Guselkumab

Source: eMC SPC for Tremfya 100 mg OnePress solution for injection in pre-filled pen, §4.2. For use under the guidance and supervision of a physician experienced in the diagnosis and treatment of the indicated conditions. PLAQUE PSORIASIS (the dermatology indication above): consider discontinuing treatment in patients who have shown no response after 16 weeks. PSORIATIC ARTHRITIS: 100 mg subcutaneously at weeks 0 and 4, then every 8 weeks; for patients at high risk of joint damage according to clinical judgement a dose of 100 mg every 4 weeks (q4w) may be considered; consider discontinuing if no response after 24 weeks. CROHN'S DISEASE and ULCERATIVE COLITIS (different presentations — see the separate SPCs for Tremfya 200 mg concentrate for solution for infusion and Tremfya 200 mg solution for injection): induction 200 mg by intravenous infusion at weeks 0, 4 and 8, OR 400 mg subcutaneously (as two consecutive 200 mg injections) at weeks 0, 4 and 8; then maintenance from week 16 of 100 mg subcutaneously every 8 weeks, or alternatively 200 mg subcutaneously from week 12 and every 4 weeks thereafter for patients without adequate therapeutic benefit from induction; consider discontinuing if no evidence of therapeutic benefit after 24 weeks. Immunomodulators and/or corticosteroids may be continued during treatment, and corticosteroids may be reduced or discontinued in responders per standard of care. MISSED DOSE: administer as soon as possible, then resume the regular schedule. ELDERLY: no dose adjustment required (limited information in those aged ≥65 years, very limited ≥75 years). PAEDIATRIC (UK SPC): safety and efficacy in children and adolescents below 18 years have not been established and no data are available — no paediatric dose is given here; verify against a children's formulary. For cross-reference only, the US label in the bundle authorises paediatric patients 6 years and older who also weigh at least 40 kg at the same flat 100 mg subcutaneous dose (weeks 0, 4, then every 8 weeks) for plaque psoriasis and psoriatic arthritis, with self-administration not recommended — US labelling, differs from the UK SPC. ADMINISTRATION: inject into the abdomen, thigh or back of the upper arm; do not inject into skin that is tender, bruised, red, hard, thick or scaly, and if possible avoid areas showing psoriasis. Patients may self-inject after proper training if the physician determines it appropriate, with appropriate medical follow-up. Evaluate for tuberculosis before initiating; complete appropriate immunisations before starting therapy.