Filgotinib

Source: UK SPC (eMC) for Jyseleca 100 mg film-coated tablets, §4.2 (https://www.medicines.org.uk/emc/product/11809/smpc). For long term treatment the lowest effective dose should be used. PRESCRIBER: treatment should be initiated by a physician experienced in the treatment of rheumatoid arthritis or ulcerative colitis. OTHER LICENSED INDICATION - ULCERATIVE COLITIS: induction treatment 200 mg once daily; for patients who do not show an adequate therapeutic benefit during the initial 10 weeks, 12 additional weeks of induction with 200 mg once daily may provide additional relief of symptoms, and patients who have not shown any therapeutic benefit after 22 weeks should discontinue filgotinib. Maintenance treatment 200 mg once daily; in adults at higher risk of VTE, MACE and malignancy the recommended maintenance dose is 100 mg once daily, escalated to 200 mg once daily in case of a flare. §4.4 RESTRICTION: filgotinib 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 (e.g. current malignancy or history of malignancy). ELDERLY: in rheumatoid arthritis patients aged 65 years and older the recommended dose is 100 mg once daily, which may be escalated to 200 mg once daily in case of insufficient disease control. In ulcerative colitis patients aged 65 and older the recommended dose is 200 mg once daily for induction and 100 mg once daily for maintenance, escalated to 200 mg once daily in case of a flare. Filgotinib is not recommended in patients aged 75 years and older as there are no data in this population. LABORATORY MONITORING AND DOSE INITIATION/INTERRUPTION (SPC Table 1): treatment should not be initiated, or should be interrupted, if the absolute neutrophil count is less than 1 x 10^9 cells/L, if the absolute lymphocyte count is less than 0.5 x 10^9 cells/L, or if haemoglobin is less than 8 g/dL - treatment may be restarted once the value returns above the threshold. These should be checked before treatment initiation and thereafter according to routine patient management. Lipid parameters should be checked 12 weeks after initiation and thereafter according to international clinical guidelines for hyperlipidaemia, with patients managed according to those guidelines. Treatment should be interrupted if a patient develops a serious infection until the infection is controlled. Patients should be screened for tuberculosis before initiating filgotinib; in patients with latent TB, standard antimycobacterial therapy should be initiated before administering filgotinib. HEPATIC IMPAIRMENT: no dose adjustment is required in mild or moderate hepatic impairment (Child-Pugh A or B); filgotinib has not been studied in severe hepatic impairment (Child-Pugh C) and is not recommended in these patients. PAEDIATRIC (no per-kg dose is stated): the safety and efficacy of filgotinib in children under the age of 18 years have not yet been established and no data are available. Verify any under-18 use against a children's formulary. SOURCE COVERAGE: this bundle contains no openFDA (US) label for filgotinib - the draft rests on the UK SPC alone.