TOFATOR 5

Tofacitinib
Anti-rheumatic agents (Special categories)

Indication:
Rheumatoid Arthritis: Tofacitinib is indicated for the treatment of adult patients with moderately to severely active Rheumatoid Arthritis 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).

Psoriatic Arthritis: Tofacitinib is indicated for the treatment of adult patients with active Psoriatic Arthritis who have had an inadequate response or intolerance to Methotrexate or other Disease-Modifying Antirheumatic Drugs (DMARDs).

Ulcerative Colitis: Tofacitinib is indicated for the treatment of adult patients with moderately to severely active Ulcerative Colitis (UC).

Dosage & Administration:
Administration instructions
Do not initiate Tofacitinib if absolute lymphocyte count <500 cells/mm3, an absolute neutrophil count (ANC) <1000 cells/mm3 or hemoglobin <9 g/dL.

Recommended Dosage

Rheumatoid Arthritis: Tofacitinib 5 mg twice daily. Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is Tofacitinib 5 mg once daily.

Psoriatic Arthritis (in combination with nonbiologic DMARDs): Tofacitinib 5 mg twice daily. Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is Tofacitinib 5 mg once daily.

Ulcerative Colitis: Tofacitinib 10 mg twice daily for at least 8 weeks; then 5 or 10 mg twice daily. Discontinue after 16 weeks of 10 mg twice daily, if adequate therapeutic benefit is not achieved. Use the lowest effective dose to maintain response.

Use in patients with severe hepatic or renal impairment is not recommended.

Preparation:
Each box contains blister strip of 10 tablets.



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