Abciximab

Trade Names:ReoPro- Injection 2 mg/mL

Pharmacology

Binds to glycoprotein IIb/IIIa receptors on surface of platelets, thereby preventing platelet aggregation.

Pharmacokinetics

Distribution

Rapidly binds to glycoprotein IIb/IIIa receptors.

Elimination

Initial t _½ is less than 10 min. Second phase t _½ is about 30 min.

Duration

Platelet function generally recovers over 48 h.

Indications and Usage

Adjunct to percutaneous coronary intervention (PCI) for the prevention of cardiac ischemic complications in patients undergoing PCI and in patients with unstable angina not responding to conventional medical therapy when PCI is planned within 24 h. Intended for use with aspirin and heparin.

Unlabeled Uses

Early treatment of MI; treatment of acute ischemic stroke.

Contraindications

Active internal bleeding; recent (6 wk) GI/GU bleeding, major surgery, or trauma; history of cerebrovascular accident (CVA) within the past 2 yr or CVA with significant residual neurological deficit; use of oral anticoagulants within 7 days unless PT is equal to or less than 1.2 times control; thrombocytopenia; severe uncontrolled hypertension; vasculitis; intracranial neoplasm, aneurysm, or arteriovenous malformation; the recent or current use of IV dextran; bleeding diathesis; or hypersensitivity to any component of the product or murine proteins.

Dosage and Administration

IV 0.25 mg/kg bolus 10 to 60 min before PCI followed by continuous infusion of 0.125 mcg/kg/min (to a max of 10 mcg/min) for 12 h.

Patients with unstable angina not responding to conventional medical treatment and who are planning to undergo PCI within 24 h may be treated with 0.25 mg/kg IV bolus followed by an 18- to 24-h IV infusion of 10 mcg/min, concluding 1 h after the PCI.

General Advice

• Use only normal saline or D5W for IV infusion. Add no other medication for the infusion.
• Do not use drug if vial contains visibly opaque particles.
• Withdraw medication through a 0.2 or 5 micron filter.
• Administer drug through a separate IV line with filter.
• Avoid noncompressible sites when obtaining IV access.

Storage/Stability

Store vials at 2° to 8°C (36° to 46°F). Do not freeze. Do not shake. Discard any unused portion.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypotension (14%); bradycardia (5%); tachycardia (1%).

CNS

Headache (6%); dizziness (3%); anxiety (2%); abnormal thinking (1%).

Dermatologic

Increased sweating (1%).

GI

Nausea (14%); vomiting (7%); abdominal pain (3%); dyspepsia (2%); diarrhea (1%).

Hematologic-Lymphatic

Anemia (1%); major bleeding (including intracranial hemorrhage), minor bleeding (including gross hematuria, spontaneous hematemesis), thrombocytopenia.

Musculoskeletal

Back pain (18%).

Miscellaneous

Chest pain (11%); pain (5%); peripheral edema (2%); allergic reactions including anaphylaxis.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Readministration

Abciximab may cause antibody development. Readministration may be associated with allergic reactions.

Bleeding

Because risk of bleeding is increased, use cautiously, if at all, with thrombolytics, oral anticoagulants, NSAIDs, dipyridamole, and ticlopidine. Institute bleeding precautions.

Thrombocytopenia

Monitor platelet counts.

Allergic reactions

Allergic reactions, including anaphylaxis (sometimes fatal), have been reported.

Femoral artery access

Care should be taken when attempting vascular access so that only the anterior wall of the femoral artery is punctured.

Restoration of platelet function

In the event of serious uncontrolled bleeding or the need for emergency surgery, if platelet function does not return to normal after discontinuing abciximab, it may be restored (at least in part) with platelet transfusions.

Vascular and other trauma

Minimize other arterial and venous punctures, epidural procedures, IM injections, and use of urinary catheters, nasotracheal intubation, and nasogastric tubes.

Overdosage

Symptoms

No experience of overdosage in clinical trials.

Patient Information

• Advise patient to report any bleeding or bruising to health care provider immediately.

Copyright © 2009 Wolters Kluwer Health.