Decapeptyl Depot

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Decapeptyl Depot uses


1 INDICATIONS AND USAGE

Decapeptyl Depot is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).

Decapeptyl Depot is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years and older with central precocious puberty. (1)

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

Decapeptyl Depot must be administered under the supervision of a physician.

The dosage of Decapeptyl Depot is 22.5 mg reconstituted with accompanying diluent (Sterile Water) 2 mL, and administered as a single intramuscular injection once every 24 weeks.

Decapeptyl Depot treatment should be discontinued at the appropriate age of onset of puberty at the discretion of the physician.

2.2 Monitoring

Monitor response to Decapeptyl Depot with LH levels after a GnRH or GnRH agonist stimulation test, basal LH, or serum concentration of sex steroid levels beginning 1 to 2 months following initiation of therapy, during therapy as necessary to confirm maintenance of efficacy, and with each subsequent dose.

Measure height every 3-6 months and monitor bone age periodically.

Noncompliance with drug regimen or inadequate dosing may result in inadequate control of the pubertal process with gonadotropins and/or sex steroids increasing above prepubertal levels. If the dose of Decapeptyl Depot is not adequate switching to an alternative GnRH agonist for the treatment of CPP with the ability for dose adjustment may be necessary.

2.3 Reconstitution and Administration Instructions

Please read these instructions completely before you begin.


Important: Once mixed, proceed to the next steps and administer without delay.


After administering the injection, immediately activate the safety cover:

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3 DOSAGE FORMS AND STRENGTHS

For extended-release injectable suspension: 22.5 mg of Decapeptyl Depot as a lyophilized white to slightly yellow powder cake in a single-dose vial for reconstitution with the co-packaged 2 mL of diluent (Sterile Water) for Injection.

For extended-release injectable suspension: 22.5 mg of Decapeptyl Depot as a powder cake for reconstitution with the co-packaged 2 mL of diluent Sterile Water for Injection. (3)

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Initial Rise of Gonadotropins and Sex Steroid Levels

During the early phase of initial therapy or after subsequent doses, gonadrotropins and sex steroids may rise above baseline because of a transient stimulatory effect of the drug . Therefore, a transient increase in clinical signs and symptoms of puberty, including vaginal bleeding, may be observed during the first weeks of therapy or after subsequent doses.

5.2 Psychiatric Events

Psychiatric events have been reported in patients taking GnRH agonists, including Decapeptyl Depot. Postmarketing reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms during treatment with Decapeptyl Depot .

5.3 Convulsions

Postmarketing reports of convulsions have been observed in patients receiving GnRH agonists, including Decapeptyl Depot. These included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. Convulsions have also been reported in patients in the absence of any of the conditions mentioned above .

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6 ADVERSE REACTIONS

The following serious adverse reactions are described here and elsewhere in the label:


In clinical trials for Decapeptyl Depot, the most common adverse reactions (≥4.5%) are injection site reactions, menstrual (vaginal) bleeding, hot flush, headache, cough, and infections (bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis, sinusitis, and upper respiratory tract infection). (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Arbor Pharmaceuticals, LLC at 1-866-516-4950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

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 practice.

The safety of Decapeptyl Depot was evaluated in one uncontrolled, open-label single-arm clinical trial in which 44 children with central precocious puberty received two doses of Decapeptyl Depot and were observed for 12 months. The median age of the study population was 8 years (range 2-9 years) at treatment start; 88.6% of subjects were female, 59.1% were White, 27.3% were Black and 4.5% were Asian. Table 1 shows all the adverse reactions that occurred in at least 2 patients (≥4.5%) during the open-label single-arm trial.

Adverse Reactions Number of Patients Reporting Event (%)

(Total N=44)

Infections & Infestations
Bronchitis 2 (4.5)
Gastroenteritis 3 (6.8)
Influenza 2 (4.5)
Nasopharyngitis 6 (13.6)
Otitis externa 2 (4.5)
Pharyngitis 2 (4.5)
Sinusitis 2 (4.5)
Upper respiratory tract infection 4 (9.1)
Nervous System Disorders
Headache 6 (13.6)
Reproductive System & Breast Disorders
Menstrual (Vaginal bleeding)Includes % of patients with vaginal bleeding or menstrual disorder ("menstrual cycle returned") in 39 females out of N=44. 3 (7.7)
Respiratory, Thoracic & Mediastinal Disorder
Cough 3 (6.8)
Vascular Disorders
Hot flush 2 (4.5)

Other Selected Adverse Reactions:

Injection Site Reactions

Injection site reactions occurring in patients immediately and/or 2 hours after injection include pain (45%), redness (14%), pruritus (2.3%) and swelling (2.3%).

Psychiatric Disorders

Anxiety (2.3%) and mood altered (2.3%)

6.2 Postmarketing Experience

Because these 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.

The following adverse reactions were reported from postmarketing experience of Decapeptyl Depot in patients with CPP:

Hypersenstivity Reactions: Anaphylactic shock, anaphylactoid reaction, angioedema, urticaria.

Cardiovascular: Hypertension.

Psychiatric: Emotional lability, such as crying, irritability, impatience, anger, and aggression, has been observed with GnRH agonists, including Decapeptyl Depot ; Depression, including rare reports of suicidal ideation and attempt, has been reported for GnRH agonists in children treated for CPP. Many, but not all, of these patients had a history of psychiatric illness or other comorbidities with an increased risk of depression.

Nervous System: Convulsions

Vision Disorders: Visual impairment, visual disturbance

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7 DRUG INTERACTIONS

7.1 Drug-Drug Interactions

Results of in vitro studies show that drug-drug interactions with Decapeptyl Depot are unlikely . However, in the absence of relevant data and as a precaution, hyperprolactinemic drugs should not be used concomitantly with Decapeptyl Depot since hyperprolactinemia reduces the number of pituitary GnRH receptors.

7.2 Drug-Laboratory Test Interactions

Administration of Decapeptyl Depot results in suppression of the pituitary-gonadal system.

The effect of Decapeptyl Depot on pituitary and gonadal function is expected to disappear within six to twelve months after treatment discontinuation. Therefore, diagnostic tests of pituitary gonadotropic and gonadal functions conducted during treatment or after discontinuation of treatment may be affected.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Decapeptyl Depot is contraindicated in women who are pregnant since expected hormonal changes that occur with Decapeptyl Depot treatment increase the risk for pregnancy loss. Available data with Decapeptyl Depot use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. Based on mechanism of action in humans and findings of increased pregnancy loss in animal studies, Decapeptyl Depot may cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% -20%, respectively.

Data

Animal Data

In pregnant rats administered Decapeptyl Depot at doses of 2, 10, and 100 mcg/kg/day during the period of organogenesis, maternal toxicity (decrease in body weight) and embryo-fetal toxicities (pre-implantation loss, increased resorption, and reduced number of viable fetuses) were observed at 100 ug/kg, approximately 4 times the clinical dose based on body surface area. No embryonic and fetal developmental toxicities were observed in mice at doses up to 4 times the clinical dose. Teratogenic effects were not observed in viable fetuses in rats or mice.

8.2 Lactation

Risk Summary

There are no data on the presence of Decapeptyl Depot in human milk, or the effects of the drug on the breastfed infant, or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Decapeptyl Depot and any potential adverse effects on the breastfed child from Decapeptyl Depot or from the underlying maternal condition.

8.4 Pediatric Use

The safety and effectiveness of Decapeptyl Depot have been established in pediatric patients 2 years of age and older based on a single-arm open-label study of 44 children 2-9 years of age with CPP . The safety and effectiveness of Decapeptyl Depot have not been established in pediatric patients less than 2 years old.

8.6 Renal Impairment

Decapeptyl Depot has not been studied in children with renal impairment. Adult subjects with renal impairment had higher exposure than young healthy adult males .

8.7 Hepatic Impairment

Decapeptyl Depot has not been studied in children with hepatic impairment. Adult subjects with hepatic impairment had higher exposure than young healthy adult males .

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10 OVERDOSAGE

There is no experience with overdosage in clinical trials of Decapeptyl Depot. If overdosage occurs, therapy should be discontinued and appropriate supportive and symptomatic treatment administered.

