Oritavancin Pregnancy and Breastfeeding Warnings

Brand names: Kimyrsa, Orbactiv

Medically reviewed by Drugs.com. Last updated on Jun 5, 2025.

Oritavancin Pregnancy Warnings

Safety has not been established.
-According to some authorities, it is preferable to avoid the use of this drug during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned

Risk summary: There are no available data in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

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 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.

See references

Oritavancin Breastfeeding Warnings

Safety has not been established, and an alternate drug may be preferred while breastfeeding.

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

Comments:
-There are no data on the presence of this drug in human milk, the effects on the breastfed child, or the effects on milk production.
-This drug is poorly absorbed orally, however, a risk to the breastfed infants cannot be excluded and 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.
-According to some authorities, a decision should be made to discontinue breastfeeding or discontinue the drug, considering the importance of the drug to the mother.

See references

Further information

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

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