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On November 2, 2012, the Victrelis (boceprevir) package insert and Medication Guide was updated to include postmarketing information about serious acute hypersensitivity reactions observed during boceprevir, peginterferon and ribavirin combination therapy. The following sections of the package insert were updated.
A new contraindication was added to section 4:
- Patients with a history of a hypersensitivity reaction to boceprevir
Section 5.4 Hypersensitivity was added to Warnings and Precautions to include the following:
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 [see Contraindications (4) and Adverse Reactions (6.2)].
Section 6.2 Postmarketing Experience was added to Adverse Reactions to include the following:
The following adverse reactions have been identified during post-approval use of VICTRELIS in combination with peginterferon alfa and ribavirin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders: mouth ulceration, stomatitis
Skin and Subcutaneous Tissue Disorders: angioedema, urticaria [see Warnings and Precautions (5.4)]; drug rash with eosinophilia and systemic symptoms (DRESS) syndrome, exfoliative rash, exfoliative dermatitis, Stevens-Johnson syndrome, toxic skin eruption, toxicoderma
Section 17.4 Hypersensitivity was added to Patient Counseling Information to include the following:
Patients should be informed that serious acute hypersensitivity reactions have been observed during combination therapy with VICTRELIS, peginterferon alfa, and ribavirin therapy [see Contraindications (4) and Warnings and Precautions (5.4)]. If symptoms of acute hypersensitivity reactions (e.g., itching; hives; swelling of the face, eyes, lips, tongue, or throat; trouble breathing or swallowing) occur, patients should seek medical advice promptly.
The Medication Guide (MG) was also updated to let patients know they should not take Victrelis if they have had an allergic reaction to boceprevir or any of the ingredients in Victrelis. Also the MG was updated to inform patients that a possible side effect of Victrelis is serious allergic reactions and may become severe requiring treatment in a hospital. If patients experience itching, hives, swelling of face, eyes, lips, tongue or throat or have trouble breathing or swallowing they should tell their healthcare provider immediately.
Victrelis is a protease inhibitor for the treatment of HCV infection and manufactured by Schering Corporation, a subsidiary of Merck & Co.
The complete, revised label will be posted soon at Drugs@FDA
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
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