Do Not Use Telbivudine (Tyzeka) with Pegasys for Hepatitis B, FDA Warns

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The U.S. Food and Drug Administration (FDA) last week announced revisions to the product label for the nucleoside analog telbivudine (Tyzeka), indicating that it should not be used with pegyalted interferon alfa-2a (brand name Pegasys) for the treatment of hepatitis B because the combination can cause peripheral neuropathy, or nerve damage.

While this particular announcement does not relate to pegylated interferon alfa-2b (PegIntron), the other marketed brand, the agency noted that a similar risk "cannot be excluded" for other interferon types and dose regimens.

Below is an edited excerpt from the FDA press release describing the changes. The full announcement is available on the FDA website.

Tyzeka (telbivudine) Labeling Updates Re: Use with Pegylated Interferon Alfa-2a

On December 23, 2011, the Food and Drug Administration approved revisions to the product labeling for Tyzeka (telbivudine) to include a contraindication regarding the use of Tyzeka with Pegasys (pegylated interferon alfa-2a) due to increase risk and severity of peripheral neuropathy. The Medication Guide was also revised accordingly. The following sections were revised:

Contraindications

Combination of Tyzeka with pegylated interferon alfa-2a is contraindicated because of increased risk of peripheral neuropathy

Warnings and Precautions

Peripheral Neuropathy

Peripheral neuropathy has been reported with Tyzeka alone or in combination with pegylated interferon alfa-2a and other interferons. In one clinical trial, an increased risk and severity of peripheral neuropathy was observed with the combination use of Tyzeka 600 mg daily and pegylated interferon alfa-2a 180 micrograms once weekly compared to Tyzeka or pegylated interferon alfa-2a alone...Such risk cannot be excluded for other dose regimens of pegylated interferon alfa-2a, or other alfa interferons (pegylated or standard). The safety and efficacy of Tyzeka in combination with pegylated interferons or other interferons for the treatment of chronic hepatitis B has not been demonstrated. Patients should be advised to report any numbness, tingling, and/or burning sensations in the arms and/or legs, with or without gait disturbance. Tyzeka therapy should be interrupted if peripheral neuropathy is suspected, and discontinued if peripheral neuropathy is confirmed

Drug Interactions:

A clinical trial investigating the combination of Tyzeka, 600 mg daily, with pegylated interferon alfa-2a, 180 micrograms once weekly by subcutaneous administration, indicates that this combination is associated with an increased risk of peripheral neuropathy occurrence and severity, in comparison to Tyzeka or pegylated interferon alfa-2a alone

12/27/11

Source

R Klein and K Struble, U.S. Food and Drug Administration. Tyzeka (telbivudine) Labeling Updates Re: Use with Pegylated Interferon alfa-2a. FDA Hepatitis Update. December 23, 2011.