Amphotericin B Liposome For Injection Special Precautions

Anaphylaxis and anaphylactoid reactions: Anaphylaxis and anaphylactoid reactions have been reported in association with Amphotericin B Liposome for Injection. 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/anaphylactoid reaction occurs, the infusion should be immediately discontinued and the patient should not receive further infusion of Amphotericin B Liposome for Injection.
Infusion-related reactions: Other severe infusion-related reactions can occur during administration of amphotericin B-containing products, including Amphotericin B Liposome for Injection. 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 Amphotericin B Liposome for Injection 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: Amphotericin B Liposome for Injection has been reported 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 reported studies comparing Amphotericin B Liposome for Injection 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.
Due to the risk of hypokalaemia, appropriate potassium supplementation may be required during the course of Amphotericin B Liposome for Injection 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 transfusion. 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 Amphotericin B Liposome for Injection contains approximately 900 mg of sucrose in each vial.
Renal dialysis patients: Reported data suggest that no dose adjustment is required in patients undergoing haemodialysis or filtration procedures, however, Amphotericin B Liposome for Injection administration should be avoided during the procedure.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-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.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been reported. Some of the reported undesirable effects of Amphotericin B Liposome for Injection presented (see Adverse Reactions) may impact the ability to drive and use machines.