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Generic Name: drotrecogin alfa (Intravenous route)
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
- Powder for Solution
Therapeutic Class: Anticoagulant
Pharmacologic Class: Profibrinolytic
Uses For Xigris
Drotrecogin alfa injection 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 was available only with your doctor's prescription.
Drotrecogin alfa (Xigris®) injections were withdrawn from the U.S. market by Eli Lilly and Company on October 25, 2011.
Before Using Xigris
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of drotrecogin alfa injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of drotrecogin alfa injection in the elderly.
|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.|
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.
Interactions with 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 receiving 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.
- Alteplase, Recombinant
- Dabigatran Etexilate
- Reteplase, Recombinant
Interactions with Food/Tobacco/Alcohol
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
- Head injury, severe or
- Injury to any part of the body or
- Liver disease or
- Recent spinal anesthesia or
- Stroke or
- Thrombocytopenia (low number of platelets)—The risk of bleeding may be increased.
- Single organ dysfunction or
- Surgery, recent—Use with caution. May cause serious problems.
Proper Use of Xigris
A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. The medicine is given slowly over 4 days, so the needle will remain in place during that entire time.
Precautions While Using Xigris
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 doctor. Move around as little as possible, and do not get out of bed on your own, unless your doctor tells you it is okay.
Xigris Side Effects
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 or nurse immediately if any of the following side effects occur:More common
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.
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