Somatrogon Pregnancy and Breastfeeding Warnings

Brand names: Ngenla

Medically reviewed by Drugs.com. Last updated on Sep 25, 2023.

Somatrogon Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Risk summary: There are no data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Animal studies did not observe evidence of embryofetal toxicity.
-This drug has not been shown to interfere with blood or urine pregnancy tests; however, some authorities recommend using pregnancy detection methods that are not reliant on human growth hormone.

Animal studies did not show any teratogenicity in rats at up to 30 mg/kg subcutaneously once every 2 days (which is approximately 45 to 50 times the exposure in patients at the maximum recommended human dose, based on serum AUC). No significant effects on maternal toxicity, first generation offspring, or fertility were detected. There are no controlled data in human pregnancy.

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.

See references

Somatrogon Breastfeeding Warnings

This drug should be used only if clearly needed.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Limited data indicate that exogenous human growth hormone (e.g., somatropin) does not increase normal breastmilk concentrations of growth hormone, and that no adverse effects are experienced by breastfed infants of mothers who receive somatropin.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.

See references

Further information

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