Alpha 1-proteinase inhibitor Pregnancy and Breastfeeding Warnings
Medically reviewed by Drugs.com. Last updated on Sep 27, 2021.
Alpha 1-proteinase inhibitor is also known as: Aralast, Aralast NP, Glassia, Prolastin, Prolastin-C, Zemaira
Alpha 1-proteinase inhibitor Pregnancy Warnings
Animal studies have not been performed. There are no controlled data in human pregnancy.
AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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.
This drug should be used during pregnancy only if clearly needed.
AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned
Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
Alpha 1-proteinase inhibitor Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-There is no information on the presence of this drug in human milk, the effects on a breastfed infant, or effects on milk production.
-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.
See also
References for pregnancy information
- "Product Information. Glassia (alpha 1-proteinase inhibitor)." Baxter Healthcare Corporation (2018):
- "Product Information. Prolastin-C (alpha 1-proteinase inhibitor)." Grifols USA LLC (2018):
References for breastfeeding information
- "Product Information. Glassia (alpha 1-proteinase inhibitor)." Baxter Healthcare Corporation (2018):
- "Product Information. Prolastin-C (alpha 1-proteinase inhibitor)." Grifols USA LLC (2018):
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
