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Amikacin liposome Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Mar 30, 2023.

Amikacin liposome is also known as: Arikayce

Amikacin liposome Pregnancy Warnings

Animal studies using liposomal formulations have not been reported. There are reports of total irreversible, bilateral congenital deafness in children whose mothers used aminoglycosides during pregnancy. 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.

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned.

Risk Summary: There are no data available on use of this formulation in pregnant women to inform of a drug-related risk.

-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Aminoglycosides should be considered potentially ototoxic and nephrotoxic to the fetus.

See references

Amikacin liposome 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.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

-The effects in the nursing infant are unknown.
-Some experts recommend that breastfed infants given parenteral formulations should be monitored for antibiotic-associated colitis, diarrhea, and/or candidiasis.
-When given parenterally, this drug is excreted in human milk.

See references

References for pregnancy information

  1. Product Information. Arikayce (amikacin liposome). Insmed Incorporated. 2018.

References for breastfeeding information

  1. United States National Library of Medicine. Toxnet. Toxicology Data Network. 2013.
  2. Product Information. Arikayce (amikacin liposome). Insmed Incorporated. 2018.

Further information

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