Hyaluronidase Pregnancy and Breastfeeding Warnings
Brand names: Amphadase, Hydase, Hylenex, Vitrase, Wydase
Medically reviewed by Drugs.com. Last updated on Sep 20, 2023.
Hyaluronidase Pregnancy Warnings
Animal studies have at subcutaneous doses up to 2,200,00 U/kg of recombinant human hyaluronidase no evidence of teratogenicity, but did show increased fetal resorptions and reduced fetal weight; the no effect daily dose was 360,000 U/kg (suggested human dose: 0.8 U/kg in a 60 kg subject); subcutaneous doses up to 1,100,000 U/kg showed no effects on sexual maturation, learning or memory of offspring, or ability of offspring to reproduce. There are no controlled data in human pregnancy.
AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.
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.
Use only if clearly needed.
AU TGA pregnancy category: Exempt
US FDA pregnancy category: Not assigned
Comments:
-This drug is used as an aid to in-vitro fertilization in humans; studies of this use did not report maternal or fetal harm.
-Administration during labor did not cause increased blood loss or differences in cervical trauma.
Hyaluronidase Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-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. Vitrase (hyaluronidase). Bausch and Lomb Americas, Inc. 2004.
- TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee. Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. http://www.tga.gov.au/docs/pdf/medpreg.pdf 2007.
- Product Information. Hylenex (hyaluronidase). Halozyme Therapeutics. 2018.
References for breastfeeding information
- Product Information. Vitrase (hyaluronidase). Bausch and Lomb Americas, Inc. 2004.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
