abciximab
ReoPro

Available forms
Available by prescription only
Injection: 2 mg/ml

Indications and dosages
 Adjunct to percutaneous transluminal coronary angioplasty (PTCA) or atherectomy for prevention of acute cardiac ischemic complications in patients at high risk for abrupt closure of treated coronary vessel. Adults: 0.25 mg/kg as an I.V. bolus given 10 to 60 minutes before start of PTCA; then a continuous I.V. infusion of 10 mcg/minute for 12 hours.
 Unstable angina not responding to conventional therapy with plans to undergo PTCA within 24 hours. Adults: 0.25 mg/kg I.V. bolus; then 18- or 24-hour I.V. infusion of 10 mcg/minute ending 1 hour after PTCA.

Pharmacodynamics
Platelet aggregation-inhibiting action: As the Fab fragment of the chimeric human-murine monoclonal immunoglobulin antibody 7E3, abciximab binds selectively to platelet glycoprotein (GP IIb/IIIa) receptors and inhibits platelet aggregation.

Pharmacokinetics
Absorption: Administered I.V.
Distribution: No information available.
Metabolism: No information available.
Excretion: Initial half-life is less than 10 minutes; second phase lasts about 30 minutes.

Contraindications and precautions
Contraindicated in patients hypersensitive to any component of drug or to murine proteins and in those with active internal bleeding, significant GI or GU bleeding within 6 weeks, history of CVA within 2 years or CVA with significant residual neurologic deficit, bleeding diathesis, thrombocytopenia (less than 100,000/mm³), major surgery or trauma within 6 weeks, intracranial neoplasm, intracranial arteriovenous malformation, intracranial aneurysm, severe uncontrolled hypertension, or history of vasculitis. Also contraindicated when oral anticoagulants have been administered within past 7 days unless PT is 1.2 times control or less, or when I.V. dextran is being used before or is intended to be used during PTCA.
  Use cautiously in patients who are at increased risk for bleeding, including those who weigh less than 75 kg (165 lb), those who are older than age 65, those with history of GI disease, and those receiving thrombolytics. Conditions that also increase the risk of bleeding include PTCA within 12 hours of onset of symptoms for acute MI, PTCA lasting longer than 70 minutes, and failed PTCA. Heparin anticoagulation used with abciximab also may increase the risk of bleeding.

Interactions
Drug-drug. Antiplatelet drugs, heparin, NSAIDs, thrombolytics, other anticoagulants: Increases risk of bleeding. Monitor patient closely.

Adverse reactions
CNS: confusion, hypoesthesia, pain.
CV: bradycardia,hypotension, peripheral edema.
EENT: abnormal vision.
GI: nausea, vomiting.
Hematologic: anemia, bleeding, leukocytosis, thrombocytopenia.
Respiratory: pleural effusion, pleurisy, pneumonia.

Effects on lab test results
• May decrease hemoglobin and platelet and WBC counts.

Overdose and treatment
There are no reports of overdose. However, infusion should be discontinued after 12 hours to avoid effects of prolonged platelet receptor blockade.

Special considerations
• Patients at risk for abrupt closure (thus candidates for drug therapy) include those undergoing PTCA with at least one of the following conditions: unstable angina; non-Q-wave MI; acute Q-wave MI within 12 hours of symptom onset; or the presence of two type B lesions in the artery to be dilated, one type B lesion in the artery to be dilated in a woman age 65 or older or a diabetic patient, one type C lesion in the artery to be dilated, or angioplasty of an infarct-related lesion within 7 days of MI.
• Give drug with aspirin and heparin.
• Inspect solution for particulate matter before administration. If opaque particles are present, discard solution and obtain new vial.
• Before infusion, platelet count, PT, activated clotting time, and PTT should be measured to identify hemostatic abnormalities.
• For bolus injection, withdraw needed amount of drug into a syringe through a sterile, nonpyrogenic, low-protein-binding, 0.2- or 0.22-millipore filter. Administer bolus 10 to 60 minutes before procedure.
• Keep epinephrine, dopamine, theophylline, antihistamines, and corticosteroids readily available in case of anaphylaxis.
• Administer drug in a separate I.V. line; don’t add other drugs to infusion solution.
• For continuous infusion, withdraw 4.5 ml of drug for continuous infusion through a sterile, nonpyrogenic, low-protein-binding, 0.2- or 0.22-micron filter into a syringe. Inject into 250 ml of sterile normal saline solution or D₅W and infuse at 17 ml/hour for 12 hours through a continuous infusion pump equipped with an in-line filter. Discard unused portion at end of 12-hour infusion.
• Monitor patient closely for bleeding. Bleeding may be at the arterial access site for cardiac catheterization, or it may be internal bleeding involving the GI or GU tracts or retroperitoneal sites.
• Institute bleeding precautions. Maintain patient on bed rest for 6 to 8 hours after sheath removal or drug discontinuation, whichever is later. Discontinue heparin at least 4 hours before sheath removal. Minimize or avoid, if possible, arterial and venous punctures, I.M. injections, nasotracheal intubation, and use of urinary catheters, nasogastric tubes, and automatic blood pressure cuffs.
• Monitor platelet counts before treatment, 2 to 4 hours after treatment, and at 24 hours after treatment or before discharge.
• Platelet function recovers in about 48 hours but drug remains in circulation for up to 10 days in a platelet-bound state.
Breast-feeding patients
• It’s unknown if drug appears in breast milk or is absorbed systemically after ingestion. Use cautiously.
Pediatric patients
• Safety and effectiveness in children haven’t been established.
Geriatric patients
• Use cautiously in patients older than age 65.

Patient education
• Instruct patient to report bleeding promptly.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use