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Aubagio

"The U.S. Food and Drug Administration today approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS).

MS is a chronic, inflammatory, autoimmune disease of the central nervous system"...

Aubagio

Indications
Dosage
How Supplied

INDICATIONS

AUBAGIO® is indicated for the treatment of patients with relapsing forms of multiple sclerosis.

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.

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].
  • 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].
  • 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].
  • Check blood pressure before start of AUBAGIO treatment and periodically thereafter [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

AUBAGIO is available as 7 mg and 14 mg tablets.

The 14 mg tablet is a 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 7 mg tablet is a 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 7 mg of teriflunomide.

Storage And Handling

AUBAGIO is available as 7 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 7 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 7 mg of teriflunomide.

AUBAGIO 14 mg tablets are supplied as:

NDC 58468-0210-2 Carton of 28 tablets containing 1 wallet composed of 2 folded blister cards of 14 tablets per blister card
NDC 58468-0210-1 Carton of 5 tablets with one blister card with five tablets AUBAGIO 7 mg tablets are supplied as:
NDC 58468-0211-1 Carton of 28 tablets containing 1 wallet composed of 2 folded blister cards of 14 tablets per blister card
NDC 58468-0211-2 Carton of 5 tablets with one blister card with five tablets

Store at 68°F to 77°F (20°C to 25°C) with excursions permitted between 59°F and 86°F (15°C and 30°C).

Genzyme Corporation 500 Kendall Street Cambridge, MA 02142 A SANOFI COMPANY. Revised: October 2014

Last reviewed on RxList: 11/3/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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