Daridorexant Pregnancy and Breastfeeding Warnings

Brand names: Quviviq

Daridorexant Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: There is no data on use of this drug in pregnant women to inform a drug-related risk, including the risk of fetal harm or reproductive effects.

Comments:
-A pregnancy exposure registry is available.

Animal studies in rats and rabbits showed no fetal toxicity or malformation at doses up to 8 and 10 times the maximum recommended dose (MRHD) of 50 mg, respectively. Oral administration of this drug to pregnant and lactating rats did not cause any fetal or maternal toxicities at doses up to 9 times the MRHD. Animal studies did not show any impact on male or female fertility. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians and pregnant women are encouraged to register by contacting Idorsia Pharmaceuticals Ltd.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Daridorexant Breastfeeding Warnings

Benefit should outweigh risk.

Excreted into human milk: Yes

Comments:
-This drug is present in human breast milk in low amounts. There is no information on the effects on a breastfed infant, or its effects on milk production. According to some authorities, if the mother needs treatment with this drug, there is no reason to discontinue breastfeeding.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.
-Infants exposed through breastmilk should be monitored for excessive sedation, poor feeding and poor weight gain.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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