Vonoprazan Pregnancy and Breastfeeding Warnings

Brand names: Voquezna

Medically reviewed by Drugs.com. Last updated on Jan 4, 2024.

Vonoprazan Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Insufficient data available on use of this drug in pregnant women to inform of a drug-related risk.

Comments:
-A pregnancy exposure registry is available.

Animal studies have revealed evidence of adverse embryofetal effects and maternal outcomes following oral administration of this drug to pregnant animals. In pre- and postnatal development studies, the offspring of animals treated during organogenesis through lactation exhibited liver discoloration, which in follow-up studies was associated with necrosis, fibrosis, and hemorrhage at AUC exposures approximately equal to and up to 22 times the maximum recommended human dose (MRHD); adverse liver effects were attributed to exposure during lactation. In animal studies at the highest doses tested (130 times MRHD in rats; 10 times MRHD in rabbits), fetal abnormalities and maternal death were observed in rats, and abortion and maternal adverse effects were observed in rabbits. 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 are encouraged to register patients and pregnant women are encouraged to register themselves by calling the Phathom Pharmaceuticals, Inc. Adverse Event reporting line at 1-888-775-7428.

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

Vonoprazan Breastfeeding Warnings

Breastfeeding is not recommended during treatment; an alternate drug may be preferred.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-According to some experts, nursing mothers should pump and discard human milk while taking this drug and for 2 days after the last dose.
-The effects in the nursing infant are unknown; there is a potential for serious adverse reactions based on animal studies.
-There is no information on the presence of this drug in human milk or the effects of this drug on milk production.
-When a drug is present in animal milk, it is likely to be present in human milk.

In multiple animal studies, liver injury occurred in the offspring of pregnant and lactating rats administered this drug at AUC exposures approximately equal to and up to 22 times the maximum recommended human dose. Adverse liver effects included liver discoloration associated with necrosis, fibrosis, and hemorrhage; in some studies, these effects were observed only in offspring exposed during lactation.

See references

Further information

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