Tuesday, September 4, 2012

Drug-Drug Interactions Added to Boceprevir Label

VOL. 6 • NO. 9 • SEPTEMBER 2012

IMNG Medical News

Drug-Drug Interactions Added to Boceprevir Label

New information about interactions between boceprevir and several other drugs has been added to the prescribing information for the antiviral drug, the Food and Drug Administration announced on Aug. 1.

Boceprevir (Victrelis), a protease inhibitor approved for treating hepatitis C in 2011, interacts with cyclosporine, tacrolimus (Prograf ), escitalopram (Lexapro), atorvastatin (Lipitor), and pravastatin (Pravachol), according to the FDA statement. The new information states that exposure to atorvastatin increases when given with boceprevir.

If the two drugs are used together, the lowest effective dose of atorvastatin should be used, not to exceed a daily dose of 40 mg, according to the FDA.

Dose adjustments of cyclosporine should be expected when it is given with boceprevir. Cyclosporine dosage “should be guided by close monitoring of cyclosporine blood concentrations and frequent assessments of renal function and cyclosporine-related side effects.” When administered with boceprevir, exposure of escitalopram “was slightly decreased,” the statement said. Although selective serotonin reuptake inhibitors such as escitalopram have a wide therapeutic index, it may be necessary to adjust the dosage when it is administered with boceprevir.

Coadministration of boceprevir with pravastatin increases exposure to pravastatin, but pravastatin can be started at the recommended dosage when coadministered with boceprevir. “Close clinical monitoring is warranted,” the statement said. Giving tacrolimus and boceprevir together “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,” the statement said.

Boceprevir is manufactured in a capsule formulation by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., and is taken by mouth three times a day.

The drug-drug interaction data are from in vivo drug interaction trials, which the company conducted as part of its postmarketing commitments.

At a meeting in April 2011, an FDA advisory panel enthusiastically supported the approval of boceprevir for treating hepatitis C infection because of the antiviral’s efficacy, but emphasized that postmarketing studies on interactions with other drugs, including antidepressants, were needed. ■

The revised prescribing information is available at www.accessdata.fda . gov/drugsatfda_docs/label/2012/ 202258s001lbl.pdf ?source= govdelivery .

Serious adverse events associated with boceprevir should be reported to MedWatch at 800- 332-1088 or www.fda.gov/ medwatch
GI & Hepatology News is the official newspaper of the AGA Institute and provides the gastroenterologist with timely and relevant news and commentary about clinical developments and about the impact of health-care policy. The newspaper is led by an internationally renowned board of editors.

Download PDF

No comments:

Post a Comment