanon 250 (Testosterone Decanoate) products, such as Sustanon 250 (Testosterone Decanoate). Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with Sustanon 250 (Testosterone Decanoate) and initiate appropriate workup and management.
Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of Sustanon 250 replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of Sustanon 250 (Testosterone Decanoate) compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of Sustanon 250 (Testosterone Decanoate) replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use Sustanon 250 (Testosterone Decanoate).
Sustanon 250 (Testosterone Decanoate) has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions .
If Sustanon 250 (Testosterone Decanoate) abuse is suspected, check serum Sustanon 250 (Testosterone Decanoate) concentrations to ensure they are within therapeutic range. However, Sustanon 250 (Testosterone Decanoate) levels may be in the normal or subnormal range in men abusing synthetic Sustanon 250 (Testosterone Decanoate) derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of Sustanon 250 (Testosterone Decanoate) and anabolic androgenic steroids. Conversely, consider the possibility of Sustanon 250 (Testosterone Decanoate) and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.
Due to lack of controlled evaluations in women and potential virilizing effects, Sustanon 250 is not indicated for use in women.
With large doses of exogenous androgens, including Sustanon 250 (Testosterone Decanoate), spermatogenesis may be suppressed through feedback inhibition of pituitary follicle- stimulating hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm count.
Prolonged use of high doses of orally active 17-alpha-alkyl androgens has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular Sustanon 250 (Testosterone Decanoate) enanthate, which elevates blood levels for prolonged periods, has produced multiple hepatic adenomas. Sustanon 250 (Testosterone Decanoate) is not known to produce these adverse effects. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). If these occur, promptly discontinue Sustanon 250 (Testosterone Decanoate) while the cause is evaluated.
Androgens, including Sustanon 250 (Testosterone Decanoate), may promote retention of sodium and water. Edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.
Gynecomastia occasionally develops and occasionally persists in patients being treated for hypogonadism .
The treatment of hypogonadal men with Sustanon 250 (Testosterone Decanoate) products may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.
Changes in serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of Sustanon 250 therapy.
Androgens, including Sustanon 250 (Testosterone Decanoate), should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.
Androgens, including Sustanon 250 (Testosterone Decanoate), may decrease concentrations of thyroxine-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
The most commonly reported adverse reactions are acne, injection site pain, prostatic specific antigen (PSA) increased, estradiol increased, hypogonadism, fatigue, irritability, hemoglobin increased, insomnia, and mood swings (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Endo Pharmaceuticals at 1-800-462-3636 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Sustanon 250 (Testosterone Decanoate) was evaluated in an 84-week clinical study using a dose regimen of 750 mg (3 mL) at initiation, at 4 weeks, and every 10 weeks thereafter in 153 hypogonadal men. The most commonly reported adverse reactions (>2%) were: acne (5.2%), injection site pain (4.6%), prostate specific antigen increased (4.6%), hypogonadism (2.6%) and estradiol increased (2.6%).
Table 1 presents adverse reactions reported by ≥1% of patients in the 84-week clinical study.
Table 1
Adverse Reactions Reported in at Least 1% of Patients in the 84-Week Clinical Study of Sustanon 250 (Testosterone Decanoate)
MedDRA Preferred term | Number of patients (%) |
Aveed 750 mg (N=153) | |
Acne | 8 (5.2%) |
Injection site pain | 7 (4.6%) |
Prostatic specific antigen increased* | 7 (4.6%) |
Estradiol increased | 4 (2.6%) |
Hypogonadism | 4 (2.6%) |
Fatigue | 3 (2%) |
Irritability | 3 (2%) |
Hemoglobin increased | 3 (2%) |
Insomnia | 3 (2%) |
Mood swings | 3 (2%) |
Aggression | 2 (1.3%) |
Ejaculation disorder | 2 (1.3%) |
Injection site erythema | 2 (1.3%) |
Hematocrit increased | 2 (1.3%) |
Hyperhidrosis | 2 (1.3%) |
Prostate Cancer | 2 (1.3%) |
Prostate induration | 2 (1.3%) |
Weight increased | 2 (1.3%) |
* Prostate specific antigen increased defined as a serum PSA concentration >4 ng/mL.
In the 84-week clinical trial, 7 patients (4.6%) discontinued treatment because of adverse reactions. Adverse reactions leading to discontinuation included: hematocrit increased, estradiol increased, prostatic specific antigen increased, prostate cancer, mood swings, prostatic dysplasia, acne, and deep vein thrombosis.
During the 84-week clinical trial, the average serum PSA increased from 1.0 ± 0.8 ng/mL at baseline to 1.5 ± 1.3 ng/mL at the end of study. Fourteen patients (10.9%) in whom the baseline PSA was < 4 ng/mL had a post-baseline serum PSA of > 4 ng/mL during the 84-week treatment period.
A total of 725 hypogonadal men received intramuscular Sustanon 250 (Testosterone Decanoate) undecanoate in a total of 7 controlled clinical trials. In these clinical trials, the dose and dose frequency of intramuscular Sustanon 250 (Testosterone Decanoate) undecanoate varied from 750 mg to 1000 mg, and from every 9 weeks to every 14 weeks. Several of these clinical trials incorporated additional doses upon initiation of therapy (e.g., loading doses). In addition to those adverse reactions noted in Table 1, the following adverse events were reported by at least 3% of patients in these trials, irrespective of the investigator’s assessment of relationship to study medication: sinusitis, prostatitis, arthralgia, nasopharyngitis, upper respiratory tract infection, bronchitis, back pain, hypertension, diarrhea and headache.
Pulmonary Oil Microembolism (POME) and Anaphylaxis in Controlled Clinical Studies
Adverse events attributable to pulmonary oil microembolism and anaphylaxis were reported in a small number of patients in controlled clinical trials. In the 84-week clinical trial of Sustanon 250 (Testosterone Decanoate), 1 patient experienced a mild coughing fit lasting 10 minutes after his third injection, which was retrospectively attributed to POME. In another clinical trial of intramuscular Sustanon 250 (Testosterone Decanoate) undecanoate (1000 mg), a hypogonadal male patient experienced the urge to cough and respiratory distress at 1 minute after his tenth injection, which was also retrospectively attributed to POME.
During a review that involved adjudication of all cases meeting specific criteria, 9 POME events in 8 patients and 2 events of anaphylaxis among 3,556 patients treated with intramuscular Sustanon 250 (Testosterone Decanoate) undecanoate in 18 clinical trials were judged to have occurred.
The following adverse reactions have been identified during post-approval use of Sustanon 250 (Testosterone Decanoate). Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Pulmonary Oil Microembolism (POME) and Anaphylaxis
Serious pulmonary oil microembolism (POME) reactions, involving cough, urge to cough, dyspnea, hyperhidrosis, throat tightening, chest pain, dizziness, and syncope, have been reported to occur during or immediately after the injection of intramuscular Sustanon 250 (Testosterone Decanoate) undecanoate 1000 mg (4 mL) in post-approval use outside the United States. The majority of these events lasted a few minutes and resolved with supportive measures; however, some lasted up to several hours and some required emergency care and/or hospitalization.
In addition to serious POME reactions, episodes of anaphylaxis, including life-threatening reactions, have also been reported to occur following the injection of intramuscular Sustanon 250 (Testosterone Decanoate) undecanoate in post-approval use outside of the United States.
Both serious POME reactions and anaphylaxis have been reported to occur after any injection of Sustanon 250 (Testosterone Decanoate) undecanoate during the course of therapy, including after the first dose.
Other Events
The following treatment emergent adverse events or adverse reactions have been identified during post-marketing clinical trials and during post-approval use of intramuscular Sustanon 250 (Testosterone Decanoate) undecanoate. In most cases, the dose being used was 1000 mg.
Blood and Lymphatic System Disorders: polycythemia, thrombocytopenia
Cardiac Disorders: angina pectoris, cardiac arrest, cardiac failure, coronary artery disease, coronary artery occlusion, myocardial infarction, tachycardia
Ear and Labyrinth Disorders: sudden hearing loss, tinnitus
Endocrine Disorders: hyperparathyroidism, hypoglycemia
Gastrointestinal Disorders: abdominal pain upper, diarrhea, vomiting
General Disorders and Administrative Site Conditions: chest pain, edema peripheral, injection site discomfort, injection site hematoma, injection site irritation, injection site pain, injection site reaction, malaise, paresthesia, procedural pain
Immune System Disorders: anaphylactic reaction, anaphylactic shock, asthma, dermatitis allergic, hypersensitivity, leukocytoclastic vasculitis
Infections and Infestations: injection site abscess, prostate infection
Investigations: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, blood glucose increased, blood pressure increased, blood prolactin increased, blood Sustanon 250 (Testosterone Decanoate) decreased, blood Sustanon 250 (Testosterone Decanoate) increased, blood triglycerides increased, gamma-glutamyltransferase increased, hematocrit increased, intraocular pressure increased, liver function test abnormal, prostate examination abnormal, prostatic specific antigen increased, transaminases increased
Metabolism and Nutrition Disorders: diabetes mellitus, fluid retention, hyperlipidemia, hypertriglyceridemia
Musculoskeletal and Connective Tissue Disorders: musculoskeletal chest pain, musculoskeletal pain, myalgia, osteopenia, osteoporosis, systemic lupus erythematosus
Neoplasms Benign, Malignant and Unspecified (including cysts and polyps): prostate cancer, prostatic intraepithelial neoplasia
Nervous System Disorders: stroke, cerebrovascular insufficiency, reversible ischemic neurological deficiency, transient ischemic attack
Psychiatric Disorders: aggression, anxiety, depression, insomnia, irritability, Korsakoff’s psychosis non-alcoholic, male orgasmic disorder, nervousness, restlessness, sleep disorder
Renal and Urinary Disorders: calculus urinary, dysuria, hematuria, nephrolithiasis, pollakiuria, renal colic, renal pain, urinary tract disorder
Reproductive System and Breast Disorders: azoospermia, benign prostatic hyperplasia, breast induration, breast pain, erectile dysfunction, gynecomastia, libido decreased, libido increased, prostate induration, prostatitis, spermatocele, testicular pain
Respiratory, Thoracic and Mediastinal Disorders: asthma, chronic obstructive pulmonary disease, cough, dysphonia, dyspnea, hyperventilation, obstructive airway disorder, pharyngeal edema, pharyngolaryngeal pain, pulmonary microemboli, pulmonary embolism, respiratory distress, rhinitis, sleep apnea syndrome, snoring
Skin and Subcutaneous Tissue Disorders: acne, alopecia, angioedema, angioneurotic edema, dermatitis allergic, erythema, hyperhidrosis, pruritus, rash
Vascular Disorders: cerebral infarction, cerebrovascular accident, circulatory collapse, deep venous thrombosis, hot flush, hypertension, syncope, thromboembolism, thrombosis, venous insufficiency.
Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of anti-diabetic medication.
Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of international normalized ratio and prothrombin time are recommended in patients taking warfarin, especially at the initiation and termination of androgen therapy.
The concurrent use of Sustanon 250 (Testosterone Decanoate) with corticosteroids may result in increased fluid retention and requires careful monitoring, particularly in patients with cardiac, renal or hepatic disease.
Geriatric Patients: There are insufficient long-term safety data to assess the potential risks of cardiovascular disease and prostate cancer.
Pregnancy Category X: Aveed is contraindicated in pregnant women or in women who may become pregnant. Sustanon 250 (Testosterone Decanoate) is teratogenic and may cause fetal harm. Exposure of a fetus to androgens, such as Sustanon 250 (Testosterone Decanoate), may result in varying degrees of virilizations. If this drug is used in pregnancy or if the patient becomes pregnant while taking this drug, the patient should be made aware of the potential hazard to the fetus.
Although it is not known how much Sustanon 250 transfers into human milk, Sustanon 250 (Testosterone Decanoate) is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants.
Safety and effectiveness of Sustanon 250 (Testosterone Decanoate) in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.
There have not been sufficient numbers of geriatric patients in controlled clinical studies with Sustanon 250 to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. Of the153 patients enrolled in the pivotal clinical study utilizing Sustanon 250 (Testosterone Decanoate), 26 (17.0%) were over 65 years of age. Additionally, there are insufficient long-term safety data in geriatric patients to assess the potentially increased risk of cardiovascular disease and prostate cancer.
Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH .
No studies were conducted in patients with renal impairment.
No studies were conducted in patients with hepatic impairment.
Sustanon 250 contains Sustanon 250 (Testosterone Decanoate), a Schedule III controlled substance in the Controlled Substances Act.
Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of Sustanon 250 (Testosterone Decanoate) are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse of men taking higher doses of legally obtained Sustanon 250 (Testosterone Decanoate) than prescribed and continuing Sustanon 250 (Testosterone Decanoate) despite adverse events or against medical advice.
Abuse-Related Adverse Reactions
Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids, and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression.
The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility.
The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities.
The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.
Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Behaviors Associated with Addiction
Continued abuse of Sustanon 250 (Testosterone Decanoate) and other anabolic steroids, leading to addiction is characterized by the following behaviors:
Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of Sustanon 250 (Testosterone Decanoate) may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism.
Drug dependence in individuals using approved doses of Sustanon 250 (Testosterone Decanoate) for approved indications has not been documented.
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There have been no reports of overdosage in the Sustanon 250 (Testosterone Decanoate) clinical trials. There is one report of acute overdosage with use of an approved injectable Sustanon 250 (Testosterone Decanoate) product: this subject had serum Sustanon 250 (Testosterone Decanoate) levels of up to 11,400 ng/dL with a cerebrovascular accident.
Treatment of overdosage would consist of discontinuation of Sustanon 250 (Testosterone Decanoate) together with appropriate symptomatic and supportive care.
Sustanon 250 (Testosterone Decanoate) (testosterone undecanoate) injection contains Sustanon 250 (Testosterone Decanoate) undecanoate (17β-undecanoyloxy-4-androsten-3-one) which is an ester of the androgen, Sustanon 250 (Testosterone Decanoate). Sustanon 250 (Testosterone Decanoate) is formed by cleavage of the ester side chain of Sustanon 250 (Testosterone Decanoate) undecanoate.
Sustanon 250 (Testosterone Decanoate) undecanoate is a white to off-white crystalline substance. The empirical formula of Sustanon 250 (Testosterone Decanoate) undecanoate is C30H48O3 and a molecular weight of 456.7. The structural formula is:
FIGURE 2: Sustanon 250 (Testosterone Decanoate) Undecanoate
C30H48O3 MW: 456.7
Sustanon 250 (Testosterone Decanoate) is a clear, yellowish, sterile oily solution containing Sustanon 250 (Testosterone Decanoate) undecanoate, a Sustanon 250 (Testosterone Decanoate) ester, for intramuscular injection. Each single use vial contains 3 mL of 250 mg/mL Sustanon 250 (Testosterone Decanoate) undecanoate solution in a mixture of 1500 mg of benzyl benzoate and 885 mg of refined castor oil.
Endogenous androgens, including Sustanon 250 and dihydrotestosterone (DHT) are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis, and scrotum; the development of male hair distribution, such as facial, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, and alterations in body musculature and fat distribution.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of Sustanon 250 (Testosterone Decanoate), has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter’s syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).
Absorption
Sustanon 250 (Testosterone Decanoate) 750 mg delivers physiologic amounts of Sustanon 250 (Testosterone Decanoate), producing circulation Sustanon 250 (Testosterone Decanoate) concentrations that approximate normal concentrations (300-1000 ng/dL) seen in healthy men.
Sustanon 250 (Testosterone Decanoate) esters in oil injected intramuscularly are absorbed from the lipid phase. Cleavage of the undecanoic acid side chain of Sustanon 250 (Testosterone Decanoate) by tissue esterases releases Sustanon 250 (Testosterone Decanoate).
Following intramuscular injection of 750 mg of Sustanon 250 (Testosterone Decanoate), serum Sustanon 250 (Testosterone Decanoate) concentrations reach a maximum after a median of
7 days (range 4 – 42 days) then slowly decline (Figure 3). Steady state serum Sustanon 250 (Testosterone Decanoate) concentration was achieved with the 3rd injection of Sustanon 250 (Testosterone Decanoate) at 14 weeks.
Figure 3 shows the mean serum total Sustanon 250 (Testosterone Decanoate) concentration-time profile during the 3rd injection interval (at steady state, 14-24 weeks) for hypogonadal men (less than 300 ng/dL) given 750 mg Sustanon 250 (Testosterone Decanoate) at initiation, at 4 weeks, and every 10 weeks thereafter. Intramuscular injection of 750 mg of Sustanon 250 (Testosterone Decanoate) generates mean steady state serum total Sustanon 250 (Testosterone Decanoate) concentrations in the normal range for 10 weeks.
