Label Changes for:

Victrelis (boceprevir), 200 mg capsules

January 2014

Changes have been made to the CONTRAINDICATIONS and PRECAUTIONS sections of the safety label.

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

 

February 2014

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

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

7 DRUG INTERACTIONS

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

 

February 2013

 

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.
 
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