Multiple sclerosis:

Indications for: AUBAGIO

Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Adult Dosage:

7mg or 14mg once daily.

Children Dosage:

Not established.

AUBAGIO Contraindications:

Severe hepatic impairment. Pregnant women and females of reproductive potential not using effective contraception. Allergy to or co-administration with leflunomide.

Boxed Warning:

Hepatotoxicity. Embryo-fetal toxicity.

AUBAGIO Warnings/Precautions:

Risk of potentially life-threatening liver injury: obtain serum transaminase and bilirubin levels within 6 months prior to initiation, monitor ALT at least monthly for 6 months after starting. Consider discontinuing if transaminases >3×ULN 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 >2×ULN prior to initiation: do not treat. Embryo-fetal toxicity; exclude pregnancy before starting. Advise females of reproductive potential and males to use effective contraception during treatment and until teriflunomide level is verified <0.02mg/L. 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 initiation. Severe immunodeficiency, bone marrow disease, or severe, uncontrolled infections: not recommended. Screen for latent TB; if test positive, treat prior to initiation. 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: not recommended.

AUBAGIO Classification:

Pyrimidine synthesis inhibitor.

AUBAGIO Interactions:

See Contraindications. Live vaccines: not recommended. Increased risk of liver injury with hepatotoxic drugs; monitor. 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; monitor. Antagonizes drugs metabolized by CYP1A2 (eg, duloxetine, alosetron, theophylline, tizanidine); monitor. Monitor INR with warfarin. Concomitant immunosuppressives, immunomodulators: not evaluated.

Adverse Reactions:

Headache, ALT increased, diarrhea, alopecia, nausea, paresthesia; hepatotoxicity, bone marrow suppression, immunosuppression potential, infection (consider suspending therapy), hypersensitivity, serious skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms; discontinue if occur), peripheral neuropathy, hypertension, interstitial lung disease.

Generic Drug Availability:


How Supplied:

Tabs—5, 28, 30