Baricitinib

Source: UK SPC (eMC) §4.2 for Baricitinib Lilly 2 mg film-coated tablets (https://www.medicines.org.uk/emc/product/16005/smpc). VERBATIM (RA): 'The recommended dose of baricitinib is 4 mg once daily. A dose of 2 mg once daily is recommended for patients at higher risk of venous thromboembolism (VTE), major adverse cardiovascular events (MACE) and malignancy, for patients aged >= 65 years and for patients with a history of chronic or recurrent infections.' A dose of 4 mg once daily may be considered for patients who do not achieve adequate control of disease activity on 2 mg once daily; a dose of 2 mg once daily should be considered for patients who have achieved sustained control on 4 mg once daily and are eligible for dose tapering. INITIATION: treatment should be initiated by physicians experienced in the diagnosis and treatment of the indicated conditions. TREATMENT MUST NOT BE INITIATED if the absolute lymphocyte count is less than 0.5 x 10^9 cells/L, the absolute neutrophil count is less than 1 x 10^9 cells/L, or haemoglobin is less than 8 g/dL; treatment may be initiated once values improve above these limits, and should be temporarily interrupted if these thresholds are crossed during treatment. §4.4 RESTRICTION: baricitinib 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. Screen for tuberculosis before starting; do not give in active TB; consider anti-TB therapy before initiation in previously untreated latent TB. OTHER INDICATIONS IN THE SAME SPC — atopic dermatitis (adults): 4 mg once daily with the same 2 mg risk-group/tapering rules; can be used with or without topical corticosteroids; consider discontinuing if no evidence of therapeutic benefit after 8 weeks. Alopecia areata: 4 mg once daily with the same 2 mg risk-group/tapering rules; once a stable response is achieved continue for at least several months to avoid relapse; consider discontinuing if no evidence of therapeutic benefit after 36 weeks. DOSE REDUCTION: in patients taking strong OAT3 inhibitors such as probenecid, the recommended adult dose is 2 mg (paediatric doses halved). ELDERLY: clinical experience in patients aged 75 years and over is very limited. HEPATIC IMPAIRMENT: no dose adjustment in mild or moderate impairment; not recommended in severe hepatic impairment. PAEDIATRIC (weight-band fixed doses, NOT per-kg, so paedDose is null): for atopic dermatitis in children and adolescents 2 years of age and older, and for juvenile idiopathic arthritis from 2 to less than 18 years of age, the recommended dose is 4 mg once daily for patients weighing 30 kg or more and 2 mg once daily for patients weighing 10 kg to less than 30 kg; halve the dose in paediatric patients with creatinine clearance 30-60 mL/min or on strong OAT3 inhibitors. Consider discontinuing if no therapeutic benefit after 8 weeks (atopic dermatitis) or 12 weeks (JIA). Safety and efficacy in children less than 2 years, and in children under 18 with alopecia areata, have not been established. For paediatric patients unable to swallow whole tablets, tablets may be dispersed in water only. Verify any under-18 use against a children's formulary. §4.5 was not retrieved in this bundle (§4.4 truncated at the source-fetch limit) — the only interaction captured is the OAT3-inhibitor dose reduction stated in §4.2; verify the full §4.5.