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

Precautions

US BOXED WARNINGS:
HEPATOTOXICITY:

• 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

Dialysis

Data not available

Other Comments

Administration advice:

• This drug can be taken with or without food.

• 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.

Frequently asked questions

• What are the new drugs used for multiple sclerosis (MS)?
• Ocrevus vs Aubagio: How do they compare for MS?
• Does Aubagio suppress the immune system?
• Can Aubagio cause PML as a side effect?
• How long do Aubagio side effects last?
• Does Aubagio work in multiple sclerosis (MS)?