FDA updates labeling for protease inhibitor to reflect drug-drug interactions

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.