Drotrecogin alfa

Generic Name: drotrecogin alfa (droe-tre-KOE-gin AL-fa)
Brand Name: Xigris

Drotrecogin alfa is used for:

Treating life-threatening bacterial blood infections in certain adults.

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

Do NOT use drotrecogin alfa if:

  • you are allergic to any ingredient in drotrecogin alfa
  • 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 injury
  • 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.

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Before using drotrecogin alfa:

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

  • if you are pregnant, planning 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, low platelet levels, stomach bleeding (especially within the past 6 weeks), other bleeding problems, a high risk of bleeding, blood vessel problems in the brain, or a bulging blood vessel (aneurysm) (eg, in the brain or abdomen)
  • if you have kidney or liver problems, HIV infection, an organ transplant, or ulcers
  • if you have had a recent injury, surgery, or stroke

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

  • Anticoagulants (eg, warfarin), glycoprotein IIb/IIIa inhibitors (eg, abciximab), heparin, platelet inhibitors (eg, clopidogrel), salicylates (eg, aspirin), or tissue plasminogen activators (eg, reteplase) because they may increase the risk of drotrecogin alfa's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if drotrecogin alfa 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 drotrecogin alfa:

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

  • Drotrecogin alfa is administered as an injection at your doctor's office, hospital, or clinic.
  • Do not use drotrecogin alfa if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • Do not use drotrecogin alfa past the expiration date stamped on the vial.
  • If you miss a dose of drotrecogin alfa, or if a dose is interrupted, contact your doctor right away.

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

Important safety information:

  • Drotrecogin alfa 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.
  • Tell your doctor or dentist that you take drotrecogin alfa before you receive any medical or dental care, emergency care, or surgery.
  • Drotrecogin alfa may interfere with certain lab tests, including the activated partial thromboplastin time (aPTT) and coagulation tests based on the aPTT. Be sure your doctor and lab personnel know you are using drotrecogin alfa.
  • Lab tests, including liver function and complete blood cell counts, may be performed while you use drotrecogin alfa. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Drotrecogin alfa should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if drotrecogin alfa can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using drotrecogin alfa while you are pregnant. It is not known if drotrecogin alfa is found in breast milk. Do not breast-feed while taking drotrecogin alfa.

Possible side effects of drotrecogin alfa:

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 drotrecogin alfa. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black stools; bloody diarrhea; confusion; one-sided weakness; pink-colored/red urine; slurred speech; stomach pain; unusual bruising or bleeding; 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 about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe bleeding.

Proper storage of drotrecogin alfa:

Drotrecogin alfa is usually handled and stored by a health care provider. If you are using drotrecogin alfa at home, store drotrecogin alfa as directed by your pharmacist or health care provider. Keep drotrecogin alfa out of the reach of children and away from pets.

General information:

  • If you have any questions about drotrecogin alfa, please talk with your doctor, pharmacist, or other health care provider.
  • Drotrecogin alfa 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take drotrecogin alfa or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about drotrecogin alfa. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to drotrecogin alfa. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using drotrecogin alfa.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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