Olipudase alfa Pregnancy and Breastfeeding Warnings

Brand names: Xenpozyme

Medically reviewed by Drugs.com. Last updated on Nov 30, 2022.

Olipudase alfa Pregnancy Warnings

This drug should not be used during pregnancy or in patients of childbearing potential not using effective contraception unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk summary: Based on animal studies, this drug may cause embryofetal harm when administered to a pregnant woman; no data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Dosage initiation or escalation is not recommended at any time during pregnancy; it may lead to elevated sphingomyelin metabolite levels that may increase the risk of fetal malformations.
-The decision to continue or discontinue maintenance dosing of this drug in pregnancy should consider the patient's need for the drug, the potential drug-related risks to the fetus, and the potential adverse outcomes from untreated maternal acid sphingomyelinase deficiency (ASMD) disease.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Pregnancy status should be verified in patients of childbearing potential before starting this drug.
-Patients of childbearing potential should be advised to use effective contraception during therapy and for 14 days after the last dose if this drug is discontinued.

Animal studies have revealed evidence of malformation. After pregnant mice were administered IV doses up to 30 mg/kg/day, exencephaly was observed in 5 fetuses from 2 litters; these data were consistent with published reports that brief embryonic exposures to sphingomyelin metabolites or a sphingosine-1-phosphate receptor modulator produced neural tube defects (including exencephaly) in chicks and mice. The developmental no observed adverse effect level (NOAEL) is 3 mg/kg; the AUC associated with this dose is 0.14-fold the clinical exposure at the maximum recommended human dose (MRHD). The developmental lowest-observed-adverse-effect level (10 mg/kg) is also associated with an exposure that is less than the clinical exposure at the MRHD. In pregnant rabbits, IV doses up to 30 mg/kg/day showed no maternal or developmental toxicity. The developmental NOAEL was 30 mg/kg; the 24-hour AUC at this dose is about 10.5-fold the exposure at the MRHD. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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

Olipudase alfa Breastfeeding Warnings

Because this drug is a large protein molecule (molecular weight of 76 kilodaltons), the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract; absorption by the infant is probably minimal.

Until more data are available, caution is recommended, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the child.

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

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered. A risk to the neonate/infant cannot be excluded.

See references

Further information

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