Feron

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Feron uses


INDICATIONS AND USAGE

Feron is indicated for the treatment of chronic HCV infection in patients 18 years of age or older with compensated liver disease who have anti-HCV serum antibodies and/or the presence of HCV RNA. Other causes of hepatitis, such as viral hepatitis B or autoimmune hepatitis, should be ruled out prior to initiation of therapy with Feron. In some patients with chronic HCV infection, Feron normalizes serum ALT, reduces serum HCV RNA concentrations to undetectable quantities (< 100 copies/mL), and improves liver histology.

CONTRAINDICATIONS

Feron is contraindicated in patients with

  • known hypersensitivity to alpha interferons or to any component of the product
  • decompensated hepatic disease
  • autoimmune hepatitis

WARNINGS

Treatment with Feron should be administered under the guidance of a qualified physician, and may lead to moderate-to-severe adverse experiences requiring dose reduction, temporary dose cessation, or discontinuation of further therapy.

Withdrawal from study for adverse events occurred in 7% of patients initially treated with 9 mcg Feron. Withdrawal from study due to adverse events occurred in 5% of patients subsequently treated with 15 mcg Feron for 24 weeks and 11% of patients subsequently treated with 15 mcg Feron for 48 weeks.

Neuropsychiatric Disorders

Severe psychiatric adverse events may manifest in patients receiving therapy with alpha interferons, including Feron. Depression, suicidal ideation, suicide attempt, and suicide may occur. Other prominent psychiatric adverse events may also occur, including psychosis, aggressive behavior, nervousness, anxiety, emotional lability, abnormal thinking, agitation, apathy and relapse of drug addiction. Feron should be used with extreme caution in patients who report a history of depression. Physicians should monitor all patients for evidence of depression and other psychiatric symptoms. Prior to initiation of Feron therapy, physicians should inform patients of the possible development of depression and patients should be advised to immediately report any sign or symptom of depression and/or suicidal ideation. In severe cases, therapy should be stopped immediately and psychiatric intervention instituted (SeeDOSAGE AND ADMINISTRATION: Dose Reduction).

Bone Marrow Toxicity

Alpha interferons suppress bone marrow function and may result in severe cytopenias including very rare events of aplastic anemia. It is advised that complete blood counts be obtained pretreatment and monitored routinely during therapy. Alpha Feron therapy should be discontinued in patients who develop severe decreases in neutrophil or platelet counts (<50 x 109/L).

Cardiovascular Disorders

Hypertension, tachycardia, palpitation, and tachyarrhythmias have been reported in patients treated with Feron. Feron should be administered with caution to patients with preexisting cardiac disease. Supraventricular arrhythmias, chest pain, and myocardial infarction have been associated with alpha Feron therapies.8

Hypersensitivity

Serious acute hypersensitivity reactions have been reported in rare instances following treatment with alpha interferons. If hypersensitivity reactions occur, Feron should be discontinued immediately and appropriate medical treatment instituted.

Endocrine Disorders

Feron should be administered with caution to patients with a history of endocrine disorders. Occurrence or aggravation of hyperthyroidism or hypothyroidism have been reported with Feron. Hyperglycemia and diabetes mellitus have also been observed in patients treated with Feron. Patients who develop these conditions during treatment that cannot be controlled with medication should not continue Feron therapy.

Autoimmune Disorders

Development of or exacerbation of autoimmune disorders have been reported in patients receiving alpha Feron therapies, including Feron. Feron should not be used in patients with autoimmune hepatitis (seeCONTRAINDICATIONS) and should be used with caution in patients with other autoimmune disorders.

Pulmonary Disorder

Pneumonia and interstitial pneumonitis, some resulting in respiratory failure and/or patient deaths, have been induced or aggravated by alpha Feron therapy, including Feron. Patients who develop persistent or unexplained pulmonary infiltrates or pulmonary function impairment should discontinue treatment with Feron.

Colitis

Hemorrhagic/ischemic colitis, sometimes fatal, has been observed within 12 weeks of alpha Feron therapies and has been reported in patients treated with Feron. Feron treatment should be discontinued immediately in patients who develop signs and symptoms of colitis.

Pancreatitis

Pancreatitis, sometimes fatal, has been observed in patients treated with alpha interferons, including Feron. Feron should be suspended in patients with signs and symptoms suggestive of pancreatitis and discontinued in patients diagnosed with pancreatitis.

Hepatic Exacerbations and Decompensated Hepatic Disease

Chronic hepatitis C patients with cirrhosis may be at risk of hepatic decompensation when treated with alpha interferons, including Feron. During treatment, patients’ clinical status and hepatic function should be closely monitored, and Feron treatment should be immediately discontinued if symptoms of hepatic decompensation, such as jaundice, ascites, coagulopathy, or decreased serum albumin, are observed.

