Teprotumumab Pregnancy and Breastfeeding Warnings

Brand names: Tepezza

Medically reviewed by Drugs.com. Last updated on Feb 8, 2024.

Teprotumumab Pregnancy Warnings

Animal studies of intravenous administration weekly of 2.8-fold the maximum recommended human dose from gestation day 20 through the end of gestation showed a higher incidence of abortion, decreased fetal growth during pregnancy, decreased fetal size, decreased placental weight and size, decreased amniotic fluid volume, multiple external and skeletal abnormalities including misshapen cranium, closely set eyes, micrognathia, pointing and narrowing of the nose, and ossification abnormalities of skull bones, sternebrae, carpals, tarsals, and teeth; no maternal adverse effects were observed. Based on the inhibition of IGF-1R, postnatal exposure may cause harm. 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.

This drug should not be used during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-This drug may cause fetal harm and increase fetal loss, based on animal studies and the mechanism of action.
- Adequate well controlled studies are not available in human pregnancy to inform any drugs risks, including the risk of adverse developmental outcomes.
-Animal studies showed external and skeletal abnormalities.
-Appropriate contraception should be started prior to treatment, during treatment, and for 6 months after discontinuation.

See references

Teprotumumab 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.

See references

Further information

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