Pegintron and Rebetol
"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"...
PegIntron and Rebetol Combo Pack
There is limited experience with overdosage. In the clinical studies, a few patients accidentally received a dose greater than that prescribed. There were no instances in which a participant in the combination therapy trials received more than 10.5 times the intended dose of Peglntron™. The maximum dose received by any patient was 3.45 mcg/kg weekly over a period of approximately 12 weeks. The maximum known overdosage of REBETOL® 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.
Peglntron™/REBETOL® Combo Pack therapy is contraindicated in:
- Patients with hypersensitivity to Peglntron™ or ribavirin or any other component of the product
- Women who are pregnant
- Men whose female partners are pregnant
- Patients with autoimmune hepatitis
- Patients with hepatic decompensation (Child-Pugh score > 6 [class B and C]) in cirrhotic CHC patients before or during treatment.
- Patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia)
- Patients with creatinine clearance < 50 mL/min
Last reviewed on RxList: 6/24/2013
Additional PegIntron and Rebetol Combo Pack Information
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