"The U.S. Food and Drug Administration (FDA) continues its investigation of acute hepatitis illnesses linked to products labeled OxyElite Pro.
FDA advises consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1 becau"...
There is limited experience with overdosage. In the clinical trials, a few subjects accidentally received a dose greater than that prescribed. There were no instances in which a participant in the monotherapy or combination therapy trials received more than 10.5 times the intended dose of PegIntron. The maximum dose received by any subject was 3.45 mcg/kg weekly over a period of approximately 12 weeks. The maximum known overdosage of ribavirin was an intentional ingestion of 10 g (fifty 200 mg capsules). There were no serious reactions attributed to these overdosages. In cases of overdosing, symptomatic treatment and close observation of the patient are recommended.
PegIntron is contraindicated in patients with:
- known hypersensitivity reactions, such as urticaria, angioedema, bronchoconstriction, anaphylaxis, Stevens-Johnson syndrome, and toxic epidermal necrolysis to interferon alpha or any other component of the product
- autoimmune hepatitis
- hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in cirrhotic CHC patients before or during treatment
PegIntron/ribavirin combination therapy is additionally contraindicated in:
- women who are pregnant. Ribavirin may cause fetal harm when administered to a pregnant woman. Ribavirin is contraindicated in women who are or may become pregnant. If ribavirin is used during pregnancy, or if the patient becomes pregnant while taking ribavirin, the patient should be apprised of the potential hazard to her fetus [see Use In Specific Populations].
- men whose female partners are pregnant
- patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia)
- patients with creatinine clearance less than 50 mL/min
Last reviewed on RxList: 12/6/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Peg-Intron Information
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