"The U.S. Food and Drug Administration today approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the "...
In INFERGEN trials, the maximum overdose reported was a dose of 150 mcg INFERGEN administered subcutaneously in a subject enrolled in a phase 1 advanced malignancy trial. The subject received 10 times the prescribed dosage for three days and experienced a mild increase in anorexia, chills, fever, and myalgia. Increases in ALT (15 IU/L to 127 IU/L), aspartate transaminase (AST) (15 to 164 IU/L), and lactic dehydrogenase (LDH) (183 IU/L to 281 IU/L) were reported. These laboratory values returned to normal or to the subjects baseline values within 30 days.
INFERGEN is contraindicated in patients with:
- hepatic decompensation (Child-Pugh score > 6 [class B and C])
- autoimmune hepatitis
- 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
Last reviewed on RxList: 6/17/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Infergen Information
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