Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Camzyos

CAMZYOS 2.5 mg hard capsules CAMZYOS 5 mg hard capsules CAMZYOS 10 mg hard capsules CAMZYOS 15 mg hard capsules · Abschnitt 4.5 · PDF-Seite 11

HOS-147604 · Präparat HOS-099694

Concomitant CYP2C19 poor metaboliser phenotype* CYP2C19 intermediate, medicinal product normal, rapid and ultra-rapid metaboliser phenotype Inhibitors Combined use of a Contra-indicated (see section 4.3) Contra-indicated (see strong CYP2C19 section 4.3) inhibitor and a strong CYP3A4 inhibitor Strong CYP2C19 No dose adjustment. Monitor LVEF 4 weeks Initiate mavacamten at a dose of inhibitor (e.g., later, and then resume the patient’s monitoring 2.5 mg. ticlopidine, fluconazole, and titration schedule (see section 4.2). The dose should be reduced from fluvoxamine) 15 mg to 5 mg and from 10 mg If CYP2C19 phenotype has not yet been and 5 mg to 2.5 mg or pause determined: treatment if on 2.5 mg. No adjustment of the starting dose of 2.5 mg Monitor LVEF 4 weeks later, is needed. and then resume the patient’s The dose should be reduced from 5 mg to monitoring and titration schedule 2.5 mg or pause treatment if on 2.5 mg. (see section 4.2). Monitor LVEF 4 weeks later, and then resume the patient’s monitoring and titration schedule (see section 4.2). Strong CYP3A4 Contra-indicated (see section 4.3) No dose adjustment. Monitor inhibitor (e.g., LVEF 4 weeks later, and then clarithromycin, resume the patient’s monitoring itraconazole, and titration schedule (see ketoconazole, section 4.2). voriconazole, ritonavir, cobicistat, ceritinib, idelalisib, tucatinib) Moderate CYP2C19 No dose adjustment. Monitor LVEF 4 weeks No adjustment of the starting inhibitor (e.g., later, and then resume the patient’s monitoring dose of 5 mg is needed. fluconazole, fluoxetine, and titration schedule. Adjust mavacamten Initiating or increasing the dose omeprazolea) dose based on clinical assessment (see of a moderate inhibitor while on section 4.2). mavacamten treatment: Dose should be reduced by one If CYP2C19 phenotype has not yet been dose level or pause treatment if determined: on 2.5 mg. Monitor LVEF No adjustment of the starting dose of 2.5 mg 4 weeks later, and then resume is needed. the patient’s monitoring and The dose should be reduced from 5 mg to titration schedule (see 2.5 mg or pause treatment if on 2.5 mg. section 4.2). Monitor LVEF 4 weeks later, and then resume the patient’s monitoring and titration schedule. Adjust mavacamten dose based on clinical assessment (see section 4.2). Moderate CYP3A4 If on medication when starting mavacamten, No dose adjustment. Monitor inhibitor (e.g., no adjustment of the starting dose of 2.5 mg is LVEF 4 weeks later, and then erythromycin, grapefruit needed. resume the patient’s monitoring juice, verapamil, and titration schedule (see diltiazem) Initiating or increasing the dose of a moderate section 4.2). inhibitor while on mavacamten treatment: If patients are receiving a 5 mg dose of mavacamten, their dose should be reduced to 2.5 mg or if on 2.5 mg pause treatment for 4 weeks. Monitor LVEF 4 weeks later, and then resume the patient’s monitoring and titration schedule (see section 4.2).

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): ceritinib (HOS-086215) diltiazem (HOS-086288) ketoconazole (HOS-084513) cobicistat (HOS-088111) voriconazole (HOS-084524) itraconazole (HOS-084516) fluconazole (HOS-087945) clarithromycin (HOS-084517) erythromycin (HOS-084514) fluoxetine (HOS-085946) ritonavir (HOS-084521) fluvoxamine (HOS-085908) tucatinib (HOS-145562) ticlopidine (HOS-087946) idelalisib (HOS-116811) verapamil (HOS-090602)