Momelotinib (Specialist drug)

SOURCE: UK SPC (Omjjara 100 mg film-coated tablets, https://www.medicines.org.uk/emc/product/15490/smpc), section 4.2. Verbatim: 'The recommended dose is 200 mg once daily.' Treatment should be initiated and monitored by physicians experienced in the use of anti-cancer medicinal products. MUST NOT be used in combination with other JAK inhibitors. MONITORING: complete blood cell count and liver function tests must be performed before initiating treatment, periodically during treatment, and as clinically indicated. DURATION: treatment may be continued for as long as the benefit-risk remains positive for the patient, as assessed by the treating physician. MISSED DOSE: if a dose is missed, the next scheduled dose should be taken the following day — two doses should not be taken at the same time to make up for the missed dose. DOSE MODIFICATIONS (section 4.2, Table 1) — thrombocytopenia: with a baseline platelet count of 100 x 10^9/L or more, a platelet count of 20 to below 50 x 10^9/L calls for the daily dose to be reduced by 50 mg from the last given dose; a platelet count below 20 x 10^9/L calls for interruption until platelets recover to 50 x 10^9/L, restarting at a daily dose 50 mg below the last given dose. With a baseline platelet count of 50 to below 100 x 10^9/L, or a baseline below 50 x 10^9/L, a platelet count below 20 x 10^9/L calls for interruption until platelets recover (to 50 x 10^9/L, or to baseline respectively), restarting 50 mg below the last given dose. Neutropenia: for ANC below 0.5 x 10^9/L, interrupt until ANC is 0.75 x 10^9/L or above, then restart 50 mg below the last given dose. Hepatotoxicity (unless other apparent causes): for ALT and/or AST above 5 x ULN (or above 5 x baseline if baseline is abnormal) and/or total bilirubin above 2 x ULN (or above 2 x baseline if baseline is abnormal), interrupt until AST and ALT are 2 x ULN or baseline or lower and total bilirubin is 1.5 x ULN or baseline or lower, then restart 50 mg below the last given dose; if ALT or AST elevations above 5 x ULN recur, permanently discontinue. Other non-haematologic Grade 3 or higher, or Grade 2 or higher bleeding: interrupt until the toxicity resolves to Grade 1 or lower (or baseline), then restart 50 mg below the last given dose. Treatment may be reinitiated at 100 mg if previously dosed at 100 mg, and reinitiation or escalation up to the starting dosage should be as clinically appropriate. DISCONTINUE in patients unable to tolerate 100 mg once daily. HEPATIC IMPAIRMENT: no dose adjustment is recommended for mild or moderate impairment; the recommended STARTING dose is 150 mg once daily in patients with SEVERE hepatic impairment (Child-Pugh Class C). ELDERLY: no dose adjustment is required for patients aged 65 years and older. PAEDIATRIC: 'The safety and efficacy of Omjjara in children and adolescents less than 18 years of age have not been established. No data are available.' No per-kg paediatric dose is stated, so paedDose is null; verify any under-18 use against a children's formulary. Section 4.4 and 4.8 of the SPC were truncated at the source-fetch limit.