Patient Medication Information: uses, side effects, how to take - Xigris (5mg/Vial)
ABOUT THIS MEDICATION
What XIGRIS is used for:
XIGRIS is used to treat adult patients with severe sepsis who are at high risk of death.
When a patient has a severe infection, clots can form inappropriately in their blood. These clots can block the blood supply to important parts of the body such as kidneys and lungs. This causes an illness called severe sepsis, which can make the patient very ill. Some people will die from this illness.
What XIGRIS does:
XIGRIS helps to control blood clotting and inflammation. When a patient’s body has a severe infection, clots can form in the patient’s blood. These clots can block the blood supply to important parts of the body such as kidneys and lungs. This causes an illness called severe sepsis, which can make the patient very ill. Some people will die from this illness. XIGRIS helps the patient’s body with severe sepsis to stop clots from forming, get rid of the existing clots and also reduces the inflammation caused by the infection.
When it should not be used:
A patient should not be treated with XIGRIS if they have an allergy to drotrecogin alfa (activated) or any of the other ingredients of XIGRIS listed in the “Nonmedicinal Ingredients” section of this leaflet, or bovine (cattle-derived) thrombin (protein).
They should not receive XIGRIS:
- If they have internal bleeding
- If they have had a bleed in their brain called a haemorrhagic stroke within the last 3 months
- If they have had surgery on their brain or spine or have been in hospital with severe injury to their head within the last 2 months
- If they have had a major accident and are at risk of dying from bleeding
- If they have an epidural catheter (a tube in their spine)
- If they have a brain tumour or similar mass in their head
What the medicinal ingredient is:
XIGRIS contains the active ingredient drotrecogin alfa (activated). Drotrecogin alfa (activated) is very similar to a protein that occurs naturally in the blood.
What the important nonmedicinal ingredients are: XIGRIS contains the following inactive ingredients: sucrose, sodium chloride, citrate (buffer system composed of citric acid, sodium citrate, and hydrochloric acid and sodium hydroxide). It may also contain hydrochloric acid and/or sodium hydroxide, if necessary.
What dosage forms it comes in:
XIGRIS is supplied to the hospital as a powder in 5 mg and 20 mg vials. A hospital pharmacist, nurse or doctor will dissolve the XIGRIS powder in water for injection and sodium chloride solution.
WARNINGS AND PRECAUTIONS
All medicines have risks and benefits. If a patient is being considered for therapy with XIGRIS, their doctor will carefully evaluate the potential benefits against potential risks associated with this therapy. There may be some patients with certain characteristics that may not benefit or may be harmed with this therapy. Certain conditions increase the risk of bleeding with XIGRIS therapy. Therefore, before starting XIGRIS, your doctor will examine and evaluate the need for a patient to be treated with XIGRIS.
When low dose heparin is given for prophylaxis of venous thrombotic events with Xigris, prophylactic heparin should not be discontinued unless considered medically necessary.
The doctor should be told if a patient has an increased risk of bleeding, for example:
- they have a known problem with bleeding or condition in which significant bleeding is likely or hard to control
- they are taking other drugs which affect how their blood clots
- their platelet (a type of cell in the blood) count is low
- they have bled from their stomach/intestines within the last 6 weeks
- they have had a stroke caused by a blood clot within the last 3 months
- they have abnormal blood vessels in their brain or increased pressure on the brain
- they have a long-standing, severe problem with their liver
Pregnant women: Tell the doctor or health care professional if the patient is pregnant or planned to become pregnant or is breast-feeding. XIGRIS is not recommended for use in pregnancy. The doctor can discuss the risks and benefits involved.
IMPORTANT: PLEASE READ
XIGRIS [drotrecogin alfa (activated)] Page 36 of 36 Product Monograph
INTERACTIONS WITH THIS MEDICATION
Tell the doctor or health care professional if a patient is taking any other medicines, including any that are purchased without a prescription from your pharmacy, supermarket or health food shop. Some medicines and XIGRIS may interfere with each other. These include:
- Medicines that affect blood clotting, such as warfarin, heparin and aspirin
When low dose heparin is given for prophylaxis of venous thrombotic events with Xigris, prophylactic heparin should not be discontinued unless considered medically necessary.
These medications may be affected by XIGRIS or may affect how well it works. The patient may need different amount of their medicines or may need to take different medicines.
The health care professional has more information on medicines to be careful with or avoid while receiving XIGRIS.
PROPER USE OF THIS MEDICATION
How much will be given:
The recommended dose of XIGRIS is 24 micrograms per kilogram of body weight each hour for 96 hours.
How will it be given:
A hospital pharmacist, nurse or doctor will dissolve the XIGRIS powder in water for injection and sodium chloride solution. This liquid will then be injected from a bag or pump into a patient’s veins.
XIGRIS will be given for 96 hours. If there is an interruption during the time XIGRIS is given, it may be restarted and given for a total of 96 hours.
The doctor may want to stop this therapy based on the risk involved with certain procedures or surgery. In most cases, this can be safely restarted at the discretion of the doctor.
Overdose:
As XIGRIS will be given under the supervision of a doctor, it is unlikely that too much will be given. However, if a patient experiences any side effects after having XIGRIS, tell the doctor or nurse immediately. There is no known antidote for XIGRIS. In case of overdose, the infusion should be stopped immediately, and the doctor should monitor the patient closely.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, XIGRIS can have side effects. As noted previously, XIGRIS may increase the risk of bleeding which can be serious or life threatening.
The doctor should be notified immediately if any side effects are noticed that are not mentioned in this leaflet.
This is not a complete list of side effects. For any unexpected effects while taking XIGRIS, contact the doctor or health care professional.
HOW TO STORE IT
XIGRIS is stored in hospitals under the following conditions:
- Kept in a refrigerator, between 2° to 8 °C in its original package (unreconstituted).
- Do not freeze XIGRIS. Do not use XIGRIS if it has been frozen.
- Unreconstituted vial must be protected from exposure to light by keeping the vial in carton until it is time for it to be used.
- Keep where children cannot reach.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
By toll-free telephone: 866-234-2345
By toll-free fax: 866-678-6789
Online: www.healthcanada.gc.ca/medeffect
By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and
Effectiveness Information Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
For more information, please contact your healthcare professionals or pharmacist first, or Eli Lilly Canada Inc. at: 1-888-545-5972, or visit the website at: www.lilly.ca