Tofacitnib

Indications & Dose:

Rheumatoid arthritis:Tofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs)

Psoriatic arthritis: Tofacitinib in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.

Ankylosing spondylitis: Tofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.

Ulcerative colitis: Tofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Juvenile idiopathic arthritis (JIA): Tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis and extended oligoarthritis) and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older who have responded inadequately to previous therapy with DMARDs.

POSOLOGY AND METHOD OF ADMINISTRATION

Rheumatoid arthritis and psoriatic arthritis: 5 mg film-coated tablets administered twice daily which should not be exceeded.

Ankylosing spondylitis: 5 mg administered twice daily.

Ulcerative colitis 10 mg given orally twice daily for induction for 8 weeks.

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.

Contraindications:

Hypersensitivity to the active substance or to any of the excipients Active tuberculosis (TB) serious infections such as sepsis or opportunistic infections Severe hepatic impairment. Pregnancy and lactation For further information see literature.

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