Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The serious adverse events reported in clinical trials are increased mortality and renal replacement therapy renal in critically ill patients.
Most common adverse reactions are hypersensitivity, coagulopathy, hemodilution, circulatory overload and metabolic acidosis.
6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Three randomized controlled trials (RCTs) followed critically ill adult patients treated with different HES products for 90 days.
One trial (N=804) in severe sepsis patients using HES product (not approved in the U.S.) reported increased mortality (relative risk, 1.17;
95% CI, 1.01 to 1.36;
p=0.03) and RRT (relative risk, 1.35;
95% CI, 1.01 to 1.80;
p=0.04) in the HES treatment arm.4 Another trial (N=196) using different HES in severe sepsis patients reported no difference in mortality (relative risk, 1.20;
95% CI, 0.83 to 1.74;
5 WARNINGS AND PRECAUTIONS 5.1 Renal Dysfunction • Avoid use in patients with pre-existing renal dysfunction • Discontinue use of 6% Hetastarch in 0.9% Sodium Chloride Injection 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, including 6% Hetastarch in 0.9% Sodium Chloride Injection 5.2 Coagulopathy • 6% Hetastarch in 0.9% Sodium Chloride Injection is not recommended for use as a cardiac bypass pump prime, while the patient is on cardiopulmonary bypass, or in the immediate period after the pump has been discontinued because of the risk of increasing coagulation abnormalities and bleeding in patients whose coagulation status is already impaired.
Discontinue use of 6% Hetastarch in 0.9% Sodium Chloride Injection at first sign of coagulopathy 1-2 6% Hetastarch in 0.9% Sodium Chloride Injection has not been adequately evaluated to establish its safety in uses over extended periods other than leukapheresis.
6% Hetastarch in 0.9% Sodium Chloride Injection has been associated with coagulation abnormalities in conjunction with an acquired, reversible von Willebrand's-like syndrome and/or Factor VIII deficiency when used over a period of days.
Replacement therapy should be considered if a severe Factor VIII deficiency is identified.
If a coagulopathy develops, it may take several days to resolve.
Like all medications, 6% Hetastarch In 0.9% Sodium Chloride can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: