Peginterferon alfa-2a: CONTRAINDICATIONS AND PRECAUTIONS
Peginterferon alfa-2a is contra-indicated in the following groups:
- patients with hypersensitivity to any of the components of the product, those with autoimmune hepatitis, and those with decompensated hepatic disease before or during treatment with this drug
- neonates and infants because of the ingredient benzyl alcohol, which has been reported to be associated with an increased incidence of neurological and other sometimes fatal complications
Signs and symptoms of interferon toxicity should be closely monitored in patients with impaired renal function. There is a 25% to 45% reduction in clearance for patients with end-stage renal disease who are undergoing hemodialysis. It is recommended that the dosage be reduced to 135 mcg in these patients.
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PREGNANCY AND LACTATION
There have not been any adequate or well-controlled studies of Pegasys® in pregnant women, and it is still unknown whether the drug is excreted in breast milk. This drug should be used during pregnancy only if the benefits justify the potential risk to the fetus. Mothers should be instructed not to breast-feed while taking peginter-feron alfa-2a.
The recommended dose of Pegasys® for patients with chronic HCV is 180 mcg, once a week, as an SQ injection. For patients with end-stage renal disease, the dose should be reduced to 135 mcg weekly. The optimal duration of treatment is 48 weeks.
It appears that Pegasys® can offer a significant alternative to other HCV agents because more patients have responded better to it than to nonpegy-lated interferon alfa-2a. By week 12, it is possible to determine whether or not a patient will attain a sustained virological response with Pegasys®, and this information can be used to decide whether treatment should be continued. Overall, Pegasys® appears to be a potentially viable agent against the HCV infection. cialis professional