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Generic Name: Drotrecogin Alfa (DROE-treh-KOE-jen)
Brand Name: Xigris

Xigris is used for:

Treating life-threatening bacterial blood infections in adults.

Xigris is similar to a natural protein produced by the body. In patients with severe, life-threatening bacterial infections, Xigris decreases inflammation and the formation of blood clots in blood vessels. It also increases the breakdown of blood clots.

Do NOT use Xigris if:

  • you are allergic to any ingredient in Xigris
  • you are bleeding internally or have a brain tumor or lesion
  • you have had a stroke within the last 3 months
  • you have recently (within the last 2 months) had brain or spinal surgery or suffered a severe head trauma
  • you have been severely injured and are at risk of life-threatening bleeding
  • you are using an epidural catheter

Contact your doctor or health care provider right away if any of these apply to you.

Before using Xigris :

Some medical conditions may interact with Xigris . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, plan to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have bleeding in the brain, blood clotting problems, stomach bleeding or other bleeding problems, a high risk of bleeding, blood vessel problems in the brain, kidney or liver problems, HIV infection, an organ transplant, ulcers, or low platelet counts, or have recently had trauma, surgery, or a stroke

Some MEDICINES MAY INTERACT with Xigris . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin), heparin, or salicylates (eg, aspirin) because the actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Xigris may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xigris :

Use Xigris as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Xigris is usually administered as an injection at your doctor"s office, hospital, or clinic.
  • Xigris must not be diluted with other liquids.
  • Do not shake Xigris .
  • If Xigris contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
  • If a dose of Xigris is interrupted, contact your doctor immediately to establish a new dosing schedule/rate.
  • Do not use Xigris past the expiration date stamped on the vial.
  • If you miss a dose of Xigris , contact your doctor right away.

Ask your health care provider any questions you may have about how to use Xigris .

Important safety information:

  • Xigris may cause serious bleeding. Follow your doctor"s instructions carefully. Do not get out of bed on your own unless otherwise instructed by your doctor.
  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Xigris .
  • LAB TESTS, including liver function and complete blood cell counts, may be required to monitor your progress. Be sure to keep all doctor and lab appointments.
  • Xigris is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Xigris during pregnancy. It is unknown if Xigris is excreted in breast milk. Do not breast-feed while taking Xigris .

Possible side effects of Xigris :

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with the proper use of Xigris . Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black stools; bloody diarrhea; confusion; easy bruising or bleeding; one-sided weakness; pink-colored/red urine; slurred speech; stomach pain; vision problems; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include severe bleeding.

Proper storage of Xigris :

Store Xigris in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect unreconstituted vials from light. Store in carton until time of use. Keep Xigris , as well as syringes and needles, out of the reach of children and away from pets.

General information:

  • If you have any questions about Xigris , please talk with your doctor, pharmacist, or other health care provider.
  • Xigris is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Xigris . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition
Copyright © 2006 Wolters Kluwer Health, Inc.

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