Antifungal Antibiotic
PREGNANCY RECOMMENDATION: Compatible
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
Although animal reproduction data suggest risk, no adverse effects have been reported in exposed human embryos and fetuses. The drug crosses the human placenta with cord blood concentrations up to those measured in the mother.
FETAL RISK SUMMARY
No reports linking the use of amphotericin B with congenital defects have been located. Reproduction studies of amphotericin B liposome were conducted with maternal nontoxic doses in rats (0.16–0.8 times the recommended human clinical dose range of 1–5 mg/kg based on BSA [RHCD]) and rabbits (0.2–1 times the RHCD) (1). Rabbits administered doses 0.5–2 times the RHCD had a higher rate of spontaneous abortions than did controls (1). No fetal harm was observed in reproduction studies of amphotericin B lipid complex in rats and rabbits at doses up to 0.64 times the human dose (2).
The antibiotic crosses the placenta to the fetus with cord blood:maternal serum ratios ranging from 0.38 to 1.0 (3–5). In a term (42 weeks) infant whose mother was treated with amphotericin B 0.6 mg/kg every other day, cord and maternal blood levels at delivery were both 2.6 mcg/mL, with a cord blood:maternal serum ratio of 1.0 (3). Amniotic fluid concentration was 0.08 mcg/mL at delivery. The time interval between the last dose and delivery was not specified. Concentrations in the cord blood and maternal serum of a woman treated with 16 mg of amphotericin B just before delivery (one-fifth of a planned total dose of 80 mg had infused when delivery occurred) were 0.12 and 0.32 mcg/mL, respectively, a ratio of 0.38 (4). The woman’s last dose before this time was 7 days previously when she had received 80 mg. In a third case, a mother was receiving 20 mg IV every other day (0.5 mg/kg) (5). The cord and maternal serum concentrations were 1.3 and 1.9 mcg/mL, respectively, a ratio of 0.68. The levels were determined 26 hours after her last dose.
The Collaborative Perinatal Project monitored 50,282 mother–child pairs, 9 of whom had 1st trimester exposure to amphotericin B (6). Numerous other reports have also described the use of amphotericin B during various stages of pregnancy, including the 1st trimester (4–22). No evidence of adverse fetal effects was found by these studies. Amphotericin B can be used during pregnancy in those patients who will clearly benefit from the drug.
BREASTFEEDING SUMMARY
No reports describing the use of amphotericin B during human lactation have been located. The drug probably is excreted into breast milk, but the risk, if any exists, to a nursing infant is unknown.
References
1.Product information. Ambisome. Fujisawa Healthcare, 2000.
2.Product information. Abelcet. Liposome, 2000.
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