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VOLUVEN(6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Voluven ®safely and effectively. See full prescribing information for Voluven ®.
VOLUVEN ®(6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection), for administration by intravenous infusion
Initial U.S. Approval: 2007
WARNING: MORTALITY
RENAL REPLACEMENT THERAPY
See full prescribing information for complete boxed warning.
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In critically ill adult patients, including patients with sepsis, use of hydroxyethyl starch (HES) products, including Voluven®, increases risk of
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Mortality
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Renal replacement therapy
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Do not use HES products, including Voluven®, in critically ill adult patients, including patients with sepsis.
INDICATIONS AND USAGE
Voluven® is a plasma volume substitute indicated for the treatment and prophylaxis of hypovolemia in adults and children. (1)
DOSAGE AND ADMINISTRATION
Administer by intravenous infusion only.
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Recommended Daily Dose |
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Adults (2.1) |
Up to 50 mL/kg body weight |
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Recommended Daily Dose
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Mean Daily Dose ± SD in Clinical Trials (2.2)
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Pediatric age groups (2.2)
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Up to 50 mL/kg body weight in all age groups
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< 2 years
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16 ± 9 mL/kg body weight
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2 – 12 years
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36 ± 11 mL/kg body weight
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> 12 years
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DOSAGE FORMS AND STRENGTHS
500 mL freeflex® flexible plastic intravenous solution container. Each 100 mL contains 6 g hydroxyethyl starch 130/0.4 in isotonic sodium chloride injection. (3)
CONTRAINDICATIONS
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Do not use hydroxyethyl starch (HES) products, including Voluven®, in critically ill adult patients, including patients with sepsis due to increased risk of mortality and renal replacement therapy. (4)
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Do not use HES products, including Voluven®, in patients with severe liver disease. (4)
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Do not use HES products, including Voluven®, in patients with known hypersensitivity to hydroxyethyl starch. (4)
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Do not use HES products in clinical conditions with volume overload. (4)
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Do not use HES products in patients with pre-existing coagulation or bleeding disorders. (4)
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Do not use HES products in patients with renal failure with oliguria or anuria not related to hypovolemia. (4)
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Do not use HES products in patients receiving dialysis. (4)
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Do not use HES products in patients with severe hypernatremia or severe hyperchloremia. (4)
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Do not use HES products in patients with intracranial bleeding. (4)
WARNINGS AND PRECAUTIONS
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Anaphylactoid and hypersensitivity reactions. (5.1, 6)
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Avoid use in patients with pre-existing renal dysfunction. (5.2)
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Discontinue use of Voluven® at the first sign of renal injury. (5.2)
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Continue to monitor renal function in hospitalized patients for at least 90 days as use of renal replacement therapy has been reported up to 90 days after administration of HES products. (5.2)
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Monitor the coagulation status of patients undergoing open heart surgery in association with cardiopulmonary bypass as excess bleeding has been reported with HES solutions in this population. Discontinue use of Voluven® at the first sign of coagulopathy. (5.3)
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Avoid fluid overload; adjust dosage in patients with cardiac or renal dysfunction. (5.4)
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In severe dehydration, a crystalloid solution should be given first. (5.4)
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Monitor liver function in patients receiving HES products, including Voluven®. (5.5)
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Monitor kidney function, fluid balance and serum electrolytes (5.5)
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Elevated serum amylase values may occur and interfere with the diagnosis of pancreatitis (5.5)
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High dosages may cause dilution of blood components (5.5)
ADVERSE REACTIONS
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Serious adverse reactions reported in clinical trials were increased mortality and need for renal replacement therapy in critically ill patients including sepsis.
Most common adverse reactions (incidence >1%) are pruritus, elevated serum amylase, hemodilution (resulting in dilution of blood components, e.g., coagulation factors and other plasma proteins, and in a decrease in hematocrit).
Anaphylactoid/hypersensitivity reactions can occur. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Hospira Inc. at 1-800-441-4100 or electronically at ProductComplaintsPP@hospira.com or FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
DRUG INTERACTIONS
No interactions with other drugs or nutritional products are known. (7)
The safety and compatibility of additives have not been established.
