ReoPro

ReoPro

ABCIXIMAB (Systemic)

Some commonly used brand names are:

In the U.S.

ReoPro

In Canada

ReoPro

Other commonly used names are

c7E3 Fab

Category

Antithrombotic

Monoclonal antibody (antithrombotic)

Platelet aggregation inhibitor

What is ReoPro?

ReoPro is used to lessen the chance of heart attack in people who need percutaneous coronary intervention (PCI), a procedure to open blocked arteries of the heart.

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

ReoPro is available only with your doctor's prescription, in the following dosage forms:

Parenteral

Injection (U.S. and Canada)

Before Using ReoPro

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ReoPro, the following should be considered:

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

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

Breast-feeding - It is not known whether this medicine passes into 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 using ReoPro and who wish to breast-feed should discuss this with their doctor. P>Children - Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of ReoPro in children with use in other age groups.

Older adults - Bleeding problems may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of ReoPro. It is important that you discuss the use of ReoPro with your doctor.

Other medicines - Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking ReoPro, it is especially important that your doctor and pharmacist know if 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 medicines together with ReoPro may increase the risk of bleeding.

Other medical problems - The presence of other medical problems may affect the use of ReoPro. Make sure you tell your doctor if you 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 tumor or

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 ReoPro or heparin before and had a reaction to either of them called thrombocytopenia (a low platelet count in the blood), or if new blood clots formed while you were receiving the medicine.

In addition, tell your doctor if you have recently had any bleeding from the stomach, previously had a stroke, recently fallen or 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 are taking ReoPro.

Proper Use of ReoPro

Dosing - The dose of ReoPro will be different for different patients. It is based on your body weight and must be determined by your doctor. The dose will also depend on your medical condition and your response to ReoPro. 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. Maintenance dose: 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 percutaneous coronary 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 18 to 24 hours, ending 1 hour after the procedure.

Children - Use and dose must be determined by your doctor.

Precautions While Using This Medicine

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

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

Bruising or bleeding, especially bleeding that is hard to stop. Bleeding inside the body sometimes appears as bloody or black, tarry stools, or faintness.

Back pain; burning, pricking, tickling, or tingling sensation; leg weakness; numbness; paralysis; or problems with bowel or bladder function.

Side Effects of ReoPro

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

Check with your doctor immediately 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 sitting position suddenly; sweating; unusual tiredness or weakness

Less common

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

Rare

Chest pain or discomfort; chills; cough; eye pain; fever; general feeling of illness; headache; pale skin; rapid weight 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; troubled breathing; unusual tiredness; wheezing

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

More Common

Back pain

Less common

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

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.