Ophthalmologic Disorders

Decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots; optic neuritis, and papilledema are induced or aggravated by treatment with Feron or other alpha interferons. All patients should receive an eye examination at baseline. Patients with preexisting ophthalmologic disorders (e.g., diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during Feron alpha treatment. Any patient who develops ocular symptoms should receive a prompt and complete eye examination. Feron therapy should be discontinued in patients who develop new or worsening ophthalmologic disorders.

Cerebrovascular Disorders

Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with Feron alfa-based therapies, including Feron. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45years of age. Because these are spontaneous reports, estimates of frequency cannot be made and a causal relationship between Feron alfa-based therapies and these events is difficult to establish.

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PRECAUTIONS

General

While fever may be related to the flu-like symptoms reported in patients treated with Feron, when fever occurs, other possible causes of persistent fever should be ruled out.

Bone Marrow Toxicity

Feron should be used cautiously in patients with abnormally low peripheral blood cell counts or who are receiving agents that are known to cause myelosuppression. Transplantation patients or other chronically immunosuppressed patients should receive alpha Feron therapy with caution.

Renal Impairment

Increases in serum creatinine levels, and rarely renal failure, have been observed in patients receiving Feron. Feron has not been studied in patients with renal insufficiency. Patients with impaired renal function should be closely monitored and Feron should be used with caution in patients with renal insufficiency.

Information for Patients

If home use is determined to be desirable by the physician, instructions on appropriate use should be given by a healthcare professional. The patient must be instructed as to the proper dosage and administration. Information included in the MEDICATION GUIDE should be fully reviewed with the patient; it is not a disclosure of all, or possible, adverse effects. The most common adverse reactions occurring with Feron therapy are flu-like symptoms including fatigue, fever, rigors, headache, arthralgia, myalgia, and increased sweating. Non-narcotic analgesics and bedtime administration of Feron may be used to prevent or lessen some of these symptoms.

Additionally, patients must be thoroughly instructed in the importance of proper disposal procedures and cautioned against the reuse of needles, syringes, or re-entry of the drug product. A puncture-resistant container for the disposal of used syringes and needles should be used by the patient and should be disposed of according to the directions provided by the health care provider.

Laboratory Tests

Laboratory tests are recommended for all patients on Feron therapy, prior to beginning treatment (baseline), 2 weeks after initiation of therapy, and periodically thereafter during the 24 or 48 weeks of therapy at the discretion of the physician. Following completion of Feron therapy, any abnormal test values should be monitored periodically. The entrance criteria that were used for the clinical study of Feron may be considered as a guideline to acceptable baseline values for initiation of treatment:

  • Platelet count ≥ 75 x 109/L
  • Hemoglobin concentration ≥ 100 g/L
  • ANC ≥ 1500 x 106/L
  • Serum creatinine concentration < 180 μmol/L (< 2.0 mg/dL) or creatinine clearance > 0.83 mL/second (> 50 mL/minute)
  • Serum albumin concentration ≥ 25 g/L
  • Bilirubin within normal limits
  • TSH and T4 within normal limits
Neutropenia, thrombocytopenia, hypertriglyceridemia, and thyroid disorders have been reported with administration of Feron (seeADVERSE REACTIONS). Therefore, these laboratory parameters should be monitored closely.

Drug Interactions

No formal drug interaction studies have been conducted with Feron. Feron should be used cautiously in patients who are receiving agents that are known to cause myelosuppression or with agents known to be metabolized via the cytochrome P-450 pathway.9 Patients taking drugs that are metabolized by this pathway should be monitored closely for changes in the therapeutic and/or toxic levels of concomitant drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis: No carcinogenicity data for Feron are available in animals or humans.

Mutagenesis: Feron was not mutagenic when tested in several in vitro assays, including the Ames bacterial mutagenicity assay and an in vitro cytogenetic assay in human lymphocytes, either in the presence or absence of metabolic activation.Impairment of Fertility: Feron at doses as high as 100 mcg/kg did not selectively affect reproductive performance or the development of the offspring when administered SC to male and female golden Syrian hamsters for 70 and 14 days before mating, respectively, and then through mating and to day 7 of pregnancy.

Pregnancy Category C

Feron has been shown to have embryolethal or abortifacient effects in golden Syrian hamsters when given at 135 times the human dose and in cynomolgus and rhesus monkeys when given at 9 to 81 times the human dose. There are no adequate and well-controlled studies in pregnant women. Feron should not be used during pregnancy. If a woman becomes pregnant or plans to become pregnant while taking Feron, she should be informed of the potential hazards to the fetus. Males and females treated with Feron should be advised to use effective contraception.

