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Bezlotoxumab Pregnancy and Breastfeeding Warnings

Bezlotoxumab is also known as: Zinplava

Medically reviewed on January 31, 2017.

Bezlotoxumab Pregnancy Warnings

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk Summary: No animal studies have been conducted. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

See references

Bezlotoxumab Breastfeeding Warnings

No information is available on the clinical use of this drug during breastfeeding. Because it 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 GI tract. Some experts advise that it should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comment: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Zinplava (bezlotoxumab)." Merck & Company Inc, Whitehouse Station, NJ.

References for breastfeeding information

  1. "Product Information. Zinplava (bezlotoxumab)." Merck & Company Inc, Whitehouse Station, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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