Pronunciation:

droe-tre-KOE-gin AL-fa

Brand Names:

• Xigris

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic

Anticoagulant

Pharmacologic

Profibrinolytic

Uses of This Medicine:

Drotrecogin alfa 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.

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Acenocoumarol
• Argatroban
• Bivalirudin
• Clopidogrel
• Dalteparin
• Danaparoid
• Dipyridamole
• Enoxaparin
• Eptifibatide
• Fondaparinux
• Heparin
• Lepirudin
• Phenindione
• Phenprocoumon
• Ticlopidine
• Tinzaparin
• Tirofiban
• Warfarin

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. 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 this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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.

Check with your doctor immediately if any of the following side effects occur:

More common

Bleeding

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.