Cipaglucosidase alfa Pregnancy and Breastfeeding Warnings

Brand names: Pombiliti

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

Cipaglucosidase alfa Pregnancy Warnings

Use is contraindicated.
-According to some authorities: Use is not recommended during pregnancy, or in women of childbearing potential not using reliable contraception.

US FDA pregnancy category: Not assigned

Risk summary: Based on findings from animal studies, this drug in combination with miglustat may cause embryofetal harm when administered to a pregnant woman.

Comments:
-The pregnancy status of females of reproductive potential should be verified prior to initiating therapy.
-Advise women of childbearing potential to use effective contraception during treatment and for at least 60 days (or 4 weeks according to some authorities) after the last dose.

Animal studies have revealed evidence of fetal harm when this drug was administered (alone and in combination with miglustat) to pregnant animals during the period of organogenesis and during pre- and post-natal development. Clusters of great vessel and cardiac malformations were observed in the offspring of treated rabbits, and maternal and pup mortality was increased in treated rats. Animal studies suggest this drug in combination with miglustat may impair human fertility based on preimplantation loss in female and reversible preimplantation loss in male rats. There are no controlled data using this drug, alone or in combination with miglustat, in human pregnancy.

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

Cipaglucosidase alfa Breastfeeding Warnings

Breastfeeding is not recommended during treatment; an alternate drug may be preferred.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-There is no information on the presence of this drug (alone or in combination with miglustat) in human milk or the effects on milk production.
-The effects on the nursing infant are unknown and risk cannot be excluded; there is potential for serious adverse reactions based on findings in animal studies.
-According to some authorities: A decision must be made whether to discontinue breastfeeding or discontinue/abstain from treatment, considering the benefit of breastfeeding for the child and the benefit of therapy for the woman.

In pre- and post-natal development studies, both cipaglucosidase alfa and miglustat were excreted in animal milk; however, the concentration of drug in animal milk does not necessarily predict the concentration of drug in human milk.

According to some experts, the amount of this drug in breast milk or absorbed by the breastfed child is expected to be low due to the large molecular weight of this drug and its probable destruction within the infant's gastrointestinal tract.

See references

Further information

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