Leflunomide is the generic equivalent of the brand-name drug Leflunomide. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Leflunomide through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Leflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. ( 1 ) Leflunomide tablets USP are indicated for the treatment of adults with active rheumatoid arthritis (RA).
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: 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 [se…
Drug Interactions
7 DRUG INTERACTIONS 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…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Loading dosage for patients at low risk for leflunomide tablets -associated hepatotoxicity and leflunomide tablets-associated myelosuppression: 100 mg daily for 3 days. ( 2.1 ) Maintenance dosage: 20 mg daily. ( 2.1 ) Maximum recommended daily dosage: 20 mg once daily. ( 2.1 ) If 20 mg once daily is not tolerated, may decrease dosage to 10 mg once daily. ( 2.1 ) Screen patients for active and latent tuberculosis, pregnancy test (females), blood pressure, and laborator…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Embryo-Fetal Toxicity Advise females of reproductive potential: Of the potential for fetal harm if leflunomide tablets are taken during pregnancy. To notify their healthcare provider immediately if a pregnancy occurs or is suspected. To use effective contraception during treatment with leflunomide tablets and until the active metabolite (teriflunomide) plasma concentration is verified to be less than 0.02 mg/L [see Warnings and Precautions ( 5.1 , 5.3 ), Use in Specific Populations ( 8.1 , 8.3 ), and Clinical Pharmacology ( 12.3 )]. Serious Skin Reactions Advi…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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