Bezlotoxumab

The Basics

What is Bezlotoxumab?

Designed to prevent the recurrence of Clostridium difficile infections.

Brand names for Bezlotoxumab

Zinplava

How Bezlotoxumab is classified

Antibodies – Monoclonal

Bezlotoxumab During Pregnancy

Bezlotoxumab pregnancy category

Category Not AssignedNote 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 Bezlotoxumab while pregnant

Adequate and well controlled studies with ZINPLAVA have not been conducted in pregnant women. No animal reproductive and developmental studies have been conducted with bezlotoxumab. The background risk of major birth defects and miscarriage for the indicated population is unknown; however, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.

Taking Bezlotoxumab While Breastfeeding

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

No information is available on the clinical use of bezlotoxumab during breastfeeding. Because bezlotoxumab is a large protein molecule with a molecular weight of about 148,200 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, bezlotoxumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during bezlotoxumab therapy. Bezlotoxumab is a human immunoglobulin G1 (IgG1) antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G in mature milk by 60 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 bezlotoxumab during breastfeeding. Because bezlotoxumab is a large protein molecule with a molecular weight of about 148,200 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, bezlotoxumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during bezlotoxumab therapy. Bezlotoxumab is a human immunoglobulin G1 (IgG1) antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G in mature milk by 60 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 Bezlotoxumab on milk supply

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

Possible alternatives to Bezlotoxumab

None listed