Xigris

What is Xigris (drotrecogin alfa)?

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.

What is the most important information I should know about Xigris (drotrecogin alfa)?

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.

What should I discuss with my health care provider before receiving Xigris (drotrecogin alfa)?

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.

How is drotrecogin alfa given?

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.

What happens if I miss a dose?

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

What happens if I overdose?

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.

What should I avoid while receiving Xigris (drotrecogin alfa)?

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

Xigris (drotrecogin alfa) side effects

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.

What other drugs will affect Xigris (drotrecogin alfa)?

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.

Where can I get more information?

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

• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.