• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Victrelis (Boceprevir) Capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

July 2014

Summary View

WARNINGS AND PRECAUTIONS

Laboratory Tests
  • Refer to the prescribing information for peginterferon alfa and ribavirin for pre-treatment, on-treatment and post-treatment laboratory testing recommendations including hematology, biochemistry (including hepatic function tests), and pregnancy testing requirements

Medication Guide

What should I tell my healthcare provider before taking VICTRELIS?

  • have liver failure

 

February 2014

Summary View

WARNINGS AND PRECAUTIONS

5.4 Pancytopenia (Use with Ribavirin and Peginterferon Alfa)
  • Serious cases of pancytopenia have been reported postmarketing in patients receiving VICTRELIS in combination with peginterferon alfa and ribavirin. Complete blood counts (with white blood cell differential counts) should be obtained at pretreatment, and at Treatment Weeks 2, 4, 8, and 12, and should be monitored closely at other time points, as clinically appropriate. Refer to the Package Inserts for ribavirin and peginterferon alfa for guidelines for discontinuation of therapy based on laboratory parameters.

ADVERSE REACTIONS

6.1 Clinical Trials Experience
  • Pancytopenia
6.2 Postmarketing Experience
  • Blood and Lymphatic System Disorders: agranulocytosis, pancytopenia, thrombocytopenia [seeWarnings and Precautions (5.4)]
  • Infections and Infestations: pneumonia, sepsis

17 PATIENT COUNSELING INFORMATION

Pancytopenia
  • Patients should be informed that serious cases of pancytopenia have been reported during postmarketing when VICTRELIS was administered with peginterferon alfa and ribavirin [see Warnings and Precautions (5.4) and Adverse Reactions (6.2)]. Patients should be advised that laboratory evaluations are required prior to starting therapy and periodically thereafter [see Warnings and Precautions]

MEDICATION GUIDE

What should I tell my healthcare provider before taking VICTRELIS?  Before and while you take VICTRELIS, tell your healthcare provider if you:

  • …or combination of low platelet, red and white blood cell counts (pancytopenia) s5.7)].

The most common side effects of VICTRELIS in combination with peginterferon alfa and ribavirin include:

  • … infections of the blood and pneumonia have been reported…

 

January 2014

Summary View

4 CONTRAINDICATIONS

Table 2
  • added ... alfusozin, doxasozin, silodosin and tamsulosin

7 DRUG INTERACTIONS

  • added... calcium channel blockers, amlodipine, diltiazem, nisoldipine and verapamil

MEDICATION GUIDE

Do not take VICTRELIS if you take a medicine that contains:

  • added the new information (above) from Contraindications and Drug Interactions to Medication Guide 

 

September 2013

Summary View

7 DRUG INTERACTIONS

7.3 Established and Other Potential Significant Drug Interactions
  • See Table 5 ............ interactions with raltegravir, rilpivirine and sirolimus added 

 

February 2013

Summary View

 

WARNINGS AND PRECAUTIONS

Pregnancy (Use with Ribavirin and Peginterferon Alfa)
  • One of these forms of contraception can be a combined oral contraceptive product containing at least 1 mg of norethindrone. Oral contraceptives containing lower doses of norethindrone and other forms of hormonal contraception have not been studied or are contraindicated. Routine monthly pregnancy tests must be performed during this time.
 
Anemia (Use with Ribavirin and Peginterferon Alfa)
  • If ribavirin is permanently discontinued for management of anemia, then peginterferon alfa and Victrelis must also be discontinued
  • In clinical trials, the median time to onset of hemoglobin less than 10 g per dL from the initiation of therapy was similar among subjects treated with the combination of...
  • A randomized, parallel-arm, open-label clinical trial was conducted in previously untreated CHC subjects with genotype 1 infection to compare use of an ESA versus ribavirin dose reduction for initial management of anemia during therapy...
 
Neutropenia (Use with Ribavirin and Peginterferon Alfa)
  • If peginterferon alfa and ribavirin are permanently discontinued, then Victrelis must also be discontinued.
 
Laboratory Tests
  • Complete blood count (with white blood cell differential counts) must be conducted in all patients prior to initiating Victrelis/peginterferon alfa/ribavirin combination therapy.

 

November 2012

Summary View

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

Summary View

 

USE IN SPECIFIC POPULATIONS

  • For data regarding drug-drug interactions with antiretroviral agents in healthy subjects…
 

MEDICATION GUIDE

What is Victrelis?
  • Victrelis is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (long-lasting) hepatitis C genotype 1 infection in adults with stable (compensated) liver disease who have not been treated before or who have failed previous treatment
 
What should I tell my healthcare provider before taking Victrelis?
  • Victrelis and other medicines may affect each other, causing serious and/or life-threatening side effects or affecting the way VICTRELIS and your other medicines work. Do not start taking a new medicine without telling your healthcare provider or pharmacist.
 
Tell your healthcare provider if you are taking or starting to take any of these medications:
  • Atazanavir (Reyataz)
  • Darunavir (Prezista)
  • Lopinavir (Kaletra)