Medically reviewed by Drugs.com. Last updated on Dec 8, 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.
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