The FDA recently announced revisions to product labeling for Victrelis (boceprevir), a protease inhibitor used in conjunction with ribavirin and peginterferon alfa to treat adult patients with genotype 1 chronic hepatitis C.
Revisions to labeling for the product, manufactured by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., included updates to several drug-drug interactions, as well as information on the magnitude of these interactions. The following medications were mentioned in the update:
- Atorvastatin (HMG-CoA reductase inhibitor): Should be prescribed at the lowest effective dose, without exceeding 40 mg daily, when administered with Victrelis.
- Pravastatin (HMG-CoA reductase inhibitor): Exposure is increased with Victrelis coadministration. The recommended dose can be used at initiation, but careful monitoring is recommended.
- Cyclosporine (immunosuppressant): Physicians should anticipate the need for dose adjustments when coadministered with Victrelis. Cyclosporine blood concentration, cyclosporine-related side effects and renal function should be frequently assessed.
- Tacrolimus (immunosuppressant): A significant dose reduction and lengthening of dose interval is necessary when coadministered with Victrelis. Patients should be monitored closely for tacrolimus blood concentrations, related side effects and renal function.
- Escitalopram (antidepressant): Exposure to this drug decreases slightly with Victrelis; dose adjustments may be required.
The drug is intended for patients with compensated liver disease who are either treatment-naïve or were unresponsive to previous treatment with interferon and ribavirin. More information, including the complete label and medication guide, is available on the FDA web site.