Telavancin Pregnancy and Breastfeeding Warnings
Brand names: Vibativ
Medically reviewed by Drugs.com. Last updated on Feb 17, 2025.
Telavancin Pregnancy Warnings
Safety has not been established during pregnancy.
-According to some authorities: Use is contraindicated.
US FDA pregnancy category: Not assigned
Risk summary: Based on the findings in animals, this drug can cause fetal harm when administered to a pregnant woman.
Comments:
-A pregnancy exposure registry is available.
-Negative pregnancy status should be verified in females of childbearing potential prior to initiating therapy.
-Women of childbearing potential should be advised to use effective contraception during therapy and for 2 days after the last dose.
-Based on the findings in animals, this drug may impair male fertility.
Animal studies have revealed evidence of reduced fetal weights, increased rates of digit and limb malformations in offspring, and increased number of stillborn pups. This drug did not affect the fertility, mating, or reproductive performance of adult male and female rats, but male rats displayed altered sperm quantity and quality that were reversible following an 8-week recovery period. There are no controlled data in human pregnancy.
To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-484-2700.
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.
Telavancin Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the benefit of breastfeeding to the child and the benefit of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments: The effects in the nursing infant are unknown.
This drug is not likely to reach the bloodstream of the infant or cause any adverse effects in breastfed infants due to its poor oral absorption. However, an alternative medication may be considered during breastfeeding as there is no lactation literature available for this drug.
See also
References for pregnancy information
- (2009) "Product Information. Vibativ (telavancin)." Theravance Inc
- (2020) "Product Information. Vibativ (telavancin)." Cumberland Pharmaceuticals Inc
References for breastfeeding information
- (2009) "Product Information. Vibativ (telavancin)." Theravance Inc
- United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.