"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is updating labeling information for the hepatitis C antivirals ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) and sofosbuvir (Sovaldi, Gilead Sciences) after th"...
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:
Last reviewed on RxList: 3/20/2017
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