Tofacitinib

SHARED CARD: one published record is shown on both the rheumatology (RA / PsA / AS) page and the gi-hepatology (ulcerative colitis) page, so each licensed adult indication is dosed separately above with its own figures as printed. Pinned product: XELJANZ 5 mg film-coated tablets (eMC product 2500). No maximum dose is stored: the SPC's 'which should not be exceeded' ceiling of 5 mg twice daily is printed for rheumatoid arthritis and psoriatic arthritis only, and no maximum is printed for ulcerative colitis. SPC section 4.2: treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of the conditions for which tofacitinib is indicated. Licensed adult indications (section 4.1): RA in combination with methotrexate (monotherapy if MTX intolerance or MTX inappropriate) after an inadequate response to, or intolerance of, one or more DMARDs; active PsA in combination with MTX after an inadequate response or intolerance to a prior DMARD; active AS inadequately responding to conventional therapy; moderately to severely active UC with an inadequate response, loss of response or intolerance to conventional therapy or a biologic agent. UC maintenance at 10 mg twice daily is not recommended in patients with known venous thromboembolism (VTE), major adverse cardiovascular events (MACE) and malignancy risk factors unless there is no suitable alternative treatment; in UC patients not at increased risk for VTE, MACE and malignancy, 10 mg twice daily may be considered if response decreases on 5 mg twice daily and alternative options such as TNF inhibitor treatment have failed; 10 mg twice daily for maintenance should be used for the shortest duration possible, and the lowest effective dose needed to maintain response should be used. In UC responders, corticosteroids may be reduced and/or discontinued in accordance with standard of care. UC retreatment: if therapy is interrupted, restarting can be considered; after a loss of response, reinduction with 10 mg twice daily may be considered (interruption in clinical studies extended up to 1 year; efficacy may be regained by 8 weeks of 10 mg twice daily). AS: clinical improvement is observed within 16 weeks of initiation; continued therapy should be carefully reconsidered in a patient with no clinical improvement in this timeframe. Switching: tofacitinib 5 mg film-coated tablets twice daily and tofacitinib 11 mg prolonged-release tablet once daily may be switched between each other on the day following the last dose of either. Dose interruption and discontinuation in adults (section 4.2): interrupt for a serious infection until it is controlled; it is recommended not to initiate dosing with absolute lymphocyte count (ALC) below 750 cells/mm3, absolute neutrophil count (ANC) below 1,000 cells/mm3 or haemoglobin below 9 g/dL; persistent (2 sequential values) ALC 500-750 or ANC 500-1,000: reduce 10 mg twice daily to 5 mg twice daily, and interrupt if already on 5 mg twice daily; ALC or ANC below 500 confirmed by repeat testing within 7 days: discontinue; haemoglobin fall of more than 2 g/dL or below 8.0 g/dL (confirmed by repeat testing): interrupt until haemoglobin has normalised. Interactions (section 4.2): the total daily dose should be reduced by half with potent CYP3A4 inhibitors (e.g. ketoconazole) and with one or more concomitant medicines giving both moderate CYP3A4 inhibition and potent CYP2C19 inhibition (e.g. fluconazole): 5 mg twice daily becomes 5 mg once daily, and 10 mg twice daily becomes 5 mg twice daily. Elderly: no dose adjustment is required in patients 65 years and older (limited data from 75 years), but section 4.4 says tofacitinib should only be used if no suitable alternative is available in patients 65 years and older, with a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers), or with malignancy risk factors. Children: the SPC also gives weight-banded doses for polyarticular juvenile idiopathic arthritis and juvenile PsA from 2 years of age (not reproduced on this card); safety and efficacy in children below 18 years with other indications, e.g. ulcerative colitis, has not been established and no data are available. Some sections of the product information we used were incomplete — check the full SPC.