Angiox

bivalirudin

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Angiox?

Angiox is a powder that is made up into a solution for injection or infusion (drip into a vein). It contains the active substance bivalirudin.

What is Angiox used for?

Angiox is used to prevent blood clots in adults who are undergoing angioplasty, including patients who are having myocardial infarction (a heart attack) with ‘ST segment elevation’ (an abnormal reading on the electrocardiogram or ECG). Angioplasty or ‘percutaneous coronary intervention’ (PCI) is a surgical procedure used to unblock the heart’s blood vessels.

Angiox is also used to treat adults with unstable angina (a type of chest pain that varies in severity) or myocardial infarction without ST segment elevation, who are about to undergo treatment such as PCI, a heart bypass or using other medicines.

Angiox is used together with aspirin and clopidogrel (medicines that help to prevent blood clots).

The medicine can only be obtained with a prescription.

How is Angiox used?

Angiox should be given by a doctor who has experience in the emergency care of patients with heart problems or in carrying out procedures on the heart.

The dose of Angiox and the duration of treatment depend on why it is being used. The first dose is given by injection into a vein, which is followed immediately by an infusion. In patients undergoing PCI, the infusion may be continued for up to 16 hours after the procedure. In patients being treated for angina or myocardial infarction without ST segment elevation, the duration of the infusion depends on how the patient is going to be treated. The speed of the infusion needs to be reduced in patients with moderate kidney problems who are undergoing PCI.

For more information, see the summary of product characteristics (also part of the EPAR).

How does Angiox work?

Blood clotting can be a problem when blood flow is disturbed in any way. Angiox is an anticoagulant, which means that it prevents the blood from clotting. The active substance in Angiox, bivalirudin, is a synthetic substance derived from hirudin, the anticoagulant substance produced by leeches. It specifically blocks one of the substances involved in the clotting process called thrombin. Thrombin is central to the processes involved in blood clotting. Using Angiox greatly reduces the risk of a blood clot forming. This can improve the effectiveness of PCI and help to maintain the flow of blood to the heart in patients with angina or myocardial infarction.

How has Angiox been studied?

In PCI, Angiox, given in combination with a glycoprotein IIb/IIIa inhibitor (GPI, another type of medicine that helps to prevent blood clots), has been compared with the standard combination of heparin (another anticoagulant) and a GPI in two studies involving a total of almost 10,000 adults. Almost 4,000 of the patients were having PCI to treat myocardial infarction with ST segment elevation.

For the treatment of angina or myocardial infarction without ST segment elevation, the main study involved almost 14,000 adults and compared Angiox taken alone or with a GPI, with the combination of heparin and a GPI.

In all of the studies, the patients also received other medicines to prevent blood clots, such as aspirin, clopidogrel and abciximab. The main measure of effectiveness was the reduction in the number of patients who had an ‘ischaemic event’ (a problem caused by reduced blood flow) including death, a heart attack, urgent revascularisation (restoration of blood flow to the heart) or stroke after 30 days. The studies also looked at the number of patients who had major bleeding.

What benefit has Angiox shown during the studies?

In both studies of patients undergoing PCI, Angiox in combination with a GPI was as effective as heparin with a GPI at preventing new ischaemic events. When used to treat angina or myocardial infarction without ST segment elevation, Angiox, given with or without a GPI, was as effective as the combination of heparin and a GPI in preventing deaths, heart attacks and revascularisations. It was most effective in patients who also took aspirin and clopidogrel. Major bleeding tended to be as common or less common with Angiox than with heparin.

What is the risk associated with Angiox?

The most common side effect with Angiox (seen in more than 1 patient in 10) is minor bleeding. For the full list of all side effects reported with Angiox, see the package leaflet.

Angiox should not be used in people who may be hypersensitive (allergic) to bivalirudin, other hirudins, or any of the other ingredients. It must not be used in patients who have recently been bleeding, or who have severe high blood pressure, severe kidney problems or a heart infection. For the full list of restrictions, see the package leaflet.

Why has Angiox been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that Angiox is an acceptable substitute for heparin during PCI and in the treatment of angina and myocardial infarction. The Committee decided that Angiox’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Angiox

The European Commission granted a marketing authorisation valid throughout the European Union for Angiox to The Medicines Company UK Ltd on 20 September 2004. After five years, the marketing authorisation was renewed for a further five years.

This EPAR was last updated on 29/06/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

25/05/2012  Angiox -EMEA/H/C/000562 -Art20/0042

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI.

Angiox is also indicated for the treatment of adult patients with unstable angina / non-ST segment elevation myocardial infarction (UA/NSTEMI) planned for urgent or early intervention.

Angiox should be administered with aspirin and clopidogrel.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents