"WASHINGTON, DC â€” The FDA is investigating the significant increase in major adverse cardiac events (MACE) seen for the everolimus-eluting bioresorbable vascular scaffold (Absorb BVS, Abbott Vascular) vs everolimus-eluting metal stent ("...
There has been only limited experience with overdosage of INTEGRILIN. There were 8 patients in the IMPACT II study, 9 patients in the PURSUIT study, and no patients in the ESPRIT study who received bolus doses and/or infusion doses more than double those called for in the protocols. None of these patients experienced an intracranial bleed or other major bleeding.
Eptifibatide was not lethal to rats, rabbits, or monkeys when administered by continuous intravenous infusion for 90 minutes at a total dose of 45 mg/kg (about 2 to 5 times the recommended maximum daily human dose on a body surface area basis). Symptoms of acute toxicity were loss of righting reflex, dyspnea, ptosis, and decreased muscle tone in rabbits and petechial hemorrhages in the femoral and abdominal areas of monkeys.
From in vitro studies, eptifibatide is not extensively bound to plasma proteins and thus may be cleared from plasma by dialysis.
Treatment with INTEGRILIN is contraindicated in patients with:
- A history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days
- Severe hypertension (systolic blood pressure > 200 mm Hg or diastolic blood pressure > 110 mm Hg) 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
- Hypersensitivity to INTEGRILIN or any component of the product (hypersensitivity reactions that occurred included anaphylaxis and urticaria).
Last reviewed on RxList: 4/4/2013
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