11 DESCRIPTION

Decapeptyl Depot contains the pamoate salt of Decapeptyl Depot, a synthetic decapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LHRH). The chemical name of Decapeptyl Depot pamoate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-tryptophyl-L-leucyl-L-arginyl-L-prolylglycine amide (pamoate salt). The molecular weight is 1699.9 and the structural formula is:

Decapeptyl Depot for extended release injectable suspension for intramuscular use is provided as a sterile, lyophilized, biodegradable microgranule formulation in a single-dose vial, co-packaged with a syringe containing 2 mL Sterile Water for Injection for reconstitution of the lyophilisate. The Decapeptyl Depot formulation is comprised of 22.5 mg Decapeptyl Depot (equivalent to 31 mg Decapeptyl Depot pamoate), poly-d,l-lactide-co-glycolide (183 mg), mannitol (74 mg), carboxymethylcellulose sodium (26 mg), and polysorbate 80 (1.7 mg). When 2 mL Sterile Water for Injection is added to the vial containing Decapeptyl Depot and mixed, a suspension is formed which is intended as a single intramuscular injection.

Chemical Structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Decapeptyl Depot is a GnRH agonist.

12.2 Pharmacodynamics

Following the first administration, there is a transient surge in circulating levels of LH, FSH, testosterone, and estradiol . After chronic and continuous administration, by 4 weeks after initiation of therapy, a sustained decrease in LH and FSH secretion and marked reduction in sex steroids are observed.

12.3 Pharmacokinetics

Absorption

After an initial intramuscular Decapeptyl Depot 22.5 mg injection and a second 22.5 mg intramuscular injection 24 weeks later in children 2 to 9 years old with CPP, Decapeptyl Depot peaked 4 hours postdose with a geometric mean Cmax of 39.9 and 36.5 ng/mL, respectively. No apparent accumulation of Decapeptyl Depot occurred after the second injection. Absorption occurred in two phases, a burst phase followed by a maintenance release phase. In children with CPP, following the burst phase after the first 22.5 mg injection, geometric mean serum Decapeptyl Depot levels were 0.11, 0.17, 0.05 and 0.03 ng/mL at Months 1, 2, 3, and 6, respectively.

Distribution

There is no evidence that Decapeptyl Depot, at clinically relevant concentrations, binds to plasma proteins.

Elimination

Metabolism

The metabolism of Decapeptyl Depot in humans is unknown, but is unlikely to involve hepatic microsomal enzymes (cytochrome P450). Thus far no metabolites of Decapeptyl Depot have been identified. Pharmacokinetic data suggest that C-terminal fragments produced by tissue degradation are either completely degraded in the tissues, or rapidly degraded in plasma, or cleared by the kidneys.

Excretion

Decapeptyl Depot is eliminated by both the liver and the kidneys. Following intravenous administration of 0.5 mg Decapeptyl Depot peptide to six healthy male volunteers with a creatinine clearance of 149.9 mL/min, 41.7% of the dose was excreted in urine as intact peptide with a total Decapeptyl Depot clearance of 211.9 mL/min. This percentage increased to 62.3% in patients with liver disease who have a lower creatinine clearance (89.9 mL/min). It has also been observed that the nonrenal clearance of Decapeptyl Depot (patient anuric, Clcreat = 0) was 76.2 mL/min, thus indicating that the nonrenal elimination of Decapeptyl Depot is mainly dependent on the liver.

Specific Populations

Renal Impairment

After intravenous bolus injection of 0.5 mg Decapeptyl Depot in adults, the two distribution half-lives were unaffected by renal impairment. However, renal insufficiency led to a decrease in total Decapeptyl Depot clearance proportional to the decrease in creatinine clearance as well as increases in volume of distribution and consequently, an increase in the elimination half-life. Adult male subjects with moderate or severe renal impairment had approximately 2-fold higher exposure (AUC values) than young healthy adult males .

Hepatic Impairment

After intravenous bolus injection of 0.5 mg Decapeptyl Depot in adults, the two distribution half-lives were unaffected by hepatic impairment. In adult males with hepatic insufficiency, Decapeptyl Depot clearance was reduced and exposure (AUC) was increased 3.7-fold compared to young healthy adult males (Table 2) .

