The Basics
What is Ado-Trastuzumab Emtansine?
Used to treat a certain type of breast cancer that has spread to other parts of the body and has not improved or has worsened after treatment with other medications.
Brand names for Ado-Trastuzumab Emtansine
Kadcyla
How Ado-Trastuzumab Emtansine is classified
Antibodies – Monoclonal, Antineoplastic Agents
Ado-Trastuzumab Emtansine During Pregnancy
Ado-Trastuzumab Emtansine pregnancy category
Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Ado-Trastuzumab Emtansine while pregnant
KADCYLA can cause fetal harm when administered to a pregnant woman. There are no available data on the use of KADCYLA in pregnant women. Cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death were observed in the postmarketing setting in patients treated with trastuzumab, the antibody component of KADCYLA . Based on its mechanism of action, the DM1 component of KADCYLA can also cause embryo-fetal harm when administered to a pregnant woman . Apprise the patient of the potential risks to a fetus. There are clinical considerations if KADCYLA is used in a pregnant woman, or if a patient becomes pregnant within 7 months following the last dose of KADCYLA [see Clinical Considerations]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Taking Ado-Trastuzumab Emtansine While Breastfeeding
What are recommendations for lactation if you're taking Ado-Trastuzumab Emtansine?
No information is available on the clinical use of ado-trastuzumab during breastfeeding. Because trastuzumab is a large protein molecule with a molecular weight of 145,531, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. However, ado-trastuzumab emtansine also contains the small molecule cytotoxin, DM1, the manufacturer recommends avoiding breastfeeding during and for 7 months following ado-trastuzumab emtansine therapy.
Maternal / infant drug levels
No information is available on the clinical use of ado-trastuzumab during breastfeeding. Because trastuzumab is a large protein molecule with a molecular weight of 145,531, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. However, ado-trastuzumab emtansine also contains the small molecule cytotoxin, DM1, the manufacturer recommends avoiding breastfeeding during and for 7 months following ado-trastuzumab emtansine therapy.
Possible effects of Ado-Trastuzumab Emtansine on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Ado-Trastuzumab Emtansine
None listed
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Koenig A, de Albuquerque Diniz EM, Barbosa SF et al. Immunologic factors in human milk: The effects of gestational age and pasteurization. J Hum Lact. 2005;21:439-43. PMID: 16280560
2. Adhisivam B, Vishnu Bhat B, Rao K et al. Effect of Holder pasteurization on macronutrients and immunoglobulin profile of pooled donor human milk. J Matern Fetal Neonatal Med. 2018;1-4. PMID: 29587541
3. Rodriguez-Camejo C, Puyol A, Fazio L et al. Antibody profile of colostrum and the effect of processing in human milk banks: Implications in immunoregulatory properties. J Hum Lact. 2018;34:137-47. PMID: 28586632
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
