INFERGEN® (Interferon alfacon-1)
INFERGEN® (interferon alfacon-1) Injection for Subcutaneous Use
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INDICATIONS AND USAGE
INFERGEN (interferon alfacon-1) is indicated for treatment of chronic hepatitis C in patients 18 years of age or older with compensated liver disease. This indication is based on clinical trials conducted using INFERGEN as monotherapy prior to the time that combination treatment was the standard of care and on a single trial evaluating INFERGEN in combination with ribavirin in patients who failed to respond to previous treatment with a pegylated interferon and ribavirin. The following points should be considered when initiating treatment with INFERGEN: Use of monotherapy with an interferon such as INFERGEN for the treatment of hepatitis C is not recommended unless a patient is unable to take ribavirin.
The safety and efficacy of the combination of INFERGEN/ribavirin in treatment-naive patients or in patients co-infected with HBV or HIV-1 has not been evaluated. Patients with the following characteristics are less likely to benefit from retreatment with INFERGEN/ribavirin combination therapy: response of <1 log10 drop HCV RNA on previous treatment, Genotype 1, high viral load (≥ 850,000 IU/mL), African American race, and/or presence of cirrhosis. No safety and efficacy data are available for treatment of longer than one year.
IMPORTANT SAFETY INFORMATION
WARNING: FATAL OR LIFE-THREATENING DISORDERS AND RIBAVIRIN ASSOCIATED EFFECTS
Alpha interferons, including INFERGEN, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening symptoms of these conditions should be withdrawn from therapy. In many but not all cases, these disorders resolve after stopping interferon alfacon-1 therapy.
Use with Ribavirin: Ribavirin may cause birth defects and/or death of the unborn child. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease.
Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen.
CONTRAINDICATIONS:
INFERGEN is contraindicated in patients with hepatic decompensation (Child-Pugh score >6 [class B and C]), autoimmune hepatitis, and known hypersensitivity reactions such as urticaria, angioedema, bronchoconstriction, anaphylaxis to interferon alphas or to any component of the product. Additionally, ribavirin is contraindicated in women who are pregnant, men whose female partners are pregnant, patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia), patients with hypersensitivity to ribavirin or any other component of the product, patients with creatinine clearance <50 mL/min.
WARNINGS AND PRECAUTIONS:
Treatment with INFERGEN and combination treatment with INFERGEN/ribavirin should be administered under the guidance of a qualified physician, and may lead to moderate-to-severe adverse reactions requiring dose reduction, temporary dose cessation, or discontinuation of further therapy.
Ribavirin may cause birth defects and death of the unborn child. INFERGEN/ribavirin combination therapy should not be started until a report of a negative pregnancy test has been obtained immediately prior to planned initiation of therapy. Pregnancy should be avoided for at least six months after discontinuation of ribavirin.
Ribavirin caused hemolytic anemia in 30% of INFERGEN/ribavirin-treated subjects. Complete blood counts should be obtained pretreatment and at Week 2 and Week 4 of therapy or more frequently if clinically indicated. Anemia associated with ribavirin therapy may result in a worsening of cardiac disease.
Severe psychiatric adverse reactions may manifest in patients receiving therapy with interferon alphas, including INFERGEN. Depression, suicidal ideation, suicide attempt, suicide, and homicidal ideation may occur. Other prominent psychiatric adverse reactions including psychosis, aggressive behavior, nervousness, anxiety, emotional lability, abnormal thinking, agitation, apathy and relapse of drug addiction may occur.
Patients exhibiting any of the following conditions should be closely monitored and may require dose reduction or discontinuation of therapy, specific details of which can be found in the Full Prescribing Information: cardiovascular events, pulmonary disorders, hepatic failure, renal insufficiency, cerebrovascular disorders, bone marrow toxicity, colitis, pancreatitis, hypersensitivity, autoimmune disorders, ophthalmologic disorders, peripheral neuropathy, or endocrine disorders.
COMMON ADVERSE REACTIONS:
The most common adverse reactions reported in the combination treatment in the INFERGEN/ribavirin trial were fatigue (76%), nausea (45%), flu-like symptoms (40%), headache (42%), arthralgia (31%), myalgia (29%), neutropenia (40%), leukopenia (29%), insomnia (39%), and depression (26%).
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