Drotrecogin Alfa Solution for injection

What is this medicine?

DROTRECOGIN ALFA (droe tre KOE gin AL fa) is used to treat life-threatening sepsis.

NOTE: Drotecogin alfa has been withdrawn from the market and is no longer available.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding disorders

• brain or spine surgery or injury

• history of any bleeding event

• low platelet count in the blood

• liver disease

• stroke

• take medicines that treat or prevent blood clots

• an unusual or allergic reaction to drotrecogin alfa, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

• aspirin and aspirin-like medicines

• cilostazol

• clopidogrel

• dipyridamole

• medicines that treat or prevent blood clots like warfarin, enoxaparin, dalteparin, heparin

• pentoxifylline

• ticlopidine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• black or tarry stools

• breathing problems

• coughing up blood

• dark urine

• unusual bleeding or bruising

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.