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Contraindication regarding the use of Tyzeka (telbivudine) with Pegasys
FDA Hepatitis Update - 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 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 600mg daily and pegylated interferon alfa-2a 180 micrograms    once weekly compared to Tyzeka or pegylated interferon alfa-2a alone [see Contraindications    (4) and Drug Interactions (7)]. 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 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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