Aubagio 7 mg/1
teriflunomide · TABLET, FILM COATED · Genzyme Corporation
Aubagio is a tablet, film coated containing teriflunomide at 7 mg/1, taken oral. Manufactured by Genzyme Corporation.
Key Facts
- Brand Name
- Aubagio
- Generic Name
- teriflunomide
- NDC Code (Product)
58468-0211- Manufacturer
- Genzyme Corporation
- Strength
- 7 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA202992
- Drug Class
- Pyrimidine Synthesis Inhibitor [EPC]
- Marketing Start
- 05/01/2013
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE AUBAGIO ® is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. AUBAGIO is a pyrimidine synthesis inhibitor indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dose of AUBAGIO is 7 mg or 14 mg orally once daily. AUBAGIO can be taken with or without food. 7 mg or 14 mg orally once daily, with or without food. ( 2 ) Monitoring to Assess Safety Obtain transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for six months after starting AUBAGIO [see Warnings and Precautions (5.1) ] . Obtain a complete blood cell count (CBC) within 6 months before the initiation of treatment with AUBAGIO. Further monitoring should be based on signs and symptoms of infection [see Warnings and Precautions (5.4) ] . Prior to initiating AUBAGIO, screen patients for latent tuberculosis infection with a tuberculin skin test or blood test for mycobacterium tuberculosis infection [see Warnings and Precautions (5.4) ] . Exclude pregnancy prior to initiation of treatment with AUBAGIO in females of reproductive potential [see Warnings and Precautions (5.2) ] . Check blood pressure before start of AUBAGIO treatment and periodically thereafter [see Warnings and Precautions (5.10) ] .
Contraindications
4 CONTRAINDICATIONS Severe hepatic impairment ( 4 , 5.1 ) Pregnancy ( 4 , 5.2 , 8.1 ) Hypersensitivity ( 4 , 5.5 ) Current leflunomide treatment ( 4 ) AUBAGIO is contraindicated in/with: Patients with severe hepatic impairment [see Warnings and Precautions (5.1) ] . Pregnant women and females of reproductive potential not using effective contraception. AUBAGIO may cause fetal harm [see Warnings and Precautions (5.2 , 5.3) and Use in Specific Populations (8.1) ] . Patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in AUBAGIO. Reactions have included anaphylaxis, angioedema, and serious skin reactions [see Warnings and Precautions (5.5) ]. Coadministration with leflunomide [see Clinical Pharmacology (12.3) ].
Drug Interactions
7 DRUG INTERACTIONS Drugs metabolized by CYP2C8 and OAT3 transporters: Monitor patients because teriflunomide may increase exposure of these drugs. ( 7 ) Teriflunomide may increase exposure of ethinylestradiol and levonorgestrel. Choose an appropriate oral contraceptive. ( 7 ) Drugs metabolized by CYP1A2: Monitor patients because teriflunomide may decrease exposure of these drugs. ( 7 ) Warfarin: Monitor INR as teriflunomide may decrease INR. ( 7 ) Drugs metabolized by BCRP and OATP1B1/B3 transporters: Monitor patients because teriflunomide may increase exposure of these drugs. ( 7 ) Rosuvastatin: The dose of rosuvastatin should not exceed 10 mg once daily in patients taking AUBAGIO. ( 7 ) Effect of AUBAGIO on CYP2C8 Substrates Teriflunomide is an inhibitor of CYP2C8 in vivo . In patients taking AUBAGIO, exposure of drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone, repaglinide, rosiglitazone) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP2C8 as required [see Clinical Pharmacology (12.3) ] . Effect of AUBAGIO on Warfarin Coadministration of AUBAGIO with warfarin requires close monitoring of the international norm…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the prescribing information: Hepatotoxicity [see Contraindications (4) and Warnings and Precautions (5.1) ] Bone Marrow Effects/Immunosuppression Potential/Infections [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Contraindications (4) and Warnings and Precautions (5.5) ] Serious Skin Reactions [see Warnings and Precautions (5.6) ] Drug Reaction with Eosinophilia and Systemic Symptoms [see Warnings and Precautions (5.7) ] Cutaneous or Mucocutaneous Ulcers and Impaired Wound Healing [see Warnings and Precautions (5.8) ] Peripheral Neuropathy [see Warnings and Precautions (5.9) ] Increased Blood Pressure [see Warnings and Precautions (5.10) ] Respiratory Effects [see Warnings and Precautions (5.11) ] Pancreatitis in Pediatric Patients [see Warnings and Precautions (5.12) ] Most common adverse reactions (≥10% and ≥2% greater than placebo): headache, diarrhea, nausea, alopecia, increase in ALT. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-800-745-4447 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience…
Frequently Asked Questions
What is Aubagio used for?
Aubagio contains teriflunomide. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Aubagio a controlled substance?
Aubagio is not classified as a controlled substance by the DEA.
What is the generic name for Aubagio?
The generic name for Aubagio is teriflunomide. There are 11 other brand versions of teriflunomide.
What is the NDC code for Aubagio 7 mg/1?
The NDC (National Drug Code) for Aubagio 7 mg/1 is 58468-0211, listed by Genzyme Corporation.