Foscavir (Foscarnet Sodium Injection) Drug Information: Overdosage and Contraindications

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May 27, 2012

Foscavir

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Foscavir

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OVERDOSE

In controlled clinical trials performed in the United States, overdosage with FOSCAVIR (foscarnet sodium injection) was reported in 10 out of 189 patients. All 10 patients experienced adverse events and all except one made a complete recovery. One patient died after receiving a total daily dose of 12.5 g for three days instead of the intended 10.9 g. The patient suffered a grand mal seizure and became comatose. Three days later the patient expired with the cause of death listed as respiratory/cardiac arrest. The other nine patients received doses ranging from 1.14 times to 8 times their recommended doses with an average of 4 times their recommended doses. Overall, three patients had seizures, three patients had renal function impairment, four patients had paresthesias either in limbs or periorally, and five patients had documented electrolyte disturbances primarily involving calcium and phosphate.

Overdose (up to 20 times the recommended dose) has been reported in post-marketing use of FOSCAVIR (foscarnet sodium injection) . Some of these post-marketing reports were relative overdoses in that the dose of FOSCAVIR (foscarnet sodium injection) had not been adjusted in patients with a reduced renal function. The pattern of adverse events associated with a FOSCAVIR (foscarnet sodium injection) overdose is consistent with the known adverse event profile of the drug.

There is no specific antidote for FOSCAVIR (foscarnet sodium injection) overdose. Hemodialysis and hydration may be of benefit in reducing drug plasma levels in patients who receive an overdosage of FOSCAVIR (foscarnet sodium injection) , but the effectiveness of these interventions has not been evaluated. The patient should be observed for signs and symptoms of renal impairment and electrolyte imbalance. Medical treatment should be instituted if clinically warranted.