Medically reviewed by Drugs.com. Last updated on Nov 28, 2022.
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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