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Women of child bearing potential and pregnancy: MULTAQ is not recommended during pregnancy and in women of childbearing potential not using contraception. There are no or limited data from the use of dronedarone in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Women of childbearing potential should use effective methods of contraception during treatment with MULTAQ and for 7 days after the final dose.
Prior to initiating MULTAQ, the prescriber should confirm that women of childbearing potential are not pregnant.
Breast-feeding: It is unknown whether dronedarone and its metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of dronedarone and its metabolites in milk. A risk to the newborns/infants cannot be excluded. Women should be advised not to breastfeed during treatment with MULTAQ and for 7 days (about 5 half-lives) after the final dose.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from MULTAQ therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: Dronedarone was not shown to alter fertility in animal studies.
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