Nursing Mothers

It is not known whether Feron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if Feron is administered to a nursing woman. The effect on the nursing neonate of orallyingested Feron in breast milk has not been evaluated.

Pediatric Use

The safety and effectiveness of Feron have not been established in patients below the age of 18 years. Feron therapy is not recommended in pediatric patients.

Geriatric Use

Clinical studies of Feron did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, treatment with Interferons, including Feron, is associated with psychiatric, cardiac, and systemic (flu-like) adverse effects. Since decreased hepatic, renal or cardiac function, concomitant disease and the use of other drug therapies in elderly patients may produce adverse reactions of greater severity, caution should be exercised in the use of Feron in this population.

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ADVERSE REACTIONS

Adverse experiences that were reported, regardless of attribution to treatment, in at least 5% of patients in the 9 mcg Feron or 3 MIU IFN α-2b groups of the pivotal study are presented in Table 3, listed in decreasing order by the 9 mcg Feron group. The incidence of adverse events is expressed based on the number of patients experiencing each event at least once during treatment or during posttreatment observation.

Most adverse events were mild-to-moderate in severity and abated with cessation of therapy. Flu-like symptoms were the most frequently reported treatment-related adverse reactions. Most were short-lived and could be treated symptomatically. Depression, usually mild-to-moderate in severity, was reported in 26% of patients who received 9 mcg Feron and was the most common adverse event resulting in study drug discontinuation. In patients who had tolerated previous Feron therapy (9 mcg Feron or 3 MIU IFN α-2b) and failed to normalize ALT, or who had achieved normalization of ALT during the treatment period but who relapsed during the posttreatment observation period, subsequent treatment with 15 mcg TIW of Feron for 24 or 48 weeks was generally tolerated. Adverse experiences of patients receiving subsequent treatment, regardless of attribution to treatment, are reported in Table 3. The higher dose of Feron used in these patients was associated with a greater incidence of leukopenia and granulocytopenia. One or more dose reductions for all causes were required in up to 36% of patients. Patients who do not tolerate initial standard Feron therapy should not receive therapy with 15 mcg TIW of Feron.

Initial TreatmentbSubsequent Treatmentb
FeronIFN α-2bFeronFeron
9 mcg15 mcg15 mcg
(n = 231)(n = 236)24 wks48 wks
(n = 165)(n = 168)
Body System/Preferred Term% of Patients% of Patients
a. Only events that occurred at a frequency of ≥ 5% in any treatment group are included. Patients can appear more than once in Table 3. Because the 2 studies were conducted at different times with nonidentical patient groups, the adverse events profile for the subsequent treatment study is not directly comparable to the initial treatment study.
b. Adverse events reported in patients during treatment or posttreatment observation in the pivotal initial treatment and subsequent treatment studies are listed regardless of attribution to treatment.
c. Influenza-like symptoms: presumed viral etiology.
APPLICATION SITE
     Injection Site Erythema23151722
     Injection Site Pain93811
     Injection Site Ecchymosis6755
BODY AS A WHOLE
      Fatigue69676571
      Fever61455855
      Rigors57456266
      Body Pain54453951
      Influenza-like Symptomsc151188
      Pain Chest131459
      Hot Flushes13774
      Malaise111025
      Asthenia911107
      Edema Peripheral9843
      Access Pain8911
      Allergic Reaction7534
      Weight Decrease5752
CARDIOVASCULAR
      Hypertension5324
      Palpitation3652
CNS/PNS
      Headache82837880
      Insomnia39302428
      Dizziness22251825
      Paresthesia131099
      Hypoesthesia108810
      Amnesia10625
      Hypertonia71066
      Somnolence4867
      Confusion4645
      Hyperesthesia1115
ENDOCRINE DISORDERS
      Thyroid Test Abnormal9546
GASTROINTESTINAL
      Abdominal Pain41402432
      Nausea40363036
      Diarrhea29242422
      Anorexia24172114
      Dyspepsia21181210
      Vomiting12111311
      Constipation9656
      Flatulence8965
      Tooth Ache7737
      Saliva Decreased6741
      Hemorrhoids6312
      Stomatitis Ulcerative3426
      Gingivitis2315
HEARING/VESTIBULAR
      Tinnitus6442
      Earache5755
      Otitis2513
HEMATOLOGIC
      Granulocytopenia23254239
      Thrombocytopenia19161818
      Leukopenia15131928
      Lymphadenopathy6844
      Ecchymosis6442
      Lymphocytosis57115
      PT Increased3510
      Anemia2326
LIVER AND BILIARY
      Liver Tender5362
      Hepatomegaly3552
METABOLIC/NUTRITION
      Hypertriglyceridemia6755
MUSCULO-SKELETAL
      Myalgia58565155
      Arthralgia51444346
      Back Pain42372923
      Limb Pain26251323
      Skeletal Pain14141012
      Neck Pain141385
      Musculo-skeletal Disorder4474
PSYCHIATRIC DISORDER
      Nervousness31291622
      Depression26251819
      Anxiety1918914
      Emotional Lability121163
      Thinking Abnormal8121020
      Agitation6644
      Libido Decreased5554
      Apathy2345
REPRODUCTIVE (FEMALE)
      Dysmenorrhea9927
      Vaginitis8255
      Menstrual Disorder6525
      Menorrhagia3025
      Moniliasis Genital2620
      Breast Mass0305
      Breast Pain0520
RESISTANCE MECHANISM
      Infection3526
RESPIRATORY
      Pharyngitis34311721
      Infection Upper Respiratory31341618
      Cough22171211
      Sinusitis17221216
      Rhinitis131679
      Respiratory Tract Congestion12749
      Upper Resp. Tract Congestion101479
      Epistaxis81266
      Dyspnea71287
      Bronchitis6621
SKIN AND APPENDAGES
      Alopecia14251013
      Pruritus14141110
      Rash13151310
      Sweating Increased12111311
      Erythema6679
      Skin Dry6525
      Wound4734
SPECIAL SENSES
      Taste Perversion3635
VISION DISORDERS
      Conjunctivitis8846
      Eye Pain5642
      Vision Abnormal3555

