AUBAGIO (teriflunomide) tablet, film coated
[Genzyme Corp.]
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 for oral administration.
Initial U.S. Approval: 2012
WARNING: HEPATOTOXICITY and RISK OF TERATOGENICITY
See full prescribing information for complete boxed warning
Hepatotoxicity
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).
Risk of Teratogenicity
Based on animal data, AUBAGIO may cause major birth defects if used during pregnancy. AUBAGIO is contraindicated in pregnant women or women of childbearing potential who are not using reliable contraception. Pregnancy must be avoided during AUBAGIO treatment. (4.2, 5.2)
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
Severe hepatic impairment (4.1, 5.1)
Pregnancy (4.2, 5.2, 8.1)
Current leflunomide treatment (4.3)
WARNINGS AND PRECAUTIONS
Elimination of AUBAGIO can be accelerated by administration of cholestyramine or activated charcoal for 11 days (5.3)
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 and using accelerated elimination procedure in case of serious infection. Do not start AUBAGIO in patients with active infections (5.4)
Peripheral neuropathy: If patient develops symptoms consistent with peripheral neuropathy, eva luate patient and consider discontinuing AUBAGIO and using accelerated elimination procedure (5.5)
Acute renal failure/hyperkalemia: Monitor renal function and potassium in patients with symptoms of renal failure or hyperkalemia (5.6, 5.7)
Severe skin reaction: Stop AUBAGIO and use accelerated elimination procedure (5.8)
Blood pressure: Measure at treatment initiation. Monitor and manage appropriately during treatment (5.9)
ADVERSE REACTIONS
Most common adverse reactions (≥10% and ≥2% greater than placebo): ALT increased, alopecia, diarrhea, influenza, nausea, and paresthesia. (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
Drugs metabolized by CYP2C8: Monitor patients as teriflunomide may increase their exposure (7)
Teriflunomide may increase exposure of ethinylestradiol and levonorgestrel. Choose an appropriate oral contraceptive (7)
Drugs metabolized by CYP1A2: Monitor patients as teriflunomide may decrease their exposure (7)
Warfarin: monitor INR as teriflunomide may decrease INR (7)
USE IN SPECIFIC POPULATIONS
Contraindicated in pregnancy; pregnancy registry available (4.2, 8.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide
Revised: 09/2012
FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
WARNING: HEPATOTOXICITY AND RISK OF TERATOGENICITY
1. INDICATIONS AND USAGE
2. DOSAGE AND ADMINISTRATION
3. DOSAGE FORMS AND STRENGTHS
4. CONTRAINDICATIONS
4.1. Severe Hepatic Impairment
4.2 Patients Who are Pregnant or Women of Childbearing Potential Not Using Reliable Contraception
4.3. Current treatment with leflunomide
5. WARNINGS AND PRECAUTIONS
5.1 Hepatotoxicity
5.2 Use in Women of Childbearing Potential
5.3 Procedure for Accelerated Elimination of Teriflunomide
5.4 Bone Marrow Effects/Immunosuppression Potential/Infections
5.5 Peripheral Neuropathy
5.6 Acute Renal Failure
5.7 Hyperkalemia
5.8 Skin Reactions
5.9 Blood Pressure Increase
5.10 Respiratory Effects
5.11 Concomitant Use with Immunosuppressive or Immunomodulating Therapies
6. ADVERSE REACTIONS
6.1 Clinical Trial Experience
7. DRUG INTERACTIONS
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
10. OVERDOSAGE
11. DESCRIPTION
12. CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13. NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
