Possia

Posology Possia treatment should be initiated with a single 180 mg loading dose (two tablets of 90 mg) and then continued at 90 mg twice daily. Patients taking Possia should also take ASA daily, unless specifically contraindicated. 1).

1). Experience beyond 12 months is limited. In patients with Acute Coronary Syndromes (ACS), premature discontinuation with any antiplatelet therapy, including Possia, could result in an increased risk of cardiovascular death, or myocardial infarction due to the patient’s underlying disease.

Therefore, premature discontinuation of treatment should be avoided. Lapses in therapy should also be avoided. A patient who misses a dose of Possia should take only one 90 mg tablet (their next dose) at its scheduled time. 1). Switching from prasugrel to Possia has not been investigated.

2). 2). No information is available concerning treatment of patients on renal dialysis and therefore Possia is not recommended in these patients. Patients with hepatic impairment No dose adjustment is necessary for patients with mild hepatic impairment.

Possia has not been studied in patients with moderate or severe hepatic impairment. 2). Paediatric patients The safety and efficacy of Possia in children below the age of 18 in the approved adult indication has not been established. 2).

Method of administration For oral use. Possia can be administered with or without food.

Medicinal product no longer authorised 8 The most commonly reported adverse reactions in patients treated with ticagrelor were dyspnoea, contusion and epistaxis and these reactions occurred at higher rates than in the clopidogrel treatment group.

Tabulated summary of adverse reactions The following adverse reactions have been identified following studies with Possia (Table 1). Adverse reactions are classified according to frequency and System Organ Class.

Frequency categories are defined according to the following conventions:

Very common (≥1/10), Common (≥1/100 to 1/10), Uncommon (≥1/1,000 to 1/100), Rare (≥1/10,000 to 1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data). g. 9235). This is calculated as 3/9235 which equates to a frequency category of ‘rare’ Description of selected adverse reactions Bleeding Overall outcome of bleeding rates in the PLATO study are shown in Table 2.

3272 Bleeding category definitions: Major Fatal/Life-threatening Bleed: Clinically apparent with >50 g/l decrease in haemoglobin or ≥4 red cell units transfused; or fatal; or intracranial; or intrapericardial with cardiac tamponade; or with hypovolaemic shock or severe hypotension requiring pressors or surgery.

Major Other:

Clinically apparent with 30-50 g/l decrease in haemoglobin or 2-3 red cell units transfused; or significantly disabling.

Minor Bleed:

Requires medical intervention to stop or treat bleeding.

TIMI Major Bleed:

Clinically apparent with >50 g/l decrease in haemoglobin or intracranial haemorrhage.

Bleeding risk In the phase 3 pivotal trial (PLATO [PLATelet Inhibition and Patient Outcomes], 18,624 patients) key exclusion criteria included an increased risk for bleeding, clinically important thrombocytopenia or anaemia, previous intracranial bleed, gastrointestinal bleed within the past 6 months or major surgery within the past 30 days.

e. 8). Therefore, the use of Possia in patients at known increased risk for bleeding should be balanced against the benefit in terms of prevention of atherothrombotic events. g. due to recent trauma, recent surgery, coagulation disorders, active or recent gastrointestinal bleeding).

3). g. non-steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulants and/or fibrinolytics) within 24 hours of Possia dosing. No data exist with Possia regarding a haemostatic benefit of platelet transfusions; circulating Possia may inhibit transfused platelets.

Medicinal product no longer authorised 4 Antifibrinolytic therapy (aminocaproic acid or tranexamic acid) and/or recombinant factor VIIa may increase haemostasis. Possia may be resumed after the cause of bleeding has been identified and controlled.

Surgery Patients should be advised to inform physicians and dentists that they are taking Possia before any surgery is scheduled and before any new medicinal product is taken. 8). 1). g. patients without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree AV block or bradycardic-related syncope) were excluded from the main PLATO study evaluating the safety and efficacy of Possia.

1). In addition, caution should be exercised when administering Possia concomitantly with medicinal products known to induce bradycardia. 5). During the Holter substudy in PLATO, more patients had ventricular pauses >3 seconds with ticagrelor than with clopidogrel during the acute phase of their ACS.

The increase in Holter-detected ventricular pauses with ticagrelor was higher in patients with chronic heart failure (CHF) than in the overall study population during the acute phase of ACS, but not at one month with ticagrelor or compared to clopidogrel.

8).  Active pathological bleeding. 8). 2). 5).