Group Cmax

(ng/mL)

AUCinf

(h∙ng/mL)

Clp

(mL/min)

Clrenal

(mL/min)

t1/2 (h) Clcreat

(mL/min)

6 healthy male volunteers 48.2 ±11.8 36.1 ±5.8 211.9 ±31.6 90.6 ±35.3 2.81 ±1.21 149.9 ±7.3
6 males with moderate renal impairment 45.6 ±20.5 69.9 ±24.6 120.0 ±45.0 23.3 ±17.6 6.56 ±1.25 39.7 ±22.5
6 males with severe renal impairment 46.5 ±14.0 88.0 ±18.4 88.6 ±19.7 4.3 ±2.9 7.65 ±1.25 8.9 ±6.0
6 males with liver disease 54.1 ±5.3 131.9 ±18.1 57.8 ±8.0 35.9 ±5.0 7.58 ±1.17 89.9 ±15.1

Drug-Drug Interactions

In Vitro Assessment of Drug Interactions

Drug Metabolizing Enzyme Inhibition

Decapeptyl Depot did not inhibit CYP1A2, 2B6, 2C8, 2C9, 2C19 or 2D6, or CYP 3A4/5 at clinically relevant concentrations.

Drug Metabolizing Enzyme Induction

In fresh human hepatocytes from three human donors, Decapeptyl Depot did not induce CYP1A2 or CYP3A4/5 activity.

Transporters

Decapeptyl Depot was a poor P-gp substrate and had no inhibitory effect toward P-gp.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis was evaluated in an 18-month study in mice and a 24-month study in rats. In rats, Decapeptyl Depot doses of 120, 600, and 3000 mcg/kg given every 28 days (approximately 0.2, 0.8, and 4 times the estimated human monthly dose based on body surface area) resulted in increased mortality with a drug treatment period of 13 to 19 months. The incidences of benign and malignant pituitary tumors and histosarcomas were increased in a dose-related manner. There were no treatment-related tumors in mice at exposure up to 4-fold higher than the estimated human monthly dose based on body surface area.

Mutagenicity studies performed with Decapeptyl Depot using bacterial and mammalian systems (in vitro Ames test and chromosomal aberration test in CHO cells and an in vivo mouse micronucleus test) provided no evidence of mutagenic potential.

After 60 days of subcutaneous treatment followed by a minimum of four estrus cycles prior to mating, Decapeptyl Depot at doses of 2, 20, and 200 mcg/kg (approximately 0.07, 0.7, and 7 times the estimated human daily dose based on body surface area) or two monthly injections as slow release microspheres (~20 mcg/kg/day) had no effect on the fertility or general reproductive function of female rats.

No studies were conducted to assess the effect of Decapeptyl Depot on male fertility.

14 CLINICAL STUDIES

In a single-arm open-label study, 44 children 2 to 9 years of age with CPP, 39 females and 5 males, all naïve to previous GnRH agonist treatment, were administered Decapeptyl Depot 22.5 mg at a dosing interval of 24 weeks. Subjects were evaluated over two dosing intervals for a total of 12 months.

Decapeptyl Depot 22.5 mg suppressed pituitary release of LH and FSH and, consequently, gonadal secretion of estradiol in girls and testosterone in boys (Table 3). At all timepoints evaluated, ≥93% of children achieved LH suppression to prepubertal levels (i.e., serum LH ≤5 IU/L 30 minutes after GnRH agonist stimulation), ≥79% of girls achieved prepubertal levels of estradiol (i.e., <20 pg/mL), and ≥80% of boys achieved prepubertal levels of testosterone (i.e., <30 ng/dL). Decapeptyl Depot arrested or reversed progression of clinical signs of puberty with 95% of children showing no increase in the bone age/chronological age ratio, and 89% showing stabilization of sexual maturation at Month 12.

Endpoint % (n/N) of Children Achieving Endpoint
Month 1 Month 2 Month 3 Month 6 Month 9 Month 12
% with prepubertal LH (GnRH-stim LH ≤5 IU/L) 95%

(42/44)

95%

(42/44)

95%

(42/44)

93%Primary efficacy endpoint

(41/44)

95%

(42/44)

98%

(43/44)

% girls with prepubertal estradiol (<20 pg/mL) 87%

(34/39)

89%

(34/38)

92%

(36/39)

79%

(31/39)

82%

(32/39)

79%

(31/39)

% boys with prepubertal testosterone (<30 ng/dL) 80%

(4/5)

80%

(4/5)

100%

(5/5)

100%

(5/5)

80%

(4/5)

80%

(4/5)

% with no increase in BA/CABone Age/Chronological Age ratio vs. baseline 64%

(28/44)

95%

(42/44)

% achieving stabilization of sexual maturation 91%

(40/44)

89%

(39/44)

% girls with regression of uterine length 69%

(27/39)

77%

(30/39)

% boys with no progression in testis volumes 100%

(5/5)

100%

(5/5)


Following the second Decapeptyl Depot injection, 22 children (all girls) were assessed for evidence of an acute-on-chronic phenomenon (i.e., increase in basal LH >5 IU/L or serum estradiol level >20 pg/mL 48 hours after the second Decapeptyl Depot injection). Of these, one girl who achieved prepubertal hormone levels prior to the second injection showed biochemical evidence of acute-on-chronic phenomenon .

