VOLUVEN

What it is

Voluven is hydroxyethyl starch 130/0.4, supplied as a 6% solution containing 60 g per litre in 0.9% sodium chloride . It is a solution for injection that is colourless, clear and slightly acidic . Voluven is an artificial colloid for volume replacement .

Approved indications

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

Dosing overview

Voluven is administered by intravenous infusion . Use 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 . In all patients, the initial 10–20 mL of Voluven should be infused slowly, keeping the patient under close observation for anaphylactic or anaphylactoid reactions manifesting as unexpected hypotension, or the development of wheeze or rash .

Key safety warnings

Administration of Voluven may cause anaphylactic reactions that may manifest as acute hypotension . Administration of Voluven may cause fluid overload, resulting in cardiac and pulmonary failure, and administration should be carefully titrated to relevant physiological endpoints . Voluven 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 . Prolonged administration of high doses of hydroxyethyl starch commonly causes pruritus (itching) . It is important to supply sufficient fluid and to regularly monitor kidney function and fluid balance, and avoid use in patients with pre-existing renal dysfunction . Discontinue use of Voluven at the first sign of renal injury. A need for renal replacement therapy has been reported up to 90 days after administration. Continue to monitor renal function for at least 90 days in any case of deterioration of renal function .

Contraindications

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

PBS listing

Voluven is listed on the PBS as a 500 mL intravenous infusion at 30 g per 500 mL. The listing is unrestricted with an ex-manufacturer price of A$6.82 .

Regulatory history

Voluven was first registered on the ARTG on 13 November 2006 . In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods .