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Integrilin is a brand name for Eptifibatide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: INTEGRILIN is intended for use with acetylsalicylic acid and unfractionated heparin. INTEGRILIN is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-Q-wave myocardial infarction, with the last episode of chest pain occurring within 24 hours and with…
Verbatim from this product's EMA label. Tap a section to expand.
This product is for hospital use only. It should be administered by specialist physicians experienced in the management of acute coronary syndromes. INTEGRILIN solution for infusion must be used in conjunction with INTEGRILIN solution for injection.
4). INTEGRILIN is also intended for concurrent use with acetylsalicylic acid, as it is part of standard management of patients with acute coronary syndromes, unless its use is contraindicated. Posology Medicinal product no longer authorised 3 Adults ( ≥ 18 years of age) presenting with unstable angina (UA) or non-Q-wave myocardial infarction (NQMI) The recommended dosage is an intravenous bolus of 180 microgram/kg administered as soon as possible following diagnosis, followed by a continuous infusion of 2 microgram/kg/min for up to 72 hours, until initiation of coronary artery bypass graft (CABG) surgery, or until discharge from the hospital (whichever occurs first).
If Percutaneous Coronary Intervention (PCI) is performed during eptifibatide therapy, continue the infusion for 20-24 hours post-PCI for an overall maximum duration of therapy of 96 hours. Emergency or semi-elective surgery If the patient requires emergency or urgent cardiac surgery during the course of eptifibatide therapy, terminate the infusion immediately.
If the patient requires semi-elective surgery, stop the eptifibatide infusion at an appropriate time to allow time for platelet function to return towards normal. Hepatic impairment Experience in patients with hepatic impairment is very limited.
3, prothrombin time). It is contraindicated in patients with clinically significant hepatic impairment. 0 microgram/kg/min for the duration of therapy. This recommendation is based on pharmacodynamic and pharmacokinetic data. 1). 3). Paediatric population It is not recommended for use in children and adolescents below 18 years of age, due to a lack of data on safety and efficacy.
The majority of adverse reactions experienced by patients treated with eptifibatide were generally related to bleeding or to cardiovascular events that occur frequently in this patient population. Clinical Trials The data sources used to determine adverse reaction frequency descriptors included two phase III clinical studies (PURSUIT and ESPRIT).
These trials are briefly described below.
PURSUIT:
This was a randomised, double-blind evaluation of the efficacy and safety of Integrilin versus placebo for reducing mortality and myocardial (re)infarction in patients with unstable angina or non-Q-wave myocardial infarction.
ESPRIT:
This was a double-blind, multicentre, randomised, parallel-group, placebo-controlled trial evaluating the safety and efficacy of eptifibatide therapy in patients scheduled to undergo non- emergent percutaneous coronary intervention (PCI) with stent implantation.
In PURSUIT, bleeding and non-bleeding events were collected from hospital discharge to the 30 day visit. In ESPRIT, bleeding events were reported at 48 hours, and non-bleeding events were reported at 30 days. While Thrombolysis in Myocardial Infarction TIMI bleeding criteria were used to categorize the incidence of major and minor bleeding in both the PURSUIT and the ESPRIT trials, PURSUIT data was collected within 30 days while ESPRIT data was limited to events within 48 hours or discharge, whichever came first.
The undesirable effects are listed by body system and frequency. Frequencies are defined as 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). These are absolute reporting frequencies without taking into account placebo rates.
8). Women, the elderly, patients with low body weight or with moderate renal impairment (creatinine Medicinal product no longer authorised 4 clearance > 30 - < 50 ml/min) may have an increased risk of bleeding. Monitor these patients closely with regard to bleeding.
g. upon diagnosis) compared to receiving it immediately prior to PCI, as seen in the Early ACS trial. 1). Bleeding is most common at the arterial access site in patients undergoing percutaneous arterial procedures. , catheter insertion sites; arterial, venous, or needle puncture sites; cutdown sites; gastrointestinal and genitourinary tracts) must be observed carefully.
Other potential bleeding sites such as central and peripheral nervous system and retroperitoneal sites, must be carefully considered too. 5). There is no experience with INTEGRILIN and low molecular weight heparins. g. acute transmural myocardial infarction with new pathological Q-waves or elevated ST-segments or left bundle branch block in the ECG).
5). INTEGRILIN infusion should be stopped immediately if circumstances arise that necessitate thrombolytic therapy or if the patient must undergo an emergency CABG surgery or requires an intraortic balloon pump. If serious bleeding occurs that is not controllable with pressure, the INTEGRILIN infusion should be stopped immediately and any unfractionated heparin that is given concomitantly.
Arterial procedures During treatment with eptifibatide there is a significant increase in bleeding rates, especially in the femoral artery area, where the catheter sheath is introduced. Take care to ensure that only the anterior wall of the femoral artery is punctured.
g. when activated clotting time (ACT) is less than 180 seconds (usually 2- 6 hours after discontinuation of heparin). After removal of the introducer sheath, careful haemostasis must be ensured under close observation. Thrombocytopenia and Immunogencity related to GP IIb/IIIa inhibitors INTEGRILIN inhibits platelet aggregation, but does not appear to affect the viability of platelets.
