Drug information of Drotrecogin alfa

Drotrecogin alfa

Drug group:

Drotrecogin alfa is activated human protein C that is synthesized by recombinant DNA technology. It is a glycoprotein of approximately 55 kilodalton molecular weight, consisting of a heavy chain and a light chain linked by a disulfide bond. Drotrecogin alfa was withdrawn from the market after a major study indicated that it was not effective in improving outcomes in patients with sepsis.(drug bank)

Mechanism of effect

Activated protein C combines with protein S on platelet surfaces and then degrades factor Va and factor VIIIa, thereby reducing blood coagulability.(drug bank)

Pharmacokinetics

Half life

 hours (mammalian reticulocytes, in vitro)(drug bank)5.5   

Drug indications

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.

Drug contraindications

 

Side effects

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.

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.

Alerts

1-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.

2-Tell your doctor or dentist that you take drotrecogin alfa before you receive any medical or dental care, emergency care, or surgery.

3-Drotrecogin alfa should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.

Points of recommendation

1-Do NOT use drotrecogin alfa if:

- 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

2-Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

-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)

-you have kidney or liver problems, HIV infection, an organ transplant, or ulcers

-you have had a recent injury, surgery, or stroke

3-Drotrecogin alfa is administered as an injection at your doctor's office, hospital, or clinic

4-Do not use drotrecogin alfa if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged

5-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

6-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.

 storage

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.

Pregnancy level

HAVE NOT BEEN ESTABLISHED

 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.

Breast feeding warning

It is not known if this medicine is found in breast milk. Do not breast-feed while taking drotrecogin alfa.

Drug forms

Xigris

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