Adlyxin Pregnancy Warnings
Animal studies have shown reproductive toxicity. Studies in pregnant rats and rabbits at doses of 1 and 6 times the recommended human dose, respectively, were associated with visceral closure and skeletal defects. There are no controlled data in human pregnancy.
In humans, poorly controlled diabetes during pregnancy increases fetal risk for major birth defects, still birth, and macrosomia related mortality.
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 should be avoided.
AU TGA pregnancy category: B3
US FDA pregnancy category: Not Assigned
Risk Summary: There is no enough available data in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.
Comments:
-Insulin is generally considered the drug of choice during pregnancy.
-Use of adequate methods of contraception should be encouraged in women of childbearing potential; if a patient wishes to become pregnant, or pregnancy occurs, this drug should be discontinued.
-Administration times for oral contraceptives should be at least 1 hour before or 11 hours after dosing of this drug.
See references
Adlyxin Breastfeeding Warnings
Use is not recommended
Excreted into human milk: Unknown
Excreted into animal milk: Yes
In lactating rats, milk transfer of this drug and its metabolites was low (9.4%) and levels of unchanged drug in the gastric contents of weaning offspring was negligible (0.01%). There is no information on its presence in human milk, the effects on the breastfed infant, or the effects on milk production.
See references
