LEFLUNOMIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEFLUNOMIDE (UNII: G162GK9U4W) (LEFLUNOMIDE - UNII:G162GK9U4W)

Available from:

Lupin Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Leflunomide tablets USP are indicated for the treatment of adults with active rheumatoid arthritis (RA). Leflunomide tablet is contraindicated in: - Pregnant women. Leflunomide tablets may cause fetal harm.  If a woman becomes pregnant while taking this drug, stop leflunomide tablets, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see Warnings and Precautions (5.1 and 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)]. Risk Summary Leflunomide tablet is contraindicated for use in pregnant women because of the potential for fetal harm.  In animal reproduction studies, oral administration of leflunomi

Product summary:

How Supplied Leflunomide tablets USP; 10 mg and 20 mg Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEFLUNOMIDE - LEFLUNOMIDE TABLET, FILM COATED
LUPIN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEFLUNOMIDE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEFLUNOMIDE TABLETS
LEFLUNOMIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Leflunomide is a pyrimidine synthesis inhibitor indicated for the
treatment of adults with active rheumatoid
arthritis. (1)
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
laboratory tests before starting leflunomide tablets. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg and 20 mg. (3)
CONTRAINDICATIONS
Pregnancy. (4, 5.1,8.1)
Severe hepatic impairment. (4,5.2)
Hypersensitivity to leflunomide tablets or any of its inactive
components. (4)
Current teriflunomide treatment. (4)
WARNINGS AND PRECAUTIONS
After stopping leflunomide tablets, it is recommended that an
accelerated drug elimination procedure
be used to reduce the plasma concentrations of the active metabolite,
teriflunomide. (5.3)
Severe infections (including sepsis), pancytopenia, agranulocytosis
and thrombocytopenia: Stop
leflunomide tablets and use accelerated elimination procedure. Do not
start leflunomide tablets in
patients with active infection. Monitor CBCs during treatment with
leflunomide tablets (5.4)
Stevens-Johnson syndrome and toxic epidermal necrolysis: Stop
leflunomide tablets and use
accelerated elimination procedure. (5.5)
Peripheral neuropathy: If patient develops symptoms consistent with
peripheral neuropathy, evaluate
patient and consider disc