Instruction for use: ReoPro

Dosage form: solution for injection

Active substance: Abciximab* (Abciximabum)

ATX

B01AC13 Abciximab

Pharmacological group

Antiaggregants

The nosological classification (ICD-10)

I20 Stenocardia [Cardiac Angina]: Heberden disease; Angina pectoris; The attack of angina pectoris; recurrent angina; Spontaneous angina; Stable angina pectoris; Angina rest; Angina progressing; Angina mixed; Angina spontaneous; stable angina; Chronic stable angina; Angina Syndrome X

I20.0 Unstable angina: heberden disease; Angina pectoris; The attack of angina pectoris; recurrent angina; Spontaneous angina; Stable angina pectoris; Angina rest; Angina progressing; Angina mixed; Angina spontaneous; stable angina; Chronic stable angina; Angina Syndrome X

I21 Acute myocardial infarction: Myocardial infarction in the acute phase; Acute Myocardial Infarction; Myocardial infarction with pathologic Q wave and without; Myocardial infarction complicated by cardiogenic shock; Infarction left ventricular; Transmural myocardial infarction; Myocardial infarction netransmuralny (subendocardial); Netransmuralny myocardial infarction; Subendocardial myocardial infarction; The acute phase of myocardial infarction; Acute myocardial infarction;Sub-acute phase of myocardial infarction; Subacute phase of myocardial infarction; Thrombosis of the coronary arteries (the arteries); Threatened myocardial infarction; Myocardial infarction without Q wave

R07.2 Heart pain: neuroses of the heart; Myocardial ischemic pain; Pain syndrome in myocardial infarction; cardialgia; cardioneurosis; Cardiac syndrome; Pain in cardiac patients; Cardialgia on background dyshormonal myocardial dystrophy; Functional cardialgia; Psevdostenokardiya; pericardial pain

Structure and Composition

1 ml injection solution contains abciximab (Fab-fragment of the chimeric human / mouse monoclonal antibody 7E3) 2 mg; in bottles of 5 ml, in a cardboard box.

Pharmachologic effect

Mode of action - antithrombotic.

Contacting with receptor type glycoprotein IIb / IIIa (GPIIb / IIIa) human platelet aggregation inhibit them, blocks the binding of fibrinogen, von Willebrand factor and others. Adhesion molecules to the receptor site on the activated platelets. It inhibits the vitronectin receptors (alfav, beta3) and receptors Mac1 monocytes and macrophages, what has caused the drug-effect (reduction in risk of death by 60% in 3 years «EPIC» -study).

Pharmacokinetics

After I.V. plasma concentration rapidly decreases (reference T1 / 2 - less than 10 minutes, T1 / 2 of the second phase - about 30 minutes). I.V. a dose of 0.25 mg / kg followed by a continuous infusion at a rate of 10 g / min produces a constant plasma concentration throughout infusion. After infusion of the free drug concentration in plasma decreases rapidly for about 6 hours and then decline more slowly (remains in the blood condition associated with platelet to 10 days).

Clinical pharmacology

I.V. injection (0.15-0.3 mg / kg) results in a rapid inhibition of ADP-induced platelet aggregation. After 2 hours after the administration of high doses (0.25 and 0.3 mg / kg) is more than 80% blocked receptor GPIIb / IIIa, thus increasing the average duration of bleeding, and is more than 30 min. The effect gradually decreased: normal platelet aggregation after 48 hours, the duration of bleeding - after 24 h (90% of patients).

Indications of the drug ReoPro

Prevention of ischemic complications in patients with cardiac risk groups undergoing angioplasty or atherectomy (as an adjunct to heparin and aspirin) rest angina, recurrent angina, or postinfarction angina resistant to drug therapy; acute myocardial infarction with Q wave changes within 12 hours after it began; angiography revealed an obstruction in the coronary circulation system.

Contraindications

Hypersensitivity, active internal bleeding, recent (within 6 weeks) gastrointestinal bleeding, or genitourinary system, cerebrovascular disease (including a history of the past 2 years, or with significant residual neurological changes), hemorrhagic diathesis, use of oral anticoagulants during the preceding 7 days, thrombocytopenia (less than 100,000 cells / microliter), recent (within 6 weeks) extensive surgery or trauma, intracranial neoplasm, malformations of the arteries of veins and or aneurysm, severe decompensated hypertension, vasculitis history, I.V. to the introduction dextran before coronary angioplasty or its intention to apply during coronary angioplasty, children's age (safety and efficacy have not been studied).

Pregnancy and breast-feeding

When pregnancy - only if clearly needed. In appointing lactating women should be careful (it is better to stop breast-feeding).

Side effects

Bleeding (at the blood access for cardiac catheterization or internal bleeding in the gastrointestinal tract, urinary tract, retroperitoneal sites), thrombocytopenia, allergic reactions (including anaphylaxis).

Interaction

Effect increase anticoagulant, thrombolytic and antiplatelet agents. Monoclonal antibodies are administered for the purpose of diagnosis and treatment, increase the risk of sensitization.

Dosing and Administration

I.V. 0.25 mg / kg bolus (over 10-60 min before coronary angioplasty), followed by infusion at a rate of 10 g / min for 12 hours.

Precautionary measures

When profuse hemorrhage (uncontrolled blood pressure), severe allergic reactions or thrombocytopenia administration immediately stopped and platelet transfusions mass.

Storage conditions of the drug ReoPro

Keep out of the reach of children.