LEFLUNOMIDE tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Zydus Lifesciences Limited

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Leflunomide tablets are indicated for the treatment of adults with active rheumatoid arthritis (RA). Leflunomide is 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 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)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to leflunomide during pregnancy. Health care providers and patients are encouraged to report pregnancies by calling 1-877-311-8972 or visit

Περίληψη προϊόντος:

How Supplied Leflunomide tablets USP, 10 mg, white to off white, round, film-coated tablets debossed with "57" on one side and "11" on the other side, and are supplied as follow: NDC 70771-1491-3 in bottle of 30 tablets with child-resistant closure NDC 70771-1491-1 in bottle of 100 tablets with child-resistant closure NDC 70771-1491-5 in bottle of 500 tablets Leflunomide tablets USP, 20 mg, white to off white, triangular, film-coated tablets debossed with "58" on one side and "11" on the other side, and are supplied as follow: NDC 70771-1492-3 in bottle of 30 tablets with child-resistant closure NDC 70771-1492-1 in bottle of 100 tablets with child-resistant closure NDC 70771-1492-5 in bottle of 500 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

LEFLUNOMIDE- LEFLUNOMIDE TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
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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
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
EMBRYO-FETAL TOXICITY
TERATOGENICITY AND EMBRYO-LETHALITY OCCURRED IN ANIMALS
ADMINISTEREDLEFLUNOMIDE.
(5.1, 8.1)
EXCLUDE PREGNANCY PRIOR TO INITIATING LEFLUNOMIDE THERAPY. (5.1,8.3)
ADVISE USE OF EFFECTIVE CONTRACEPTION IN FEMALES OF REPRODUCTIVE
POTENTIAL DURING
TREATMENT AND DURING A DRUG ELIMINATION PROCEDURE. (5.1,5.3, 8.3)
STOP LEFLUNOMIDE AND USE AN ACCELERATED DRUG ELIMINATION PROCEDURE IF
THE PATIENT
BECOMES PREGNANT. (5.1, 5.3,8.1)
HEPATOTOXICITY
SEVERE LIVER INJURY AND FATAL LIVER FAILURE HAVE BEEN REPORTED. (5.2)
AVOID LEFLUNOMIDE USE IN PATIENTS WITH PRE-EXISTING LIVER DISEASE, OR
THOSE WITH
SERUM ALANINE AMINOTRANSFERASE (ALT) >2XULN. (5.2,8.6)
USE CAUTION WHEN LEFLUNOMIDE IS GIVEN WITH OTHER POTENTIALLY
HEPATOTOXIC DRUGS.
(5.2)
MONITOR ALT LEVELS. INTERRUPT LEFLUNOMIDE TREATMENT IF ALT ELEVATION >
3 FOLD ULN. IF
LIKELY LEFLUNOMIDE-INDUCED, START ACCELERATED DRUG ELIMINATION
PROCEDURE AND
MONITOR LIVER TESTS WEEKLY UNTIL NORMALIZED. (5.2,5.3)
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-associated
hepatotoxicity and leflunomide-
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. (2.2)