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Prevention of cardiac ischemic complications in patients undergoing percutaneous coronary intervention (PCI); 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.
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 neurological deficit; clotting abnormalities or administration of oral anticoagulants within 7 days unless prothrombin time (PT) is ≤1.2 times control PT value; thrombocytopenia (<100,000 cells/ Ž ¼L); recent (within 6 weeks) major surgery or trauma; intracranial tumor, arteriovenous malformation, or aneurysm; severe uncontrolled hypertension; history of vasculitis; use of dextran before PTCA or intent to use dextran during PTCA; concomitant use of another parenteral GP IIb/IIIa inhibitor
Percutaneous coronary intervention (PCI): IV: 0.25 mg/kg bolus administered 10-60 minutes prior to start of PCI followed by an infusion of 0.125 mcg/kg/minute (maximum: 10 mcg/minute) for 12 hours
Unstable angina/non-ST-elevation MI (UA/NSTEMI) unresponsive to conventional medical therapy with planned PCI within 24 hours: IV: 0.25 mg/kg bolus followed by an 18- to 24-hour infusion of 10 mcg/minute, concluding 1 hour after PCI.
ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) (off-label use) (ACCF/AHA [OGara, 2013]):
IV:
Loading dose: 0.25 mg/kg bolus administered at the time of PCI
Maintenance infusion: 0.125 mcg/kg/minute (maximum: 10 mcg/minute) continued for up to 12 hours
Intracoronary (off-label route): 0.25 mg/kg bolus administered directly to the site of the infarct lesion; may be followed with an intravenous maintenance infusion if refractory intraprocedural thrombotic complications occur (Stone, 2012)
Refer to adult dosing.
There are no dosage adjustments provided in the manufacturers labeling.
There are no dosage adjustments provided in the manufacturers labeling.
Bolus dose: Aseptically withdraw the necessary amount of abciximab for the bolus dose into a syringe using a 0.2 or 5 micron low protein-binding syringe filter (or equivalent); the bolus should be administered 10-60 minutes before the procedure.
Continuous infusion: Aseptically withdraw amount required of abciximab for the infusion through a 0.2 or 5 micron low protein-binding syringe filter into a syringe; inject this into 250 mL of NS or D5W to make solution. If a syringe filter was not used when preparing the infusion, administer using an in-line 0.2 or 0.22 micron low protein-binding filter.
Note: A standard concentration of 7.2 mg in 250 mL of NS or D5W may also be prepared for all patients and administered at the standard dose (0.125 mcg/kg/minute; maximum: 10 mcg/minute) with a variable rate in mL/hour. Infuse for 12-24 hours via pump after bolus dose; length of therapy dependent on indication. Some institutions use a standard concentration of 9 mg in 250 mL of D5W or NS.
Abciximab is intended for coadministration with aspirin postangioplasty and heparin infused and weight adjusted to maintain a therapeutic bleeding time (eg, ACT 300 to 500 seconds). Solution must be filtered prior to administration. Do not shake the 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)
Vials should be stored at 2 ‚ °C to 8 ‚ °C (36 ‚ °F to 46 ‚ °F). Do not freeze or shake. After admixture in NS or D5W, the prepared solution is stable for 12 hours.
The following stability information has also been reported: May store intact vials at 24 ‚ °C to 28 ‚ °C (76 ‚ °F to 82 ‚ °F) for up to 8 days (data on file [Eli Lilly, 2011]). However, the manufacturer recommends storage under refrigeration. Room temperature stability information should only be utilized in situations where the drug has been inadvertently exposed to prolonged room temperature.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
ReoPro: 2 mg/mL (5 mL)
Stable in D5W, NS. Requires separate intravenous line; no incompatibilities have been observed with glass bottles or PVC bags.
Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the antiplatelet effect of other Agents with Antiplatelet Properties. Monitor therapy
Anticoagulants: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Anticoagulants. Monitor therapy
Apixaban: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Apixaban. Specifically, the risk for bleeding may be increased. Management: Carefully consider risks and benefits of this combination and monitor closely. Monitor therapy
Belimumab: Monoclonal Antibodies may enhance the adverse/toxic effect of Belimumab. Avoid combination
Cephalothin: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Cephalothin. Specifically, the risk for bleeding may be increased. Monitor therapy
Collagenase (Systemic): Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Collagenase (Systemic). Specifically, the risk of injection site bruising and/or bleeding may be increased. Monitor therapy
Dabigatran Etexilate: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Dabigatran Etexilate. Agents with Antiplatelet Properties may increase the serum concentration of Dabigatran Etexilate. This mechanism applies specifically to clopidogrel. Management: Carefully consider risks and benefits of this combination and monitor closely; Canadian labeling recommends avoiding prasugrel or ticagrelor. Monitor therapy
Dasatinib: May enhance the anticoagulant effect of Agents with Antiplatelet Properties. Monitor therapy
Deoxycholic Acid: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Monitor therapy
Dextran: May enhance the anticoagulant effect of Abciximab. Avoid combination
Edoxaban: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Edoxaban. Specifically, the risk of bleeding may be increased. Monitor therapy
Glucosamine: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy
Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Bleeding may occur. Consider therapy modification
Ibritumomab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Ibritumomab. Both agents may contribute to impaired platelet function and an increased risk of bleeding. Monitor therapy
Ibrutinib: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Monitor therapy
Limaprost: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy
Multivitamins/Fluoride (with ADE): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy
Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy
Multivitamins/Minerals (with AE, No Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy
Obinutuzumab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Obinutuzumab. Specifically, the risk of serious bleeding-related events may be increased. Monitor therapy
Omega-3 Fatty Acids: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy
Pentosan Polysulfate Sodium: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Specifically, the risk of bleeding may be increased by concurrent use of these agents. Monitor therapy
Pentoxifylline: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy
Prostacyclin Analogues: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy
Rivaroxaban: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Rivaroxaban. Management: Carefully consider risks and benefits of this combination and monitor closely; Canadian labeling recommends avoiding prasugrel or ticagrelor. Monitor therapy
Salicylates: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Salicylates. Increased risk of bleeding may result. Monitor therapy
Thrombolytic Agents: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Thrombolytic Agents. Monitor therapy
Tipranavir: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy
Tositumomab and Iodine I 131 Tositumomab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Tositumomab and Iodine I 131 Tositumomab. Specifically, the risk of bleeding-related adverse events may be increased. Monitor therapy
Urokinase: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Urokinase. Avoid combination
Vitamin E (Systemic): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy
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, 2-4 hours following bolus infusion, and at 24 hours (or prior to discharge, if before 24 hours). To minimize risk of bleeding:
Abciximab initiated 18-24 hours prior to PCI: Maintain aPTT between 60-85 seconds during the heparin/abciximab infusion period
During PCI: Maintain ACT between 200-300 seconds
Following PCI (if anticoagulation is maintained): Maintain aPTT between 50-75 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; and examine urine, stool, and emesis for presence of occult or frank blood; gentle care should be provided when removing dressings.
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
Concerns related to adverse effects:
- Anaphylaxis/hypersensitivity reactions: Administration may result in human antichimeric antibody formation that can cause hypersensitivity reactions (including anaphylaxis).
- Bleeding: The most common complication is bleeding, including retroperitoneal, pulmonary, and spontaneous GI and/or GU bleeding; watch closely for bleeding, especially the arterial access site for the cardiac catheterization. Use with extreme caution in patients with platelet counts <150,000/mm3, patients with hemorrhagic retinopathy, previous history of GI disease, recent thrombolytic therapy and in chronic dialysis patients. Use caution with administration of other drugs affecting hemostasis. Minimize other procedures including arterial and venous punctures, IM injections, nasogastric tubes, etc. Increased risk of hemorrhage during or following angioplasty is associated with unsuccessful PTCA, PTCA procedure >70 minutes duration, or PTCA performed within 12 hours of symptom onset for acute myocardial infarction. When attempting IV access, avoid noncompressible sites (eg, subclavian or jugular veins).
- Thrombocytopenia: Administration may result in human antichimeric antibody formation that can cause thrombocytopenia; readministration within 30 days or in patients with human antichimeric antibodies (HACA) increases the incidence and severity of thrombocytopenia.
Special populations:
- Elderly: Use with caution in patients >65 years of age; increased risk of bleeding.
- Low weight patients: Use with caution in patients weighing <75 kg; increased risk of bleeding.
Other warnings/precautions:
- Diminished efficacy: Administration may result in human antichimeric antibody formation that can cause diminished efficacy.
- Sheath removal: Prior to pulling the sheath, heparin should be discontinued for 3-4 hours and ACT ≤175 seconds or aPTT ≤50 seconds. Use standard compression techniques after sheath removal. Watch the site closely afterwards for further bleeding.
C
Animal reproduction studies have not been conducted. In vitro studies have shown only small amounts of abciximab to cross the placenta. It is not known whether abciximab can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Fab antibody fragment of the chimeric human-murine monoclonal antibody 7E3; this agent binds to platelet IIb/IIIa receptors, resulting in steric hindrance, thus inhibiting platelet aggregation
Vd: 0.07 L/kg (Schror, 2003)
Unbound abciximab metabolized via proteolytic cleavage (Schror, 2003)
Rapid; platelet aggregation reduced to <20% of baseline at 10 minutes
Platelet inhibition: ~30 minutes (Mascelli, 1998)
Up to 72 hours for restoration of normal hemostasis (Schror, 2003)
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). Platelet function may remain abnormal for up to 7 days post infusion (Osende, 2001).
Mostly bound to GP IIb/IIIa receptors on platelet surface
- 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, hit head in a fall or crash, 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.