Effective® (Effient®)

Side effects identified in clinical trials (in the treatment of acute coronary syndromes)

Bleeding not associated with aortocoronary bypass (CABG)

The number of cases of complications and bleeding^a, not associated with CABG (% of patients):

^aRecorded cases identified by classification criteria TIMI.

^bVarious versions of standard therapy were used, where this was applicable. In the third phase of clinical trials, all patients also took acetylsalicylic acid.

^at Any intracranial hemorrhage or any clinically pronounced bleeding associated with a decrease in hemoglobin ≥ 5 g / dl.

^g Threatening lives - a subgroup of large bleeding by TIMI, which includes, among others, the types of bleeding presented below. Patients can be assigned to more than one group.

^d Intracranial hemorrhage (ICH).

^e Clinically marked bleeding associated with a decrease in hemoglobin ≥ 3 g / dl, but <5 g / dl.

It was determined that patients with a body weight of less than 60 kg have a greater risk of bleeding when they receive prasugrel in a daily maintenance dose of 10 mg or receive clopidogrel in a daily maintenance dose of 75 mg in patients with ACS who underwent percutaneous coronary angioplasty than patients with a body weight greater than 60 kg.

When taking prasugrel in a daily maintenance dose of 10 mg or taking clopidogrel in a daily maintenance dose of 75 mg in patients with ACS who underwent percutaneous coronary angioplasty, the incidence of large and minor bleeding in TIMI not associated with CABG in two age groups was as follows:

Other clinical studies

In patients with IMBPT who took a loading dose of 30 mg on average 4 hours before coronary angiography and 30 mg during subsequent percutaneous coronary angioplasty,there was a higher risk of minor bleeding during non-CABG procedures and there were no additional benefits compared to patients taking a 60 mg loading dose during percutaneous coronary angioplasty.

Frequency of large and small bleedings by TIMI, not associated with CABG, in patients for 7 days was the following:

^a Various versions of standard therapy were used, where this was applicable. In the third phase of clinical trials, all patients also took acetylsalicylic acid.

^b Any intracranial hemorrhage or any clinically pronounced bleeding associated with a decrease in hemoglobin ≥5 g / dl.

^at Threatening lives - a subgroup of large bleeding by TIMI, which includes, among others, the types of bleeding presented below. Patients can be assigned to more than one group.

^g Intracranial hemorrhage (ICH).

^d Clinically pronounced bleeding associated with a decrease in hemoglobin ≥ 3 g / dl, but <5 g / dl.

Patients with ACS who did not undergo percutaneous coronary angioplasty received prasugrel or clopidogrel in combination with acetylsalicylic acid.

In patients older than 75 years with a body weight of less than 60 kg, taking prasugrel in a maintenance dose of 5 mg per day on average for 15 months (a maximum of 30 months), frequency of large and small bleedings by TIMI, not associated with CABG in two weight categories was as follows:

^a Maintenance dose of 5 mg.

^b Maintenance dose of 10 mg; in patients older than 75 years, a maintenance dose of 5 mg.

^at Maintenance dose of 75 mg.

Frequency of large and small bleedings by TIMI, not associated with CABG in two age groups was as follows:

^a Maintenance dose of 5 mg.

^b Maintenance dose of 10 mg; in patients with a body weight of less than 60 kg, a maintenance dose of 5 mg.

^at Maintenance dose of 75 mg.

Bleeding associated with CABG

Frequency of major or minor bleeding according to classification TIMIassociated with CABG was 14.1% in patients taking prasugrel and 4.5% in patients taking clopidogrel. High risk of bleeding in participants who took prasugrel, remained until 7 days after the last dose of the study drug.

The number of cases of complications and bleeding^aassociated with CABG (% of patients):

Recorded cases identified by classification criteria TIMI The following briefly outlines the adverse reactions of hemorrhagic and nonhemorrhagic nature and their frequency recorded during clinical trials.

Adverse reactions of hemorrhagic nature

Disturbances on the part of the organ of sight

Infrequently (≥0.1% and <1%): bleeding in the eye.

Vascular disorders

Often (≥> 1% and <10%): a hematoma.

Disturbances from the respiratory system, chest and mediastinal organs

Often (≥ 1% and <10%): nasal bleeding.

Infrequently (≥0.1% and <1%): hemoptysis.

Disorders from the gastrointestinal tract

Often (≥1% and <10%): gastrointestinal bleeding.

Infrequently (> 0.1% and <1%): rectal bleeding, gum bleeding, bloody stools (haemathece), retroperitoneal bleeding.

Disturbances from the skin and subcutaneous tissues

Often (≥1% and <10%): ecchymosis.

Disorders from the kidneys and urinary tract

Often (≥1% and <10%): hematuria.

General disorders and disorders at the site of administration

Often (≥1% and <10%): a hematoma at the site of the vascular puncture, bleeding at the puncture site.

Trauma, intoxication and complications of manipulation

Often (≥1% and <10%): a bruise.

Infrequently (> 0.1% and <1%): subcutaneous hematoma, bleeding after the procedure.

Adverse reactions of nonhemorrhagic nature

Violations of the blood and lymphatic system

Often (≥1% and <10%): anemia.

Rarely (≥0.01% and <0.1%): thrombocytopenia (platelet count <50 x 10⁹/ l).

Disturbances from the skin and subcutaneous tissues

Often (≥1% and <10%): a rash.

It was determined that patients who had previously had a stroke or transient ischemic attack (TIA) with a standard prasugrel dosing regimen have a greater risk of developing a stroke or TIA than patients with no history of these diseases:

* Intracranial bleeding (VCK).

Spontaneous adverse reactions

Hypersensitivity reactions, including angioedema, occurred at a frequency of> 0.01% and <0.1%. Thrombocytopenic purpura occurred at a frequency of <0.01%.