Rx Item-Aubagio Ks 14mg Tab by Richmond Warehouse Serv Prog

AUBAGIO- teriflunomide tablet, film coated
Genzyme Corp.

WARNING: HEPATOTOXICITY and RISK OF TERATOGENICITY
Hepatotoxicity
Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide, which is indicated for rheumatoid arthritis. similar risk would be expected for teriflunomide because recommended doses of teriflunomide and leflunomide result in similar range of plasma concentrations of teriflunomide. Concomitant use of AUBAGIO with other potentially hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for six months after starting AUBAGIO If drug induced liver injury is suspected, discontinue AUBAGIO and start an accelerated elimination procedure with cholestyramine or charcoal AUBAGIO is contraindicated in patients with severe hepatic impairment Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking AUBAGIO.


DESCRIPTION
AUBAGIO (teriflunomide) is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12 H9 F3 N2 O2
Teriflunomide is white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water.
Teriflunomide is formulated as film-coated tablets for oral administration. AUBAGIO tablets contain mg or 14 mg of teriflunomide and the following inactive ingredients: lactose monohydrate, corn starch, hydroxypropylcellulose, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. The film coating for the 14 mg tablet is made of hypromellose, titanium dioxide, talc, polyethylene glycol and indigo carmine aluminum lake. In addition to these, the mg tablet film coating includes iron oxide yellow.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Teriflunomide, an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase, mitochondrial enzyme involved in de novo pyrimidine synthesis. The exact mechanism by which teriflunomide exerts its therapeutic effect in multiple sclerosis is unknown but may involve reduction in the number of activated lymphocytes in CNS.

Risk of Teratogenicity
Based on animal data, AUBAGIO may cause major birth defects if used during pregnancy. Pregnancy must be excluded before starting AUBAGIO. AUBAGIO is contraindicated in pregnant women or women of childbearing potential who are not using reliable contraception. Pregnancy must be avoided during AUBAGIO treatment or prior to the completion of an accelerated elimination procedure after AUBAGIO treatment
INDICATIONS AND USAGE
AUBAGIO? is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
2 DOSAGE AND ADMINISTRATION
The recommended dose of AUBAGIO is mg or 14 mg orally once daily. AUBAGIO can be taken with or without food.
Monitoring to assess safety
Obtain transaminase and bilirubin levels within months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for six months after starting AUBAGIO .
Obtain complete blood cell count (CBC) within months before the initiation of treatment with AUBAGIO. Further monitoring should be based on signs and symptoms of infection .
Prior to initiating AUBAGIO, screen patients for latent tuberculosis infection with tuberculin skin test or blood test for mycobacterium tuberculosis infection .
Check blood pressure before start of AUBAGIO treatment and periodically thereafter
3 DOSAGE FORMS AND STRENGTHS
AUBAGIO is available as mg and 14 mg tablets.
The 14 mg tablet is pale blue to pastel blue, pentagonal film-coated tablet with the dose strength, ?14? imprinted on one side and engraved with the corporate logo on the other side. Each tablet contains 14 mg of teriflunomide.
The mg tablet is very light greenish-bluish grey to pale greenish-blue, hexagonal film-coated tablet with dose strength ?7? imprinted on one side and engraved with the corporate logo on other side. Each tablet contains mg of teriflunomide.
4 CONTRAINDICATIONS
? AUBAGIO is contraindicated in/with:
Patients with severe hepatic impairment .
Pregnant women or women of childbearing potential not using reliable contraception. AUBAGIO may cause fetal harm
Patients with history of hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in AUBAGIO. Reactions have included anaphylaxis, angioedema, and serious skin reactions .
Co-administration with leflunomide

ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the prescribing info.:
Hepatotoxicity
Bone Marrow Effects/Immunosuppression Potential/Infections [
Hypersensitivity and Serious Skin Reactions
Peripheral Neuropathy
Increased Blood Pressure
Respiratory Effect

Pregnancy
Pregnancy Category
HOW SUPPLIED/STORAGE AND HANDLING
AUBAGIO is available as mg and 14 mg tablets.
The 14 mg tablet is pale blue to pastel blue, pentagonal film-coated tablet with dose strength ?14? imprinted on one side and engraved with corporate logo on the other side. Each tablet contains 14 mg of teriflunomide.
The mg tablet is very light greenish-bluish grey to pale greenish-blue, hexagonal film-coated tablet with dose strength ?7? imprinted on one side and engraved with corporate logo on other side. Each tablet contains mg of teriflunomide

Aubagio Ks 14mg Tab by Richmond Warehous
NDC No.58468-0210-02 UPC/GTIN No.3-58468-21002-9 MPN 21002 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapis

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Richmond Warehouse Serv Prog

TERIFLUNOMIDE ORAL TABLET
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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