Avibactam / ceftazidime Pregnancy and Breastfeeding Warnings

Brand names: Avycaz

Medically reviewed by Drugs.com. Last updated on Apr 4, 2024.

Avibactam / ceftazidime Pregnancy Warnings

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

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

Animal studies have failed to reveal evidence of fetal harm with ceftazidime at doses up to 40 times the human dose in mice and rats. Animal studies have failed to reveal evidence of teratogenicity or embryofetal toxicity with avibactam at doses up to 11 and 2 times the human exposure (based on AUC) in rats and rabbits, respectively; increased postimplantation loss, reduced fetal weights, delayed ossification of several bones, and other anomalies were seen with higher doses in rabbits. Ceftazidime readily crosses the placenta. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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 / ceftazidime Breastfeeding Warnings

LactMed: Use is considered acceptable.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the infant.

Excreted into human milk: Unknown (avibactam); Yes (ceftazidime [low levels])
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 side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-Disruption of infant's gastrointestinal flora (resulting in diarrhea or thrush) reported occasionally with cephalosporins; such effects have not been adequately evaluated. This drug has not been studied during breastfeeding; similar concerns expected.

According to limited data, single maternal doses of ceftazidime (up to 2 g) produce low levels in milk that are not expected to cause harmful effects in the nursing infant.

Ceftazidime (2 g IV every 8 hours for 5 days) was used in 11 women. The trough milk levels averaged 3.8, 5.2, and 4.5 mg/L before the next dose, 1 hour after the dose, and 3 hours after the dose, respectively; not statistically significant. Drug milk levels averaged 3.9 mg/L for samples before the 7th dose and 4.9 mg/L in samples after the 7th dose; not statistically significant. There was no link between mother's weight and drug milk levels.

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Further information

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