Abciximab

What is Abciximab?

• Abciximab (ReoPro) a glycoprotein IIb/IIIa receptor antagonist manufactured by Janssen Biologics BV and distributed by Eli Lilly under the trade name ReoPro, is a platelet aggregation inhibitor mainly used during and after coronary artery procedures like angioplasty to prevent platelets from sticking together and causing thrombus (blood clot) formation within the coronary artery.
• It is a glycoprotein IIb/IIIa inhibitor.

Abciximab

Reopro

What are the uses of this medicine?

Abciximab (ReoPro) is used as an adjunct to percutaneous coronary intervention for the prevention of cardiac ischemic complications:

• in patients undergoing percutaneous coronary intervention
• in patients with unstable angina not responding to conventional medical therapy when percutaneous coronary intervention is planned within 24 hours.

Limitations of use:

• Abciximab use in patients not undergoing percutaneous coronary intervention has not been studied.
• Abciximab is intended for use with aspirin and heparin.

How does this medicine work?

• Abciximab binds to the intact platelet GPIIb/IIIa receptor, which is a member of the integrin family of adhesion receptors and the major platelet surface receptor involved in platelet aggregation.
• Abciximab inhibits platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor, and other adhesive molecules to GPIIb/IIIa receptor sites on activated platelets.
• The mechanism of action is thought to involve steric hindrance and/or conformational effects to block access of large molecules to the receptor rather than direct interaction with the RGD (arginine-glycine-aspartic acid) binding site of GPIIb/IIIa.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Active internal bleeding
• Recent (within six weeks) gastrointestinal (GI) or genitourinary (GU) bleeding of clinical significance.
• History of cerebrovascular accident (CVA) within two years, or CVA with a significant residual neurological deficit
• Bleeding diathesis
• Administration of oral anticoagulants within seven days unless prothrombin time is I 1.2 times control
• Thrombocytopenia (< 100,000 cells/pL)
• Recent (within six weeks) major surgery or trauma
• Intracranial neoplasm, arteriovenous malformation, or aneurysm
• Severe uncontrolled hypertension
• Presumed or documented history of vasculitis
• Use of intravenous dextran before percutaneous coronary intervention, or intent to use it during an intervention
• known hypersensitivity to any component of this product or to murine proteins.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Is this medicine FDA approved?

• Yes, it is FDA approved.

How should this medicine be used?

Recommended dosage:

• The recommended dosage of Abciximab in adults is a 0.25 mgkg intravenous bolus administered IO-60 minutes before the start of percutaneous coronary intervention, followed by a continuous intravenous infusion of 0.125 pgkg/min (to a maximum of 10 pg/min) for 12 hours.
• Patients with unstable angina not responding to conventional medical therapy and who are planned to undergo percutaneous coronary intervention within 24 hours may be treated with an Abciximab 0.25 mgkg intravenous bolus followed by an 18 to 24-hour intravenous infusion of 10 pg/min, concluding one hour after the percutaneous coronary intervention.

Administration:

• As intravenous bolus administered IO-60 minutes before the start of percutaneous coronary intervention, followed by a continuous intravenous infusion of 0.125 pgkg/min (to a maximum of 10 pg/min) for 12 hours.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Abciximab (ReoPro@) 2 mg/mL is supplied in 5 mL vials containing 10 mg

This medicine is available in fallowing brand namesː

• ReoPro

What side effects can this medication cause?

The most common side effects of this medicine include:

• Bleeding
• Intracranial Hemorrhage and Stroke
• Thrombocytopenia
• Hypotension
• Bradycardia
• Nausea
• Vomiting
• Abdominal Pain
• Back Pain
• Chest Pain
• Headache
• Puncture Site Pain
• Peripheral Edema

What special precautions should I follow?

• Abciximab has the potential to increase the risk of bleeding, particularly in the presence of anticoagulation, e.g., from heparin, other anticoagulants, or thrombolytics.
• Therapy with Abciximab requires careful attention to all potential bleeding sites.
• Platelet counts should be monitored prior to treatment, two to four hours following the bolus dose of Abciximab and at 24 hours or prior to discharge, whichever is first.
• In the event of serious uncontrolled bleeding or the need for emergency surgery, Abciximab should be discontinued. If platelet function does not return to normal, it may be restored, at least in part, with platelet transfusions.
• Administration of Abciximab may result in human anti-chimeric antibody (HACA) formation that could potentially cause allergic or hypersensitivity reactions (including anaphylaxis), thrombocytopenia or diminished benefit upon readministration of Abciximab.
• Anaphylaxis has not been reported for Abciximab-treated patients. Administration of Abciximab should be immediately stopped and standard appropriate resuscitative measures should be initiated.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category C
• It is also not known whether Abciximab can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
• Abciximab should be given to a pregnant woman only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been studied.

What are the active and inactive ingredients in this medicine?

• Each single use vial contains 2 mg/mL of Abciximab in a buffered solution (pH 7.2) of 0.01 M sodium phosphate, 0.15 M sodium chloride and 0.00 1% polysorbate 80 in Water for Injection.
• No preservatives are added.

Who manufactures and distributes this medicine?

Manufactured by:

• Centocor B.V.
• Leiden, The Netherlands

Distributed by:

• Eli Lilly and Company
• Indianapolis, IN

What should I know about storage and disposal of this medication?

• Vials should be stored at 2 to 8°C (36 to 46’F).
• Do not freeze.
• DO not shake.
• Do not use beyond the expiration date.
• Discard any unused portion left in the vial.

• Dailymed label info on Abciximab
• FDA Abciximab