Label Changes for:
Victrelis (boceprevir) Capsules
November 2012
Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
November 2012
CONTRAINDICATIONS
- Patients with a history of a hypersensitivity reaction to boceprevir
WARNINGS AND PRECAUTIONS
Hypersensitivity
- Serious acute hypersensitivity reactions (e.g., urticaria, angioedema) have been observed during combination therapy with VICTRELIS, peginterferon alfa and ribavirin. If such an acute reaction occurs, combination therapy should be discontinued and appropriate medical therapy immediately instituted
ADVERSE REACTIONS
Post-Marketing Experience
- Skin and Subcutaneous Tissue Disorders: angioedema, urticaria
PATIENT COUNSELING INFORMATION
Hypersensitivity
- Patients should be informed that serious acute hypersensitivity reactions have been observed during combination therapy with VICTRELIS, peginterferon alfa, and ribavirin therapy
July 2012
Drug Interactions
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.
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
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.
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.
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.
April 2012
USE IN SPECIFIC POPULATIONS
- For data regarding drug-drug interactions with antiretroviral agents in healthy subjects…