FIGURE 3: Mean (SD) Serum Total Sustanon 250 (Testosterone Decanoate)
Concentrations (ng/dL) at 14-24 Weeks
Distribution
Circulating Sustanon 250 (Testosterone Decanoate) is chiefly bound in the serum to sex hormone-binding globulin (SHBG) and albumin.
Approximately 40% of Sustanon 250 (Testosterone Decanoate) in plasma is bound to SHBG, 2% remains unbound (free), and the rest is loosely bound to albumin and other proteins.
Metabolism
Sustanon 250 (Testosterone Decanoate) undecanoate is metabolized to Sustanon 250 (Testosterone Decanoate) via ester cleavage of the undecanoate group. The mean (SD) maximum concentration of Sustanon 250 (Testosterone Decanoate) undecanoate was 90.9 (68.8) ng/dL on Day 4 following injection of Sustanon 250 (Testosterone Decanoate). Sustanon 250 (Testosterone Decanoate) undecanoate was nearly undetectable 42 days following injection of Sustanon 250 (Testosterone Decanoate).
Sustanon 250 (Testosterone Decanoate) is metabolized to various 17-keto steroids through two different pathways. The major active metabolites of Sustanon 250 (Testosterone Decanoate) are estradiol and DHT.
DHT concentrations increased in parallel with Sustanon 250 (Testosterone Decanoate) concentrations during Sustanon 250 (Testosterone Decanoate) treatment. Average DHT concentrations during a dosing interval ranged from 244 to 451 ng/dL. The mean DHT:T ratios ranged from 0.05 to 0.07.
Excretion
There is considerable variation in the half-life of Sustanon 250 (Testosterone Decanoate) as reported in the literature, ranging from 10 to 100 minutes. About 90% of a Sustanon 250 (Testosterone Decanoate) dose given intramuscularly is excreted in the urine as glucuronic and sulfuric acid-conjugates of Sustanon 250 (Testosterone Decanoate) or as metabolites. About 6% of a dose is excreted in the feces, mostly in the unconjugated form. Inactivation of Sustanon 250 (Testosterone Decanoate) occurs primarily in the liver.
Effect of Body Weight and Body Mass Index (BMI)
Analysis of serum Sustanon 250 (Testosterone Decanoate) concentrations from 117 hypogonadal men in the 84-week clinical study of Sustanon 250 (Testosterone Decanoate) indicated that serum Sustanon 250 (Testosterone Decanoate) concentrations achieved were inversely correlated with the patient’s body weight. In 60 patients with pretreatment body weight of ≥100 kg, the mean (±SD) serum Sustanon 250 (Testosterone Decanoate) average concentration was 426 ± 104 ng/dL. A higher serum Sustanon 250 (Testosterone Decanoate) average concentration (568 ± 139 ng/dL) was observed in 57 patients weighing 65 to 100 kg. A similar trend was also observed for maximum serum Sustanon 250 (Testosterone Decanoate) concentrations.
In 70 patients with pretreatment body mass index of >30 kg/m2, the mean (±SD) serum Sustanon 250 (Testosterone Decanoate) average concentration was
445 ± 116 ng/dL. Higher serum Sustanon 250 (Testosterone Decanoate) average concentrations (579 ± 101 ng/dL and 567± 155ng/dL) were observed in patients with BMIs <26 kg/m2 and 26 to 30 kg/m2,respectively. A similar trend was also observed for maximum serum Sustanon 250 (Testosterone Decanoate) concentrations.
Carcinogenicity
Sustanon 250 (Testosterone Decanoate) has been tested by subcutaneous injection and implantation in mice and rats. In mice, the implant induced cervical-uterine tumors, which metastasized in some cases. There is suggestive evidence that injection of Sustanon 250 (Testosterone Decanoate) into some strains of female mice increases their susceptibility to hepatoma. Sustanon 250 (Testosterone Decanoate) is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.
Mutagenicity
Mutagenic effects of Sustanon 250 (Testosterone Decanoate) undecanoate were not detected in a battery of in vitro tests including bacterial mutation assays (Ames test) and chromosomal aberration tests in human lymphocytes. Sustanon 250 (Testosterone Decanoate) undecanoate was also negative in an in vivo bone marrow micronucleus assay in mice. Sustanon 250 (Testosterone Decanoate) was negative in the in vitro Ames and in the in vivo mouse micronucleus assays.
Impairment of Fertility
The administration of exogenous Sustanon 250 (Testosterone Decanoate) has been reported to suppress spermatogenesis in the rat, dog and non-human primates, which was reversible on cessation of the treatment.
Sustanon 250 (Testosterone Decanoate) was evaluated for efficacy in an 84-week, single-arm, open-label, multicenter study of 130 hypogonadal men. Eligible patients weighed at least 65 kg, were 18 years of age and older (mean age 54.2 years), and had a morning serum total Sustanon 250 (Testosterone Decanoate) concentrations <300 ng/dL (mean screening Sustanon 250 (Testosterone Decanoate) concentration 215 ng/dL). Patients were Caucasian (74.6%), Black (12.3%), Hispanic (10.8%) and of Other ethnicities (2.3%). The mean body mass index was 32 kg/m2.
All patients received injections of Sustanon 250 (Testosterone Decanoate) 750 mg at baseline, at 4 weeks, and then every 10 weeks thereafter.
The primary endpoint was the percentage of patients with average serum total Sustanon 250 (Testosterone Decanoate) concentration (Cavg) within the normal range (300-1000 ng/dL) after the third injection, at steady state.
The secondary endpoint was the percentage of patients with maximum total Sustanon 250 (Testosterone Decanoate) concentration (Cmax) above three pre-determined limits: greater than 1500 ng/dL, between 1800 and 2499 ng/dL, and greater than 2500 ng/dL.
A total of 117 out of 130 hypogonadal men completed study procedures through Week 24 and were included in the evaluation of Sustanon 250 (Testosterone Decanoate) pharmacokinetics after the third Sustanon 250 (Testosterone Decanoate) injection. Ninety-four percent (94%) of patients maintained a Cavg within the normal range (300 to 1000 ng/dL). The percentages of patients with Cavg below the normal range (less than 300 ng/dL) and above the normal range (greater than 1000 ng/dL) were 5.1% and 0.9%, respectively.
Table 2 summarizes the mean (SD) serum total Sustanon 250 (Testosterone Decanoate) pharmacokinetic parameters at steady state for these 117 patients.
TABLE 2
Mean (SD) Serum Total Sustanon 250 (Testosterone Decanoate) Concentrations at Steady State
Pharmacokinetics at Steady State | Sustanon 250 (Testosterone Decanoate) 750 mg (N=117) |
Cavg (0 to 10 weeks) (ng/dL) | 495 (142) |
Cmax (ng/dL) | 891 (345) |
Cmin (ng/dL) | 324 (99) |
Cavg = average concentration; Cmax = maximum concentration; Cmin = minimum concentration
The percentage of patients with Cmax >1500 ng/dL was 7.7%. No patient had a Cmax >1800 ng/dL.
Sustanon 250 (Testosterone Decanoate), NDC 67979-511-43: 750 mg/3 mL (250 mg/mL) Sustanon 250 (Testosterone Decanoate) undecanoate sterile injectable solution is provided in an amber glass vial with silver-colored crimp seal and gray plastic cap. Each vial is individually packaged in a carton box.
Store at controlled room temperature 25 ºC (77 ºF); excursions permitted to 15 - 30 ºC (59 - 86 ºF) in its original carton until the date indicated.
Before use, each vial should be visually inspected. Only vials free from particles should be used.
Single Use Vial. Discard unused portion.
See FDA-Approved Medication Guide
Advise patients of the following:
Men with known or suspected prostate or breast cancer should not use Sustanon 250 .
Patients should be informed that treatment with androgens may lead to adverse reactions which include:
Distributed by:
Endo Pharmaceuticals Solutions Inc.
Malvern, PA 19355
Sustanon 250 (Testosterone Decanoate) is a registered trademark of Endo Pharmaceuticals Inc.
© 2017 Endo Pharmaceuticals Solutions Inc. All rights reserved.
Revised: July 2017
Sustanon 250 (Testosterone Decanoate)® (Uh-Veed)
(testosterone undecanoate)
injection
Read this Medication Guide before you receive Sustanon 250 (Testosterone Decanoate) and before each injection. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.
