Baqsimi nasal powder Pregnancy Warnings
Studies with animal-sourced glucagon have not revealed evidence of fetal harm. This drug does not appear to cross the human placenta barrier. Use in a limited number of pregnant women have revealed no harmful effects with respect to pregnancy or health of the neonate. There are no adequate and well controlled studies in pregnant women.
AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
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.
Use is considered acceptable
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned
Risk Summary: A drug associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes has not been identified; multiple small studies have shown that this drug does not cross the human placental barrier during early gestation.
Comments:
-This drug has been used in pregnant women with diabetes and no harmful effects are known with respect to the course of pregnancy and the health of the unborn and the neonate.
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Baqsimi nasal powder Breastfeeding Warnings
Use with caution
Excreted into human milk: Unknown
Excreted into animal milk: Unknown
Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production; it is unlikely to cause harm to an exposed infant.
This drug has a very short half-life and therefore the amount excreted into milk, if any, would be extremely small. This drug is not active when taken orally because it is destroyed in the gastrointestinal tract before it can be absorbed.
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