AmBisome Side Effects

In pooled study data from randomized, controlled clinical trials comparing AmBisome with conventional amphotericin B therapy in >1000 patients, reported adverse effects were considerably less severe and less frequent in AmBisome-treated patients, as compared with conventional amphotericin B-treated patients. Fever and chills/rigors are the most frequent infusion-related reactions expected to occur during the first AmBisome dose administration when no premedication to prevent these reactions is provided. In 2 double-blind, comparative studies, AmBisome-treated patients experienced a significantly lower incidence of infusion-related reactions, as compared to patients treated with conventional amphotericin B or amphotericin B lipid complex. Less frequent infusion-related reactions may consist of one or more of the following symptoms including back pain and/or chest tightness or pain, dyspnoea, bronchospasm, flushing, tachycardia and hypotension, and these resolved rapidly when the infusion was stopped. These reactions may not occur with every subsequent dose or when slower infusion rates (>2 hrs) are used (see Precautions).
The following adverse effects have been attributed to AmBisome. The incidence is based on analysis from pooled clinical trials of 688 AmBisome-treated patients. ≥10%: Fever, chills/rigors, hypokalaemia, nausea, vomiting.
10% to ≥1%: Creatinine increase, BUN increase, hypomagnesaemia, hypocalcaemia, hyperglycaemia, hyponatraemia, increased alkaline phosphatase, bilirubinaemia, abnormal liver function tests, diarrhoea, abdominal pain, dyspnoea, flushing/vasodilatation, headache, back pain, chest pain, tachycardia, hypotension, rash.
1% to ≥0.1%: Convulsion, bronchospasm, thrombocytopenia, anaphylactoid reaction, anaemia, phlebitis.
In 2 double-blind studies, the incidence of nephrotoxicity with AmBisome (as measured by serum creatinine increase >2 times the baseline measurement), is approximately ½ of that reported for conventional amphotericin B or amphotericin B lipid complex.
In addition to rare post-marketing reports of anaphylactoid reactions, occasional reports of less severe allergic-type reactions have been received in association with AmBisome infusion including very rare reports of angioedema.