In INFERGEN (interferon alfacon-1) trials, the maximum overdose reported was a dose of 150 mcg INFERGEN (interferon alfacon-1) 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 (interferon alfacon-1) 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: 7/28/2010
This monograph has been modified to include the generic and brand name in many instances.