Somapacitan-beco Pregnancy and Breastfeeding Warnings
Brand names: Sogroya
Medically reviewed by Drugs.com. Last updated on Aug 17, 2023.
Somapacitan-beco Pregnancy Warnings
The manufacturer makes no recommendation regarding use during pregnancy.
According to some authorities, "Use is not recommended during pregnancy and in women of childbearing potential not using contraception."
Risk summary: No data available on use of this drug in pregnant women to inform a drug related risk.
AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned
-Animal reproduction studies did not show teratogenicity when given subcutaneously during organogenesis at approximately 12 times the maximum recommended human dose (MRHD); a pre- and post-natal study (organogenesis through lactation) at 275 times the MRHD did not show adverse developmental outcomes. Studies of administration of short-acting recombinant growth hormone (rhGH) during pregnancy over several decades have not identified a drug-associated risk of major birth defects, miscarriage, or adverse fetal or maternal outcomes.
-Animal studies of subcutaneous administration during organogenesis in rats at doses of 2, 6, and 18 mg/kg/day showed no effects on fetal viability or development at 6 mg/kg/day (31 times the maximum recommended human dose [MRHD]), but transient fetal skeletal variations (short/bent/thickened long bones) were seen at 18 mg/kg/day (261 times the MRHD). Animal studies of subcutaneous administration during organogenesis in rabbits at doses of 1, 3, and 9 mg/kg every 2 days showed no effects on fetal viability or development at 1 mg/kg (12 times the MRHD) and reduced fetal growth at doses over 3 mg/kg (over 130 times the MRHD). A pre- and post-natal development study (organogenesis through lactation day 18) showed no adverse developmental effects at 275 times the MRHD; an increased incidence of renal pelvic dilatation was seen on post-natal day 21 at 630 times the MRHD but was not seen in the adult F1 generation.
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.
Somapacitan-beco Breastfeeding Warnings
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug as well as any potential adverse effects from this drug or the underlying maternal condition.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
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.
-Data on administration of short-acting recombinant growth hormone (rhGH) during lactation for 7 days did not show an increase in the breastmilk growth hormone concentration and no adverse effects in the infants were noted.
-If a substance is excreted in animal milk, it is likely that the substance will be present in human milk.
See also
References for pregnancy information
- (2020) "Product Information. Sogroya (somapacitan)." Novo Nordisk Pharmaceuticals Inc
- (2022) "Product Information. Sogroya (somapacitan)." Novo Nordisk Pharmaceuticals Pty Ltd, Sogroya PI v2.0
References for breastfeeding information
- (2020) "Product Information. Sogroya (somapacitan)." Novo Nordisk Pharmaceuticals Inc
- (2022) "Product Information. Sogroya (somapacitan)." Novo Nordisk Pharmaceuticals Pty Ltd, Sogroya PI v2.0
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.