Boceprevir Label Information - Updated

[HectorSF]

Boceprevir Label Information Updated to Include Acute Hypersensitivity Risk
FDA  November 2, 2012.

Package information for the recently approved HCV protease inhibitor boceprevir (Victrelis) was recently updated to include post-marketing data about the risk of serious hypersensitivity, or allergic reactions, among hepatitis C patients taking it as part of triple therapy with pegylated interferon and ribavirin. People who experience hypersensitivity symptoms including itching, hives, swelling of the face, tongue, or throat, or trouble breathing or swallowing should seek prompt medical attention.

Victrelis (boceprevir) Labeling Update

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 (Hives are raised, often itchy, red welts on the surface of the skin) , angioedema (swelling that happens just below the surface of the skin, most often around the lips and eyes) 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 (Stomatitis is an inflammation of the mucous lining of any of the structures in the mouth, which may involve the cheeks, gums, tongue, lips, throat, and roof or floor of the mouth).

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 and Co.

The complete, revised label will be posted soon at Drugs@FDA

11/2/12

Source

R Klein and K Struble, U.S. Food and Drug Administration. Victrelis (boceprevir) labeling update. FDA Hepatitis Update. November 2, 2012.

[Parker19]

thanks hector for that update.  I am sure the list will keep growing.  

[BoceprevirGal]

   Good looking out, with this update, Hector.   The allergic reaction that they are describing sounds similar to say, an allergic reaction to a bee -sting. Many people get stung by a bee, and they have a bit of pain, but they are fine. Other people get stung by a bee, and have allergic symptoms, sometimes even fatal.
   It is important for Triple-Txers on Boceprevir to monitor their health
carefully, and if this kind of swelling is experienced, to get to the E.R.

[jules2551]

Thanks Hector.  I am sure as time goes on there will be more additions to the list.  And they definitely need to put "alligator skin" on the list.

Jules

[srw920]

Thanks Hector.

[Idyllic]

Thanks Hector.

Wow that allergic reaction bit is scary. Never heard of that one before. The eMedicine site put it like this:

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat