WARNINGS AND PRECAUTIONS
[see Clinical Pharmacology and Clinical Studies]. If the QTc Bazett interval is
≥500 ms, MULTAQ should be stopped [see Contraindications (4) ].
[see Use in Specific Populations ].
USE IN SPECIFIC POPULATIONS
[see Contraindications (4) ]
MULTAQ may cause fetal harm when administered to a pregnant woman. In animal
studies, dronedarone was teratogenic in rats at the maximum recommended human
dose (MRHD), and in rabbits at half the MRHD. If this drug is used during
pregnancy or if the patient becomes pregnant while taking this drug, the patient
should be apprised of the potential hazard to the fetus.
When pregnant rats received dronedarone at oral doses greater than or equal
to the MRHD (on a mg/m2 basis), fetuses had increased
rates of external, visceral and skeletal malformations (cranioschisis, cleft
palate, incomplete evagination of pineal body, brachygnathia, partially fused
carotid arteries, truncus arteriosus, abnormal lobation of the liver, partially
duplicated inferior vena cava, brachydactyly, ectrodactylia, syndactylia, and
anterior and/or posterior club feet). When pregnant rabbits received
dronedarone, at a dose approximately half the MRHD (on a mg/m2
basis), fetuses had an increased rate of skeletal abnormalities
(anomalous ribcage and vertebrae, pelvic asymmetry) at doses ≥20 mg/kg (the
lowest dose tested and approximately half the MRHD on a mg/m2 basis).
Actual animal doses: rat (≥80 mg/kg/day); rabbit (≥20 mg/kg)
[see Contraindications (4) ].
[see Clinical Pharmacology ], no dosing alteration is
needed.
[see Contraindications and Clinical Pharmacology ].
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