Zontivity - vorapaxar

What is Zontivity and what is it used for - vorapaxar?

Zontivity is a medicine used to reduce the occurrence of atherothrombotic events (problems caused by blood clots and thickening of the arteries) including new myocardial infarctions or stroke in adult patients with a history of myocardial infarction. It is given concurrently. with aspirin and, where appropriate, with a third medicine, clopidogrel; these two medicines also help prevent atherothrombotic events. Zontivity contains the active substance vorapaxar.

How is Zontivity used - vorapaxar?

Zontivity is available as tablets (2 mg) and can only be obtained with a prescription. The recommended dose is one tablet once a day. Treatment with Zontivity should be started at least 2 weeks after a myocardial infarction, preferably within the first 12 months following the event. Data on the use of Zontivity for longer than 2 years are limited; therefore, after 2 years of therapy, the benefits and risks of Zontivity should be re-evaluated in individual patients by the treating physician.

How does Zontivity - vorapaxar work?

The active substance in Zontivity, vorapaxar, is an inhibitor of platelet aggregation. This means that it helps prevent blood clots from forming. The blood clots when certain blood cells, called platelets, stick to each other. Vorapaxar blocks it. PAR-1 receptors (known as "thrombin receptors") present on the surface of platelets. Thrombin is one of the substances that contribute to the coagulation process: by binding to the PAR-1 receptor, it causes platelets to become "viscous" and, in doing so, it promotes clot formation.By blocking the PAR-1 receptor, the medicine prevents platelets from becoming viscous, reducing the risk of clots forming and helping to prevent a stroke or new myocardial infarction.

What benefit has Zontivity - vorapaxar shown during the studies?

Zontivity was compared with placebo (a dummy treatment) in one main study involving over 26,000 adults with a history of myocardial infarction or other atherothrombotic events. Almost all patients were also taking aspirin and / or another medicine for the prevention of atherothrombotic events, and were treated for at least one year. The main measure of effectiveness was the number of patients who reported an "event" including a new myocardial infarction or stroke, or who died from a cardiovascular disease (problems affecting the heart and blood vessels). Zontivity was more effective than placebo in reducing the occurrence of atherothrombotic events. Overall, an atherothrombotic event was seen in 9.5% of patients (1 259 out of 13 225 subjects) who took Zontivity compared to 10.7%. (1 417 out of 13 224 subjects) of patients treated with placebo. The benefit of Zontivity was most evident in a subgroup of 16 897 patients with a history of myocardial infarction but who had never had a stroke or transient ischemic attack ( the so-called "mini-infarction"). In this group an atherothrombotic event was observed in "8.5% of patients (719 out of 8 458 patients) who took Zontivity compared to 10.3% (867 out of 8 439 patients) of patients treated with placebo.

What is the risk associated with Zontivity - vorapaxar?

The most common side effect with Zontivity (which may affect up to 1 in 10 people) is bleeding, especially epistaxis (nosebleed). For the full list of side effects reported with Zontivity, see the package leaflet. Zontivity should not be used in patients who have had a stroke or mini-heart attack. It must also not be used in patients who have had an "intracranial haemorrhage (cerebral haemorrhage) or with active bleeding, nor in patients with severe hepatic impairment. Zontivity must not be used in combination with prasugrel or ticagrelor, two other medicines that contribute to prevent platelet aggregation. For the full list of restrictions, see the package leaflet.

Why has Zontivity - vorapaxar been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zontivity's benefits are greater than its risks and recommended that it be approved for use in the EU. The medicine has been shown to be beneficial in reducing the number of atherothrombotic events in patients who have had myocardial infarction. Regarding the safety profile of Zontivity, the CHMP was concerned about the risk of haemorrhage in patients taking Zontivity in addition to standard therapy, in particular the risk of haemorrhage severe which is more common in patients with a history of stroke.

It therefore considered it appropriate to limit its use to patients who have never had a stroke before.

What measures are being taken to ensure the safe and effective use of Zontivity - vorapaxar?

A risk management plan has been developed to ensure that Zontivity is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Zontivity, including the appropriate precautions to be followed by healthcare professionals and patients. Further information can be found in the summary of the risk management plan.

More information about Zontivity - vorapaxar

On January 19, 2015, the European Commission issued a "Marketing Authorization" for Zontivity, valid throughout the European Union. For the full version of the EPAR and the summary of the Zontivity Risk Management Plan please visit the website Agency: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Zontivity therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. Last update of this summary: 01-2015.

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