Risk Factor: BM
Class: Anti-infectives/ Antifungals
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 non-toxic doses in rats (5 mg/kg; equivalent to 0.16 to 0.8 times the recommended human clinical dose [RHCD] range of 1 to 5 mg/kg based on body surface area) and rabbits (3 mg/kg; equivalent to 0.2 to 1 times the RHCD) (1). Rabbits administered doses equivalent to 0.5 to 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 the human dose (2).
The antibiotic crosses the placenta to the fetus with cord blood:maternal serum ratios ranging from 0.381.0 (3,4 and 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 g/mL, a cord blood:maternal serum ratio of 1.0 (3). Amniotic fluid concentration was 0.08 g/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 g/mL and 0.32 g/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 g/mL and 1.9 g/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 (4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21 and 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.
Breast Feeding Summary
No data are available.
- Product information. Ambisome. Fujisawa Healthcare, 2000.
- Product information. Abelcet. Liposome, 2000.
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