Abciximab

Name: Abciximab

Abciximab Dosage and Administration

General

  • Discontinue infusion in patients in whom PCI has failed.1

Adjunctive Antithrombotic Therapy: General Considerations

  • Used in conjunction with aspirin and heparin in clinical studies.1

  • Dosage of heparin required to maintain an appropriate activated clotting time (ACT) during concomitant therapy with abciximab may be lower than with heparin monotherapy.19 994 (See Specific Drugs under Interactions.)

Adjunctive Antithrombotic Therapy When Used to Prevent Acute Ischemic Complications of PCI

  • Aspirin: In clinical studies, patients received 325 mg 2 hours prior to PCI and daily thereafter.1 77 ACCF/AHA/SCAI recommends that aspirin 325 mg be given prior to PCI in patients not already receiving maintenance aspirin therapy.994 Patients already receiving maintenance aspirin therapy should receive a dose of 81–325 mg before the procedure.994

  • P2Y12-receptor antagonist: A loading dose of clopidogrel, prasugrel, or ticagrelor also is recommended prior to PCI in those undergoing stent placement.994

  • Heparin sodium: In clinical studies, patients received 70 units/kg if baseline ACT <150 seconds, 50 units/kg if baseline ACT was 150–199 seconds, or no heparin if baseline ACT ≥200 seconds; additional injections of 20 units/kg were given to maintain an ACT of ≥200 seconds during the procedure.1 Experts suggest use of lower dosages of concomitant IV heparin sodium (e.g., 50–70 units/kg) given 6 hours prior to PCI and targeted to an ACT of ≥200 seconds.10 12 16 19 45 46 77 994 (See Laboratory Monitoring under Cautions.) Postprocedural use of heparin generally not recommended.1 10 22 77

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV injection followed by IV infusion using a controlled-infusion device (e.g., pump).1

Do not shake vial.1

Filter injection upon dilution, prior to IV administration, or during IV infusion using a sterile, nonpyrogenic, low-protein-binding filter (0.2 or 5 µm).1 7

For IV injection, withdraw appropriate dose into syringe and filter injection prior to administration.1

Discard unused portion.1

Do not admix or administer other drugs in the same IV line with abciximab injection or infusion.1

Dilution

For IV infusion, withdraw appropriate dose into syringe and inject into an appropriate container of 0.9% sodium chloride or 5% dextrose injection.1

Rate of Administration

For IV injection, administer over at least 1 minute.1 7

Dosage

Adults

Acute Ischemic Complications of PCI IV

Patients undergoing PCI: 0.25 mg/kg by IV injection 10–60 minutes prior to PCI,1 7 followed by IV infusion of 0.125 mcg/kg per minute (maximum of 10 mcg/minute) for 12 hours.1

Patients scheduled to receive PCI within 24 hours: 0.25 mg/kg by IV injection, followed by IV infusion of 10 mcg/minute for 18–24 hours, concluding 1 hour after procedure.1 4

Prescribing Limits

Adults

Acute Ischemic Complications of PCI IV

Patients undergoing PCI: Maximum 10 mcg/minute (as IV infusion) for 12 hours.1

Special Populations

No special population dosage recommendations at this time.1

What are some things I need to know or do while I take Abciximab?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • If you fall or hurt yourself, or if you hit your head, call your doctor right away. Talk with your doctor even if you feel fine.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Very bad and sometimes deadly bleeding problems have happened with abciximab. Talk with the doctor.
  • Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

What are some other side effects of Abciximab?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Back pain.
  • Upset stomach or throwing up.
  • Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about abciximab, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about abciximab. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using abciximab.

Review Date: October 4, 2017

Index Terms

  • 7E3
  • C7E3

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

ReoPro: 2 mg/mL (5 mL) [contains polysorbate 80]

Adverse Reactions

As with all drugs which may affect hemostasis, bleeding is associated with abciximab. Hemorrhage may occur at virtually any site. Risk is dependent on multiple variables, including the concurrent use of multiple agents which alter hemostasis and patient susceptibility.

