Interferon alfacon-1 indications and usage

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Interferon alfacon-1
INFERGEN® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

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

Indications And Usage

Chronic Hepatitis C

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-naïve patients or in patients co-infected with HBV or HIV-1 have not been evaluated.
  • Patients with the following characteristics are less likely to benefit from retreatment with 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.[1]

References

  1. "INFERGEN (INTERFERON ALFACON-1) INJECTION [KADMON PHARMACEUTICALS, LLC]". Retrieved 8 January 2014.

Adapted from the FDA Package Insert.