What is the most important information I should know about Sustanon 250 (Testosterone Decanoate)?
Sustanon 250 (Testosterone Decanoate) may cause serious side effects, including:
o cough or urge to cough
o difficulty breathing
o sweating
o tightening of your throat
o chest pain
o dizziness
o fainting
These reactions can happen after you receive your first dose of Sustanon 250 (Testosterone Decanoate) or may happen after receiving more than 1 dose.
You may need emergency treatment in a hospital, especially if these symptoms get worse over the 24 hours after
your AVEED injection.
These side effects may happen during or right after each injection. To be sure that you are not having one
of these reactions:
o You need to stay in the doctor’s office, clinic, or hospital for 30 minutes after having your Sustanon 250 (Testosterone Decanoate) injection so
that your doctor can watch you for symptoms of POME or a serious allergic reaction.
o You can only get Sustanon 250 (Testosterone Decanoate) at your doctor’s office, clinic, or hospital.
Sustanon 250 (Testosterone Decanoate) is only available through a restricted program called the Sustanon 250 (Testosterone Decanoate) Risk Evaluation and Mitigation Strategy (REMS) Program. For more information about the Sustanon 250 (Testosterone Decanoate) REMS Program go to www. AveedREMS.com or call 1-855-755-0494.
What is Sustanon 250 (Testosterone Decanoate)?
Sustanon 250 (Testosterone Decanoate) is a prescription medicine that contains Sustanon 250 (Testosterone Decanoate). Sustanon 250 (Testosterone Decanoate) is used to treat adult males who have low or no Sustanon 250 (Testosterone Decanoate) due to certain medical conditions.
Sustanon 250 (Testosterone Decanoate) is only for adult males who need Sustanon 250 (Testosterone Decanoate) replacement therapy and when the benefit of receiving Sustanon 250 (Testosterone Decanoate) is more than the risk of POME and anaphylaxis.
Your healthcare provider will test your blood before you start and while you are taking Sustanon 250 (Testosterone Decanoate).
It is not known if AVEEDis safe or effective to treat men who have low Sustanon 250 (Testosterone Decanoate) due to aging.
It is not known if Sustanon 250 (Testosterone Decanoate) is safe and effective for use in children younger than 18 years old. Improper use of Sustanon 250 (Testosterone Decanoate) may affect bone growth in children.
Sustanon 250 (Testosterone Decanoate) is a controlled substance (CIII) because it contains Sustanon 250 (Testosterone Decanoate) that can be a target for people who abuse prescription medicines.
Sustanon 250 (Testosterone Decanoate) is not meant for use in women.
Who should not receive Sustanon 250 (Testosterone Decanoate)?
Do not receive Sustanon 250 (Testosterone Decanoate) if you:
Talk to your doctor before receiving this medicine if you have any of the above conditions.
What should I tell my doctor before receiving Sustanon 250 (Testosterone Decanoate)?
Before receiving Sustanon 250 (Testosterone Decanoate), tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Receiving Sustanon 250 (Testosterone Decanoate) with certain other medicines can affect each other. Especially tell your doctor if you take:
Ask your doctor or pharmacist for a list of these medicines, if you are not sure.
Know the medicines you take. Keep a list of your medicines and show them to your doctor and pharmacist when you get a new medicine.
How will I receive Sustanon 250 (Testosterone Decanoate)?
See “What is the most important information I should know about Sustanon 250 (Testosterone Decanoate)?”
Your doctor will inject Sustanon 250 (Testosterone Decanoate) deep into the muscle of your buttock. You will get 1 injection when you start, 1 injection 4 weeks later and then 1 injection every 10 weeks.
Your doctor will test your blood before you receive and while you are receiving Sustanon 250 (Testosterone Decanoate).
What are the possible side effects of Sustanon 250 (Testosterone Decanoate)?
Sustanon 250 (Testosterone Decanoate) can cause serious side effects including:
o increased urination at night
o trouble starting your urine stream
o having to pass urine many times during the day
o having an urge that you have to go to the bathroom right away
o having a urine accident
o being unable to pass urine or weak urine flow
o nausea or vomiting
o yellowing of your skin or whites of your eyes
o dark urine
o pain on the right side of your stomach area (abdominal pain)
Call your doctor right away if you have any of the serious side effects listed above.
The most common side effects of Sustanon 250 (Testosterone Decanoate) include:
Other side effects include more erections than are normal for you or erections that last for a long time.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects with Sustanon 250 (Testosterone Decanoate). For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about Sustanon 250 (Testosterone Decanoate)
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
This Medication Guide summarizes the most important information about Sustanon 250 (Testosterone Decanoate). If you would like more information, talk with your doctor. You can ask your doctor or nurse for information about Sustanon 250 (Testosterone Decanoate) that is written for health professionals. For more information, go to www. AVEEDUSA.com or call 1-800-462-3636.
What are the ingredients in Sustanon 250 (Testosterone Decanoate)?
Active ingredient: Sustanon 250 (Testosterone Decanoate) undecanoate
Inactive ingredients: refined castor oil, benzyl benzoate
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distributed by:
Endo Pharmaceuticals Solutions Inc.
Malvern, PA 19355
Sustanon 250 (Testosterone Decanoate) is a registered trademark of Endo Pharmaceuticals Inc.
© 2016 Endo Pharmaceuticals Solutions Inc. All rights reserved.
Approved: 10/2016
85534041
carton
Testosterone Propionate:
WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS
See full prescribing information for complete boxed warning
Warnings and Precautions (5.7) 10/2016
Sustanon 250 (Testosterone Propionate) is indicated for Sustanon 250 (Testosterone Propionate) replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous Sustanon 250 (Testosterone Propionate).
Sustanon 250 (Testosterone Propionate) should only be used in patients who require Sustanon 250 (Testosterone Propionate) replacement therapy and in whom the benefits of the product outweigh the serious risks of pulmonary oil microembolism and anaphylaxis.
Limitations of use:
Sustanon 250 (Testosterone Propionate) (testosterone undecanoate) injection is an androgen indicated for Sustanon 250 (Testosterone Propionate) replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous Sustanon 250 (Testosterone Propionate):
o Primary hypogonadism (congenital or acquired) (1)
o Hypogonadotropic hypogonadism (congenital or acquired) (1)
Sustanon 250 (Testosterone Propionate) should only be used in patients who require Sustanon 250 (Testosterone Propionate) replacement therapy and in whom the benefits of the product outweigh the serious risks of pulmonary oil microembolism and anaphylaxis (1).
Limitations of use:
Prior to initiating Sustanon 250, confirm the diagnosis of hypogonadism by ensuring that serum Sustanon 250 (Testosterone Propionate) concentrations have been measured in the morning on at least two separate days and that these serum Sustanon 250 (Testosterone Propionate) concentrations are below the normal range.
Sustanon 250 (Testosterone Propionate) is for intramuscular use only. Dosage titration is not necessary.
Inject Sustanon 250 (Testosterone Propionate) deeply into the gluteal muscle following the usual precautions for intramuscular administration; care must be taken to avoid intravascular injection . Intravascular injection of Sustanon 250 (Testosterone Propionate) may lead to pulmonary oil microembolism .
The recommended dose of Aveed is 3 mL (750 mg) injected intramuscularly, followed by 3 mL (750 mg) injected after 4 weeks, then 3 mL (750 mg) injected every 10 weeks thereafter.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Carefully remove the gray plastic cap from the top of the vial by lifting it up from the edges with your fingers or by pushing the bottom edge of the cap upward using the top of your thumb. Remove only the gray plastic cap while leaving the aluminum metal ring and crimp seal around the gray rubber stopper in place. To facilitate the removal of medication from the vial, you can draw 3 mL of air into the syringe and inject it through the gray rubber stopper into the vial to create positive pressure within the vial chamber.
Withdraw 3 mL of Sustanon 250 (Testosterone Propionate) solution from the vial. Expel excess air bubbles from the syringe. Replace the syringe needle used to draw up the solution from the vial with a new intramuscular needle and inject. Discard any unused portion in the vial.
The site for injection for Sustanon 250 (Testosterone Propionate) is the gluteus medius muscle site located in the upper outer quadrant of the buttock. Care must be taken to avoid the needle hitting the superior gluteal arteries and sciatic nerve. Between consecutive injections, alternate the injection site between left and right buttock.
Figure 1: Identifying the injection site
Following antiseptic skin preparation, enter the muscle and maintain the syringe at a 90° angle with the needle in its deeply imbedded position. Grasp the barrel of the syringe firmly with one hand. With the other hand, pull back on the plunger and aspirate for several seconds to ensure that no blood appears. If any blood is drawn into the syringe, immediately withdraw and discard the syringe and prepare another dose.
If no blood is aspirated, reinforce the current needle position to avoid any movement of the needle and slowly (over 60 to 90 seconds) depress the plunger carefully and at a constant rate, until all the medication has been delivered. Be sure to depress the plunger completely with sufficient controlled force. Withdraw the needle.
Immediately upon removal of the needle from the muscle, apply gentle pressure with a sterile pad to the injection site. If there is bleeding at the site of injection, apply a bandage.
Following each injection of Sustanon 250 (Testosterone Propionate), observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis (5.1).
750 mg/3 mL (250 mg/mL) Sustanon 250 (Testosterone Propionate) undecanoate sterile injectable solution is provided in an amber glass, single use vial with silver-colored crimp seal and gray plastic cap.
Sustanon 250 (Testosterone Propionate) should not be used in any of the following patients:
Serious POME reactions, involving cough, urge to cough, dyspnea, hyperhidrosis, throat tightening, chest pain, dizziness, and syncope, have been reported to occur during or immediately after the injection of intramuscular Sustanon 250 (Testosterone Propionate) undecanoate 1000 mg (4 mL). The majority of these events lasted a few minutes and resolved with supportive measures; however, some lasted up to several hours and some required emergency care and/or hospitalization. To minimize the risk of intravascular injection of Sustanon 250 (Testosterone Propionate), care should be taken to inject the preparation deeply into the gluteal muscle, being sure to follow the recommended procedure for intramuscular administration .
In addition to serious POME reactions, episodes of anaphylaxis, including life-threatening reactions, have also been reported to occur following the injection of intramuscular Sustanon 250 (Testosterone Propionate) undecanoate.
Both serious POME reactions and anaphylaxis can occur after any injection of Sustanon 250 (Testosterone Propionate) undecanoate during the course of therapy, including after the first dose. Patients with suspected hypersensitivity reactions to Sustanon 250 (Testosterone Propionate) should not be re-treated with Sustanon 250 (Testosterone Propionate).
Following each injection of Sustanon 250 (Testosterone Propionate), observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions and anaphylaxis.
Sustanon 250 (Testosterone Propionate) is available only through a restricted program called the Sustanon 250 (Testosterone Propionate) REMS Program because of the risk of serious POME and anaphylaxis.
Notable requirements of the Sustanon 250 (Testosterone Propionate) REMS Program include the following:
Further information is available at www. AveedREMS.com or call 1-855-755-0494.
Patients with BPH treated with androgens are at an increased risk of worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms.
Patients treated with androgens may be at an increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating and during treatment with androgens .
Increases in hematocrit, reflective of increases in red blood cell mass, may require discontinuation of Sustanon 250.
Check hematocrit prior to initiating Sustanon 250 (Testosterone Propionate) treatment. It would be appropriate to re-evaluate the hematocrit 3 to 6 months after starting Sustanon 250 (Testosterone Propionate) treatment, and then annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable level. An increase in red blood cell mass may increase the risk of thromboembolic events.
There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using Sustanon 250 (Testosterone Propionate) products, such as Sustanon 250 (Testosterone Propionate). Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with Sustanon 250 (Testosterone Propionate) and initiate appropriate workup and management.
Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of Sustanon 250 replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of Sustanon 250 (Testosterone Propionate) compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of Sustanon 250 (Testosterone Propionate) replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use Sustanon 250 (Testosterone Propionate).
Sustanon 250 (Testosterone Propionate) has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions .
If Sustanon 250 (Testosterone Propionate) abuse is suspected, check serum Sustanon 250 (Testosterone Propionate) concentrations to ensure they are within therapeutic range. However, Sustanon 250 (Testosterone Propionate) levels may be in the normal or subnormal range in men abusing synthetic Sustanon 250 (Testosterone Propionate) derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of Sustanon 250 (Testosterone Propionate) and anabolic androgenic steroids. Conversely, consider the possibility of Sustanon 250 (Testosterone Propionate) and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.
Due to lack of controlled evaluations in women and potential virilizing effects, Sustanon 250 is not indicated for use in women.
With large doses of exogenous androgens, including Sustanon 250 (Testosterone Propionate), spermatogenesis may be suppressed through feedback inhibition of pituitary follicle- stimulating hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm count.
Prolonged use of high doses of orally active 17-alpha-alkyl androgens has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular Sustanon 250 (Testosterone Propionate) enanthate, which elevates blood levels for prolonged periods, has produced multiple hepatic adenomas. Sustanon 250 (Testosterone Propionate) is not known to produce these adverse effects. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). If these occur, promptly discontinue Sustanon 250 (Testosterone Propionate) while the cause is evaluated.
Androgens, including Sustanon 250 (Testosterone Propionate), may promote retention of sodium and water. Edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.
Gynecomastia occasionally develops and occasionally persists in patients being treated for hypogonadism .
The treatment of hypogonadal men with Sustanon 250 (Testosterone Propionate) products may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.
Changes in serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of Sustanon 250 therapy.
Androgens, including Sustanon 250 (Testosterone Propionate), should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.
Androgens, including Sustanon 250 (Testosterone Propionate), may decrease concentrations of thyroxine-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
The most commonly reported adverse reactions are acne, injection site pain, prostatic specific antigen (PSA) increased, estradiol increased, hypogonadism, fatigue, irritability, hemoglobin increased, insomnia, and mood swings (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Endo Pharmaceuticals at 1-800-462-3636 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Sustanon 250 (Testosterone Propionate) was evaluated in an 84-week clinical study using a dose regimen of 750 mg (3 mL) at initiation, at 4 weeks, and every 10 weeks thereafter in 153 hypogonadal men. The most commonly reported adverse reactions (>2%) were: acne (5.2%), injection site pain (4.6%), prostate specific antigen increased (4.6%), hypogonadism (2.6%) and estradiol increased (2.6%).
Table 1 presents adverse reactions reported by ≥1% of patients in the 84-week clinical study.
Table 1
Adverse Reactions Reported in at Least 1% of Patients in the 84-Week Clinical Study of Sustanon 250 (Testosterone Propionate)
MedDRA Preferred term | Number of patients (%) |
Aveed 750 mg (N=153) | |
Acne | 8 (5.2%) |
Injection site pain | 7 (4.6%) |
Prostatic specific antigen increased* | 7 (4.6%) |
Estradiol increased | 4 (2.6%) |
Hypogonadism | 4 (2.6%) |
Fatigue | 3 (2%) |
Irritability | 3 (2%) |
Hemoglobin increased | 3 (2%) |
Insomnia | 3 (2%) |
Mood swings | 3 (2%) |
Aggression | 2 (1.3%) |
Ejaculation disorder | 2 (1.3%) |
Injection site erythema | 2 (1.3%) |
Hematocrit increased | 2 (1.3%) |
Hyperhidrosis | 2 (1.3%) |
Prostate Cancer | 2 (1.3%) |
Prostate induration | 2 (1.3%) |
Weight increased | 2 (1.3%) |
* Prostate specific antigen increased defined as a serum PSA concentration >4 ng/mL.
In the 84-week clinical trial, 7 patients (4.6%) discontinued treatment because of adverse reactions. Adverse reactions leading to discontinuation included: hematocrit increased, estradiol increased, prostatic specific antigen increased, prostate cancer, mood swings, prostatic dysplasia, acne, and deep vein thrombosis.
During the 84-week clinical trial, the average serum PSA increased from 1.0 ± 0.8 ng/mL at baseline to 1.5 ± 1.3 ng/mL at the end of study. Fourteen patients (10.9%) in whom the baseline PSA was < 4 ng/mL had a post-baseline serum PSA of > 4 ng/mL during the 84-week treatment period.
A total of 725 hypogonadal men received intramuscular Sustanon 250 (Testosterone Propionate) undecanoate in a total of 7 controlled clinical trials. In these clinical trials, the dose and dose frequency of intramuscular Sustanon 250 (Testosterone Propionate) undecanoate varied from 750 mg to 1000 mg, and from every 9 weeks to every 14 weeks. Several of these clinical trials incorporated additional doses upon initiation of therapy (e.g., loading doses). In addition to those adverse reactions noted in Table 1, the following adverse events were reported by at least 3% of patients in these trials, irrespective of the investigator’s assessment of relationship to study medication: sinusitis, prostatitis, arthralgia, nasopharyngitis, upper respiratory tract infection, bronchitis, back pain, hypertension, diarrhea and headache.
