Warnings & Recalls for Xigris
Xigris Withdrawal from market
In October of 2011, Lilly agreed to
voluntarily withdraw Xigris from the market because studies failed to show benefits for patients being administered the drug.
Xigris can cause
severe bleeding and for this reason guidelines have been set for its use. Xigris should only be administered by intensive care units where close monitoring of the patients can occur, and it should only be administered by a medical professional capable of weighing the true benefits and risks of Xigris.
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Other warnings
Patients who have
organ dysfunction from sepsis and have undergone recent surgery may have a
higher chance of death on Xigris.
Patients on Xigris should be on bed rest and should inform their doctor of any other medical care/surgery.
Xigris may effect lab tests for partial thromboplastin time and coagulation so patients on the drug should be advised.
Xigris
SHOULD NOT be used in:
- children
- those who are allergic to any ingredients in Xigris (drotrecogin alfa, sucrose, sodium chloride, citrate, sodium citrate, hydrochloric acid and sodium hydroxide)
- those who have any internal bleeding or brain tumors
- anyone who has had a stroke within the last 3 months
- persons who have had brain or spinal surgery including severe head trauma within the last 2 months
- those who have been traumatically hurt with a risk of life-threatening bleeding
- anyone using an epidural catheter
- those with known mass lesions
- anyone who is hypersensitive to Xigris or any ingredient of Xigris
Before using Xigris patients should let their physician know if they are in/have any of the following situations:
- taking herbal and dietary supplements
- any allergies
- bleeding/blood clotting problems
- low platelet levels
- high risk of bleeding including stomach bleeding, aneurysms
- kidney or liver problems
- HIV infections
- organ transplants and ulcers
- anyone who has had any recent surgery or stroke.
Those who fall under the following categories are
at risk for increased bleeding complications while on Xigris:
- those on concurrent therapeutic heparin of 15 kg/h or greater
- low platelet count
- gastrointestinal bleeding within 6 weeks
- those given thrombolytic therapy within 3 days, those on oral anticoagulants, aspirin or platelet inhibitors within 7 days
- those with known bleeding problems
- chronic hepatic disease
- persons with an HIV infection with low CD4 counts
- anyone with a prothrombin time reading of less than 3.0
- those with bleeding hazards at unreachable locations
- persons who have previously received Xigris.
Contraindications
Include anticoagulants, glycoprotein inhibitors, heparin, platelet inhibitors, salicylates and tissue plasminogen activators. Drugs that affect hemostasis (the stoppage of blood flow) like aspirin, warfarin and clopidogrel, should be used with caution.
Ibuprofen, acetaminophen, naproxen, and Vitamin E are also known to interfere with Xigris.
Xigris and Pregnancy
It is unknown if Xigris will cause fetal harm, therefore patients should consult their doctor to weigh the benefits and risks of using this drug while pregnant.
It is also unknown whether Xigris will pass through breast milk, therefore nursing mothers are advised not to breast feed.
Xigris Treatment and Use
What is Xigris?
Xigris |drotrecogin alfa is an intravenous injection produced by Lilly used to treat the bacterial infection of the blood known as sepsis. In October 0f 2011, Xigris was withdrawn from the market after studies showed little to no efficacy in the treatment of sepsis.
How does Xigris work?
The drug Xigris is a human activated Protein C that slow down blood clotting by inhibiting facts Va and VIIIa (blood clotting proteins) and permits profibrinolytic activity (the prevention and breakdown of blood clots). Xigris also exerts anti-inflammatory responses by blocking leukocytes (white blood cells) adhering to an infection site, and limits inflammation.
Dosage information
Xigris should be administered intravenously by a medial professional at an infusion rate of 24 mcg/kg/hr and based on total body weight for the duration of 96 hours.
Serious Side Effects of Xigris