Galafold Pregnancy Warnings
Benefit should outweigh risk
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned
Risk Summary: Data are insufficient to assess drug associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes; animal reproduction studies have not shown adverse developmental effects.
Comments:
-Some experts recommend against use in women of childbearing potential unless they are using contraception.
-The Pregnancy Exposure Study is collecting data on pregnant women with Fabry disease who have either been exposed to this drug or not; healthcare providers can register their patients or obtain additional information by contacting the Pregnancy Coordinating Center at 1-888-239-0758, email [email protected], or visit www.fabrypregnancyregistry.com.
Pregnant rats and rabbits receiving this drug during organogenesis at doses 26 (rat) and 54 (rabbit) times the recommended human dose showed no adverse developmental effects. No post-natal development effects were observed with administration of doses up to 16 times the recommended dose from organogenesis through lactation. In rabbits, developmental toxicity was observed at maternally toxic doses. Three women were pregnant during clinical trials (no data provided). There are no controlled data in human pregnancy.
Fertility effects in humans have not been studied; transient and fully reversible infertility in male rats was observed at an AUC equivalent to human exposure at recommended doses. No effect on fertility were observed in female rats.
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.
See references
Galafold Breastfeeding Warnings
Benefit should outweigh risk
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.
Administration to rats at doses approximately 16 times the recommended human dose resulted in rat milk concentrations approximately 2.5 times higher than maternal plasma levels at 4 hours post-dose. In rat pups, plasma concentrations were approximately 11 times lower than maternal plasma concentrations at 1-hour post-dose.
The Pregnancy Coordinating Center is collecting data on use of this drug during breastfeeding; healthcare providers can register their patients or obtain additional information at 1-888-239-0758, email [email protected], or visit www.fabrypregnancyregistry.com.
See references
