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|Xigris

DROTRECOGIN ALFA (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Xigris

† Not commercially available in Canada.

Category

• Antithrombotic

Description

Drotrecogin alfa ((droh-truh-KO-jin al-fa)) is used to treat severe cases of sepsis, a life threatening infection in the blood. This medicine has been shown to reduce the risk of death in patients with severe sepsis who are at high risk of death. This medicine works by decreasing inflammation and the formation of blood clots in blood vessels.

This medicine is available only with your doctor"s prescription, in the following dosage form:

• Parenteral
• Injection (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For drotrecogin alfa, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to drotrecogin alfa. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals.

Breast-feeding— It is not known whether drotrecogin alfa passes into human breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information on the safety and effectiveness of drotrecogin alfa in children.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose of the other medicine, or other precautions may be necessary. When you are taking drotrecogin alfa it is especially important that your health care professional know if you are taking any of the following:

• Aspirin or
• Clot-dissolving drugs (alteplase [e.g., Activase], streptokinase [e.g., Streptase], urokinase [e.g., Abbokinase]), or
• Heparin or
• Medicines that prevent blood clots from forming (abciximab [e.g., ReoPro], enoxaparin [e.g., Lovenox], warfarin [e.g., Coumadin]) or
• Medicines that prevent platelets from sticking together (clopidogrel [e.g., Plavix], ticlopidine [e.g., Ticlid])—These medicines may increase the effects of drotrecogin alfa and may increase the chance of bleeding.

Other medical problems—The presence of other medical problems may affect the use of drotrecogin alfa. Make sure you tell your doctor if you have any other medical problems, especially:

• Aneurysm (swelling in a blood vessel) especially in the head or
• Blood disease or a history of unusual bleeding or
• Brain problems which may include bleeding, disease, injury or tumor or
• Injury to any part of the body or
• Liver disease or
• Recent spinal anesthesia
• Severe head injury
• Stroke or
• Thrombocytopenia (a low platelet count in the blood)—The risk of bleeding may be increased

• Recent surgery or
• Single organ dysfunction—May cause serious problems; caution should be used

Proper Use of This Medicine

Dosing—The dose of drotrecogin alfa will be different for different patients. It is based on your body weight and must be determined by your doctor. The dose will also depend on your medical condition and your response to drotrecogin alfa. Follow your doctor"s orders .

• For injection dosage form:
  • To treat the most severe cases of sepsis (infection in the blood):
    • Adults—The dose is usually 24 micrograms (mcg) per kilogram (10.9 mcg per pound) of body weight per hour injected into a vein over a period of 4 days (96 hours).
    • Children—Use and dose must be determined by your doctor.

Precautions While Using This Medicine

Drotrecogin alfa can cause bleeding that usually is not serious. However, serious bleeding may occur in some people. To help prevent serious bleeding, carefully follow any instructions given by your health care professional. Move around as little as possible, and do not get out of bed on your own, unless your health care professional tells you it is okay .

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Tell your health care professional immediately if the following side effect occurs :

Developed: 06/30/2002
Revised: 04/14/2005

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