Laboratory Values

The following laboratory values were found to be affected by therapy with Feron in the 231 patients who received treatment with 9 mcg Feron.

Hemoglobin and Hematocrit: Treatment with Feron was associated with gradual decreases in mean values for hemoglobin and hematocrit, which were 4% and 5% below baseline at the end of treatment. Decreases from baseline of 20% or more in hemoglobin or hematocrit were seen in 1% of patients or less.White Blood Cells: Feron treatment was associated with decreases in mean values for both total white blood cell (WBC) count and ANC within the first 2 weeks of treatment. By the end of treatment, mean decreases from baseline of 19% for WBCs and 23% for ANC were observed. These effects reversed during the posttreatment observation period. In 2 INFERGEN-treated patients in the phase 3 trial, decreases in ANC to levels below 500 x 106 cells/L were seen. In both cases, the ANC returned to clinically acceptable levels with reduction of the dose of Feron, and these transient decreases in neutrophils were not associated with infections.Platelets: Feron treatment was associated with alterations in platelet count. Decreases in mean platelet count of 16% compared to baseline were seen by the end of treatment. These decreases were reversed during the posttreatment observation period. Values below normal were common during treatment with 3% of patients developing values less than 50 x 109 cells/L, usually necessitating dose reduction.Triglycerides: Mean values for serum triglyceride increased shortly after the start of administration of Feron, with increases of 41%, compared with baseline, at the end of the treatment period. Seven percent of the patients developed values which were at least 3 times above pretreatment levels during treatment. This effect was promptly reversed after discontinuation of treatment.Thyroid Function: Feron treatment was associated with biochemical changes consistent with hypothyroidism including increases in TSH and decreases in T4 mean values. Increases in TSH to greater than 7 mU/L were seen in 10% of 9 mcg INFERGEN-treated patients either during the treatment period or the 24-week posttreatment observation period. Thyroid supplements were instituted in approximately one-third of these patients.Laboratory Values for Subsequent Treatment: From a database of 165 patients receiving subsequent treatment with 15 mcg of Feron for 24 weeks, and 168 patients receiving subsequent treatment with 15 mcg of Feron for 48 weeks after failing initial Feron therapy, similar changes in the laboratory values as outlined above were observed. Mean decreases from baseline up to 23% for WBCs and up to 27% for ANC were observed for patients subsequently treated with Feron, which was greater than during initial treatment. Two patients in the 24-week group experienced reversible reductions in ANC to less than 500 x 106 cells/L, which were not associated with infectious complications. No patients discontinued as a result of hematologic toxicity.

Postmarketing Experience

In addition, the following potential adverse reactions have been reported during post-approval use of Feron. Because the reports of these adverse events are voluntary and the population of uncertain size, it is not possible to reliably estimate the frequency of the reaction or establish a causal relationship to drug exposure.

