ABCIXIMAB (Systemic)

Some commonly used brand names are:

In the U.S.?

• ReoPro

In Canada?

• ReoPro

Other commonly used names are

Category

• Antithrombotic
• Monoclonal antibody (antithrombotic)
• Platelet aggregation inhibitor

Description

Abciximab(ab-SIKS-ih-mab) is used to lessen the chance of heart attackin people who need percutaneous coronary intervention (PCI), a procedure toopen blocked arteries of the heart.

A heart attack may occur when a blood vessel in the heart is blocked bya blood clot. Blood clots can sometimes form during PCI. Abciximab reducesthe chance that a harmful clot will form by preventing certain cells in theblood from clumping together. Abciximab is used with aspirin and heparin,which are other medicines used to keep your blood from clotting.

This medicine is available only with your doctor's prescription, in thefollowing dosage forms:

Parenteral
• Injection (U.S. and Canada)

Before Using This Medicine

In decidingto use a medicine, the risks of using the medicine must be weighed againstthe good it will do. This is a decision you and your doctor will make. ForAbciximab, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to abciximab or murine (mouse) proteins. If you havehad abciximab before, you may have developed an allergy to it. Tell your doctorif you have ever had abciximab. Also tell your doctor and pharmacist if youare allergic to any other substances, such as [foods, preservatives, or dyes].

Pregnancy?Studies on effects in pregnancy have not been donein either humans or animals. Before taking this medicine, make sure your doctorknows if you are pregnant or if you may become pregnant.

Breast-feeding?It is not known whether this medicine passesinto breast milk. Although most medicines pass into breast milk in small amounts,many of them may be used safely while breast-feeding. Mothers who are usingthis medicine and who wish to breast-feed should discuss this with their doctor.

Children?Studies on this medicine have been done only inadult patients, and there is no specific information comparing use of abciximabin children with use in other age groups.

Older adults?Bleeding problems may be especially likely to occurin elderly patients, who are usually more sensitive than younger adults totthe effects of abciximab. It is important that you discuss the use of thismedicine with your doctor.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingabciximab, it is especially important that your doctor and pharmacist knowif you are taking any of the following:

• Aspirin or
• Anticoagulants (blood thinners such as warfarin [Coumadin]) or
• Cefamandole (e.g., Mandol) or
• Cefoperazone (e.g., Cefobid) or
• Cefotetan (e.g., Cefotan) or
• Clot-dissolving drugs (alteplase [e.g., Activase], streptokinase[e.g., Streptase], urokinase [e.g., Abbokinase]), or
• Dextran, or
• Dipyridamole (e.g., Persantine, Aggrenox) or
• Heparin, or
• Inflammation or pain medicine, except narcotics, or
• Medicines that prevent platelets from sticking together (clopidogrel[e.g., Plavix], ticlopidine [e.g., Ticlid])?Using any of these medicinestogether with abciximab may increase the risk of bleeding.

Other medical problems?The presence of other medicalproblems may affect the use of abciximab. Make sure you tell your doctor ifyou have any other medical problems, especially:

• Aneurysm (swelling in a blood vessel) especially in the head or
• Blood disease or a history of unusual bleeding or
• Brain problems which may include bleeding, disease, injury or tumoror
• If you weigh less than 150 pounds or
• If you are over 65 years of age or
• Injury to any part of the body or
• Liver disease or
• Stroke?The risk of bleeding may be increased

Also, tell your doctor if you have received abciximab or heparin beforeand had a reaction to either of them called thrombocytopenia (a low plateletcount in the blood), or if new blood clots formed while you were receivingthe medicine.

In addition, tell your doctor if you have recentlyhad any bleeding from the stomach, previously had a stroke, recently fallenor suffered a blow to the body or head, or had major medical or dental surgery. These events may increase the risk of serious bleeding when you aretaking abciximab.

Proper Use of This Medicine

Dosing?The dose of abciximab will be different for different patients.It is based on your body weight and must be determined by your doctor. Thedose will also depend on your medical condition and your response to abciximab. Follow your doctor's orders.

• For injection dosage form:
  • For prevention of blood clots during percutaneous coronary intervention(the procedure to open blocked blood vessels):
    • Adults?Initial dose: 250 micrograms (mcg) per kilogram (kg)of body weight injected 10 to 60 minutes before the procedure. Maintenancedose: 0.125 mcg per kg of body weight per minute (maximum of 10 mcg per minute)by IV for 12 hours.
    • Children?Use and dose must be determined by your doctor.
  • For patients with unstable angina that will undergo percutaneouscoronary intervention within 24 hours:
    • Adults?Initial dose: 250 micrograms (mcg) per kilogram (kg)of body weight injected. Maintenance dose: 10 mcg per minute by IV for 18to 24 hours, ending 1 hour after the procedure.
    • Children?Use and dose must be determined by your doctor.

Precautions While Using This Medicine

Tell allof your medical doctors and dentists that you are using this medicine.

Check with your doctor immediately if you notice any of the following sideeffects:

• Bruising or bleeding, especially bleeding that is hard to stop. Bleedinginside the body sometimes appears as bloody or black, tarry stools, or faintness.
• Back pain; burning, pricking, tickling, or tingling sensation; legweakness; numbness; paralysis; or problems with bowel or bladder function.

Side Effects of This Medicine

Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

Check with your doctorimmediately if any of the following side effects occur:

More common

Bleeding; blurred vision; confusion;dizziness, faintness, or lightheadedness when getting up from a lying or sittingposition suddenly; sweating; unusual tiredness or weakness

Less common

Black, tarry stools; bleeding gums; blood in urine or stools; pinpoint redspots on skin; unusual bleeding or bruising

Rare

Chest pain or discomfort; chills; cough; eye pain; fever; general feeling of illness; headache; pale skin; rapidweight gain; shortness of breath; slow or irregular heartbeat; sneezing; sore throat; swelling of hands, ankles,feet, or lower legs; tightness in chest; tingling of hands or feet; troubledbreathing; unusual tiredness; wheezing

Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome.

More Common

Back pain

Less common

Acid or sour stomach; belching; burning, crawling, itching, numbness, prickling, ?pinsand needles?, or tingling feelings; changesin vision; delusions; dementia; fear; heartburn; indigestion or stomach discomfort, upset or pain; mood or mental changes; nausea; nervousness; vomiting

Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.