USE IN SPECIFIC POPULATIONS
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Pediatric patients: Dosage should be adjusted to individual patient needs. (2.2, 8.4)
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Renal impaired or geriatric patients: Dose adjustment needed dependent on patient's status. (8.5, 8.6)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 2/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
Voluven® (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is indicated for the treatment and prophylaxis of hypovolemia in adults and children. It is not a substitute for red blood cells or coagulation factors in plasma.
2 DOSAGE AND ADMINISTRATION
Voluven® is administered by intravenous infusion only. The daily dose and rate of infusion depend on the patient’s blood loss, on the maintenance or restoration of hemodynamics and on the hemodilution (dilution effect). Voluven® can be administered repetitively over several days. [see Warnings and Precautions (5)]
The initial 10 to 20 mL should be infused slowly, keeping the patient under close observation due to possible anaphylactoid reactions. [see General Warnings and Precautions (5.1)]
2.1 Adult Dose
Up to 50 mL of Voluven® per kg of body weight per day (equivalent to 3 g hydroxyethyl starch and 7.7 mEq sodium per kg of body weight). This dose is equivalent to 3500 mL of Voluven® for a 70 kg patient.
2.2 Pediatric Dose
The dosage in children should be adapted to the individual patient colloid needs, taking into account the disease state, as well as the hemodynamic and hydration status.
In 41 newborns to infants (< 2 years), a mean dose of 16 ± 9 mL/kg was administered. In 31 children from 2 to 12 years of age a mean dose of 36 ± 11 mL/kg was administered. The dose in adolescents > 12 is the same as the adult dose. [see Pediatric Use (8.4)]
2.3 Directions for Use of Voluven
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Do not remove the freeflex ® IV container from its overwrap until immediately before use.
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Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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Do not administer unless the solution is clear, free from particles and the freeflex® IV container is undamaged.
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Voluven® should be used immediately after insertion of the administration set.
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Do not vent.
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If administered by pressure infusion, air should be withdrawn or expelled from the bag through the medication/administration port prior to infusion.
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Discontinue the infusion if an adverse reaction occurs.
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It is recommended that administration sets be changed at least once every 24 hours.
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For single use only. Discard unused portion.
3 DOSAGE FORMS AND STRENGTHS
500 mL freeflex® flexible plastic intravenous solution container are available. Each 100 mL contains 6 g hydroxyethyl starch 130/0.4 in isotonic sodium chloride injection.
4 CONTRAINDICATIONS
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Do not use hydroxyethyl starch (HES) products, including Voluven®, in critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy (RRT).
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Do not use HES products, including Voluven®, in patients with severe liver disease.
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Do not use HES products, including Voluven®, in patients with known hypersensitivity to hydroxyethyl starch [see General Warnings and Precautions (5.1)]
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Do not use HES products in clinical conditions with volume overload.
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Do not use HES products in patients with pre-existing coagulation or bleeding disorders.
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Do not use HES products in patients with renal failure with oliguria or anuria not related to hypovolemia.
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Do not use HES products in patients receiving dialysis treatment.
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Do not use HES products in patients with severe hypernatremia or severe hyperchloremia.
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Do not use HES products in patients with intracranial bleeding.
5 WARNINGS AND PRECAUTIONS
5.1 Anaphylactoid Reactions
Anaphylactoid reactions (mild influenza-like symptoms, bradycardia, tachycardia, bronchospasm, non-cardiac pulmonary edema) have been reported with solutions containing hydroxyethyl starch. If a hypersensitivity reaction occurs, administration of the drug should be discontinued immediately and the appropriate treatment and supportive measures should be undertaken until symptoms have resolved. [see Adverse Reactions (6)]
5.2 Renal Dysfunction
Avoid use in patients with pre-existing renal dysfunction.
Discontinue use of Voluven® at the first sign of renal injury.
Continue to monitor renal function in hospitalized patients for at least 90 days as use of RRT has been reported up to 90 days after administration of HES products.
5.3 Coagulopathy
Monitor the coagulation status of patients undergoing open heart surgery in association with cardiopulmonary bypass as excess bleeding has been reported with HES solutions in this population. Discontinue use of Voluven® at the first sign of coagulopathy.
5.4 Fluid Equilibrium
Avoid fluid overload; adjust dosage in patients with cardiac or renal dysfunction. Fluid status and rate of infusion should be assessed regularly during treatment, especially in patients with car |
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