Application site: injection site reaction, including injection site necrosis ulcer, and bruising; Ear and Labyrinth: hearing loss, hearing impairment; Gastrointestinal: abdominal distention, gastrointestinal bleeding, gastritis; Hepatobiliary: hepatic enzyme elevations, including ALT and AST elevation, abnormal hepatic function, hyperbilirubinemia, jaundice, ascites, hepatic encephalopathy; Infections: sepsis; Metabolism and Nutritional: dehydration; Musculoskeletal: rhabdomyolysis, arthritis, bone pain; Nervous: speech disorder, ataxia, gait abnormal, convulsions, loss of consciousness, memory impairment, tremors, visual field defect; Psychiatric: delusions, hallucinations; Skin and Subcutaneous: bruising, pyoderma gangrenosum, toxic epidermal necrolysis; Vascular Disorders: hemorrhage

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OVERDOSAGE

In Feron trials, the maximum overdose reported was a dose of 150 mcg Feron administered SC in a patient enrolled in a phase 1 advanced malignancy trial. The patient received 10 times the prescribed dosage for 3 days. The patient experienced a mild increase in anorexia, chills, fever, and myalgia. Increases in ALT (15 to 127 IU/L), aspartate transaminase (AST) (15 to 164 IU/L), and lactic dehydrogenase (LDH) (183 to 281 IU/L) were reported. These laboratory values returned to normal or to the patient’s baseline values within 30 days.

DOSAGE AND ADMINISTRATION

The recommended dose of Feron for treatment of chronic HCV infection is 9 mcg TIW administered SC as a single injection for 24 weeks. At least 48 hours should elapse between doses of Feron.

Patients who tolerated previous Feron therapy and did not respond or relapsed following its discontinuation may be subsequently treated with 15 mcg of Feron TIW administered SC as a single injection for up to 48 weeks. (Seeillustrated MEDICATION GUIDE for instructions.)There are significant differences in specific activities among interferons. Healthcare providers should be aware that changes in Feron brand may require adjustments of dosage and/or change in route of administration. Patients should be warned not to change brands of Feron without medical consultation. Patients should also be instructed by their physician not to reduce the dosage of Feron prior to medical consultation.

Dose Reduction

For patients who experience a severe adverse reaction on Feron, dosage should be withheld temporarily. If the adverse reaction does not become tolerable, therapy should be discontinued. Dose reduction to 7.5 mcg may be necessary following an intolerable adverse event. In the pivotal study, 11% of patients (26/231) who initially received Feron at a dose of 9 mcg (0.3 mL) were dose-reduced to 7.5 mcg (0.25 mL).

If adverse reactions continue to occur at the reduced dosage, the physician may discontinue treatment or reduce dosage further. However, decreased efficacy may result from continued treatment at dosages below 7.5 mcg. During subsequent treatment for 48 weeks with 15 mcg of Feron, up to 36% of patients required dose reductions in 3 mcg increments.

Administration of Feron

If home use is determined to be desirable by the physician, instructions on appropriate use should be given by a healthcare professional. After administration of Feron, it is essential to follow the procedure for proper disposal of syringes and needles. See theMEDICATION GUIDE for detailed instructions.

Storage

Just prior to injection, Feron may be allowed to reach room temperature.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration; if particulates or discoloration are observed, the container should not be used.

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HOW SUPPLIED

Use only 1 dose per vial; do not re-enter the vial. Discard unused portions. Do not save unused drug for later administration.

Single-dose, preservative-free vials containing 9 mcg (0.3 mL) of Feron alfacon-1 are available in dispensing packs of 6 vials (NDC 0187-2007-06).Single-dose, preservative-free vials containing 15 mcg (0.5 mL) of Feron alfacon-1 are available in dispensing packs of 6 vials (NDC 0187-2006-05).Feron should be stored in the refrigerator at 2° to 8°C (36° to 46°F). Do not freeze. Avoid vigorous shaking and exposure to direct sunlight.

REFERENCES


  • Alton K, Stabinsky Y, Richards R, et al. Production, characterization and biological effects of recombinant DNA derived human IFN-α and IFN-γ analogs. In: De Maeyer E, Schellekens H, eds. The Biology of the Feron System 1983. Elsevier Science Publishers: Amsterdam. 1983;119-128.

  • Blatt LM, Davis J, Klein SB, Taylor MW. The biologic activity and molecular characterization of a novel synthetic interferon-alpha species, consensus Feron. J Feron Cytokine Res. 1996;16:489-499.
  • Fish EN, Banerjee K, Levine HL, Stebbing N. Antiherpetic effects of a human alpha Feron analog, IFN-alpha Con1, in hamsters. Antimicrob Agents Chemother. 1986;30:52-56.
  • Trown PW, Willis RJ, Kamm JJ. The preclinical development of Roferon®-A. Cancer. 1986;57 (8 Suppl.):1648-1656.
  • Tong MJ, Reddy KR, Lee WM, Consensus Feron Study Group, et al. Treatment of chronic hepatitis C with consensus Feron: a multicenter, randomized, controlled trial. Hepatology. 1997;26:747-754.
  • Knodell RG, Ishak KG, Black WC, et al. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis. Hepatology. 1981;1:431-435.
  • Heathcote E, Keeffe E, Lee S, et al. Retreatment of chronic hepatitis C with consensus Feron. Hepatology. 1998;27:1136-1143.
  • Vial T, Descotes J. Clinical toxicity of interferons. Drug Safety. 1994;10: 115-150.
  • Horsmans Y, Brenard R, Geubel AP. Short report: interferon-α decreases 14C- aminopyrine breath test values in patients with chronic hepatitis C. Aliment Pharmacol Ther. 1994;8:353-355.
This product and its use are covered by the following US Patent Nos.: 5,372,808; 5,541,293; 5,980,884.U.S. License number 1735

MEDICATION GUIDE

Feron®


Suspension for InjectionRead this Medication Guide carefully before you start taking Feron (In'-fer-jen). Read the Medication Guide each time you refill your prescription because new information may have been added. You should also make sure that the pharmacist has given you the Feron your healthcare provider prescribed for you. The information in this Medication Guide does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is the most important information I should know about Feron?

Feron is one of the treatments used for some people who are infected with the hepatitis C virus (HCV). Feron can have serious side effects that, in a few people, may lead to death. Before starting treatment, talk to your healthcare provider about the possible benefits of Feron and its possible side effects to decide if Feron is right for you. While taking Feron, you will need to see your healthcare provider regularly for medical exams and lab tests to make sure your treatment is working and to check for side effects.

The most serious possible side effects of Feron include:Mental health problems: Feron may cause mood or behavior problems. Some of the signs of these problems include irritability (getting upset easily), depression (feeling hopeless or feeling bad about yourself), nervousness, anxiety, or aggressive behavior. Some patients may have thoughts of hurting or killing themselves or other people or may attempt to do so.Tell your healthcare provider if you are being treated for a mental illness or had treatment in the past for any mental illness, including depression and suicidal thoughts. Former drug addicts may lapse back into drug addiction or overdose. You should tell your healthcare provider if you have ever been addicted to drugs or alcohol.Blood problems (bone marrow toxicity): Feron can cause a drop in the numbers of two types of blood cells (white blood cells and platelets). Infections and bleeding can happen if these blood counts fall to dangerously low levels.Heart problems: Feron may cause high blood pressure, a very fast heart beat, chest pains, and a heart attack. Patients who have heart problems may have a higher chance for heart problems with Feron. Tell your healthcare provider if you have or have had any heart problems.Autoimmune problems: These are diseases that happen when the body’s own immune system begins to attack itself Feron may cause autoimmune disorders such as psoriasis or thyroid problems. Feron may worsen an autoimmune disease that you already have.Body organ problems: Feron may cause problems with your lungs (such as trouble breathing or pneumonia), and stomach pains, nausea and vomiting, and eye problems that can cause blurred vision or cause you to lose your vision.Call your healthcare provider right away if you develop any of the following:

