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…
 
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