Aubagio(teriflunomide，特立氟胺)-新一代复发型多发性硬化症治疗新药
Generic Name and Formulations:
Teriflunomide 7mg, 14mg; tablets.
Company:
Genzyme Corporation
Indications for AUBAGIO:
Relapsing forms of multiple sclerosis (MS).
Adult:
7mg or 14mg once daily.
Children:
Not established.
Pharmacological Class:
Pyrimidine synthesis inhibitor.
Contraindications:
Severe hepatic impairment. Pregnancy (Cat.X), women of childbearing potential not using reliable contraception. Co-administration with leflunomide.
Warnings/Precautions:
Perform accelerated elimination procedure (see literature) after drug discontinuance. Severe liver injury may be possible; obtain transaminase and bilirubin levels within 6 months before starting, monitor ALT at least monthly for 6 months after starting. Discontinue if drug-induced liver injury suspected; monitor liver tests weekly until normalized. Pre-existing liver disease: increased risk of developing elevated serum transaminases. Obtain CBCs within 6 months prior to starting. Severe immunodeficiency, bone marrow disease, or severe, uncontrolled infections: not recommended. Screen for latent TB; do not start therapy until infection resolved. Monitor BP before starting and periodically. Diabetes, >60 years: increased risk of peripheral neuropathy. Monitor for new onset or worsening pulmonary symptoms, discontinue if interstitial lung disease suspected. Male patients: undergo elimination procedure before fathering child. Nursing mothers: not recommended.
Interactions:
See Contraindications. Live vaccines: not recommended. Risk of liver injury with hepatotoxic drugs. Risk of peripheral neuropathy with neurotoxic drugs. Potentiates drugs metabolized by CYP2C8 (eg, repaglinide, paclitaxel, pioglitazone, rosiglitazone), oral contraceptives. Antagonizes drugs metabolized by CYP1A2 (eg, duloxetine, alosetron, theophylline, tizanidine). Monitor INR. Concomitant immunosuppressives, immunomodulators: not eva luated.
Adverse Reactions:
ALT increased, alopecia, diarrhea, influenza, nausea, paresthesia; bone marrow suppression, immunosuppression potential, infection (consider suspending therapy), peripheral neuropathy; hyperkalemia, acute renal failure (check K+ levels); possible severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis; discontinue if occurs), respiratory effects.
Metabolism:
Hepatic; >99% protein bound.
Elimination:
Fecal, renal.
How Supplied:
Tabs—5, 28
FDA批准多发性硬化治疗新药Aubagio(teriflunomide，特立氟胺)
美国食品药品监督管理局(FDA)9月12日批准Aubagio(teriflunomide，特立氟胺)，每天1次的片剂治疗成人复发型多发性硬化症(MS)。
FDA的药物评价和研究中心神经学产品分部主任Russell Katz博士说：“在一项临床试验中，用Aubagio患者的复发率比服用安慰剂患者低约30%”。“多发性硬化症可损害运动，感觉，和思维，所以给患者多种治疗选择很重要。”
MS 是一种中枢神经系统的慢性、炎性、自身免疫疾性病，疾病破坏脑与身体其他部位的练习。它是造成年轻患者神经疾病最常见的原因，女性发病是男性的至少两倍。对大多数MS患者来说，疾病早期有多次复发和缓解，随着时间的推移，缓解可能不完全，导致渐进性恶化。
在临床试验中患者经历的最常见副作用包括腹泻，肝功能试验异常，恶心和脱发。
药物包含一个黑框警告，警告处方者和患者注意肝脏问题的风险，包括死亡，以及出生缺陷的风险。患者开始服用Aubagio前和治疗期间，医生应定期对其进行肝功能检测。
黑框警告还提到，根据动物研究，药物可能会对胎儿造成危害。基于这个理由，Aubagio被标记为妊娠X类，即意味着育龄妇女在用药前妊娠检验需阴性，且治疗期间使用有效的避孕措施。
Aubagio由赛诺菲 (Sanofi)及其子公司健赞（GenzyME）制造。
