Generic Name and Formulations:
Teriflunomide 7mg, 14mg; tabs.
Sanofi Genzyme Company
Indications for AUBAGIO:
Relapsing forms of multiple sclerosis (MS).
7mg or 14mg once daily.
Severe hepatic impairment. Pregnant women and females of reproductive potential not using effective contraception. Allergy to or co-administration with leflunomide.
Hepatotoxicity. Risk of teratogenicity.
Risk of severe liver injury: obtain serum transaminase and bilirubin levels within 6 months before initiation, monitor ALT at least monthly for 6 months after starting. Consider discontinuing if transaminases >3XULN is confirmed. Discontinue if drug-induced liver injury suspected and start elimination procedure; monitor liver tests weekly until normalized. Pre-existing acute or chronic liver disease, or those with ALT >2XULN prior to initiation: do not treat. Risk of teratogenicity; exclude pregnancy before starting and confirm use of effective contraception during treatment. Perform accelerated elimination procedure: after drug discontinuance, females of reproductive potential who wish to become pregnant or becomes pregnant during therapy, males before fathering child; see full labeling. 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 (with/without fever); discontinue and evaluate if occurs. Nursing mothers.
Pyrimidine synthesis inhibitor.
See Contraindications. Live vaccines: not recommended. Increased risk of liver injury with hepatotoxic drugs. Increased risk of peripheral neuropathy with neurotoxic drugs. Potentiates drugs metabolized by CYP2C8 (eg, repaglinide, paclitaxel, pioglitazone, rosiglitazone), OAT3 substrates (eg, cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine), BCRP substrates (eg, mitoxantrone), OATP drugs (eg, methotrexate, rifampin), HMG-CoA reductase inhibitors (eg, atorvastatin, pravastatin, simvastatin, rosuvastatin [max 10mg once daily]), nateglinide, repaglinide, oral contraceptives. Antagonizes drugs metabolized by CYP1A2 (eg, duloxetine, alosetron, theophylline, tizanidine). Monitor INR with warfarin. Concomitant immunosuppressives, immunomodulators: not evaluated.
Headache, ALT increased, diarrhea, alopecia, nausea, paresthesia; hepatotoxicity, bone marrow suppression, immunosuppression potential, infection (consider suspending therapy), hypersensitivity, severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis; discontinue if occur), peripheral neuropathy, hypertension, respiratory effects.
Hepatic; >99% protein bound.