0 − severe hypertension (systolic blood pressure > 200 mm Hg or diastolic blood pressure > 110 mm Hg on antihypertensive therapy) − severe renal impairment (creatinine clearance < 30 ml/min) or dependency on renal dialysis − clinically significant hepatic impairment − concomitant or planned administration of another parenteral glycoprotein (GP) IIb/IIIa inhibitor
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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For a particular adverse reaction, if data was available from both PURSUIT and ESPRIT, then the highest reported incidence was used to assign adverse reaction frequency. Medicinal product no longer authorised 7 Note that causality has not been determined for all adverse reactions.
Blood and Lymphatic System Disorder Very common Bleeding (major and minor bleeding including femoral artery access, CABG- related, gastrointestinal, genitourinary, retroperitoneal, intracranial, haematemesis, haematuria, oral/oropharyngeal, haemoglobin/haematocrit decreased and other).
Uncommon Thrombocytopenia. Nervous System disorders Uncommon Cerebral ischaemia. Cardiac Disorders Common Cardiac arrest, ventricular fibrillation, ventricular tachycardia, congestive heart failure, atrioventricular block, atrial fibrillation.
Vascular Disorders Common Shock, hypotension, phlebitis. Cardiac arrest, congestive heart failure, atrial fibrillation, hypotension, and shock, which are commonly reported events from the PURSUIT trial, were events related to the underlying disease.
Administration of eptifibatide is associated with an increase in major and minor bleeding as classified by the criteria of the TIMI study group. At the recommended therapeutic dose, as administered in the PURSUIT trial involving nearly 11,000 patients, bleeding was the most common complication encountered during eptifibatide therapy.
The most common bleeding complications were associated with cardiac invasive procedures (coronary artery bypass grafting (CABG)-related or at femoral artery access site). Minor bleeding was defined in the PURSUIT trial as spontaneous gross haematuria, spontaneous haematemesis, observed blood loss with a haemoglobin decrease of more than 3 g/dl, or a haemoglobin decrease of more than 4 g/dl in the absence of an observed bleeding site.
6% for placebo). 4, heparin use). Major bleeding was defined in the PURSUIT trial as either an intracranial haemorrhage or a decrease in haemoglobin concentrations of more than 5 g/dl. 3%), but it was infrequent in the vast majority of patients who did not undergo CABG within 30 days of inclusion in the study.
In patients undergoing CABG, the incidence of bleeding was not increased by Integrilin compared to the patients treated with placebo. 7 % of Integrilin-treated patients vs. 6 % of placebo-treated patients. 1% with placebo. 3% for placebo).
, inhibition of platelet aggregation. g. bleeding time) are common and expected. No apparent differences were observed between patients treated with eptifibatide or with placebo in values for liver function (SGOT/AST, SGPT/ALT, bilirubin, alkaline phosphatase) or renal function (serum creatinine, blood urea nitrogen).
Post-marketing experience Medicinal product no longer authorised 8 Blood and lymphatic system disorders Very rare Fatal bleeding (the majority involved central and peripheral nervous system disorders: cerebral or intracranial haemorrhages); pulmonary haemorrhage, acute profound thrombocytopenia, haematoma.
Immune system disorders Very rare Anaphylactic reactions. Skin and subcutaneous tissue disorders Very rare Rash, application site disorders such as urticaria. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. […]
As demonstrated in clinical trials, the incidence of thrombocytopenia was low, and similar in patients treated with eptifibatide or placebo. 8) The mechanism, whether immune- and/or non-immune-mediated, by which eptifibatide may induce thrombocytopaenia is not fully understood.
However, treatment with eptifibatide was associated with antibodies that recognise GPIIb/IIIa occupied by eptifibatide, suggesting an immune-mediated mechanism. Thrombocytopaenia occurring after first exposure to a GPIIb/IIIa inhibitor may be explained by the fact that antibodies are naturally present in some normal individuals.
e. platelet counts should be monitored prior to Medicinal product no longer authorised 5 treatment, within 6 hours of administration, and at least once daily thereafter while on therapy and immediately at clinical signs of unexpected bleeding tendency.
If either a confirmed platelet decrease to < 100,000/mm3 or acute profound thrombocytopaenia is observed, discontinuation of each treatment medication having known or suspected thrombocytopenic effects, including eptifibatide, heparin and clopidogrel, should be considered immediately.
The decision to use platelet transfusions should be based upon clinical judgment on an individual basis. In patients with previous immune-mediated thrombocytopaenia from other parenteral GP IIb/IIIa inhibitors, there are no data with the use of INTEGRILIN.
Therefore, it is not recommended to administer eptifibatide in patients who have previously experienced immune mediated thrombocytopenia with GP IIb/IIIa inhibitors, including eptifibatide. Heparin administration Heparin administration is recommended unless a contraindication (such as a history of thrombocytopenia associated with use of heparin) is present.
UA/NQMI:
For a patient who weighs ≥ 70 kg, it is recommended that a bolus dose of 5,000 units is given, followed by a constant intravenous infusion of 1,000 units/hr. If the patient weighs < 70 kg, a bolus dose of 60 units/kg is recommended, followed by an infusion of 12 units/kg/hr.
The activated partial thromboplastin time (aPTT) must be monitored in order to maintain a value between 50 and 70 seconds, above 70 seconds there may be an increased risk of bleeding. If PCI is to be performed in the setting of UA/NQMI, monitor the activated clotting time (ACT) to maintain a value between 300-350 seconds.
Stop heparin administration if the ACT exceeds 300 seconds; […]