drotrecogin alfa

	What is the most important information I should know about drotrecogin alfa?
	What is drotrecogin alfa?
	What should I discuss with my health care provider before receiving drotrecogin alfa?
	How is drotrecogin alfa given?
	What happens if I miss a dose?
	What happens if I overdose?
	What should I avoid while receiving drotrecogin alfa?
	What are the possible side effects of drotrecogin alfa?
	What other drugs will affect drotrecogin alfa?
	Where can I get more information?
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You should not receive this medication if you have active internal bleeding, brain cancer, tumor, or bleeding in the brain. You should also not receive drotrecogin alfa if you have had brain or spine surgery or a head injury in the past 2 months, or if you have had a stroke within the past 3 months.

Before receiving drotrecogin alfa, tell your doctor if you have severe liver disease, a bleeding or blood clotting disorder, if you have recently had stomach or intestinal bleeding, or have recently taken aspirin, a blood-thinner, or medications to treat or prevent blood clots.

Drotrecogin alfa is a form of human protein (Protein C).

Drotrecogin alfa is used to treat sepsis in patients who have a high risk of death due to multi-system organ failure.

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

You should not use this medication if you are allergic to drotrecogin alfa, or if you have:

• active internal bleeding;
• brain cancer, tumor, or bleeding in the brain;
• if you have had brain or spine surgery or a head injury in the past 2 months; or
• if you have had a stroke within the past 3 months.

Before you receive drotrecogin alfa, tell your doctor if you are allergic to any drugs, or if you have:

• severe liver disease;
• a bleeding or blood clotting disorder;
• if you have had stomach or intestinal bleeding within the past 6 weeks;
• if you have received treatment for blood clots within the past 3 days; or
• if you have taken aspirin or a blood thinner (such as warfarin, Coumadin), or anti-platelet medication (dipyridamole, Persantine, clopidogrel, Plavix) within the past 7 days.

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive drotrecogin alfa.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether drotrecogin alfa passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

Drotrecogin alfa is given as an injection through a needle placed into a vein. You will most likely receive this injection in a hospital setting.

Drotrecogin alfa must be given slowly through an IV infusion, and can take up to 4 days to complete.

Since drotrecogin alfa is given as needed by a healthcare professional, it is not likely that you will miss a dose.

Seek emergency medical attention if you think you have received too much of this medicine.

Overdose symptoms may include unusual bleeding, or any bleeding that won't stop.

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are receiving drotrecogin alfa..

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 at once if you have any of these serious side effects:

• blood in your urine or stools;
• coughing up blood or vomit that looks like coffee grounds;
• bleeding from any incision or injection in your skin; or
• any bleeding that won't stop.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Before receiving drotrecogin alfa, tell your doctor if you have recently received any of the following medications prevent blood clots:

• alteplase (Activase);
• anistreplase (Eminase);
• clopidogrel (Plavix);
• dipyridamole (Persantine);
• streptokinase (Kabikinase, Streptase);
• ticlopidine (Ticlid);
• urokinase (Abbokinase).

This list is not complete and there may be other drugs that can interact with drotrecogin alfa. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Your doctor or pharmacist can provide more information about drotrecogin alfa.