VOLULYTE

What it is

Volulyte is hydroxyethyl starch 130/0.4 supplied as a solution for injection containing 60 g per litre of the active ingredient in a balanced electrolyte solution with sodium chloride and other electrolytes. It is presented as a solution for injection.

Approved indications

— Treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient.

Dosing overview

Volulyte is administered by intravenous infusion and should be restricted to the initial phase of volume resuscitation with a maximum duration of use of 24 hours. The daily dose and rate of infusion depend on the patient's blood loss, on the maintenance or restoration of haemodynamics and on the haemodilution; in clinical trials, infusions up to 33 mL/kg/day were most commonly used. There is limited experience with infusions between 33 mL/kg/day and 50 mL/kg/day, and hepatic and renal monitoring is necessary at higher doses.

Key safety warnings

Administration of Volulyte may cause anaphylactic reactions that may manifest as acute hypotension; the initial 10–20 mL should be infused slowly with close observation for anaphylactic or anaphylactoid reactions manifesting as unexpected hypotension, wheeze or rash. Administration of Volulyte may cause fluid overload, resulting in cardiac and pulmonary failure; administration should be carefully titrated to relevant physiological endpoints, and particular care must be taken in patients with cardiac insufficiency or severe renal dysfunction. Volulyte administration may cause coagulopathy, either through a direct effect or indirectly through the dilution effect, which will increase the risk of bleeding; administration should be ceased if a coagulopathy develops or excessive bleeding occurs. Coagulation status must be closely monitored during cardiopulmonary bypass in patients receiving Volulyte because of the bleeding risk. In renal impairment, sufficient fluid must be supplied and kidney function and fluid balance regularly monitored; use should be avoided in patients with pre-existing renal dysfunction; Volulyte should be discontinued at the first sign of renal injury; a need for renal replacement therapy has been reported up to 90 days after hydroxyethyl starch administration; renal function should be monitored for at least 90 days in any case of deterioration. Liver function should be monitored in patients receiving Volulyte.

Contraindications

Volulyte should not be used in critically ill patients (typically admitted to intensive care unit), including those with sepsis; in fluid overload or hyperhydration, especially in cases of pulmonary oedema and congestive cardiac failure; in patients with pre-existing coagulation or bleeding disorders; in renal failure with oliguria or anuria not related to hypovolaemia; in patients receiving dialysis treatment; in intracranial bleeding; in severe hypernatraemia or severe hyperchloraemia; in patients with known hypersensitivity to hydroxyethyl starches; or in patients with severe liver disease.

Regulatory history

Volulyte was first approved on 13 November 2006. Volulyte 6% hydroxyethyl starch 130/0.4 in freeflex bags of 250 mL and 500 mL were listed on the Australian Register of Therapeutic Goods on 26 August 2011.