Tofacit 5 mg Tablet

Oral JAK inhibitor (specialist use) for:

• Moderate to severe rheumatoid arthritis (with or without methotrexate) when other DMARDs fail
• Psoriatic arthritis, ankylosing spondylitis
• Moderate to severe ulcerative colitis
• Polyarticular juvenile idiopathic arthritis (2 years and over)

Rheumatoid/psoriatic arthritis, ankylosing spondylitis: 5 mg twice daily (or 11 mg extended-release once daily).

Ulcerative colitis: induction 10 mg twice daily for 8 weeks (up to 16), then 5 mg twice daily (10 mg twice daily if needed).

• Moderate–severe kidney or moderate liver impairment: 5 mg once daily.
• Screen for TB, hepatitis B/C, blood counts and lipids before starting.

• Active serious infections, active tuberculosis
• Severe liver impairment
• Pregnancy and breastfeeding
• Absolute neutrophil count < 1,000, lymphocytes < 500, haemoglobin < 8 g/dL
• Live vaccines during treatment

Common: upper respiratory infections, headache, diarrhoea, nausea, raised cholesterol, raised liver enzymes, shingles (herpes zoster), high blood pressure.

Serious: serious infections (pneumonia, TB reactivation, opportunistic infections), blood clots (DVT, pulmonary embolism), major cardiovascular events and cancers (higher risk in age ≥ 50 with cardiovascular risk factors, smokers), gastrointestinal perforation, low blood counts.

• Use only when suitable alternatives are not appropriate in people over 65, smokers, or with cardiovascular or cancer risk factors.
• Monitor blood counts, liver tests and lipids.
• Report fever, cough, rash with blisters, leg swelling or chest pain.
• Update vaccinations (including shingles) before starting.

Contraindicated in pregnancy (use contraception during and for 4 weeks after) and breastfeeding.

• Ketoconazole, fluconazole (raise levels — reduce dose to 5 mg once daily)
• Rifampicin (greatly reduces effect)
• Biologic DMARDs, azathioprine, ciclosporin, tacrolimus (excess immunosuppression — avoid)
• Live vaccines

Supportive care; monitor for infection and blood count changes.

Store below 30°C.