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Somapacitan-beco Pregnancy and Breastfeeding Warnings

Somapacitan-beco is also known as: Sogroya

Somapacitan-beco Pregnancy Warnings

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]), with 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 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. 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%.


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.

The manufacturer makes no recommendation regarding use during pregnancy.

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 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 and drug-associated risk of major birth defects, miscarriage, or adverse fetal or maternal outcomes.

See references

Somapacitan-beco Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Data not available
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.
-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.
-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.

See references

References for pregnancy information

  1. "Product Information. Sogroya (somapacitan)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.

References for breastfeeding information

  1. "Product Information. Sogroya (somapacitan)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.