DROTRECOGIN ALFA (Systemic)?

Some commonly used brand names are:

In the U.S.?

• Xigris

? Not commercially available in Canada.

Category

• Antithrombotic

Description

Drotrecoginalfa ((droh-truh-KO-jin al-fa)) is used to treatsevere 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 sepsiswho are at high risk of death. This medicine works by decreasing inflammationand the formation of blood clots in blood vessels.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

Parenteral
• Injection (U.S.)

Before Using This Medicine

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

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

Pregnancy?Studies on effects in pregnancy have not been donein either humans or animals.

Breast-feeding? It is not known whether drotrecogin alfa passesinto human breast milk. Although most medicines pass into breast milk in smallamounts, many of them may be used safely while breast-feeding. Mothers whoare taking this medicine and who wish to breast-feed should discuss this withtheir doctor.

Children?Studies on this medicine have been done only inadult patients, and there is no specific information on the safety and effectivenessof drotrecogin alfa in children.

Older adults?This medicine has been tested and has not beenshown to cause different side effects or problems in older people than itdoes in younger adults.

Other medicines?Although certain medicines should not be used together at all, in other casestwo different medicines may be used together even if an interaction mightoccur. In these cases, your doctor may want to change the dose of the othermedicine, or other precautions may be necessary. When you are taking drotrecoginalfa it is especially important that your health care professional know ifyou 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 increasethe 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 drotrecoginalfa. 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 tumoror
• 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 riskof bleeding may be increased

• Recent surgery or
• Single organ dysfunction?May cause serious problems; cautionshould be used

Proper Use of This Medicine

Dosing?The dose of drotrecoginalfa will be different for different patients. It is based on your body weightand must be determined by your doctor. The dose will also depend on your medicalcondition and your response to drotrecogin alfa. Followyour 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 periodof 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 usuallyis not serious. However, serious bleeding may occur in some people. To help prevent serious bleeding, carefully follow any instructionsgiven 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 professionaltells you it is okay.

Side Effects of This Medicine

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

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

More common

Bleeding

Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.