viernes, 3 de agosto de 2012

FDA Hepatitis Update - Victrelis (boceprevir) label updated for drug-drug interactions

On July 31, 2012, FDA updated the Victrelis (boceprevir) label to include drug-drug interactions between Victrelis and cyclosporine, tacrolimus, escitalopram, atorvastatin and pravastatin. The main changes to the label are highlighted below.
Changes were also made to the Medication Guide to reflect the new interaction data.
Section 7: Drug Interactions was updated to include information regarding the following drug-drug interactions:
  • Atorvastatin: Exposure to atorvastatin was increased when administered with VICTRELIS. Use the lowest effective dose of atorvastatin, but do not exceed a daily dose of 40 mg when coadministered with VICTRELIS
  • Cyclosporine: Dose adjustments of cyclosporine should be anticipated when administered with VICTRELIS and should be guided by close monitoring of cyclosporine blood concentrations, and frequent assessments of renal function and cyclosporine-related side effects.
  • Escitalopram: Exposure of escitalopram was slightly decreased when coadministered with VICTRELIS. Selective serotonin reuptake inhibitors such as escitalopram have a wide therapeutic index, but doses may need to be adjusted when combined with VICTRELIS
  • Pravastatin: Concomitant administration of pravastatin with VICTRELIS increased exposure to pravastatin. Treatment with pravastatin can be initiated at the recommended dose when coadministered with VICTRELIS. Close clinical monitoring is warranted
  • Tacrolimus: Concomitant administration of VICTRELIS with tacrolimus requires significant dose reduction and prolongation of the dosing interval for tacrolimus, with close monitoring of tacrolimus blood concentrations and frequent assessments of renal function and tacrolimus-related side effects.
Section 12: Clinical Pharmacology was updated to include the magnitude of interaction between boceprevir and these medications.
Victrelis is a protease inhibitor for the treatment of HCV infection and manufactured by Merck Sharp & Dohme Corp, a subsidiary of Merck & Co.
The complete, revised label and Medication Guide can be viewed at Drugs@FDA.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

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