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FDA Hepatitis Update - Tyzeka (telbivudine) labeling updates re: use
with pegylated interferon alfa-2a
FDA hepatitis electronic list serve. The purpose of the list serve is to
relay important information about viral hepatitis-related products and
issues, including product approvals, significant labeling changes, safety
warnings, notices of upcoming public meetings and alerts to proposed
regulatory guidances for comment.
Please do not reply to this message.
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 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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发表于 2011-12-24 09:21