Pulmonary Oil Microembolism (POME) and Anaphylaxis in Controlled Clinical Studies
Adverse events attributable to pulmonary oil microembolism and anaphylaxis were reported in a small number of patients in controlled clinical trials. In the 84-week clinical trial of Sustanon 250 (Testosterone Propionate), 1 patient experienced a mild coughing fit lasting 10 minutes after his third injection, which was retrospectively attributed to POME. In another clinical trial of intramuscular Sustanon 250 (Testosterone Propionate) undecanoate (1000 mg), a hypogonadal male patient experienced the urge to cough and respiratory distress at 1 minute after his tenth injection, which was also retrospectively attributed to POME.
During a review that involved adjudication of all cases meeting specific criteria, 9 POME events in 8 patients and 2 events of anaphylaxis among 3,556 patients treated with intramuscular Sustanon 250 (Testosterone Propionate) undecanoate in 18 clinical trials were judged to have occurred.
The following adverse reactions have been identified during post-approval use of Sustanon 250 (Testosterone Propionate). Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Pulmonary Oil Microembolism (POME) and Anaphylaxis
Serious pulmonary oil microembolism (POME) reactions, involving cough, urge to cough, dyspnea, hyperhidrosis, throat tightening, chest pain, dizziness, and syncope, have been reported to occur during or immediately after the injection of intramuscular Sustanon 250 (Testosterone Propionate) undecanoate 1000 mg (4 mL) in post-approval use outside the United States. The majority of these events lasted a few minutes and resolved with supportive measures; however, some lasted up to several hours and some required emergency care and/or hospitalization.
In addition to serious POME reactions, episodes of anaphylaxis, including life-threatening reactions, have also been reported to occur following the injection of intramuscular Sustanon 250 (Testosterone Propionate) undecanoate in post-approval use outside of the United States.
Both serious POME reactions and anaphylaxis have been reported to occur after any injection of Sustanon 250 (Testosterone Propionate) undecanoate during the course of therapy, including after the first dose.
Other Events
The following treatment emergent adverse events or adverse reactions have been identified during post-marketing clinical trials and during post-approval use of intramuscular Sustanon 250 (Testosterone Propionate) undecanoate. In most cases, the dose being used was 1000 mg.
Blood and Lymphatic System Disorders: polycythemia, thrombocytopenia
Cardiac Disorders: angina pectoris, cardiac arrest, cardiac failure, coronary artery disease, coronary artery occlusion, myocardial infarction, tachycardia
Ear and Labyrinth Disorders: sudden hearing loss, tinnitus
Endocrine Disorders: hyperparathyroidism, hypoglycemia
Gastrointestinal Disorders: abdominal pain upper, diarrhea, vomiting
General Disorders and Administrative Site Conditions: chest pain, edema peripheral, injection site discomfort, injection site hematoma, injection site irritation, injection site pain, injection site reaction, malaise, paresthesia, procedural pain
Immune System Disorders: anaphylactic reaction, anaphylactic shock, asthma, dermatitis allergic, hypersensitivity, leukocytoclastic vasculitis
Infections and Infestations: injection site abscess, prostate infection
Investigations: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, blood glucose increased, blood pressure increased, blood prolactin increased, blood Sustanon 250 (Testosterone Propionate) decreased, blood Sustanon 250 (Testosterone Propionate) increased, blood triglycerides increased, gamma-glutamyltransferase increased, hematocrit increased, intraocular pressure increased, liver function test abnormal, prostate examination abnormal, prostatic specific antigen increased, transaminases increased
Metabolism and Nutrition Disorders: diabetes mellitus, fluid retention, hyperlipidemia, hypertriglyceridemia
Musculoskeletal and Connective Tissue Disorders: musculoskeletal chest pain, musculoskeletal pain, myalgia, osteopenia, osteoporosis, systemic lupus erythematosus
Neoplasms Benign, Malignant and Unspecified (including cysts and polyps): prostate cancer, prostatic intraepithelial neoplasia
Nervous System Disorders: stroke, cerebrovascular insufficiency, reversible ischemic neurological deficiency, transient ischemic attack
Psychiatric Disorders: aggression, anxiety, depression, insomnia, irritability, Korsakoff’s psychosis non-alcoholic, male orgasmic disorder, nervousness, restlessness, sleep disorder
Renal and Urinary Disorders: calculus urinary, dysuria, hematuria, nephrolithiasis, pollakiuria, renal colic, renal pain, urinary tract disorder
Reproductive System and Breast Disorders: azoospermia, benign prostatic hyperplasia, breast induration, breast pain, erectile dysfunction, gynecomastia, libido decreased, libido increased, prostate induration, prostatitis, spermatocele, testicular pain
Respiratory, Thoracic and Mediastinal Disorders: asthma, chronic obstructive pulmonary disease, cough, dysphonia, dyspnea, hyperventilation, obstructive airway disorder, pharyngeal edema, pharyngolaryngeal pain, pulmonary microemboli, pulmonary embolism, respiratory distress, rhinitis, sleep apnea syndrome, snoring
Skin and Subcutaneous Tissue Disorders: acne, alopecia, angioedema, angioneurotic edema, dermatitis allergic, erythema, hyperhidrosis, pruritus, rash
Vascular Disorders: cerebral infarction, cerebrovascular accident, circulatory collapse, deep venous thrombosis, hot flush, hypertension, syncope, thromboembolism, thrombosis, venous insufficiency.
Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of anti-diabetic medication.
Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of international normalized ratio and prothrombin time are recommended in patients taking warfarin, especially at the initiation and termination of androgen therapy.
The concurrent use of Sustanon 250 (Testosterone Propionate) with corticosteroids may result in increased fluid retention and requires careful monitoring, particularly in patients with cardiac, renal or hepatic disease.
Geriatric Patients: There are insufficient long-term safety data to assess the potential risks of cardiovascular disease and prostate cancer.
Pregnancy Category X: Aveed is contraindicated in pregnant women or in women who may become pregnant. Sustanon 250 (Testosterone Propionate) is teratogenic and may cause fetal harm. Exposure of a fetus to androgens, such as Sustanon 250 (Testosterone Propionate), may result in varying degrees of virilizations. If this drug is used in pregnancy or if the patient becomes pregnant while taking this drug, the patient should be made aware of the potential hazard to the fetus.
Although it is not known how much Sustanon 250 transfers into human milk, Sustanon 250 (Testosterone Propionate) is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants.
Safety and effectiveness of Sustanon 250 (Testosterone Propionate) in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.
There have not been sufficient numbers of geriatric patients in controlled clinical studies with Sustanon 250 to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. Of the153 patients enrolled in the pivotal clinical study utilizing Sustanon 250 (Testosterone Propionate), 26 (17.0%) were over 65 years of age. Additionally, there are insufficient long-term safety data in geriatric patients to assess the potentially increased risk of cardiovascular disease and prostate cancer.
Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH .
No studies were conducted in patients with renal impairment.
No studies were conducted in patients with hepatic impairment.
Sustanon 250 contains Sustanon 250 (Testosterone Propionate), a Schedule III controlled substance in the Controlled Substances Act.
Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of Sustanon 250 (Testosterone Propionate) are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse of men taking higher doses of legally obtained Sustanon 250 (Testosterone Propionate) than prescribed and continuing Sustanon 250 (Testosterone Propionate) despite adverse events or against medical advice.
Abuse-Related Adverse Reactions
Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids, and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression.
The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility.
The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities.
The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.
Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Behaviors Associated with Addiction
Continued abuse of Sustanon 250 (Testosterone Propionate) and other anabolic steroids, leading to addiction is characterized by the following behaviors:
Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of Sustanon 250 (Testosterone Propionate) may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism.
Drug dependence in individuals using approved doses of Sustanon 250 (Testosterone Propionate) for approved indications has not been documented.
.
There have been no reports of overdosage in the Sustanon 250 (Testosterone Propionate) clinical trials. There is one report of acute overdosage with use of an approved injectable Sustanon 250 (Testosterone Propionate) product: this subject had serum Sustanon 250 (Testosterone Propionate) levels of up to 11,400 ng/dL with a cerebrovascular accident.
