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New drug index
Drug: AUBAGIO ®(teriflunomide) tablets, for oral
/ PDF] Dosing: Click (+) next to Dosage and Administration section
(drug info link)
Initial U.S. Approval: 2012
Mechanism of Action: Teriflunomide, an immunomodulatory agent
with anti-inflammatory properties, inhibits dihydroorotate
dehydrogenase, a 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 a
reduction in the number of activated lymphocytes in CNS.
INDICATIONS AND USAGE: AUBAGIO is a pyrimidine synthesis
inhibitor 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 (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)].
Check blood pressure before start of AUBAGIO treatment and periodically
thereafter [see Warnings and Precautions (5.7)].
HEPATOTOXICITY and RISK OF TERATOGENICITY
See full prescribing information for complete boxed warning
Severe hepatic impairment
Current leflunomide treatment