16 HOW SUPPLIED/STORAGE AND HANDLING

Each Decapeptyl Depot 22.5 mg single-use kit (NDC 24338-150-20) contains:


Store at 20-25°C (68-77°F). Do not freeze.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Medication Guide).

Hypersensitivity Reactions

Inform caregivers that anaphylactic shock, hypersensitivity, and angioedema have been reported with Decapeptyl Depot use and to immediately seek medical attention if any hypersensitivity reaction occurs.

Symptoms after Initial Decapeptyl Depot Administration

Inform caregivers that during the first weeks after the first Decapeptyl Depot injection, signs of puberty may occur such as vaginal bleeding . Caregivers should notify the physician if these symptoms continue beyond the second month after Decapeptyl Depot administration.

Psychiatric Events

Inform caregivers that symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression have been observed in patients receiving GnRH agonists, including Decapeptyl Depot. Alert caregivers to the possibility of development or worsening of psychiatric symptoms, including depression, during treatment with Decapeptyl Depot .

Convulsions

Inform caregivers that reports of convulsions have been observed in patients receiving GnRH agonists, including Decapeptyl Depot. Patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions may be at increased risk .

Pregnancy is Contraindicated

Decapeptyl Depot is contraindicated in pregnancy. If the patient becomes pregnant while taking the drug, the patient should be informed of the potential risk to fetus .

Compliance with the Dosing Schedule

Inform caregivers about the importance of adherence to the Decapeptyl Depot dosing schedule of one injection every 24 weeks. Patients should not miss or delay a scheduled dose.

Manufactured for:

Arbor Pharmaceuticals, LLC

Atlanta, GA 30328

Manufactured by:

Debiopharm Research & Manufacturing SA

CH-1920 Martigny, Switzerland

©2017 Arbor Pharmaceuticals, LLC

Decapeptyl Depot is a registered trademark of Arbor Pharmaceuticals, LLC.

Issue: June 2017

TRIP-PI-01

MEDICATION GUIDE

Decapeptyl Depot [TRIP-toe-der]

(triptorelin)

for extended-release injectable suspension, for intramuscular use

This Medication Guide has been approved by the U.S. Food and Drug Administration Issue: 06/2017
What is the most important information I should know about Decapeptyl Depot?
  • In the first few weeks after your child receives their first Decapeptyl Depot injection or after additional injections, Decapeptyl Depot can cause a brief increase in some hormones. During this time you may notice more signs of puberty in your child, including vaginal bleeding. Call your child's doctor if signs of puberty continue after 2 months of receiving Decapeptyl Depot.
  • Some people taking gonadotropin releasing hormone (GnRH) agonists like Decapeptyl Depot have had new or worsened mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as:
    • crying
    • irritability
    • restlessness (impatience)
    • anger
    • acting aggressive
Call your child's doctor right away if your child has any new or worsening emotional symptoms while taking Decapeptyl Depot.
  • Some people taking GnRH agonists like Decapeptyl Depot have had seizures. The risk of seizures may be higher in people who:
    • have a history of seizures
    • have a history of epilepsy
    • have a history of brain or brain vessel (cerebrovascular) problems or tumors
    • are taking a medicine that has been connected with seizures such as bupropion or selective serotonin reuptake inhibitors (SSRIs)
Seizures have also happened in people who have not had any of these problems.

Call your child's doctor right away if your child has a seizure while taking Decapeptyl Depot.

