Intended for patients receiving aprotinin treatment

What is coronary artery bypass graft surgery (CABG)?

The coronary arteries are the blood vessels that deliver oxygen-rich blood to the heart. If these arteries become restricted or blocked, you may experience chest pain (angina) or, in time, a heart attack.1

A CABG procedure is performed to relieve chest pain. Successful CABG can improve your course of the disease (prognosis) and provide a better quality of life by lessening pain and disability related to angina.1,2

During the procedure, your surgeon will graft a blood vessel between the aorta (the main blood vessel leaving the heart) and a point along the coronary artery, bypassing the obstructed vessel.2 Donor vessels for the graft can be taken from your leg, inside your chest, or your arm.2 The number of blood vessels grafted will depend on many of your coronary blood vessels have become narrowed or obstructed.3

Your heart will be temporarily stopped using medication while your surgeon performs the bypass surgery, and you may be supported by a heart–lung bypass machine.3 After the grafts have been attached, your heart will be restarted with electrical pulses.3

CABG illustration

Reprinted with permission from The Society of Thoracic Surgeons: ctsurgerypatients.org.

During a CABG, your surgeon will bypass an obstructed vessel in order to allow greater blood flow and relief from chest pain3

Aprotinin: understanding the medication that can be used in your operation

Aprotinin is a medication used to help reduce blood loss in patients undergoing heart surgery. Aprotinin is licensed in adults undergoing isolated coronary artery bypass graft surgery (CABG).4

After careful consideration of the risks and benefits, your doctor or surgeon has recommended that you would benefit from this treatment because you are at increased risk of major blood loss during your heart surgery.

What is aprotinin and how does it work?

Aprotinin minimises blood loss during and after your surgery, to reduce the risk of complications, including the need for blood transfusions, which are associated with poorer outcomes post-surgery5

You must not be given Aprotinin Injection:
– if you are allergic to Aprotinin Injection or any of the other ingredients of this medicine.
– if a positive aprotinin-specific IgG antibody test is available, showing an increased risk of an allergic reaction to Aprotinin Injection
– if no aprotinin specific IgG antibody test is possible prior to treatment and you have received or you suspect that you have received Aprotinin-containing medicinal products in the last 12 months.

Warnings and precautions
Talk to your doctor before receiving Aprotinin Injection.

Tell your doctor if any of these apply to you, to help him or her decide if Aprotinin Injection is suitable for you:
– Your kidneys do not work properly. If you have kidney problems Aprotinin Injection should only be used if your doctor/surgeon feels it will be of benefit.
– You have or suspect you have received aprotinin or aprotinin containing fibrin sealants in the last 12 months.

If any of these apply to you, your doctor will decide whether Aprotinin Injection is suitable for you or not.

Aprotinin Injection will only be given if your doctor has done blood tests before to check you are suitable (e.g. an appropriate aprotinin-specific IgG antibody test), otherwise other medicines may be a better option for you.

You will be monitored carefully for any allergic reaction to the medicine and your doctor/surgeon will treat any symptoms you may experience. Standard emergency treatment for severe allergic reactions should be readily available during treatment with Aprotinin Injection.

Children and adolescents
The safety and efficacy of Aprotinin Injection in children below the age of 18 years have not been established.

Other medicines and Aprotinin Injection
Tell your doctor if you are taking, have recently taken or might take any other medicines.

You should specifically tell your doctor if you take:
– medicines used to dissolve blood clots, such as streptokinase, urokinase, alteplase (r-tPA)
– aminoglycosides (antibiotics, medicines used to treat infections)

It is recommended that your doctor/surgeon should, in addition to Aprotinin Injection administer heparin (a medicine used to prevent blood clots) before and during the operation. Your doctor will evaluate the dose of heparin based from the results from tests of your blood.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine. If you are pregnant or breast-feeding Aprotinin Injection should only be used if your doctor/surgeon finds it will be of benefit. Your doctor will discuss with you the risks and benefits of using this medicine.6

How will you be given aprotinin?

Aprotinin is given into a large blood vessel (intravenously) during your operation.4 The surgical team will monitor the effect of aprotinin throughout your surgery.

You will receive a small amount of Aprotinin Injection (1 ml) before the operation begins, to test if you are allergic to the Aprotinin Injection.

Medicines used to prevent the symptoms of allergy (H1 ‑antagonist and a H2 ‑antagonist) may be administered 15 minutes prior to the test dose of Aprotinin Injection

If there are no signs of allergy, you will be given 100- 200 ml Aprotinin Injection over 20 to 30 minutes, followed by 25  ‑ 50 ml per hour (max. 5 ‑ 10 ml/min) until the end of the operation.

In general, you will not be given more than 700 ml of Aprotinin Injection at any one time.

There is no special dose recommendation for elderly patients or patients with poor kidney function

Aprotinin Injection will usually be given to you lying down by slow injection or infusion (through ‘a drip’) through a catheter into a larger vein in your body.

The surgical team will monitor the effect of Aprotinin throughout your surgery.6

Are there any side effects of using aprotinin?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Although allergic reactions are rare in patients receiving an aprotinin-containing medicinal product for the first time, patients who are given aprotinin more than once may have an increased chance of an allergic reaction. The symptoms of an allergic reaction may include:

  • Breathing difficulties
  • Blood pressure
  • Itching, rash and hives
  • Feeling sick

If any of these occur during administration of aprotinin your doctor/surgeon will stop treatment with the drug. Other side effects are:4

Uncommon: may affect up to 1 in 100 patients
  • Chest pain (myocardial ischaemia, coronary occlusion / thrombosis), heart attack (myocardial infarction)
  • Leakage of heart fluid into the surrounding body cavity (pericardial effusion)
  • Blood clot (thrombosis)
  • Kidney disease (acute renal failure, renal tubular necrosis)
  • Passing less urine than is normal
Rare: may affect up to 1 in 1,000 patients
  • Blood clot in blood vessels (arteries)
  • Severe allergic reaction (anaphylactic / anaphylactoid reaction)
Very rare: may affect up to 1 in 10,000 patients
  • Swelling on or around the location of the injected skin (injection and infusion site reactions, infusion site (thrombo- phlebitis)
  • Blood clot in the lungs (pulmonary embolism)
  • Severe blood clotting disorder that results in tissue damage and bleeding (disseminated intravascular coagulation)
  • Inability of the blood to clot or coagulate normally (coagulopathy)
  • Severe allergic shock (anaphylactic shock), which is potentially life threatening

How can I find out more about aprotinin?

There is a leaflet for patients included in the pack. It contains more information about the medicine. You can find a copy here. If you have any further questions or concerns, please speak to your doctor, surgeon, or pharmacist.

References

  1. NHS Overview: Coronary Artery Bypass Graft. Available from: https://www.nhs.uk/conditions/coronary-artery-bypass-graft-cabg/
  2. British Heart Foundation Coronary bypass surgery. Available from: https://www.bhf.org.uk/informationsupport/treatments/coronary-bypass-surgery
  3. NHS How it’s performed: Coronary artery bypass graft: Available from: https://www.nhs.uk/conditions/coronary-artery-bypass-graft-cabg/what-happens/
  4. Aprotinin 10,000 KIU/ml Injection BP Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/product/2472/smpc
  5. Koch CG et al. Morbidity and mortality risk associated with red blood cell and blood-component transfusion in isolated coronary artery bypass grafting. Crit Care Med 2006;34:1608–1616.
  6. Aprotinin Patient Information Leaflet (PIL). Available from https://www.medicines.org.uk/emc/files/pil.2472.pdf


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