INDICATION AND USAGE

Tofacitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, ulcerative colitis (UC) who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

DOSAGE AND ADMINISTRATION

Administration Instructions

Do not initiate TOFAXEN if absolute lymphocyte count <500 cells/mm3, an absolute neutrophil count (ANC) <1000 cells/mm3 or hemoglobin <9 g/dL.

Recommended Dosage

Rheumatoid Arthritis and Psoriatic Arthritis (in combination with nonbiologic DMARDs)

•Tofacitinib (TOFAXEN) 5 mg twice daily. TOFAXEN can be taken with or without food.

•Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is Tofacitinib 5 mg (TOFAXEN) once daily.

Ulcerative Colitis

• The recommended dose is 10 mg Tofacitinib (TOFAXEN) given orally twice daily for induction for 8 weeks and 5 mg given twice daily for maintenance.

•For patients who do not achieve adequate therapeutic benefit by week 8, the induction dose of 10 mg twice daily can be extended for an additional 8 weeks (16 weeks total), followed by 5 mg twice daily for maintenance. Tofacitinib induction therapy should be discontinued in any patient who shows no evidence of therapeutic benefit by week 16.

•Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is half the total daily dose. 
 

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