Hetastarch (hydroxyethyl starch) is made from natural sources of starch. Hetastarch increases the volume of blood plasma that can be lost from bleeding or severe injury. Plasma is needed to circulate red blood cells that deliver oxygen throughout the body.

Hetastarch is used to treat or prevent hypovolemia (decreased blood plasma volume, also called "shock") that may occur as a result of serious injury, surgery, severe blood loss, burns, or other trauma.

Hetastarch may also be used for purposes not listed in this medication guide.

You should not receive this medication if you have a bleeding or blood clotting disorder, congestive heart failure, kidney disease, or urination problems not caused by hypovolemia (decreased blood plasma volume).

Hetastarch can harm your kidneys. Call your doctor at once if you have any of these symptoms of kidney damage: swelling, rapid weight gain, unusual tiredness, nausea, vomiting, feeling short of breath, red or pink urine, painful or difficult urination, or little or no urinating.

Hetastarch is injected into a vein through an IV. A healthcare provider will give you this injection.

Your breathing, blood pressure, oxygen levels, kidney function, and other vital signs will be watched closely while you are receiving hetastarch. Your blood will also need to be tested daily during treatment.

Usual Adult Dose for Hypovolemia:

Dosage for Acute Use in Plasma Volume Expansion: 500 to 1000 mL IV
Maintenance dose: Total dosage and rate of infusion depends on the amount of blood or plasma lost and the resultant hemoconcentration.
Maximum dose: Doses more than 1500 mL per day (approximately 20 mL per kg of body weight) are usually not required although higher doses have been used in postoperative and trauma patients with severe blood loss.

Dosage in Leukapheresis: 250 to 700 mL to which citrate anticoagulant has been added and administered to the input line of the centrifugation apparatus at a ratio of 1:8 to 1:13 to venous whole blood.

Comments:
-Hetastarch and citrate should be thoroughly mixed to assure effective anticoagulation.
-Hetastarch admixtures of 500 to 560 mL with citrate concentrations up to 2.5% are compatible for 24 hours at room temperature.

Uses:
-For treatment of hypovolemia when plasma volume expansion is desired
-This drug in leukapheresis improves the harvesting and increasing the yield of granulocytes by centrifugal means

You should not receive this medication if you are allergic to hetastarch, or if you have:

• a bleeding or blood clotting disorder;

• kidney disease;

• congestive heart failure; or

• urination problems not caused by hypovolemia (decreased blood plasma volume).

If possible before you receive hetastarch, tell your doctor if you have:

• liver disease;

• a history of heart disease; or

• if you are allergic to corn.

FDA pregnancy category C. It is not known whether hetastarch will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether hetastarch passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In an emergency situation it may not be possible to tell your caregivers about your health conditions, or if you are pregnant or breast-feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received hetastarch.

Because you will receive hetastarch in a clinical setting, you are not likely to miss a dose.

Since hetastarch is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have:

• wheezing or gasping for breath, rapid breathing, sweating, and anxiety;

• a light-headed feeling, like you might pass out;

• weak pulse, slow breathing;

• chest pain, fever, chills, cough; or

• easy bruising, unusual bleeding, or any bleeding that will not stop.

Rare but serious side effects may include:

• severe headache, vision or speech problems, mental changes;

• drooping eyelids, loss of feeling in your face, tremors, trouble swallowing; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Hetastarch can harm your kidneys. Call your doctor at once if you have any of these symptoms of kidney damage: swelling, rapid weight gain, unusual tiredness, nausea, vomiting, feeling short of breath, red or pink urine, painful or difficult urination, or little or no urinating.

Common side effects of hetastarch may include:

• mild itching or skin rash;

• mild headache;

• muscle pain; or

• swollen glands, mild flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.