Indications for INTEGRILIN Injection
- For the treatment of patients with acute coronary syndrome (unstable angina/non–ST-segment elevation myocardial infarction), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI).
- For the treatment of patients undergoing PCI, including those undergoing intracoronary stenting.
Selected Safety Information
INTEGRILIN Is Contraindicated in Patients With:
- A history of bleeding diathesis, or evidence of active abnormal bleeding within the previous
- Severe hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg) not adequately controlled on antihypertensive therapy.
- Major surgery within the preceding 6 weeks.
- History of stroke within 30 days or any history of hemorrhagic stroke.
- Current or planned administration of another parenteral GP IIb/IIIa inhibitor.
- Dependency on renal dialysis.
- Known hypersensitivity to any component of the product.
Selected Warnings and Precautions
- Bleeding is the most common complication encountered during INTEGRILIN therapy.
The majority of excess major bleeding events were localized at the femoral artery access
site. Oropharyngeal, genitourinary, gastrointestinal, and retroperitoneal bleeding were also
seen more commonly with INTEGRILIN compared to placebo.
- If bleeding cannot be controlled with pressure, infusion of INTEGRILIN and concomitant
heparin should be stopped immediately.
- INTEGRILIN is cleared in part by the kidney and its plasma concentrations are doubled in patients
with renal disease (creatinine clearance <50 mL/min). Therefore, the infusion dose of INTEGRILIN
needs to be reduced to 1 mcg/kg/min in these patients.
- In the event of acute profound thrombocytopenia or a confirmed platelet decrease to <100,000/mm3, discontinue INTEGRILIN and heparin
(UFH or LMWH).
- There has been no clinical experience with INTEGRILIN initiated in patients with a baseline platelet count <100,000/mm3. If a patient with low platelet counts is receiving INTEGRILIN, their platelet count should be monitored closely.
- In patients undergoing PCI, INTEGRILIN is associated with an increase in major and minor bleeding at the site of arterial sheath placement.
Special care should be employed to minimize the risk of bleeding among these patients.
- Because INTEGRILIN inhibits platelet aggregation, caution should be employed when it is used with other drugs that affect hemostasis,
including thrombolytics, oral anticoagulants, NSAIDs, and dipyridamole.
- Use with other GP IIb/IIIa inhibitors should be avoided.
Before prescribing INTEGRILIN, please read the Prescribing Information.