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标题: FDA Label Change: Telbivudine contraindication Interferon [打印本页]

作者: StephenW    时间: 2011-12-24 09:21     标题: FDA Label Change: Telbivudine contraindication Interferon

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

作者: StephenW    时间: 2011-12-24 09:21

FDA肝炎更新 - TYZEKA(替比夫定)标签更新:使用
聚乙二醇干扰素α- 2a

FDA的肝炎电子列表服务。列表服务的目的是
继电器病毒性肝炎相关产品的重要信息和
问题,包括产品认证,显著改变标签,安全
警告,即将到来的告示公众集会和警报,以建议
监管指导意见征求意见。

  请不要回复此邮件。
2011年12月23日,食品和药物管理局(FDA)批准修订
TYZEKA产品的标签(替比夫定)包括
禁忌症就与派罗欣(聚乙二醇TYZEKA使用
干扰素α- 2a),由于增加外围的风险和严重程度
神经病。用药指南“也作了相应修改。 “
下面的部分进行了修订:禁忌的TYZEKA结合
聚乙二醇干扰素α- 2a是因为禁忌
周围神经病变的警告和注意事项外设的风险增加
神经病变周围神经病变已TYZEKA单独或在报告
聚乙二醇干扰素α- 2a和其他干扰素的组合。在
一个临床试验的风险增加和周边的严重性
神经病观察TYZEKA每日600mg的组合使用
和聚乙二醇干扰素α- 2a 180微克,每周一次相比,
TYZEKA或聚乙二醇干扰素α- 2a单独[见禁忌(4)
和药物相互作用(7)]。这种风险不能排除其他剂量
方案的聚乙二醇干扰素α- 2a,或其他阿尔法干扰素
(聚乙二醇或标准)。 TYZEKA的安全性和疗效
结合聚乙二醇干扰素或其他干扰素
治疗慢性乙型肝炎尚未得到证实。患者
应告知报告任何麻木,刺痛,和/或燃烧
在武器和/或腿的感觉,或步态不稳。
TYZEKA治疗应中断,如果怀疑是周围神经病变,
并停止周围神经病变,如果证实药物相互作用:
调查TYZEKA,每天600毫克的组合,一个临床试验
聚乙二醇干扰素α- 2a,180微克,每周一次
皮下给药,表明这个组合是
与周围神经病变的发生风险增加
和严重程度,在比较TYZEKA或聚乙二醇干扰素α- 2a
特别健康问题的食品和药物单独理查德克莱因办公室
金佰利斯特鲁布尔管理部的抗病毒药物,食品加工业
药品监督管理局




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