Arava

• Teratogenicity and embryo-lethality occurred in animals administered leflunomide.
• Exclude pregnancy prior to initiating ARAVA therapy.
• Advise use of effective contraception in females of reproductive potential during treatment and during a drug elimination procedure.
• Stop ARAVA and use an accelerated drug elimination procedure if the patient becomes pregnant.

• Severe liver injury and fatal liver failure have been reported.
• Avoid ARAVA use in patients with pre-existing liver disease, or those with serum alanine aminotransferase (ALT) >2 × ULN.
• Use caution when ARAVA is given with other potentially hepatotoxic drugs.
• Monitor ALT levels. Interrupt ARAVA treatment if ALT elevation >3-fold ULN. If likely leflunomide-induced, start accelerated drug elimination procedure and monitor liver tests weekly until normalized.

ARAVA is indicated for the treatment of adults with active rheumatoid arthritis (RA).

• Loading dosage for patients at low risk for ARAVA-associated hepatotoxicity and ARAVA-associated myelosuppression: 100 mg daily for 3 days.
• Maintenance dosage: 20 mg daily.
  • Maximum recommended daily dosage: 20 mg once daily.
  • If 20 mg once daily is not tolerated, may decrease dosage to 10 mg once daily.
• Screen patients for active and latent tuberculosis, pregnancy test (females), blood pressure, and laboratory tests before starting ARAVA.

ARAVA Tablets are available in three strengths:

• Tablets: 10 mg, supplied as white, round film-coated tablet embossed with "ZBN" on one side
• Tablets: 20 mg, supplied as light-yellow, triangular film-coated tablet embossed with "ZBO" on one side
• Tablets: 100 mg, supplied as white, round film-coated tablet embossed with "ZBP" on one side

• Lactation: Discontinue breastfeeding.
• Females and Males of Reproductive Potential: See FPI for information regarding contraception.
• Safety and effectiveness in pediatric patients <12 years of age have not been established.