The Basics

What is Avelumab?

Used to treat metastatic Merkel cell carcinoma as well as urothelial carcinoma, a type of bladder cancer, that has spread throughout the body.

Brand names for Avelumab

Bavencio

How Avelumab is classified

Antineoplastic Agents, Biological Response Modifiers, Immunologic Adjuvants, Immune Checkpoint Inhibitors, Antibodies – Monoclonal

Avelumab During Pregnancy

Avelumab 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 Avelumab while pregnant

N/A

Taking Avelumab While Breastfeeding

What are recommendations for lactation if you're taking Avelumab?

No information is available on the clinical use of avelumab during breastfeeding. Because avelumab is a large protein molecule with a molecular weight of about 147,000, 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. Until more data become available, avelumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that mothers not breastfeed during treatment and for at least one month after the last dose of avelumab. Avelumab is a human immunoglobulin G1 (IgG1) lambda antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G by up to 79%.[1][2] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with IgG1 activity decreasing by about 37%.[3] None of the studies measured IgG activity.

Maternal / infant drug levels

No information is available on the clinical use of avelumab during breastfeeding. Because avelumab is a large protein molecule with a molecular weight of about 147,000, 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. Until more data become available, avelumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that mothers not breastfeed during treatment and for at least one month after the last dose of avelumab. Avelumab is a human immunoglobulin G1 (IgG1) lambda antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G by up to 79%.[1][2] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with IgG1 activity decreasing by about 37%.[3] None of the studies measured IgG activity.

Possible effects of Avelumab on milk supply

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

Possible alternatives to Avelumab

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.

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