Avibactam / aztreonam Pregnancy and Breastfeeding Warnings

Brand names: Emblaveo

Avibactam / aztreonam Pregnancy Warnings

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

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.
-Available data over several decades with aztreonam and over about 1 decade with avibactam have not identified a drug-related risk of major birth defects, miscarriage, or other maternal/fetal outcomes.

Animal studies with aztreonam have failed to reveal evidence of fetal harm. No embryofetal toxicity or fetal malformations were observed at aztreonam doses (based on body surface area) 2.7-fold (rats) and 3.6-fold (rabbits) greater than the maximum recommended human dose (MRHD) for adults of 6.5 g/day. Animal studies with avibactam have revealed evidence of embryofetal toxicity but no evidence of teratogenicity. After IV dosing in pregnant rats during organogenesis, no embryofetal toxicity was observed at doses up to about 6 times the MRHD based on exposure (AUC). After IV dosing in pregnant rabbits during organogenesis, no effects on embryofetal development were seen at a dose 2 times the MRHD (based on AUC comparison); at doses at least 5 times the MRHD (based on AUC comparison), increased postimplantation loss, lower mean fetal weights, delayed ossification of several bones, and other anomalies were observed. Aztreonam crosses the placenta. 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.

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Avibactam / aztreonam Breastfeeding Warnings

Use is generally considered acceptable; benefit to mother should outweigh risk to the infant.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue/abstain from the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the child.

Excreted into human milk: Unknown (avibactam); Yes (aztreonam)
Excreted into animal milk: Yes (avibactam)

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered. A risk to the breastfed child cannot be excluded.
-Limited information indicates the low levels of aztreonam in milk are not expected to cause adverse effects in breastfed infants; avibactam has not been studied in nursing mothers.
-Disruption of the infant's gastrointestinal flora (resulting in diarrhea or thrush) has been reported occasionally with beta-lactams; however, such effects have not been adequately evaluated.

AZTREONAM:
Aztreonam is excreted in human milk in levels less than 1% of those in maternal serum obtained at the same time.

Milk levels ranging from 0.4 to 1 mg/L occurred 1 to 5 hours after a single 1 g IV dose of aztreonam in 10 women; there was little variation in milk levels during this time in each woman. On average, levels were slightly higher 2 hours after dosing, but the peak level occurred at various times in individual patients (between 1 and 4 hours).

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Further information

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