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Bleeding is the most common complication encountered during INTEGRILIN therapy. Administration of INTEGRILIN is associated with an increase in major and minor bleeding, as classified by the criteria of the Thrombolysis in Myocardial Infarction Study group (TIMI) [see ADVERSE REACTIONS]. Most major bleeding associated with INTEGRILIN has been at the arterial access site for cardiac catheterization or from the gastrointestinal or genitourinary tract. Minimize the use of arterial and venous punctures, intramuscular injections, and the use of urinary catheters, nasotracheal intubation, and nasogastric tubes. When obtaining intravenous access, avoid non-compressible sites (e.g., subclavian or jugular veins).
Use of Thrombolytics, Anticoagulants, and Other Antiplatelet Agents
Risk factors for bleeding include older age, a history of bleeding disorders, and concomitant use of drugs that increase the risk of bleeding (thrombolytics, oral anticoagulants, nonsteroidal anti-inflammatory drugs, and P2Y12 inhibitors). Concomitant treatment with other inhibitors of platelet receptor glycoprotein (GP) IIb/IIIa should be avoided. In patients treated with heparin, bleeding can be minimized by close monitoring of the aPTT and ACT [see DOSAGE AND ADMINISTRATION].
Care of the Femoral Artery Access Site in Patients Undergoing Percutaneous Coronary Intervention (PCI)
In patients undergoing PCI, treatment with INTEGRILIN is associated with an increase in major and minor bleeding at the site of arterial sheath placement. After PCI, INTEGRILIN infusion should be continued until hospital discharge or up to 18 to 24 hours, whichever comes first. Heparin use is discouraged after the PCI procedure. Early sheath removal is encouraged while INTEGRILIN is being infused. Prior to removing the sheath, it is recommended that heparin be discontinued for 3 to 4 hours and an aPTT of < 45 seconds or ACT < 150 seconds be achieved. In any case, both heparin and INTEGRILIN should be discontinued and sheath hemostasis should be achieved at least 2 to 4 hours before hospital discharge. If bleeding at access site cannot be controlled with pressure, infusion of INTEGRILIN and heparin should be discontinued immediately.
There have been reports of acute, profound thrombocytopenia (immune-mediated and non-immune mediated) with INTEGRILIN. In the event of acute profound thrombocytopenia or a confirmed platelet decrease to < 100,000/mm³, discontinue INTEGRILIN and heparin (unfractionated or low-molecular weight). Monitor serial platelet counts, assess the presence of drug-dependent antibodies, and treat as appropriate [see ADVERSE REACTIONS].
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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term studies in animals have been performed to evaluate the carcinogenic potential of eptifibatide. Eptifibatide was not genotoxic in the Ames test, the mouse lymphoma cell (L 5178Y, TK+/-) forward mutation test, the human lymphocyte chromosome aberration test, or the mouse micronucleus test. Administered by continuous intravenous infusion at total daily doses up to 72 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis), eptifibatide had no effect on fertility and reproductive performance of male and female rats.
Use In Specific Populations
Pregnancy Category B
Teratology studies have been performed by continuous intravenous infusion of eptifibatide in pregnant rats at total daily doses of up to 72 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis) and in pregnant rabbits at total daily doses of up to 36 mg/kg/day (also about 4 times the recommended maximum daily human dose on a body surface area basis). These studies revealed no evidence of harm to the fetus due to eptifibatide. There are, however, no adequate and well-controlled studies in pregnant women with INTEGRILIN. Because animal reproduction studies are not always predictive of human response, INTEGRILIN should be used during pregnancy only if clearly needed.
It is not known whether eptifibatide is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when INTEGRILIN is administered to a nursing mother.
Safety and effectiveness of INTEGRILIN in pediatric patients have not been studied.
The PURSUIT and IMPACT II clinical studies enrolled patients up to the age of 94 years (45% were age 65 and over; 12% were age 75 and older). There was no apparent difference in efficacy between older and younger patients treated with INTEGRILIN. The incidence of bleeding complications was higher in the elderly in both placebo and INTEGRILIN groups, and the incremental risk of INTEGRILIN-associated bleeding was greater in the older patients. No dose adjustment was made for elderly patients, but patients over 75 years of age had to weigh at least 50 kg to be enrolled in the PURSUIT study; no such limitation was stipulated in the ESPRIT study [see ADVERSE REACTIONS].
Approximately 50% of eptifibatide is cleared by the kidney in patients with normal renal function. Total drug clearance is decreased by approximately 50% and steady-state plasma INTEGRILIN concentrations are doubled in patients with an estimated CrCl < 50 mL/min (using the Cockcroft-Gault equation). Therefore, the infusion dose should be reduced to 1 mcg/kg/min in such patients [see DOSAGE AND ADMINISTRATION]. The safety and efficacy of INTEGRILIN in patients dependent on dialysis has not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/4/2013
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