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AUBAGIO (teriflunomide) tablets, for oral use
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use AUBAGIO - ® safely and effectively. See full prescribing information for AUBAGIO. AUBAGIO (teriflunomide) tablets ...
These highlights do not include all the information needed to use AUBAGIO ® safely and effectively. See full prescribing information for AUBAGIO.
AUBAGIO (teriflunomide) tablets, for oral use
Initial U.S. Approval: 2012
WARNING: HEPATOTOXICITY and RISK OF TERATOGENICITY
See full prescribing information for complete boxed warning
Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide, which is indicated for rheumatoid arthritis. A similar risk would be expected for teriflunomide because recommended doses of teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. Obtain transaminase and bilirubin levels within 6 months before initiation of AUBAGIO and monitor ALT levels at least monthly for six months (5.1). If drug induced liver injury is suspected, discontinue AUBAGIO and start accelerated elimination procedure (5.3).
Teratogenicity and embryolethality occurred in animals administered teriflunomide (5.2, 8.1). Exclude pregnancy prior to initiating AUBAGIO therapy (4, 5.2, 8.1). Advise use of effective contraception in females of reproductive potential during treatment and during an accelerated drug elimination procedure (4, 5.2, 5.3, 8.1). Stop AUBAGIO and use an accelerated drug elimination procedure if the patient becomes pregnant (5.2, 5.3, 8.1).
RECENT MAJOR CHANGES
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Boxed Warning,Risk of Teratogenicity |
11/2016 |
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Dosage and Administration (2) |
11/2016 |
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Contraindications, Hypersensitivity (4) |
06/2016 |
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Warnings and Precautions, Teratogenicity (5.2) |
11/2016 |
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Warnings and Precautions, Bone Marrow Effects/Immunosuppression Potential/Infections (5.4) |
06/2016 |
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Warnings and Precautions, Hypersensitivity and Serious Skin Reactions (5.5) |
06/2016 |
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Warnings and Precautions, Respiratory Effects (5.8) |
06/2016 |
INDICATIONS AND USAGE
AUBAGIO is a pyrimidine synthesis inhibitor indicated for the treatment of patients with relapsing forms of multiple sclerosis (1)
DOSAGE AND ADMINISTRATION
7 mg or 14 mg orally once daily, with or without food. (2)
DOSAGE FORMS AND STRENGTHS
7 mg and 14 mg film-coated tablets (3)
CONTRAINDICATIONS
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Severe hepatic impairment (4, 5.1)
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Pregnancy (4, 5.2, 8.1)
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Hypersensitivity (4, 5.5)
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Current leflunomide treatment (4)
WARNINGS AND PRECAUTIONS
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Elimination of AUBAGIO can be accelerated by administration of cholestyramine or activated charcoal for 11 days (5.3)
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AUBAGIO may decrease WBC. A recent CBC should be available before starting AUBAGIO. Monitor for signs and symptoms of infection. Consider suspending treatment with AUBAGIO in case of serious infection. Do not start AUBAGIO in patients with active infections (5.4)
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Stop AUBAGIO if patient has anaphylaxis, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis; initiate rapid elimination (5.3, 5.5)
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If patient develops symptoms consistent with peripheral neuropathy, eva luate patient and consider discontinuing AUBAGIO (5.6)
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AUBAGIO may increase blood pressure. Measure blood pressure at treatment initiation and monitor blood pressure during treatment (5.7)
ADVERSE REACTIONS
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.
DRUG INTERACTIONS
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Drugs metabolized by CYP2C8 and OAT3 transporters: Monitor patients because teriflunomide may increase exposure of these drugs (7)
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Teriflunomide may increase exposure of ethinylestradiol and levonorgestrel. Choose an appropriate oral contraceptive (7)
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Drugs metabolized by CYP1A2: Monitor patients because teriflunomide may decrease exposure of these drugs (7)
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Warfarin: Monitor INR as teriflunomide may decrease INR (7)
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Drugs metabolized by BCRP and OATP1B1/B3 transporters: Monitor patients because teriflunomide may increase exposure of these drugs (7)
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Rosuvastatin: The dose of rosuvastatin should not exceed 10 mg once daily in patients taking AUBAGIO (7)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 11/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
Table of Contents
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