Summary of Use during Lactation

No information is available on the clinical use of inotuzumab ozogamicin during breastfeeding. Because inotuzumab ozogamicin is a large protein molecule with a molecular weight of 168,000 Da and its active metabolite is 97% plasma protein bound, 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] Ozogamicin (N-acetyl gamma calicheamicin) is a small-molecule that causes double-stranded DNA 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 inotuzumab ozogamicin therapy for at least 2 months 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

Inotuzumab Ozogamicin

CAS Registry Number

635715-01-4

Drug Class

Breast Feeding

Lactation

Milk, Human

Antibodies, Monoclonal, Humanized

Antineoplastic Agents