Abciximab

Storage

Parenteral

2–8°C.1 Do not freeze.1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

No incompatibilities observed with glass bottles, PVC bags, or IV administration sets.1

No incompatibilities observed with IV fluids.1

No incompatibilities observed with commonly used cardiovascular drugs.1 Nevertheless, administer abciximab in separate IV line whenever possible; do not mix with other drugs.1

• It is used during a heart treatment to protect the arteries.
• It is used to lower the number of heart attacks in patients who have unstable angina or mild heart attacks.

• If you have an allergy to abciximab or any other part of abciximab.
• If you are allergic to mouse proteins, talk with the doctor.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Aneurysm, arteriovenous malformations, bleeding problems, blood vessel problems, brain tumor, low platelet count, or high blood pressure.
• If you have ever had a stroke.
• If you have had any of these health problems within the past 6 weeks: Blood in the urine, stomach or bowel bleeding, surgery or injury, or vaginal bleeding.
• If you are taking a blood thinner.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take abciximab with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Platelet function recovery: 24 to 48 hours (Tcheng 1994; Mascelli 1998); may be up to 72 hours for restoration of normal hemostasis (Schror 2003). Platelet function may remain abnormal for up to 7 days post infusion based on shear-dependent platelet function testing as opposed to platelet aggregometry (Osende 2001)

Half-Life Elimination

Plasma: ~30 minutes; dissociation half-life from GP IIb/IIIa receptors: up to 4 hours (Schror 2003). Note: 29% and 13% of abciximab estimated to remain on GP IIb/IIIa receptors at 8 and 15 days, respectively (Mascelli 1998)

Protein Binding

Mostly bound to GP IIb/IIIa receptors on platelet surface

Percutaneous coronary intervention: Prevention of cardiac ischemic complications in patients undergoing percutaneous coronary intervention (PCI)

Unstable angina/non-ST-elevation myocardial infarction: Prevention of cardiac ischemic complications in patients with unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI) unresponsive to conventional therapy when PCI is scheduled within 24 hours

Note: Intended for use with aspirin and heparin, at a minimum. Safety and efficacy of abciximab use in patients not undergoing PCI have not been established.

ST-elevation myocardial infarction (STEMI) undergoing primary PCI

Data from a double-blind, placebo controlled trial in patients with STEMI undergoing primary PCI demonstrated that the use of abciximab in this setting reduces the incidence of the primary outcome of death, reinfarction, or urgent target vessel revascularization [Montalescot 2001]. Additional data from a randomized study with a 2x2 factorial design demonstrated that abciximab may be used to support primary PCI (ie, PTCA or stent) in patients with STEMI [Stone 2002]. Additional trials may be necessary to further define the role of abciximab in this setting.

Based on the 2013 American College of Cardiology/American Heart Association (ACCF/AHA) guidelines for the management of ST-elevation myocardial infarction (STEMI), abciximab may be administered at the time of primary PCI in select patients with STEMI in combination with heparin.

Intracoronary (off-label route): Mixed data exists on the administration of abciximab via the intracoronary route. In a randomized, open-label, 2x2 factorial designed study, patients with large anterior STEMI who were administered intracoronary abciximab to the infarct lesion site, demonstrated a significant reduction in infarct size whereas manual aspiration thrombectomy did not demonstrate a reduction [Stone 2012]. In another randomized, open-label, multicenter trial, abciximab did not reduce the composite endpoint (death, reinfarction, or congestive heart failure) in all patients with STEMI; however, patients who received intracoronary abciximab had lower rates of congestive heart failure [Thiele 2012]. The ACCF/AHA guidelines for the management of STEMI, state that it may be reasonable to administer intracoronary abciximab to select patients with STEMI undergoing primary PCI [ACCF/AHA [O'Gara 2013]].

Hypersensitivity to abciximab, murine proteins, or any component of the formulation; active internal hemorrhage or recent (within 6 weeks) clinically-significant GI or GU bleeding; history of cerebrovascular accident within 2 years or with significant residual neurological deficit; bleeding diathesis; administration of oral anticoagulants within 7 days unless prothrombin time (PT) is ≤1.2 times control PT value; thrombocytopenia (<100,000 cells/mcL); recent (within 6 weeks) major surgery or trauma; intracranial tumor, arteriovenous malformation, or aneurysm; severe uncontrolled hypertension; history of vasculitis (presumed or documented); use of dextran before PCI or intent to use dextran during PCI.

There are no dosage adjustments provided in the manufacturer's labeling.

Hemodialysis: Dialyzable: Unknown, but unlikely (NCS/SCCM [Frontera 2016])

For IV administration. Solution must be filtered using a 0.2 or 5 micron low protein-binding syringe filter during preparation or via a 0.2 to 0.22 micron low protein-binding inline filter during administration. Do not shake vial.

Intracoronary administration (off-label route): In select STEMI cases (eg, anterior STEMI), abciximab bolus may be administered through the guiding catheter directly to the culprit lesion site (Stone 2012; Thiele 2012)

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience back pain, nausea, vomiting, or headache. Have patient report immediately to prescriber signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), severe dizziness, passing out, angina, bradycardia, fall or crash hitting head, or severe loss of strength and energy (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Applies to abciximab: intravenous solution

Along with its needed effects, abciximab 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 while taking abciximab:

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

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

• 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 of abciximab 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:

• Back pain

• 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