"The U.S. Food and Drug Administration today approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver"...
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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