>10%:

Cardiovascular: Hypotension (14%), chest pain (11%)

Gastrointestinal: Nausea (14%)

Hematologic & oncologic: Minor hemorrhage (4% to 17%), major hemorrhage (1% to 14%)

Neuromuscular & skeletal: Back pain (18%)

Miscellaneous: Antibody development (HACA, first exposure: 6%; readministration: 27%; four or more exposures: 44%)

1% to 10%:

Cardiovascular: Bradycardia (5%), peripheral edema (2%)

Gastrointestinal: Abdominal pain (3%)

Hematologic & oncologic: Thrombocytopenia: <100,000 cells/mm3 (3% to 6%); <50,000 cells/mm3 (0.4% to 2%)

Local: Pain at injection site (4%)

<1% (Limited to important or life-threatening): Abnormality in thinking, abscess, allergic reaction (possible), anaphylaxis (possible), arteriovenous fistula, bronchitis, bullous skin disease, cellulitis, cerebrovascular accident, coma, complete atrioventricular block, confusion, diabetes mellitus, edema, embolism, gastroesophageal reflux disease, hyperkalemia, hypertonia, incomplete atrioventricular block, inflammation, intestinal obstruction, intracranial hemorrhage, leukocytosis, nodal arrhythmia, pleural effusion, pleurisy, pneumonia, prostatitis, pseudoaneurysm, pulmonary alveolar hemorrhage, pulmonary embolism, renal insufficiency, thrombophlebitis, urinary retention, ventricular tachycardia

Monitoring Parameters

Prothrombin time, activated partial thromboplastin time (aPTT), hemoglobin, hematocrit, platelet count, fibrinogen, fibrin split products, transfusion requirements, signs of hypersensitivity reactions, guaiac stools, Hemastix urine. Platelet count should be monitored at baseline, 2 to 4 hours following bolus infusion, and at 24 hours (or prior to discharge, if before 24 hours). To minimize risk of bleeding:

Abciximab initiated 18 to 24 hours prior to PCI: Maintain aPTT between 60 to 85 seconds during the heparin/abciximab infusion period

During PCI: Maintain ACT between 200 to 300 seconds

Following PCI (if anticoagulation is maintained): Maintain aPTT between 50 to 75 seconds

Sheath removal should not occur until aPTT is ≤50 seconds or ACT ≤175 seconds.

Maintain bleeding precautions, avoid unnecessary arterial and venous punctures, use saline or heparin lock for blood drawing, assess sheath insertion site and distal pulses of affected leg every 15 minutes for the first hour and then every 1 hour for the next 6 hours. Arterial access site care is important to prevent bleeding. Care should be taken when attempting vascular access that only the anterior wall of the femoral artery is punctured, avoiding a Seldinger (through and through) technique for obtaining sheath access. Femoral vein sheath placement should be avoided unless needed. While the vascular sheath is in place, patients should be maintained on complete bedrest with the head of the bed at a 30° angle and the affected limb restrained in a straight position.

Observe patient for mental status changes, hemorrhage; assess nose and mouth mucous membranes, puncture sites for oozing, ecchymosis, and hematoma formation; examine urine, stool, and emesis for presence of occult or frank blood; gentle care should be provided when removing dressings.

Abciximab Drug Class

Abciximab is part of the drug class:

  • Platelet aggregation inhibitors excl. heparin

Adverse Effects

>10%

Bleeding, minor (70-82%)

Bleeding, major (17-21%)

Hypotension (14-21%)

Back pain (17.6%)

Nausea (13.6%)

Chest pain (11.4%)

Vomiting (7-11%)

1-10%

Headache (6%)

Thrombocytopenia (2-6%)

Bradycardia (5%)

Injection site pain (3.6%)

Extremity pain (3.5%)

Abdominal pain (3%)

UTI (2%)

Dizziness (1.8%)

Peripheral edema (1.6%)

Anemia (1.2%)

Diarrhea (1%)

Hypoesthesia (1%)

(web3)