Brentuximab Pregnancy and Breastfeeding Warnings

Brand names: Adcetris

Medically reviewed by Drugs.com. Last updated on Feb 29, 2024.

Brentuximab Pregnancy Warnings

This drug should not be used during pregnancy 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 and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman; insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-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.
-Female patients of childbearing potential should be advised to use effective contraception (2 methods) during therapy and for 2 or 6 months after the last dose; local protocol should be consulted regarding contraception timing. Patients should be advised to immediately report pregnancy.
-This drug may damage spermatozoa and testicular tissue, resulting in possible genetic abnormalities. Male patients with female partners of childbearing potential should use effective contraception during therapy and for 4 months or up to 6 months after the last dose; local protocol should be consulted regarding contraception timing.
---According to some authorities: Male patients are advised to have sperm samples frozen and stored before therapy; male patients are advised not to father a child during therapy and for up to 6 months after the last dose. Effects on spermatogenesis cannot be excluded after a 6-month therapy-free period.

Animal studies have revealed evidence of embryofetal toxicity. After pregnant rats received 2 IV doses (0.3, 1, 3, or 10 mg/kg) during organogenesis (once each on pregnancy days 6 and 13), drug-induced embryofetal toxicities were observed primarily with the 3 and 10 mg/kg doses and included early resorption (at least 99%), postimplantation loss (at least 99%), decreased number of live fetuses, and external malformations (umbilical hernias, malrotated hindlimbs). Systemic exposure in animals at the dose of 3 mg/kg is about the same exposure in patients receiving the recommended dose of 1.8 mg/kg every 3 weeks. There are no controlled data in human pregnancy.

Based on animal studies with antibody-drug conjugates containing monomethyl auristatin E (MMAE), this drug may impair female fertility; the effect on fertility is reversible. Based on findings in rats, male fertility may be compromised by treatment with this drug.

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

Brentuximab Breastfeeding Warnings

Until more data are available, caution is recommended, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: Breastfeeding is not recommended during use of this drug.
-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: Data not available

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant are unknown; there is the potential for serious adverse reactions (including cytopenias, neurologic toxicities, gastrointestinal toxicities). A risk to breastfed children cannot be excluded.

Because this drug is a large protein molecule (molecular weight about 153 kilodaltons), the amount in milk is likely to be very low. In addition, absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer