AmBisome Special Precautions

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially 'sodium-free'.
Anaphylaxis and anaphylactoid reactions: Anaphylaxis and anaphylactoid reactions have been reported in association with AmBisome infusion. To detect idiosyncratic anaphylactic reactions and minimise the dose administered if a reaction occurs, a test dose should be administered initially. If a severe anaphylactic/anaphylactoid reaction occurs, the infusion should be immediately discontinued and the patient should not receive further infusion of AmBisome.
Infusion-related reactions: Other severe infusion-related reactions can occur during administration of amphotericin B-containing products, including AmBisome (see Adverse Reactions). 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 (over 2 hours) or routine doses of diphenhydramine, paracetamol, pethidine, and/or hydrocortisone have been reported as successful in their prevention or treatment.
Renal effects: AmBisome has been shown to be substantially less toxic than conventional amphotericin B; particularly with respect to nephrotoxicity, however, adverse reactions, including renal adverse reactions, may still occur.
In studies comparing AmBisome 3 mg/kg daily with higher doses (5, 6 or 10 mg/kg daily), it was found that the incidence rates of increased serum creatinine, hypokalaemia and hypomagnesaemia were notably higher in the high dose groups.
Regular laboratory evaluation of serum electrolytes, particularly potassium and magnesium, as well as renal, hepatic and haematopoietic function should be performed. This is particularly important in patients receiving concomitant nephrotoxic medications (see Interactions). Due to the risk of hypokalaemia, appropriate potassium supplementation may be required during the course of AmBisome administration. If clinically significant reduction in renal function or worsening of other parameters occurs, consideration should be given to dose reduction, treatment interruption or discontinuation.
Pulmonary effects: Acute pulmonary toxicity has been reported in patients given amphotericin B (as sodium deoxycholate complex) during or shortly after leukocyte transfusions. It is recommended that infusions are separated by as long a period as possible and pulmonary function should be monitored.
Diabetic patients: It should be noted that AmBisome contains approximately 900 mg of sucrose in each vial.
Renal dialysis patients: Data suggest that no dose adjustment is required in patients undergoing haemodialysis or filtration procedures, however, AmBisome administration should be avoided during the procedure.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. Some of the undesirable effects of AmBisome presented in Adverse Reactions may impact the ability to drive and use machines.