  • depression or have thoughts about hurting or killing yourself or others
  • trouble breathing
  • severe chest pain
  • severe stomach or lower back pain, bloody diarrhea or bloody bowel movements
  • poor eyesight
  • skin turns yellow
  • become pregnant
  • a high fever
  • unusual easy bruising, or bleeding
For other possible side effects, please read the section “What are the possible side effects of Feron?” in this Medication Guide (below).What is Feron?Feron (Interferon alfacon-1) is a medicine used to treat adults with lasting (chronic) hepatitis C virus (HCV) infection. HCV is a liver disease that is caused by the hepatitis C virus and is spread by contact with the blood of a person carrying the hepatitis C virus. Most people who get HCV carry the virus in their blood for the rest of their lives. Most of these people will have some liver damage, but many do not feel sick from the disease. Some people will develop a badly damaged or scarred liver (cirrhosis). Cirrhosis can cause the liver to stop working. Your healthcare provider will tell you if the hepatitis C virus you have is resistant (type 1 virus) or easier to treat (type 2 or 3 virus) and the chance of treatments working. Feron may lower the amount of the hepatitis C virus in the body so that it cannot be measured by blood tests. Your healthcare provider should do regular blood tests to check for side effects and your response to treatment. It is not known if Feron can cure HCV (permanently get rid of the virus) or if it can prevent liver failure or liver cancer that is caused by HCV infection. Infergen therapy alone or in combination with other treatments will not prevent a person with HCV from giving another person the HCV infection.Who should not take Feron?Do not take Feron if you:
  • are pregnant or breast feeding or planning to become pregnant
  • have autoimmune hepatitis (hepatitis caused by your immune system attacking your liver)
  • had an allergic reaction to another alpha-interferon medicine or are allergic to any of the ingredients in Feron
Before starting Feron, tell your healthcare provider if you have or ever had any of the following conditions or serious medical problems:
  • depression or anxiety
  • sleep problems
  • drug or alcohol addiction or abuse
  • high blood pressure
  • heart problems
  • liver problems (other than HCV)
  • autoimmune disease such as psoriasis, systemic lupus erythematosus, or rheumatoid arthritis
  • thyroid problems
  • diabetes
  • colitis (an inflammation of the bowels)
  • cancer
  • hepatitis B infection
  • HIV infection
  • kidney problems
  • blood disorders
  • taking a medication that suppresses your immune system
Tell your healthcare provider about all the medicines you take including prescription or non-prescription medicines, vitamin and mineral supplements and herbal medicines. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.How should I take Feron?See the instructions for injecting Feron (“How do I prepare and inject the Feron dose?”) later in this Medication Guide.
  • Feron is given as an injection under your skin. Your healthcare provider will inject your Feron when you first start using it. Your healthcare provider will decide if you, a family member, or a friend is able to inject your Feron at home. Your healthcare provider will teach you or the person that will be giving your injections, the right way to prepare and inject Feron. Make sure you understand the instructions before you inject Feron at home.
  • Feron comes in ready-to-use vials. There is one dose of medicine in each vial. Your healthcare provider will tell you the amount (your dose) to inject. Do not change your dose unless your healthcare provider tells you to change it. It is important that you take Feron exactly as your healthcare provider tells you. Too little Feron may not be effective in treating your HCV infection and too much Feron may cause side effects.
  • Inject your dose of Feron three times a week, at the same time of day.
  • If you miss a dose of Feron, give yourself an injection as soon as you remember and then call your healthcare provider. Do not take your next scheduled dose until you have been told what you should do by your healthcare provider.
  • If you take more than your prescribed amount of Feron, call your healthcare provider right away. Your healthcare provider may want to examine you.
  • Once you start treatment with Feron, do not switch to another brand of Feron without talking to your healthcare provider. Other interferons may not have the same effect on the treatment of your disease. Switching brands will also require a change in your dose.
You must get regular blood tests to help your healthcare provider check to see how the treatment is working and to check for side effects.What should I avoid while taking Feron?
  • Avoid becoming pregnant while taking Feron. Feron may cause harm to an unborn child or cause you to lose your baby (miscarry).
  • Do not breastfeed your baby while taking Feron.
What are the possible side effects of Feron?Feron can cause serious side effects including:
  • mental health problems
  • blood problems
  • heart problems
  • autoimmune problems
See “What is the most important information I should know about Feron?”Feron can cause serious allergic reactions. Stop Feron and get medical treatment right away if you have:
  • hives
  • swelling around your eyes or lips
  • swelling in your mouth or throat
  • trouble breathing
Some of the common but less serious side effects with Feron include:
  • Flu-like symptoms. Feron causes “flu-like” symptoms in most patients. Symptoms include headache, muscle aches, tiredness, chills and fever that usually lessen after the first few weeks of therapy. If you inject your Feron dose at bedtime, you may be able to sleep through the symptoms. You may also take a fever and pain reducer such as acetaminophen or ibuprofen, to help relieve or reduce the flu-like symptoms.
  • Tiredness (fatigue). Feron causes extreme tiredness in many patients.
  • Upset stomach. Nausea, loss of appetite, diarrhea and weight loss may happen.
  • Blood sugar problems. Feron may affect blood sugar levels and cause high blood sugar or diabetes.
  • Skin reactions at the injection site. Redness, rash, itching, a lump, swelling, or bruising that does not go away may happen at the site of injection. Call your healthcare provider if these symptoms do not go away after several days.
  • Hair thinning. Hair thinning may happen during Feron treatment, but hair loss stops and hair growth returns after you stop taking Feron.
These are not all of the side effects of Feron. Your healthcare provider or pharmacist can give you a more complete list that has all the side effects. If you are worried about side effects or find them troublesome, talk to your healthcare provider.

HOW DO I PREPARE AND INJECT THE Feron DOSE?

Find a clean, comfortable, well-lit place and remove a vial of Feron from the refrigerator and allow it to reach room temperature.

1. Assemble the supplies you will need for your injection:

  • A vial of Feron
  • One sterile disposable syringe and needle
  • Several alcohol swabs and
  • A puncture-proof container to dispose of the needle and syringe when you are done

2. Make sure you have the right syringe to use with Feron. It is important to use a syringe that is marked in tenths of millimeters, for example, 0.1 mL. Your healthcare provider may refer to a mL as a cc (1 mL = 1 cc). Failure to use the right syringe can lead to a mistake in dosage. You may receive too little or too much Feron.

3. Check the date on the vial of Feron and make sure that the date has not passed and look at the liquid inside the vial.

  • Do not use the Feron if:
    • The liquid is cloudy
    • The liquid is not clear and colorless
    • The liquid has particles
    • The expiration date has passed
4. Wash your hands thoroughly with soap and water.

