Antihemophilic factor Pregnancy and Breastfeeding Warnings
Brand names: Advate, Adynovate, Afstyla, Altuviiio, Beriate P, Eloctate, Esperoct, Fanhdi, Genarc, Helixate NexGen, Hemofil-M, Jivi, Koate, Koate-DVI, Kogenate Bayer, Kogenate FS, Kovaltry, Liberate, Monoclate-P, Nuwiq, Obizur, ReFacto, Recombinate, Replenate, Xyntha
Medically reviewed by Drugs.com. Last updated on Jan 22, 2024.
Antihemophilic factor Pregnancy Warnings
The manufacturer makes no recommendation regarding use during pregnancy.
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.
Animal studies have not been conducted. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.
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.
Antihemophilic factor Breastfeeding Warnings
The manufacturer makes no recommendation regarding use during lactation.
Excreted into human milk: Data not available
Excreted into animal milk: Data not available
Comments:
-There is no information regarding this drug on the presence 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
- TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee. Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. http://www.tga.gov.au/docs/html/medpreg.htm 2010.
- Product Information. Obizur (antihemophilic factor). Baxter Healthcare Corporation. 2020.
References for breastfeeding information
- Product Information. Obizur (antihemophilic factor). Baxter Healthcare Corporation. 2020.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
