Skip to Content

Dornase alfa Pregnancy and Breastfeeding Warnings

Dornase alfa is also known as: Pulmozyme

Dornase alfa Pregnancy Warnings

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.

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.

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

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Pulmozyme (dornase alfa)." Genentech, South San Francisco, CA.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Pulmozyme (dornase alfa)." Genentech, South San Francisco, CA.

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.