Intravenous (liposomal) amphotericin B treatment is given for serious fungal infections. Nowadays, only liposomal amphotericin B is used due to the lower risk of serious nephrotoxicity compared to the conventional variant.
The package leaflets of both conventional amphotericin B (Fungizone) and liposomal amphotericin B (Ambisome) list hyperkalemia as a side effect. For Fungizone it has been reported that hyperkalaemia may occur with rapid intravenous infusion, especially in patients with poor renal function. But with Ambisome, the warnings only describe the risk of hypokalemia (too low potassium levels), for which potassium supplementation may be necessary.
“Monitoring the potassium level around administration can prevent a fatal course through early detection,” says Lareb. “Extra caution is advised when using potassium supplementation simultaneously.”
Notifications Lareb
The Lareb Side Effects Center received a total of thirteen reports. In six cases the patient died. Four deaths involved the liposomal variant.
In most reports of hyperkalaemia with (liposomal) amphotericin B infusion, renal function was undisturbed or the patient was receiving renal replacement therapy and the infusion rate was according to protocol.
The hyperkalemia occurs during or within a few hours after the start of the intravenous infusion, is serious and does not respond or does not respond sufficiently to treatment and in some cases leads to life-threatening cardiac arrhythmias. Acute hyperkalemia can occur both with the first dose and after several days to weeks of treatment. Even in the case of a longer treatment duration, hyperkalemia occurs during or soon after the start of the intravenous amphotericin B infusion.
According to Lareb, a causal relationship is plausible given the temporal relationship and absence of alternative explanations. The underlying mechanism is as yet unclear but is unrelated to nephrotoxicity or rapid infusion.
However, in a number of reports there was a gradual increase in potassium levels, which occurred later in the treatment, with a simultaneous decline in renal function. “The course of this was mild,” the side effects center said.
European procedure
Adverse drug reaction centers in Europe received a total of 76 reports of hyperkalemia associated with the use of (liposomal) amphotericin B. In 28 cases there was a fatal outcome. Lareb has shared its findings with the Medicines Evaluation Board (MEB), after which a European procedure has been initiated. More will be known about this later this year.
2023-10-27 13:16:13
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