Abciximab (Intravenous Route)

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. Abciximab reduces the chance that a harmful clot will form by preventing certain cells in the blood 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.

This product is available in the following dosage forms:

• Solution

Before Using

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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

Geriatric

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

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab


• Acenocoumarol


• Alteplase, Recombinant


• Anisindione


• Anistreplase


• Ardeparin


• Argatroban


• Bivalirudin


• Certoparin


• Cilostazol


• Citalopram


• Clopidogrel


• Dalteparin


• Danaparoid


• Defibrotide


• Dermatan Sulfate


• Desirudin


• Desvenlafaxine


• Dextran


• Dicumarol


• Duloxetine


• Enoxaparin


• Eptifibatide


• Escitalopram


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Heparin


• Lamifiban


• Milnacipran


• Nadroparin


• Nefazodone


• Parnaparin


• Paroxetine


• Phenindione


• Phenprocoumon


• Reteplase, Recombinant


• Reviparin


• Sertraline


• Sibrafiban


• Streptokinase


• Tenecteplase


• Ticlopidine


• Tinzaparin


• Tirofiban


• Urokinase


• Warfarin


• Xemilofiban

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Vitamin A

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. 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


• Strokea€”The risk of bleeding may be increased

Also, tell your doctor if you have received abciximab 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 abciximab.

Proper Use

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  
  
  • For prevention of blood clots during percutaneous coronary intervention (the procedure to open blocked blood vessels):
    
    
    
    • Adultsa€”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.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • For patients with unstable angina that will undergo percutaneous coronary intervention within 24 hours:
    
    
    
    • Adultsa€”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.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Precautions

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

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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

• Back pain

Less common

• Acid or sour stomach


• Belching


• Burning, crawling, itching, numbness, prickling, a€śpins and needlesa€ť, 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 may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.