Lazertinib (Specialist drug)

eMC SPC (Lazcluze 240 mg film-coated tablets) §4.2: 'The recommended dose of Lazcluze is 240 mg once daily in combination with amivantamab.' Treatment should be initiated by a physician experienced in the use of anticancer medicinal products, and EGFR mutation-positive status must be established in tumour tissue or plasma using a validated test before initiation. Administer lazertinib any time prior to amivantamab when given on the same day; refer to the amivantamab SPC for amivantamab dosing. Duration: continue until disease progression or unacceptable toxicity. Missed dose: may be taken within 12 hours of the planned time; if more than 12 hours have passed, omit and resume the usual schedule. If vomiting occurs any time after a dose, take the next dose the next day. Dose reductions for adverse reactions (§4.2 Table 1): initial 240 mg once daily; 1st reduction 160 mg once daily; 2nd reduction 80 mg once daily; 3rd reduction discontinue. Prophylaxis: prophylactic anticoagulants (e.g. low-molecular-weight heparin) are recommended for the first four months of treatment — vitamin K antagonists are NOT recommended. Prophylactic oral and topical antibiotics, non-comedogenic moisturiser and chlorhexidine hand/foot washing are recommended to reduce skin and nail reactions; limit sun exposure during and for 2 months after treatment. Withhold/discontinue per §4.2 Table 2 for ILD (discontinue if confirmed), VTE, skin/nail reactions and other Grade 3-4 reactions. Elderly: no dose adjustment required. Hepatic impairment: no dose adjustment for mild or moderate; PK unknown and caution required in severe hepatic impairment. Paediatric: 'There is no relevant use of lazertinib in the paediatric population for the treatment of non-small cell lung cancer.' NOTE: the eMC §4.4 and §4.8 text in the fetched bundle was truncated at the source-fetch limit — clinician to verify against the full current SPC.