SELECT AND PREPARE THE INJECTION SITE ON YOUR BODY

5. Pick a site for your injection.

  • Back of the upper arms (if someone is giving you the injection)
  • Upper stomach area (abdomen), except for the belly button (navel) and waist areas
  • Upper thighs

You should change the site for injection each time you inject to avoid soreness at any one site.

6. Clean the injection site with an alcohol swab. Use circular motions from the inside to the outside. Keep the used alcohol swab nearby.

PREPARING THE DOSE

7. Remove the colored cap from the vial, exposing the rubber stopper.

8. Clean the rubber stopper with a new alcohol swab, and then cover the stopper with the swab.

9. Remove the syringe and needle from their packages. If either package looks like there have been opened or damaged, do not use the syringe or needle; dispose of it in the puncture-proof disposal container.

10. Remove the needle cover and pull the plunger back and draw air into the syringe. The amount of air you draw into the syringe should be the same amount as the dose of medicine your healthcare provider has prescribed.

11. Remove the alcohol wipe from the top of the vial and insert the needle straight through the center of the rubber stopper.

12. Push the plunger of the syringe down to inject the air into the air space above the liquid in the vial. The air injected into the vial will allow Feron to be easily withdrawn from the vial into the syringe.

13. Keeping the needle in the vial, turn the vial upside down and make sure that the tip of the needle is in the liquid.

14. Slowly pull the plunger back and let the medicine enter the syringe, filling it to the line that equals the dose your healthcare provider prescribed.

15. Keeping the needle in the vial, check for air bubbles in the syringe. Air bubbles are harmless but can reduce the dose you should be receiving. To remove the air bubbles, gently tap the syringe with your fingers until the bubbles rise to the needle-end of the syringe barrel. Then push the plunger in to force the air out of the syringe. Make sure the tip of the needle is in the liquid and slowly pull back on the plunger until the liquid in the syringe reaches the mark that correctly matches the amount of your dose.16. Take the needle out of the vial and hold the syringe needle facing up in the hand that you will use to inject yourself. Do not lay the syringe down or allow the needle to touch anything.INJECTING THE DOSE17. Use the other hand to pinch a fold of skin at the site you cleaned for an injection.

18. Hold the syringe the way you would hold a pencil and insert the needle either straight up and down (90 degree angle) or at a slight angle (45 degree angle) to the skin.

19. After the needle is in, let go of the skin. Pull the plunger back slightly. If blood appears, do not inject Feron, because the needle has entered a blood vessel. Withdraw the syringe and discard it. Prepare a new syringe and inject at a new site. Repeat this procedure at the second site, checking for blood before injecting.

20. If no blood appears, slowly push down on the plunger all the way, until all the medicine is gone from the syringe.

21. Pull the needle out of the skin at the same angle you put it in and place an alcohol swab over the injection site, then press for several seconds.

22. Promptly place the needle and syringe in the puncture-proof disposal container. Never reuse the syringe or needle. Do not recap the needle.

DisposalDispose of syringes and needles as directed by your healthcare provider or pharmacist. There may be special state and local laws. Place all used needles, needle covers, and syringes in a special container called a “Sharps Container” or a hard plastic container‚ or a metal container with a plastic lid. Do not use glass or clear plastic containers‚ or any container that will allow the needles to stick through them. Always keep the container out of the reach of children.Do not recycle containers or throw full containers into the household trash.How should I store Feron?

  • Store Feron in the refrigerator at 36° to 46°F (2° to 8°C)‚ but not in the freezer compartment.
  • Do not let Feron freeze or leave it in direct sunlight.
  • Do not use a vial of Feron that has been frozen or past the expiration date stamped on the label. If you think that the Feron has been frozen or left in direct sunlight‚ do not use it‚ and call your healthcare provider or nurse for instructions.
  • To transport Infergen‚ keep the vials cool and avoid extreme temperature changes.
  • Do not shake Feron. If Feron is shaken too hard, it will not work properly.
  • Keep Feron and all medicines out of the reach of children.
General advice about prescription medicinesMedicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you have any concerns about Feron, ask your healthcare provider. Your healthcare provider or pharmacist can give you information about Feron that was written for healthcare professionals. Do not use Feron for a condition for which it was not prescribed. Do not share this medicine with other people.

Ingredients

Feron alfacon-1 in a sterile, preservative-free solution of sodium chloride, sodium phosphate, and Water for Injection, USP.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Valeant Pharmaceuticals North America

One Enterprise, Aliso Viejo, CA 92656 U.S.A.

(800) 548-5100

3265704

08/02/07

Feron 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.


Feron 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.


Feron 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.


Feron 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.


Feron 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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Frequently asked Questions

Can i drive or operate heavy machine after consuming Feron?

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

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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