Voluven6%+0.9%

Voluven is a colloid intravenous fluid indicated for the treatment and prophylaxis of hypovolemia (low circulating blood volume) when treatment with crystalloid solutions alone is considered insufficient.

• Established/approved use: Volume replacement for acute (sudden) blood loss during surgery or trauma, in patients who are not critically ill.
• Adjunct use: Short-term plasma volume expansion as part of a broader fluid resuscitation strategy, alongside crystalloids and, where indicated, blood products.

Voluven does not replace red blood cells or plasma coagulation factors and is not intended as a substitute for blood transfusion when blood products are clinically required.

Important restriction: Current safety data show that Voluven should generally not be used in critically ill patients (including those with sepsis), in patients with pre-existing renal impairment, or in burn injury patients, because of an increased risk of death and severe kidney injury in these populations. Use in these settings is considered inappropriate and not evidence-supported.

Voluven is a semisynthetic colloid plasma volume expander dissolved in isotonic sodium chloride solution, administered intravenously. It is derived from waxy maize or potato starch and modified by hydroxyethylation to slow its degradation and prolong its intravascular volume-expanding effect.

By drawing and retaining fluid within the vascular space, Voluven temporarily increases circulating blood volume, supporting blood pressure and tissue perfusion in patients with hypovolemia. It is administered under direct medical supervision, typically in a hospital or surgical setting, with close monitoring of fluid status, renal function, and coagulation.

Voluven belongs to the therapeutic class of plasma volume expanders / colloid intravenous fluid replacement solutions, used in fluid and electrolyte management.

Hydroxyethyl Starch + Sodium Chloride works through the colloid osmotic (oncotic) effect of the hydroxyethyl starch molecules. These large starch molecules remain largely within the intravascular space after infusion, raising plasma oncotic pressure and drawing fluid from the interstitial space into the circulation. This expands and helps maintain circulating plasma volume more effectively and for a longer duration than crystalloid solutions alone.

The degree and duration of volume expansion with Hydroxyethyl Starch + Sodium Chloride depend on the molecular weight, molar substitution ratio, and concentration of the hydroxyethyl starch used. The starch component is gradually broken down by plasma alpha-amylase into smaller fragments that are eliminated primarily by the kidneys, with a smaller portion metabolized or taken up by the reticuloendothelial system. The sodium chloride component provides an isotonic electrolyte vehicle contributing sodium and chloride to the extracellular fluid.

Voluven has the following well-recognized clinically significant interactions:

• Anticoagulants and antiplatelet agents: Concurrent use may increase the risk of bleeding, as hydroxyethyl starch itself can impair coagulation (dilutional coagulopathy, reduced factor VIII/von Willebrand factor activity, platelet function effects); closer monitoring of coagulation status is recommended.
• Nephrotoxic drugs: Concomitant use with other nephrotoxic agents may add to the risk of renal injury associated with Voluven, particularly in patients with reduced renal reserve.
• Other sodium-containing intravenous fluids/drugs: Concurrent administration may increase the risk of sodium and fluid overload; total fluid and electrolyte intake should be tracked.

Adverse effects reported with Voluven include:

• Common: Pruritus (itching, which may be delayed and persistent), elevated serum amylase (without necessarily indicating pancreatitis), and hemodilution-related effects (e.g., lowering of hematocrit and plasma proteins).
• Less common but clinically important: Coagulation abnormalities/increased bleeding tendency, renal impairment or acute kidney injury, and fluid overload.
• Rare but serious: Anaphylactoid/hypersensitivity reactions (ranging from mild skin reactions to severe anaphylaxis), and, with repeated or high cumulative dosing, tissue accumulation.

Patients should seek urgent medical attention for signs of severe allergic reaction, unusual bleeding, decreased urine output, or breathing difficulty during or after infusion of Voluven.

There are no adequate and well-controlled studies of Voluven in pregnant women. It should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; use only under direct medical supervision and consult a physician.

It is not known whether the hydroxyethyl starch component is excreted in human breast milk. Caution is advised, and a physician should be consulted before use of Voluven in breastfeeding women, weighing the clinical need for volume resuscitation against potential infant exposure.

Boxed warning: Voluven is associated with an increased risk of mortality and severe renal injury requiring renal replacement therapy when used in critically ill patients, including those with sepsis. It is generally not recommended for use in this population, and use has become significantly restricted by regulatory authorities in many countries.

Additional precautions:

• Use only in appropriate, non-critically-ill patients for approved indications, at the lowest effective dose and for the shortest duration necessary.
• Monitor renal function before and during treatment; discontinue at the first sign of renal injury.
• Monitor coagulation status closely, particularly with repeated dosing, in patients undergoing surgery (especially cardiac or vascular surgery), or in those with pre-existing bleeding risk (see Contraindications for severe coagulopathy).
• Monitor for signs of fluid overload and pulmonary edema, especially in patients with cardiac or renal compromise.
• Monitor serum electrolytes, particularly sodium and chloride, given the sodium chloride content.
• Discontinue immediately if signs of anaphylactoid/hypersensitivity reaction occur, and provide supportive treatment.
• Long-term or high cumulative-dose use may lead to tissue storage/accumulation and pruritus that can be delayed and persistent.

Overdosage or excessively rapid infusion of Voluven can cause circulatory (fluid) overload, pulmonary edema, and dilution of blood components leading to coagulopathy. If overdose or signs of fluid overload occur, the infusion must be stopped immediately and the patient should receive prompt medical attention; contact a physician or emergency medical services right away. Management is supportive (e.g., diuretics, oxygen, and other measures as directed by a physician) and should be provided in a monitored clinical setting; do not attempt home treatment.

Store at room temperature (below 30°C), away from light and moisture. Do not freeze. Use only if the solution is clear and the container is undamaged; discard any unused portion after opening. Keep out of reach of children.

Renal impairment: Voluven is contraindicated in patients with significant renal impairment or those on renal replacement therapy (see Contraindications).

Hepatic impairment: Contraindicated in severe hepatic disease; use with caution and close monitoring in milder liver dysfunction.

Elderly: Use with caution, as elderly patients may have reduced renal reserve and greater susceptibility to fluid overload; individualize dosing and monitor closely.

Pediatric patients: May be used cautiously for approved indications with weight-based dosing under close medical supervision; safety and efficacy for indications outside approved hypovolemia treatment are not established.

Critically ill/septic patients: Contraindicated due to increased risk of mortality and renal injury (see Contraindications).

Colloid plasma volume expander; semisynthetic hydroxyethyl starch solution in isotonic sodium chloride.

Voluven may be used in pediatric patients for the treatment or prophylaxis of hypovolemia when clearly indicated, with individualized, weight-based dosing under close medical supervision. Safety and efficacy in neonates and very young infants have not been well established, and use in these age groups should be limited to situations where the benefit clearly outweighs the risk, under specialist supervision.