What is Decapeptyl Depot?
  • Decapeptyl Depot is an injectable prescription GnRH medicine used for the treatment of children with central precocious puberty (CPP).
  • It is not known if Decapeptyl Depot is safe and effective in children under 2 years of age.
Decapeptyl Depot should not be taken if your child is:
  • allergic to gonadotropin releasing hormone (GnRH), GnRH agonist medicines, or any ingredients in Decapeptyl Depot. See the end of this Medication Guide for a complete list of ingredients in Decapeptyl Depot.
  • Some people taking Decapeptyl Depot, the active ingredient in Decapeptyl Depot, have had serious allergic reactions. Call your child's doctor or get emergency medical help right away if your child gets any of the following symptoms of a serious allergic reaction:
  • skin rashes, redness, or swelling
  • trouble breathing or swallowing
  • throat tightness, hoarseness
  • severe itching
  • fast heart beat
  • swelling of face, mouth, and tongue
  • hives
  • sweating
  • dizziness or fainting
  • pregnant or becomes pregnant. Decapeptyl Depot can cause birth defects or loss of the baby. If your child becomes pregnant call your doctor.
Before your child receives Decapeptyl Depot, tell your child's doctor about all of your child's medical conditions, including if they:
  • have a history of mental (psychiatric) problems.
  • have a history of seizures.
  • have a history of epilepsy.
  • have a history of brain or brain vessel (cerebrovascular) problems or tumors.
  • are breastfeeding or plan to breastfeed. It is not known if Decapeptyl Depot passes into breastmilk.
Tell the doctor about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will your child receive Decapeptyl Depot?
  • Your child's doctor should do tests to make sure your child has CPP before treating them with Decapeptyl Depot.
  • Decapeptyl Depot must be given under the supervision of a doctor.
  • Decapeptyl Depot is given as a single intramuscular (in the muscle) injection 1 time every 24 weeks.
  • Keep all scheduled visits to the doctor. Do not delay a scheduled dose. The doctor will do regular exams and blood tests to check for signs of puberty.
What are the possible side effects of Decapeptyl Depot?

Decapeptyl Depot may cause serious side effects. See "What is the most important information I should know about Decapeptyl Depot?"

The most common side effects of Decapeptyl Depot include injection site reactions, menstrual (vaginal) bleeding, hot flush, headache, cough, and infections (bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis, sinusitis, and upper respiratory tract infection).

These are not all the possible side effects of Decapeptyl Depot. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What are the ingredients in Decapeptyl Depot?

Active ingredient: Decapeptyl Depot

Inactive ingredients: poly-d,l-lactide-co-glycolide, mannitol, carboxymethylcellulose sodium, and polysorbate 80

Distributed by: Arbor Pharmaceuticals, LLC, Atlanta, GA 30328

Manufactured by: Debiopharm Research & Manufacturing SA, CH-1920 Martigny, Switzerland

©2017 Arbor Pharmaceuticals, LLC All rights reserved.

For more information about Decapeptyl Depot, please contact Arbor Pharmaceuticals, LLC at 1-866-516-4950.


Decapeptyl Depot is a registered trademark of Arbor Pharmaceuticals, LLC.

TRIP-MG-01

Decapeptyl Depot pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Decapeptyl Depot available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Decapeptyl Depot destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Decapeptyl Depot Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Decapeptyl Depot pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."TRIPTORELIN PAMOATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "TRIPTORELIN". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "TRIPTORELIN". http://www.drugbank.ca/drugs/DB0682... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Decapeptyl Depot?

Depending on the reaction of the Decapeptyl Depot after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Decapeptyl Depot 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 Decapeptyl Depot 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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Review

sdrugs.com conducted a study on Decapeptyl Depot, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Decapeptyl Depot consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

One visitor reported frequency of use

How often in a day do you take the medicine?
Are you taking the Decapeptyl Depot drug as prescribed by the doctor?

Few medications can be taken 3 times in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Decapeptyl Depot is mentioned below.
Visitors%
3 times in a day1
100.0%

Two visitors reported doses

What is the dose of Decapeptyl Depot drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 1-5mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
1-5mg1
50.0%
201-500mg1
50.0%

Two visitors reported time for results

What is the time duration Decapeptyl Depot drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sdrugs.com website users needed > 3 month to notice the result from using Decapeptyl Depot drug. The time needed to show improvement in health condition after using the medicine Decapeptyl Depot need not be same for all the users. It varies based on other factors.
Visitors%
> 3 month1
50.0%
1 month1
50.0%

Visitor reported administration

No survey data has been collected yet

Three visitors reported age

Visitors%
46-601
33.3%
30-451
33.3%
> 601
33.3%

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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