Indications for AUBAGIO:
Relapsing forms of multiple sclerosis (MS).
Adult Dose for AUBAGIO:
7mg or 14mg once daily.
Children's Dose for AUBAGIO:
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.
Generic Availability:
NO
How Supplied:
Tabs—5, 28
Aubagio(teriflunomide)使用说明
批准日期：September 12，2012；公司：Sanofi
FDA的药物评价和研究中心神经学产品分部主任Russell Katz，M.D.说：“在一项临床试验中，用Aubagio患者复发率比服用安慰剂患者较低约30%”。“多发性硬化症可损害运动，感觉，和思维，所以对患者有各种各样治疗选择得到很重要。”
药物包含一个黑框警告，警告处方者和患者肝脏问题的风险，包括死亡，和出生缺陷的风险。患者开始服用Aubagio前和治疗期间定期医生应进行血液检验核查肝功能。
在黑框警告中还包括一个警告指出，根据动物研究，药物致胎儿危害。因这个理由，Aubagio被标记属于妊娠类别X，意思是有生育能力年龄妇女在开始药物前必须妊娠检验必须阴性而且治疗期间使用有效避孕节育。
