Bezlotoxumab Pregnancy and Breastfeeding Warnings
Bezlotoxumab is also known as: Zinplava
Medically reviewed by Drugs.com. Last updated on Jan 21, 2020.
Bezlotoxumab Pregnancy Warnings
AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
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.
AU TGA pregnancy category: B2
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.
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.
References for pregnancy information
- "Product Information. Zinplava (bezlotoxumab)." Merck & Company Inc, Whitehouse Station, NJ.
References for breastfeeding information
- "Product Information. Zinplava (bezlotoxumab)." Merck & Company Inc, Whitehouse Station, NJ.
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Further information
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