Leflunomide Zbo 00955 1737 30 Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Leflunomide tablets is indicated for the treatment of adults with active rheumatoid arthritis (RA).
What should I know before taking it?
Leflunomide tablets are contraindicated in: •Pregnant women. Leflunomide may cause fetal harm. If a woman becomes pregnant while taking this drug, stop leflunomide, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see Warnings and Precautions (5.1, 5.3) and Use in Specific Populations (8.1)]. •Patients with severe hepatic impairment [see Warnings and Precautions (5.2)]. •Patients with known hypersensitivity to leflunomide or any of the other components of leflunomide tablets. Known reactions include anaphylaxis [see Adverse Reactions (6.1)]. •Patients being treated with teriflunomide [see Drug Interactions (7)].
What important warnings are listed?
Embryo-Fetal Toxicity Leflunomide is contraindicated for use in pregnant women because of the potential for fetal harm. Teratogenicity and embryo-lethality occurred in animals administered leflunomide at doses lower than the human exposure level. Exclude pregnancy before the start of treatment with leflunomide in females of reproductive potential. Advise females of reproductive potential to use effective contraception during leflunomide treatment and during an accelerated drug elimination procedure after leflunomide treatment. Stop leflunomide tablets and use an accelerated drug elimination procedure if the patient becomes pregnant . Hepatotoxicity Severe liver injury, including fatal liver.
How is this medication usually taken?
Leflunomide tablets, USP are available in two strengths: •Tablets: 10 mg, supplied as white, round bi-convex tablets debossed with "HP 43" on one side and plain on the other. •Tablets: 20 mg, supplied as white, triangular bi-convex tablets debossed with "HP 44" on one side and plain on the other.
What side effects are listed?
Hepatotoxicity [see Warnings and Precautions (5.2)] Immunosuppression [see Warnings and Precautions (5.4)] Bone marrow suppression [see Warnings and Precautions (5.4)] Serious infections [see Warnings and Precautions (5.4)] Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reactions with eosinophilia and systemic symptoms [see Warnings and Precautions (5.5)] Skin ulcers [see Warnings and Precautions (5.6)] Peripheral neuropathy [see Warnings and Precautions (5.8)] Interstitial lung disease [see Warnings and Precautions (5.9)]
What interactions are listed?
Following oral administration, leflunomide is metabolized to an active metabolite, teriflunomide, which is responsible for essentially all of leflunomide's in vivo activity. Drug interaction studies have been conducted with both leflunomide and with its active metabolite, teriflunomide, where the metabolite was directly administered to the test subjects. Effect of Potent CYP and Transporter Inducers Leflunomide is metabolized by CYP450 metabolizing enzymes. Concomitant use of leflunomide and rifampin, a potent inducer of CYP and transporters, increased the plasma concentration of teriflunomide by 40%. However, when coadministered with the metabolite, teriflunomide, rifampin did not affect.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=91712aad-d96c-4ef0-97e7-b31ed18ca6d8
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.