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Oritavancin Pregnancy and Breastfeeding Warnings

Brand names: Kimyrsa, Orbactiv

Medically reviewed by Last updated on Jun 5, 2023.

Oritavancin Pregnancy Warnings

Animal studies have failed to reveal evidence of fetal harm; however, the doses studied were equivalent to 25% of the single 1200 mg clinical dose. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

See references

Oritavancin Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excretion into human milk: Unknown
Excretion into animal milk: Yes

-Breastfed infants should be monitored for diarrhea, headache, nausea, subcutaneous/limb abscesses, vomiting, and candidiasis (e.g., diaper rash, thrush).
-Alternative agents (e.g., clindamycin, daptomycin, doxycycline, sulfamethoxazole-trimethoprim, vancomycin) may be preferred when breastfeeding newborn or preterm infants.

See references

References for pregnancy information

  1. Product Information. Orbactiv (oritavancin). The Medicines Company. 2014.

References for breastfeeding information

  1. Meyer Zu Schwabedissen HE, Bottcher K, Steiner T, et al. OATP1B3 is expressed in pancreatic beta-islet cells and enhances the insulinotropic effect of the sulfonylurea derivative glibenclamide. Diabetes. 2013.
  2. Product Information. Orbactiv (oritavancin). The Medicines Company. 2014.
  3. Briggs GG, Freeman RK. Drugs in Pregnancy and Lactation. Philadelphia, PA: Wolters Kluwer Health. 2015.

Further information

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