Treatment of overdosage would consist of discontinuation of Sustanon 250 (Testosterone Propionate) together with appropriate symptomatic and supportive care.
Sustanon 250 (Testosterone Propionate) (testosterone undecanoate) injection contains Sustanon 250 (Testosterone Propionate) undecanoate (17β-undecanoyloxy-4-androsten-3-one) which is an ester of the androgen, Sustanon 250 (Testosterone Propionate). Sustanon 250 (Testosterone Propionate) is formed by cleavage of the ester side chain of Sustanon 250 (Testosterone Propionate) undecanoate.
Sustanon 250 (Testosterone Propionate) undecanoate is a white to off-white crystalline substance. The empirical formula of Sustanon 250 (Testosterone Propionate) undecanoate is C30H48O3 and a molecular weight of 456.7. The structural formula is:
FIGURE 2: Sustanon 250 (Testosterone Propionate) Undecanoate
C30H48O3 MW: 456.7
Sustanon 250 (Testosterone Propionate) is a clear, yellowish, sterile oily solution containing Sustanon 250 (Testosterone Propionate) undecanoate, a Sustanon 250 (Testosterone Propionate) ester, for intramuscular injection. Each single use vial contains 3 mL of 250 mg/mL Sustanon 250 (Testosterone Propionate) undecanoate solution in a mixture of 1500 mg of benzyl benzoate and 885 mg of refined castor oil.
Endogenous androgens, including Sustanon 250 and dihydrotestosterone (DHT) are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis, and scrotum; the development of male hair distribution, such as facial, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, and alterations in body musculature and fat distribution.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of Sustanon 250 (Testosterone Propionate), has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter’s syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).
Absorption
Sustanon 250 (Testosterone Propionate) 750 mg delivers physiologic amounts of Sustanon 250 (Testosterone Propionate), producing circulation Sustanon 250 (Testosterone Propionate) concentrations that approximate normal concentrations (300-1000 ng/dL) seen in healthy men.
Sustanon 250 (Testosterone Propionate) esters in oil injected intramuscularly are absorbed from the lipid phase. Cleavage of the undecanoic acid side chain of Sustanon 250 (Testosterone Propionate) by tissue esterases releases Sustanon 250 (Testosterone Propionate).
Following intramuscular injection of 750 mg of Sustanon 250 (Testosterone Propionate), serum Sustanon 250 (Testosterone Propionate) concentrations reach a maximum after a median of
7 days (range 4 – 42 days) then slowly decline (Figure 3). Steady state serum Sustanon 250 (Testosterone Propionate) concentration was achieved with the 3rd injection of Sustanon 250 (Testosterone Propionate) at 14 weeks.
Figure 3 shows the mean serum total Sustanon 250 (Testosterone Propionate) concentration-time profile during the 3rd injection interval (at steady state, 14-24 weeks) for hypogonadal men (less than 300 ng/dL) given 750 mg Sustanon 250 (Testosterone Propionate) at initiation, at 4 weeks, and every 10 weeks thereafter. Intramuscular injection of 750 mg of Sustanon 250 (Testosterone Propionate) generates mean steady state serum total Sustanon 250 (Testosterone Propionate) concentrations in the normal range for 10 weeks.
FIGURE 3: Mean (SD) Serum Total Sustanon 250 (Testosterone Propionate)
Concentrations (ng/dL) at 14-24 Weeks
Distribution
Circulating Sustanon 250 (Testosterone Propionate) is chiefly bound in the serum to sex hormone-binding globulin (SHBG) and albumin.
Approximately 40% of Sustanon 250 (Testosterone Propionate) in plasma is bound to SHBG, 2% remains unbound (free), and the rest is loosely bound to albumin and other proteins.
Metabolism
Sustanon 250 (Testosterone Propionate) undecanoate is metabolized to Sustanon 250 (Testosterone Propionate) via ester cleavage of the undecanoate group. The mean (SD) maximum concentration of Sustanon 250 (Testosterone Propionate) undecanoate was 90.9 (68.8) ng/dL on Day 4 following injection of Sustanon 250 (Testosterone Propionate). Sustanon 250 (Testosterone Propionate) undecanoate was nearly undetectable 42 days following injection of Sustanon 250 (Testosterone Propionate).
Sustanon 250 (Testosterone Propionate) is metabolized to various 17-keto steroids through two different pathways. The major active metabolites of Sustanon 250 (Testosterone Propionate) are estradiol and DHT.
DHT concentrations increased in parallel with Sustanon 250 (Testosterone Propionate) concentrations during Sustanon 250 (Testosterone Propionate) treatment. Average DHT concentrations during a dosing interval ranged from 244 to 451 ng/dL. The mean DHT:T ratios ranged from 0.05 to 0.07.
Excretion
There is considerable variation in the half-life of Sustanon 250 (Testosterone Propionate) as reported in the literature, ranging from 10 to 100 minutes. About 90% of a Sustanon 250 (Testosterone Propionate) dose given intramuscularly is excreted in the urine as glucuronic and sulfuric acid-conjugates of Sustanon 250 (Testosterone Propionate) or as metabolites. About 6% of a dose is excreted in the feces, mostly in the unconjugated form. Inactivation of Sustanon 250 (Testosterone Propionate) occurs primarily in the liver.
Effect of Body Weight and Body Mass Index (BMI)
Analysis of serum Sustanon 250 (Testosterone Propionate) concentrations from 117 hypogonadal men in the 84-week clinical study of Sustanon 250 (Testosterone Propionate) indicated that serum Sustanon 250 (Testosterone Propionate) concentrations achieved were inversely correlated with the patient’s body weight. In 60 patients with pretreatment body weight of ≥100 kg, the mean (±SD) serum Sustanon 250 (Testosterone Propionate) average concentration was 426 ± 104 ng/dL. A higher serum Sustanon 250 (Testosterone Propionate) average concentration (568 ± 139 ng/dL) was observed in 57 patients weighing 65 to 100 kg. A similar trend was also observed for maximum serum Sustanon 250 (Testosterone Propionate) concentrations.
In 70 patients with pretreatment body mass index of >30 kg/m2, the mean (±SD) serum Sustanon 250 (Testosterone Propionate) average concentration was
445 ± 116 ng/dL. Higher serum Sustanon 250 (Testosterone Propionate) average concentrations (579 ± 101 ng/dL and 567± 155ng/dL) were observed in patients with BMIs <26 kg/m2 and 26 to 30 kg/m2,respectively. A similar trend was also observed for maximum serum Sustanon 250 (Testosterone Propionate) concentrations.
Carcinogenicity
Sustanon 250 (Testosterone Propionate) has been tested by subcutaneous injection and implantation in mice and rats. In mice, the implant induced cervical-uterine tumors, which metastasized in some cases. There is suggestive evidence that injection of Sustanon 250 (Testosterone Propionate) into some strains of female mice increases their susceptibility to hepatoma. Sustanon 250 (Testosterone Propionate) is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.
Mutagenicity
Mutagenic effects of Sustanon 250 (Testosterone Propionate) undecanoate were not detected in a battery of in vitro tests including bacterial mutation assays (Ames test) and chromosomal aberration tests in human lymphocytes. Sustanon 250 (Testosterone Propionate) undecanoate was also negative in an in vivo bone marrow micronucleus assay in mice. Sustanon 250 (Testosterone Propionate) was negative in the in vitro Ames and in the in vivo mouse micronucleus assays.
Impairment of Fertility
The administration of exogenous Sustanon 250 (Testosterone Propionate) has been reported to suppress spermatogenesis in the rat, dog and non-human primates, which was reversible on cessation of the treatment.
Sustanon 250 (Testosterone Propionate) was evaluated for efficacy in an 84-week, single-arm, open-label, multicenter study of 130 hypogonadal men. Eligible patients weighed at least 65 kg, were 18 years of age and older (mean age 54.2 years), and had a morning serum total Sustanon 250 (Testosterone Propionate) concentrations <300 ng/dL (mean screening Sustanon 250 (Testosterone Propionate) concentration 215 ng/dL). Patients were Caucasian (74.6%), Black (12.3%), Hispanic (10.8%) and of Other ethnicities (2.3%). The mean body mass index was 32 kg/m2.
All patients received injections of Sustanon 250 (Testosterone Propionate) 750 mg at baseline, at 4 weeks, and then every 10 weeks thereafter.
