Interferon alfacon-1

Interferon alfacon-1
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Interferon alfacon-1 is a Immunological Agent that is FDA approved for the treatment of INFERGEN 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 INFERGEN. In some patients with chronic HCV infection, INFERGEN normalizes serum ALT, reduces serum HCV RNA concentrations to undetectable quantities (< 100 copies/mL), and improves liver histology.. Common adverse reactions include Injection site reactions, fatigue, fever, rigors, body pain.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

INFERGEN 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 INFERGEN. In some patients with chronic HCV infection, INFERGEN normalizes serum ALT, reduces serum HCV RNA concentrations to undetectable quantities (< 100 copies/mL), and improves liver histology.

Dosage

The recommended dose of INFERGEN 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 INFERGEN. (SeeILLUSTRATED MEDICATION GUIDE for instructions.)

Patients who tolerated previous interferon therapy and did not respond or relapsed following its discontinuation may be subsequently treated with 15 mcg of INFERGEN 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 interferon brand may require adjustments of dosage and/or change in route of administration. Patients should be warned not to change brands of interferon without medical consultation. Patients should also be instructed by their physician not to reduce the dosage of INFERGEN prior to medical consultation.

Dose Reduction For patients who experience a severe adverse reaction on INFERGEN, 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 INFERGEN 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 INFERGEN, up to 36% of patients required dose reductions in 3 mcg increments.

Administration of INFERGEN 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 INFERGEN, 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, INFERGEN 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Interferon alfacon-1 in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Interferon alfacon-1 in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• Safety and effectiveness has not been established on pediatric patients

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Interferon alfacon-1 in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Interferon alfacon-1 in pediatric patients.

Contraindications

• known hypersensitivity to alpha interferons or to any component of the product

decompensated hepatic disease

autoimmune hepatitis

Warnings

Treatment with INFERGEN 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 INFERGEN (including 4% due to psychiatric events). Withdrawal from study due to adverse events occurred in 5% of patients subsequently treated with 15 mcg INFERGEN for 24 weeks and 11% of patients subsequently treated with 15 mcg INFERGEN for 48 weeks.

Neuropsychiatric Disorders Severe psychiatric adverse events may manifest in patients receiving therapy with alpha interferons, including INFERGEN. 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. INFERGEN 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 INFERGEN 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 interferon therapy should be discontinued in patients who develop severe decreases in neutrophil (<0.5 x 109/L) or platelet counts (<50 x 109/L).

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

Hypersensitivity Serious acute hypersensitivity reactions have been reported in rare instances following treatment with alpha interferons. If hypersensitivity reactions occur (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis), INFERGEN should be discontinued immediately and appropriate medical treatment instituted.

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

Autoimmune Disorders Development of or exacerbation of autoimmune disorders (e.g., autoimmune thrombocytopenia, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis) have been reported in patients receiving alpha interferon therapies, including INFERGEN. INFERGEN 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 interferon therapy, including INFERGEN. Patients who develop persistent or unexplained pulmonary infiltrates or pulmonary function impairment should discontinue treatment with INFERGEN.

Colitis Hemorrhagic/ischemic colitis, sometimes fatal, has been observed within 12 weeks of alpha interferon therapies and has been reported in patients treated with INFERGEN. INFERGEN 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 INFERGEN. INFERGEN 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 INFERGEN. During treatment, patients’ clinical status and hepatic function should be closely monitored, and INFERGEN treatment should be immediately discontinued if symptoms of hepatic decompensation, such as jaundice, ascites, coagulopathy, or decreased serum albumin, are observed (seeCONTRAINDICATIONS).

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 INFERGEN 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 interferon alpha treatment. Any patient who develops ocular symptoms should receive a prompt and complete eye examination. INFERGEN 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 interferon alfa-based therapies, including INFERGEN. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45 years of age. Because these are spontaneous reports, estimates of frequency cannot be made and a causal relationship between interferon alfa-based therapies and these events is difficult to establish.

Precautions

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

Bone Marrow Toxicity INFERGEN 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 interferon therapy with caution.

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

Laboratory Tests Laboratory tests are recommended for all patients on INFERGEN 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 INFERGEN therapy, any abnormal test values should be monitored periodically. The entrance criteria that were used for the clinical study of INFERGEN 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 INFERGEN (seeADVERSE REACTIONS). Therefore, these laboratory parameters should be monitored closely.

Adverse Reactions

Clinical Trials Experience

Adverse experiences that were reported, regardless of attribution to treatment, in at least 5% of patients in the 9 mcg INFERGEN or 3 MIU IFN α-2b groups of the pivotal study are presented in TABLE 3, listed in decreasing order by the 9 mcg INFERGEN 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 (i.e., headache, fatigue, fever, rigors, myalgia, sweating increased, and arthralgia) 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 INFERGEN and was the most common adverse event resulting in study drug discontinuation.

In patients who had tolerated previous interferon therapy (9 mcg INFERGEN 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 INFERGEN 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 INFERGEN 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 interferon therapy should not receive therapy with 15 mcg TIW of INFERGEN.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Interferon alfacon-1 in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• No formal drug interaction studies have been conducted with INFERGEN. INFERGEN 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.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

• INFERGEN 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 (based on body surface area) the human dose. There are no adequate and well-controlled studies in pregnant women. INFERGEN should not be used during pregnancy. If a woman becomes pregnant or plans to become pregnant while taking INFERGEN, she should be informed of the potential hazards to the fetus. Males and females treated with INFERGEN should be advised to use effective contraception.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Interferon alfacon-1 in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Interferon alfacon-1 during labor and delivery.

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

Clinical studies of INFERGEN 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 INFERGEN, 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 INFERGEN in this population.

Gender

There is no FDA guidance on the use of Interferon alfacon-1 with respect to specific gender populations.

Race

There is no FDA guidance on the use of Interferon alfacon-1 with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Interferon alfacon-1 in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Interferon alfacon-1 in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Interferon alfacon-1 in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Interferon alfacon-1 in patients who are immunocompromised.

Administration and Monitoring

Administration

• subcutaneous

Monitoring

There is limited information regarding Monitoring of Interferon alfacon-1 in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Interferon alfacon-1 in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Interferon alfacon-1 in the drug label.

Pharmacology

There is limited information regarding Interferon alfacon-1 Pharmacology in the drug label.

Mechanism of Action

Structure

File:Interferon alfacon-101.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Interferon alfacon-1 in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Interferon alfacon-1 in the drug label.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: No carcinogenicity data for INFERGEN are available in animals or humans.

Mutagenesis: INFERGEN 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: INFERGEN 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.

Clinical Studies

There is limited information regarding Clinical Studies of Interferon alfacon-1 in the drug label.

How Supplied

Storage

There is limited information regarding Interferon alfacon-1 Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Interferon alfacon-1 |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Interferon alfacon-1 |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

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 INFERGEN therapy are flu-like symptoms including fatigue, fever, rigors, headache, arthralgia, myalgia, and increased sweating. Non-narcotic analgesics and bedtime administration of INFERGEN 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

Precautions with Alcohol

• Alcohol-Interferon alfacon-1 interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

{{#subobject:

 |Page Name=Interferon alfacon-1
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}}
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}

{{#subobject:

 |Label Page=Interferon alfacon-1
 |Label Name=Interferon alfacon-111.png

}}

{{#subobject:

 |Label Page=Interferon alfacon-1
 |Label Name=Interferon alfacon-111.png

}}