Abrocitinib

Source: UK SPC (eMC) for Cibinqo 100 mg film-coated tablets, §4.2 (https://www.medicines.org.uk/emc/product/12873/smpc). Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of atopic dermatitis. A starting dose of 100 mg once daily is recommended for adolescents (12 to 17 years old) and for patients at higher risk of venous thromboembolism (VTE), major adverse cardiovascular event (MACE) and malignancy; if response to 100 mg once daily is inadequate the dose can be increased to 200 mg once daily. A dose of 200 mg once daily may be appropriate for patients who are not at higher risk of VTE, MACE and malignancy with high disease burden, or for patients with an inadequate response to 100 mg once daily. Upon disease control the dose should be decreased to 100 mg once daily; if disease control is not maintained after dose reduction, re-treatment with 200 mg once daily can be considered. The lowest effective maintenance dose should be considered. Discontinuation should be considered in patients showing no evidence of therapeutic benefit after 24 weeks. Can be used with or without medicated topical therapies. TREATMENT INITIATION: treatment should NOT be initiated in patients with a platelet count < 150 x 10^3/mm3, an absolute lymphocyte count (ALC) < 0.5 x 10^3/mm3, an absolute neutrophil count (ANC) < 1 x 10^3/mm3, or a haemoglobin value < 8 g/dL. DOSE INTERRUPTION: consider interruption if a serious infection, sepsis or opportunistic infection develops, until the infection is controlled; interruption may also be needed to manage laboratory abnormalities (SPC Table 1). MISSED DOSE: take as soon as possible unless less than 12 hours before the next dose, in which case skip it and resume the regular schedule. §4.4 RESTRICTION: abrocitinib should only be used if no suitable treatment alternatives are available in patients 65 years of age and older, patients with a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers), and patients with malignancy risk factors. Patients should be screened for TB before starting treatment. ELDERLY: for patients 65 years of age and older the recommended dose is 100 mg once daily. HEPATIC IMPAIRMENT: no dose adjustment in mild (Child Pugh A) or moderate (Child Pugh B); must not be used in severe (Child Pugh C). PAEDIATRIC (not a per-kg dose, so not expressed as mg/kg): the recommended starting dose for adolescents 12 to 17 years old is 100 mg once daily; safety and efficacy in children under 12 years of age have not yet been established and no data are available. Verify any under-18 use against a children's formulary. METHOD OF ADMINISTRATION: taken orally once daily with or without food at approximately the same time each day; taking with food may improve nausea; tablets swallowed whole with water, not split, crushed or chewed. §4.5 was not retrieved in this bundle — the interactions listed below are taken from the §4.2 Interactions paragraph; verify the full §4.5. No absolute adult maximum daily dose is stated in §4.2 other than the 100 mg/day cap in severe renal impairment (see renalAdjustment).