Abemaciclib [Specialist drug]

The UK SPC for Verzenios 100 mg film-coated tablets (eMC product 11046) has since been recovered, and it is the right product for this page: the page names brand Verzenios, category CDK4/6 inhibitor, route Oral, and specialty oncology / breast-cancer. The 150 mg twice daily combination dose is confirmed verbatim by this UK SPC. The 200 mg twice daily MONOTHERAPY figure is NOT in this SPC at all — this SPC states the dose only for use in combination with endocrine therapy — so it is not carried into this draft and must not be reinstated without a source that actually contains it. MISSED DOSE: if a patient vomits or misses a dose, the patient should take the next dose at its scheduled time; an additional dose should not be taken. DOSE ADJUSTMENT LEVELS (Table 1): recommended dose 150 mg twice daily, first dose adjustment 100 mg twice daily, second dose adjustment 50 mg twice daily. STRONG CYP3A4 INHIBITORS: concomitant use should be avoided; if unavoidable, reduce abemaciclib to 100 mg twice daily, then to 50 mg twice daily if a strong inhibitor still cannot be avoided; a patient already reduced to 50 mg twice daily may continue with close monitoring for signs of toxicity, or alternatively the dose may be reduced to 50 mg once daily or discontinued. If the CYP3A4 inhibitor is discontinued, increase abemaciclib back to the dose used before it was started, after 3 to 5 half-lives of the inhibitor. CYP3A4 INDUCERS: concomitant use should be avoided because of the risk of decreased efficacy of abemaciclib. BEFORE TREATMENT INITIATION: absolute neutrophil count of 1 500/mm3 or above, platelets of 100 000/mm3 or above, and haemoglobin of 8 g/dL or above are recommended. DIARRHOEA is the most common adverse reaction — median time to onset of the first event was approximately 6 to 8 days, and median duration 7 to 12 days (Grade 2) and 5 to 8 days (Grade 3); patients should start an antidiarrhoeal agent such as loperamide at the FIRST sign of loose stools, increase oral fluids and notify their healthcare provider. RENAL IMPAIRMENT: no adjustment in mild or moderate impairment; there are no data in severe renal impairment, end stage renal disease or dialysis, and abemaciclib should be administered with caution in severe renal impairment with close monitoring for signs of toxicity. HEPATIC IMPAIRMENT: no adjustment in mild (Child-Pugh A) or moderate (Child-Pugh B) impairment; in severe (Child-Pugh C) impairment a decrease in dosing frequency to once daily is recommended. ELDERLY: no dose adjustment is required based on age. PAEDIATRIC: 'The safety and efficacy of abemaciclib in children and adolescents aged less than 18 years has not been established. No data are available' — no paediatric dose is published here. Some sections of the product information we used were incomplete — check the full SPC.