The primary endpoint was the percentage of patients with average serum total Sustanon 250 (Testosterone Propionate) concentration (Cavg) within the normal range (300-1000 ng/dL) after the third injection, at steady state.
The secondary endpoint was the percentage of patients with maximum total Sustanon 250 (Testosterone Propionate) concentration (Cmax) above three pre-determined limits: greater than 1500 ng/dL, between 1800 and 2499 ng/dL, and greater than 2500 ng/dL.
A total of 117 out of 130 hypogonadal men completed study procedures through Week 24 and were included in the evaluation of Sustanon 250 (Testosterone Propionate) pharmacokinetics after the third Sustanon 250 (Testosterone Propionate) injection. Ninety-four percent (94%) of patients maintained a Cavg within the normal range (300 to 1000 ng/dL). The percentages of patients with Cavg below the normal range (less than 300 ng/dL) and above the normal range (greater than 1000 ng/dL) were 5.1% and 0.9%, respectively.
Table 2 summarizes the mean (SD) serum total Sustanon 250 (Testosterone Propionate) pharmacokinetic parameters at steady state for these 117 patients.
TABLE 2
Mean (SD) Serum Total Sustanon 250 (Testosterone Propionate) Concentrations at Steady State
Pharmacokinetics at Steady State | Sustanon 250 (Testosterone Propionate) 750 mg (N=117) |
Cavg (0 to 10 weeks) (ng/dL) | 495 (142) |
Cmax (ng/dL) | 891 (345) |
Cmin (ng/dL) | 324 (99) |
Cavg = average concentration; Cmax = maximum concentration; Cmin = minimum concentration
The percentage of patients with Cmax >1500 ng/dL was 7.7%. No patient had a Cmax >1800 ng/dL.
Sustanon 250 (Testosterone Propionate), NDC 67979-511-43: 750 mg/3 mL (250 mg/mL) Sustanon 250 (Testosterone Propionate) undecanoate sterile injectable solution is provided in an amber glass vial with silver-colored crimp seal and gray plastic cap. Each vial is individually packaged in a carton box.
Store at controlled room temperature 25 ºC (77 ºF); excursions permitted to 15 - 30 ºC (59 - 86 ºF) in its original carton until the date indicated.
Before use, each vial should be visually inspected. Only vials free from particles should be used.
Single Use Vial. Discard unused portion.
See FDA-Approved Medication Guide
Advise patients of the following:
Men with known or suspected prostate or breast cancer should not use Sustanon 250 .
Patients should be informed that treatment with androgens may lead to adverse reactions which include:
Distributed by:
Endo Pharmaceuticals Solutions Inc.
Malvern, PA 19355
Sustanon 250 (Testosterone Propionate) is a registered trademark of Endo Pharmaceuticals Inc.
© 2017 Endo Pharmaceuticals Solutions Inc. All rights reserved.
Revised: July 2017
Sustanon 250 (Testosterone Propionate)® (Uh-Veed)
(testosterone undecanoate)
injection
Read this Medication Guide before you receive Sustanon 250 (Testosterone Propionate) and before each injection. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.
What is the most important information I should know about Sustanon 250 (Testosterone Propionate)?
Sustanon 250 (Testosterone Propionate) may cause serious side effects, including:
o cough or urge to cough
o difficulty breathing
o sweating
o tightening of your throat
o chest pain
o dizziness
o fainting
These reactions can happen after you receive your first dose of Sustanon 250 (Testosterone Propionate) or may happen after receiving more than 1 dose.
You may need emergency treatment in a hospital, especially if these symptoms get worse over the 24 hours after
your AVEED injection.
These side effects may happen during or right after each injection. To be sure that you are not having one
of these reactions:
o You need to stay in the doctor’s office, clinic, or hospital for 30 minutes after having your Sustanon 250 (Testosterone Propionate) injection so
that your doctor can watch you for symptoms of POME or a serious allergic reaction.
o You can only get Sustanon 250 (Testosterone Propionate) at your doctor’s office, clinic, or hospital.
Sustanon 250 (Testosterone Propionate) is only available through a restricted program called the Sustanon 250 (Testosterone Propionate) Risk Evaluation and Mitigation Strategy (REMS) Program. For more information about the Sustanon 250 (Testosterone Propionate) REMS Program go to www. AveedREMS.com or call 1-855-755-0494.
What is Sustanon 250 (Testosterone Propionate)?
Sustanon 250 (Testosterone Propionate) is a prescription medicine that contains Sustanon 250 (Testosterone Propionate). Sustanon 250 (Testosterone Propionate) is used to treat adult males who have low or no Sustanon 250 (Testosterone Propionate) due to certain medical conditions.
Sustanon 250 (Testosterone Propionate) is only for adult males who need Sustanon 250 (Testosterone Propionate) replacement therapy and when the benefit of receiving Sustanon 250 (Testosterone Propionate) is more than the risk of POME and anaphylaxis.
Your healthcare provider will test your blood before you start and while you are taking Sustanon 250 (Testosterone Propionate).
It is not known if AVEEDis safe or effective to treat men who have low Sustanon 250 (Testosterone Propionate) due to aging.
It is not known if Sustanon 250 (Testosterone Propionate) is safe and effective for use in children younger than 18 years old. Improper use of Sustanon 250 (Testosterone Propionate) may affect bone growth in children.
Sustanon 250 (Testosterone Propionate) is a controlled substance (CIII) because it contains Sustanon 250 (Testosterone Propionate) that can be a target for people who abuse prescription medicines.
Sustanon 250 (Testosterone Propionate) is not meant for use in women.
Who should not receive Sustanon 250 (Testosterone Propionate)?
Do not receive Sustanon 250 (Testosterone Propionate) if you:
Talk to your doctor before receiving this medicine if you have any of the above conditions.
What should I tell my doctor before receiving Sustanon 250 (Testosterone Propionate)?
Before receiving Sustanon 250 (Testosterone Propionate), tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Receiving Sustanon 250 (Testosterone Propionate) with certain other medicines can affect each other. Especially tell your doctor if you take:
Ask your doctor or pharmacist for a list of these medicines, if you are not sure.
Know the medicines you take. Keep a list of your medicines and show them to your doctor and pharmacist when you get a new medicine.
How will I receive Sustanon 250 (Testosterone Propionate)?
See “What is the most important information I should know about Sustanon 250 (Testosterone Propionate)?”
Your doctor will inject Sustanon 250 (Testosterone Propionate) deep into the muscle of your buttock. You will get 1 injection when you start, 1 injection 4 weeks later and then 1 injection every 10 weeks.
Your doctor will test your blood before you receive and while you are receiving Sustanon 250 (Testosterone Propionate).
What are the possible side effects of Sustanon 250 (Testosterone Propionate)?
Sustanon 250 (Testosterone Propionate) can cause serious side effects including:
o increased urination at night
o trouble starting your urine stream
o having to pass urine many times during the day
o having an urge that you have to go to the bathroom right away
o having a urine accident
o being unable to pass urine or weak urine flow
o nausea or vomiting
o yellowing of your skin or whites of your eyes
o dark urine
o pain on the right side of your stomach area (abdominal pain)
Call your doctor right away if you have any of the serious side effects listed above.
The most common side effects of Sustanon 250 (Testosterone Propionate) include:
Other side effects include more erections than are normal for you or erections that last for a long time.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects with Sustanon 250 (Testosterone Propionate). For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about Sustanon 250 (Testosterone Propionate)
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
This Medication Guide summarizes the most important information about Sustanon 250 (Testosterone Propionate). If you would like more information, talk with your doctor. You can ask your doctor or nurse for information about Sustanon 250 (Testosterone Propionate) that is written for health professionals. For more information, go to www. AVEEDUSA.com or call 1-800-462-3636.
What are the ingredients in Sustanon 250 (Testosterone Propionate)?
Active ingredient: Sustanon 250 (Testosterone Propionate) undecanoate
Inactive ingredients: refined castor oil, benzyl benzoate
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distributed by:
Endo Pharmaceuticals Solutions Inc.
Malvern, PA 19355
Sustanon 250 (Testosterone Propionate) is a registered trademark of Endo Pharmaceuticals Inc.
© 2016 Endo Pharmaceuticals Solutions Inc. All rights reserved.
Approved: 10/2016
85534041
carton
Depending on the reaction of the Sustanon 250 after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Sustanon 250 not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Sustanon 250 addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology