Medically reviewed by Drugs.com. Last updated on Apr 28, 2020.
Applies to the following strengths: 14 mg; 7 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Multiple Sclerosis
7 mg or 14 mg orally once a day
Use: For the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
-Mild and moderate hepatic impairment: No adjustment recommended.
-Severe hepatic impairment: Contraindicated
US BOXED WARNINGS:
-Severe, sometimes fatal, liver injury has been reported.
-Concomitant use of this drug with other potentially hepatotoxic drugs may increase the risk of severe liver injury.
-Obtain transaminase and bilirubin levels within 6 months of initiating therapy.
-Monitor ALT levels at least monthly for 6 months after initiating therapy.
-If drug induced liver injury is suspected, discontinue this drug and start an accelerated elimination procedure with cholestyramine or charcoal.
-This drug is contraindicated in patients with severe hepatic impairment.
-Patients with preexisting liver disease may be at increased risk of developing elevated serum transaminases when taking this drug.
-This drug is contraindicated for use in pregnant women and in females of reproductive potential who are not using effective contraception.
-Teratogenicity and embryolethality occurred in animals at doses lower than the equivalent human dose.
-Exclude pregnancy before the start of treatment with therapy in females of reproductive potential.
-Advise females of reproductive potential to use effective contraception during therapy and during an accelerated drug elimination procedure after.
-Discontinue this drug and use an accelerated drug elimination procedure if the patient becomes pregnant.
-Hypersensitivity to the active component or any of the ingredients
-Hypersensitivity to leflunomide
-Severe hepatic impairment
-Pregnant women and females of reproductive potential not using effective contraception
-Coadministration with leflunomide
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-This drug can be taken with or without food.
Store at 20C to 25C (68F to 77F); excursions permitted between 15C to 30C (59F to 86F).
-Obtain transaminase and bilirubin levels within 6 months before initiation of therapy.
-Monitor ALT levels at least monthly for 6 months after starting therapy.
-Obtain a complete blood cell count (CBC) within 6 months before the initiation of therapy.; further monitoring should be based on signs of infection.
-Screen patients for latent tuberculosis infection with a tuberculin skin test or blood test for mycobacterium tuberculosis infection before initiating therapy.
-Exclude pregnancy prior to initiation of therapy in females of reproductive potential.
-Check blood pressure before start of therapy and periodically thereafter.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Frequently Asked Questions
- What are the new drugs used for multiple sclerosis (MS)?
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- En Español
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- Drug class: selective immunosuppressants
Other brands: Aubagio