BAQSIMI™ (glucagon) nasal powder: Use in Pregnancy and Lactation

Detailed Information

No clinical studies with Baqsimi have been performed in pregnant women or nursing mothers.

Pregnancy

Available data from case reports and a small number of observational studies with glucagon use in pregnant women over decades of use have not identified

• a drug-associated risk of major birth defects

• miscarriage, or

• adverse maternal or fetal outcomes.¹

Multiple small studies have demonstrated a lack of transfer of pancreatic glucagon across the human placental barrier during early gestation.¹

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.¹

Animal Data

In pregnant rats given animal sourced glucagon twice-daily by injection at doses up to 2 mg/kg (up to 40 times the human dose based on body surface area extrapolation, mg/m²) during the period of organogenesis, there was no evidence of increased malformations or embryofetal lethality.¹

Lactation

There is no information available on the

• presence of glucagon in human or animal milk

• effects of the drug on the breastfed infant, or

• effects of the drug on milk production.¹ 

However, glucagon is a peptide and would be expected to be broken down to its constituent amino acids in the infant's digestive tract and is therefore, unlikely to cause harm to an exposed infant.¹

Enclosed Prescribing Information

BAQSIMI™ (glucagon) nasal powder, for intranasal use, Lilly

Reference

1. Baqsimi [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.

Glossary

Baqsimi = Baqsimi™ (glucagon) nasal powder

GI = gastrointestinal