Dornase alfa Pregnancy and Breastfeeding Warnings

Brand names: Pulmozyme

Medically reviewed by Drugs.com. Last updated on Jun 28, 2023.

Dornase alfa Pregnancy Warnings

Safety has not been established during pregnancy. Caution is recommended.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.

Risk Summary:
-The background risk of major birth defects and miscarriage for the cystic fibrosis population is unknown.

Reproductive studies have been performed in rats and rabbits at intravenous doses up to approximately 600 times the maximum recommended human dose (MRHD) in adults. No evidence of maternal toxicity, embryotoxicity, or teratogenicity was observed when this drug was administered throughout organogenesis (gestation days 6 to 17). It did not elicit adverse effects on fetal or neonatal growth when administered throughout most of gestation and delivery (gestation days 6 to 25) and nursing (post-partum days 6 to 21).

In general population, the background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. There are no adequate and well-controlled studies with this drug in pregnant women.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

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

Dornase alfa Breastfeeding Warnings

Caution is recommended.

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

Comments:
-The effects in the nursing infant are unknown.

In pharmacokinetic studies in Cynomolgus monkeys, levels of this drug detected in milk were less than 0.1% of the maternal serum concentration. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need and any potential adverse effects on the breastfed child.

See references

Further information

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