AmBisome Special Precautions

Anaphylaxis has been reported rarely in association with AmBisome infusion. To detect idiosyncratic anaphylactic reactions and minimize the dose administered if a reaction occurs, a test dose should be administered initially. If a severe anaphylactic reaction occurs, the infusion should be immediately discontinued and the patient should not receive further infusions of AmBisome. Severe infusion-related reactions can occur during administration of amphotericin B-containing products, including AmBisome. Although infusion-related reactions are not usually serious, consideration of precautionary measures for the prevention or treatment of these reactions should be given to patients who receive AmBisome therapy. Slower infusion rates or routine doses of diphenhydramine, paracetamol, pethidine, and/or hydrocortisone have been reported as successful in their prevention or treatment.
AmBisome has shown to be substantially less toxic than conventional amphotericin; however, adverse events may still occur. In particular, caution should be exercised when prolonged therapy is required.
Laboratory evaluation of renal, hepatic and hematopoietic function should be performed regularly. In addition, serum electrolytes, particularly potassium and magnesium should also be evaluated. If clinically significant reduction in renal function or worsening of other parameters occurs, subsequent dosage should be reduced or interrupted on the basis of laboratory measures.
Amphotericin is nephrotoxic. If renal function deteriorates significantly during AmBisome therapy, consideration should be given to dose reduction or discontinuation until renal function improves, however, this decision should take into account any concomitant therapy with known nephrotoxic drugs.
Treatment of Diabetic Patients: It should be noted that AmBisome contains approximately 900 mg of sucrose in each vial.
Treatment of Renal Dialysis Patients: Data suggest that no dose adjustment is required in patients undergoing hemodialysis or filtration procedures, however AmBisome administration should be avoided during the procedure.
Use in Pregnancy & Lactation: Teratogenicity studies in both rats and rabbits have concluded that AmBisome had no teratogenic potential in these species.
No reproductive toxicity studies have been conducted with AmBisome in pregnant women. Systemic fungal infections have been successfully treated in pregnant women with conventional amphotericin without obvious effect on the fetus, but the number of cases reported has been small. Safety for use in pregnant women has not been established with AmBisome. It is not known if AmBisome is excreted in human milk. AmBisome should only be used during pregnancy and breastfeeding if the possible benefits to be derived outweigh the potential risks involved.