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The recommended starting dose is 6 mcg/kg/week subcutaneously for 8 doses, followed by 3 mcg/kg/week subcutaneously for up to 5 years.
Premedicate with acetaminophen 500 to 1000 mg orally 30 minutes prior to the first dose of Peginterferon alfab and as needed for subsequent doses.
The recommended starting doses of Peginterferon alfab in patients with moderate or severe renal impairment or end-stage renal disease (ESRD). No dose adjustment is needed for patients with a creatinine clearance (Cl.Cr.) > 50 mL/min/1.73m² .
Add 0.7 ml of sterile water for inj, (supplied diluent) to the vial. Gently swirl. Do not re-enter vial after dose removed. Discard unused portion.
Pediatric Use: Safety and effectiveness in patients below the age of 18 years have not been established.
Geriatric Use: Clinical studies of Peginterferon alfab did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Hepatic Impairment: Peginterferon alfab has not been studied in patients with melanoma who have hepatic impairment. In patients treated for viral hepatitis, peginterferon alfab treatment is contraindicated in those with moderate or severe hepatic impairment (Child-Pugh scores > 6). Discontinue Peginterferon alfab if hepatic decompensation (Child-Pugh scores > 6) occurs during treatment.
Renal Impairment: Reduce the dose of Peginterferon alfab by 25% in patients with moderate renal impairment (CrCl 30 to 50 mL/min/1.73m²) and 50% in patients with severe renal impairment (CrCl < 30 mL/min/1.73m²) or ESRD requiring dialysis. A study in subjects with varying degrees of renal impairment showed that the mean exposure (AUC) to peginterferon alfab increased in subjects with moderate and severe renal impairment or ESRD requiring dialysis, as compared to subjects with normal renal function (CrCl > 80 mL/min/1.73m²) following a single 4.5 mcg/kg dose of peginterferon alfab
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