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.
- McCoy MJ, Ellenberg JF, Killam AP. Coccidioidomycosis complicating pregnancy. Am J Obstet Gynecol 1980;137:73940.
- Ismail MA, Lerner SA. Disseminated blastomycosis in a pregnant woman. Review of amphotericin B usage during pregnancy. Am Rev Respir Dis 1982;126:3503.
- Hager H, Welt SI, Cardasis JP, Alvarez S. Disseminated blastomycosis in a pregnant woman successfully treated with amphotericin-B: a case report. J Reprod Med 1988;33:4858.
- Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA:Publishing Sciences Group, 1977:297.
- Neiberg AD, Maruomatis F, Dyke J, Fayyad A. Blastomyces dermatitidis treated during pregnancy. Am J Obstet Gynecol 1977;128:9112.
- Philpot CR, Lo D. Cryptococcal meningitis in pregnancy. Med J Aust 1972;2:10057.
- Aitken GWE, Symonds EM. Cryptococcal meningitis in pregnancy treated with amphotericin. A case report. Br J Obstet Gynaecol 1962;69:6779.
- Feldman R. Cryptococcosis (torulosis) of the central nervous system treated with amphotericin B during pregnancy. South Med J 1959;52:14157.
- Kuo D. A case of torulosis of the central nervous system during pregnancy. Med J Aust 1962;1: 55860.
- Crotty JM. Systemic mycotic infections in Northern territory aborigines. Med J Aust 1965;1:184.
- Littman ML. Cryptococcosis (torulosis). Current concepts and therapy. Am J Med 1959;27:9768.
- Mick R, Muller-Tyl E, Neufeld T. Comparison of the effectiveness of Nystatin and amphotericin B in the therapy of female genital mycoses. Wien Med Wochenschr 1975:125:1315.
- Silberfarb PM, Sarois GA, Tosh FE. Cryptococcosis and pregnancy. Am J Obstet Gynecol 1972;112:71420.
- Curole DN. Cryptococcal meningitis in pregnancy. J Reprod Med 1981;26:3179.
- Sanford WG, Rasch JR, Stonehill RB. A therapeutic dilemma: the treatment of disseminated coccidioidomycosis with amphotericin B. Ann Intern Med 1962;56:55363.
- Harris RE. Coccidioidomycosis complicating pregnancy. Report of 3 cases and review of the literature. Obstet Gynecol 1966;28:4015.
- Smale LE, Waechter KG. Dissemination of coccidioidomycosis in pregnancy. Am J Obstet Gynecol 1970;107:3569.
- Hadsall FJ, Acquarelli MJ. Disseminated coccidioidomycosis presenting as facial granulomas in pregnancy: a report of two cases and a review of the literature. Laryngoscope 1973;83:518.
- Daniel L, Salit IE. Blastomycosis during pregnancy. Can Med Assoc J 1984;131:75961.
- Peterson CW, Johnson SL, Kelly JV, Kelly PC. Coccidioidal meningitis and pregnancy: a case report. Obstet Gynecol 1989;73:8356.