Tisotumab Vedotin use while Breastfeeding

Summary of Use during Lactation

No information is available on the clinical use of tisotumab vedotin during breastfeeding. Because tisotumab is a large protein molecule with a molecular weight of about 153,000 Da, the amount in milk is likely to be very low.[1] It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal.[2] Vedotin (monomethyl auristatin E) is a small-molecule anticancer drug that might enter milk and be absorbed by the infant. Because of the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends that breastfeeding be discontinued during enfortumab vedotin therapy and for 3 weeks after the last dose.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1.

Stratigakis A, Paty D, Zou P, et al. A regression approach for assessing large molecular drug concentration in breast milk. Reprod Breed 2023;3:199-207. doi:10.1016/j.repbre.2023.10.003 [CrossRef]

2.

Anderson PO. Monoclonal antibodies during breastfeeding. Breastfeed Med 2021;16:591-3. [PubMed: 33956488]

Substance Name

Tisotumab Vedotin

CAS Registry Number

1418731-10-8

Drug Class

Breast Feeding

Lactation

Milk, Human

Antineoplastic Agents