Camzyos Use In Pregnancy & Lactation

Women of childbearing potential / Contraception in females: CAMZYOS is contraindicated in women of childbearing potential not using effective contraception (see Contraindications). Therefore, before initiation of treatment in women of childbearing potential, a negative pregnancy test result must be available and counselling should be provided regarding the serious risk to the foetus. Women of childbearing potential must use effective contraception during treatment and for 6 months after discontinuation of CAMZYOS, since it takes approximately 5 half-lives (approximately 45 days for CYP2C19 normal metabolisers and 115 days for CYP2C19 poor metabolisers) to eliminate mavacamten from the body after treatment discontinuation (see Precautions and Pharmacology: Pharmacokinetics under Actions).
When stopping mavacamten therapy for planning a pregnancy the possible return of LVOT obstruction and symptom burden should be considered (see Precautions).
Pregnancy: There are no data from the use of mavacamten in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Mavacamten is suspected to cause embryo-foetal toxicity when administered during pregnancy. Therefore, CAMZYOS is contraindicated during pregnancy (see Contraindications). CAMZYOS should be stopped 6 months before planning a pregnancy (see Precautions). If a patient becomes pregnant, mavacamten must be discontinued. Medical advice should be given regarding the risk of harmful effects to the foetus associated with treatment and ultrasonography examinations should be performed.
Breast-feeding: It is unknown whether mavacamten or its metabolites are excreted in human milk. There is no information on the excretion of mavacamten or its metabolites in animal milk (see Pharmacology: Toxicology: Preclinical safety data under Actions). Because of the unknown adverse effects of mavacamten in breastfed newborns/infants, women must not breast-feed during treatment with mavacamten.
Fertility: No human fertility data on mavacamten are available. Studies in animals are insufficient with respect to male or female fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).