Dacomitinib

Source: UK SPC (eMC) 4.2 for Vizimpro 15 mg film-coated tablets (https://www.medicines.org.uk/emc/product/10354/smpc). VERBATIM: 'The recommended dose of Vizimpro is 45 mg taken orally once daily, until disease progression or unacceptable toxicity occurs.' PRESCRIBER RESTRICTION: treatment should be initiated and supervised by a physician experienced in the use of anticancer medicinal products; EGFR mutation status should be established prior to initiation. MISSED/VOMITED DOSE: if the patient vomits or misses a dose, an additional dose should not be taken - the next prescribed dose should be taken at the usual time the next day. DOSE LEVELS (Table 1): recommended starting dose 45 mg once daily; first dose reduction 30 mg once daily; second dose reduction 15 mg once daily. DOSE MODIFICATION (Table 2): ILD/pneumonitis - withhold during diagnostic evaluation, permanently discontinue if confirmed. Diarrhoea - Grade 1 no modification (start anti-diarrhoeal e.g. loperamide at first onset plus adequate oral fluids); Grade 2 not improved to Grade 1 or less within 24 hours despite anti-diarrhoeals and fluids, withhold, and on recovery to Grade 1 or less resume at the same dose level or consider a reduction of 1 dose level; Grade 3 or higher, withhold, treat with anti-diarrhoeals and oral or intravenous fluids/electrolytes as appropriate, and on recovery to Grade 1 or less resume with a reduction of 1 dose level. Skin reactions - Grade 1 or 2 rash, erythematous or exfoliative conditions, no dose modification (initiate treatment e.g. oral antibiotics and topical steroids); if Grade 2 persists for 72 hours despite treatment, withhold and on recovery to Grade 1 or less resume at the same dose level or consider a reduction of 1 dose level; Grade 3 or higher, withhold and on recovery to Grade 1 or less resume with a reduction of 1 dose level. Other toxicity - Grade 1 or 2 no modification; Grade 3 or higher, withhold until symptoms resolve to Grade 2 or less then resume with a reduction of 1 dose level. HEPATIC IMPAIRMENT: no starting dose adjustment in mild (Child-Pugh A) or moderate (Child-Pugh B) impairment; in severe impairment (Child-Pugh C) the starting dose should be adjusted to 30 mg once daily, and may be increased to 45 mg once daily based on individual safety and tolerability after at least 4 weeks of treatment. ELDERLY: no starting dose adjustment in patients aged 65 years or over. PAEDIATRIC: safety and efficacy in patients under 18 years have not been established; no data are available. NOTE: the eMC 4.5 interactions section was not retrieved in this bundle - the interactions listed below are taken from the US Vizimpro prescribing information and must be checked against the UK SPC 4.5.