Abciximab

Name: Abciximab

Introduction

Platelet aggregation inhibitor; a platelet glycoprotein (GP IIb/IIIa)-receptor inhibitor.1 2 4 5

Uses for Abciximab

Acute Ischemic Complications of PCI

Adjunct to anticoagulant therapy (e.g., heparin [referring throughout this monograph to unfractionated heparin], low molecular weight heparin), aspirin, and a P2Y12 platelet adenosine diphosphate (ADP)-receptor antagonist (e.g., clopidogrel, prasugrel, ticagrelor) to prevent acute cardiac ischemic complications in patients undergoing PCI or in patients with non-ST-segment-elevation acute coronary syndromes (NSTE ACS; unstable angina or non-ST-segment-elevation MI [NSTEMI]) not responding to conventional medical therapy in whom PCI is planned within 24 hours.1 2 4 5 7 10 11 91 994 995 1100

Adjunctive therapy with a GP IIb/IIIa-receptor inhibitor can reduce the incidence of cardiac ischemic events, including subsequent MI and death, in patients with NSTE ACS undergoing PCI and in patients without these conditions undergoing PCI.10 11 17 47 48 49 50 51

Safety and efficacy in patients not undergoing PCI not established.1 1016

The American College of Cardiology Foundation (ACCF), AHA, the Society for Cardiovascular Angiography and Interventions (SCAI), and other experts currently do not recommend routine use of GP IIb/IIIa-receptor inhibitors in patients with ST-segment elevation MI (STEMI) undergoing PCI; however, selective use of these drugs as an adjunct to heparin may be reasonable in certain high-risk patients (e.g., those with large anterior MI and/or large thrombus).994 1016

ACCF/AHA/SCAI state that administration of a GP IIb/IIIa-receptor inhibitor at the time of PCI as an adjunct to heparin may be particularly useful in patients with NSTE ACS who have high-risk features (e.g., elevated troponin) and are not receiving bivalirudin and are not adequately pretreated with clopidogrel.994

Regarding choice of GP IIb/IIIa-receptor inhibitor in patients undergoing PCI, IV abciximab, “double-bolus” IV eptifibatide, and high-dose tirofiban given by direct IV injection all produce a high degree of platelet inhibition and reduce ischemic complications.994

Non-ST-Segment-Elevation Acute Coronary Syndromes

Has been used in patients with unstable angina or NSTEMI (i.e., NSTE ACS) managed with conservative medical therapy only†; however, manufacturer and some clinicians state that safety and efficacy of abciximab not established in such patients who are not undergoing PCI.1 991

A GP IIb/IIIa-receptor inhibitor may be used in conjunction with aspirin prior to diagnostic angiography (“upstream”) in patients with NSTE ACS in whom an initial invasive management strategy is planned; however, IV eptifibatide or tirofiban is the preferred GP IIb/IIIa inhibitor for this use.991 Abciximab is recommended in this situation only if there is no appreciable delay before angiography and PCI is likely to be performed.991

Interactions for Abciximab

No formal drug interaction studies to date.1

Specific Drugs

Drug

Interaction

Comments

Anticoagulants, oral

Potential increased risk of bleeding1

Use with caution1

Dextran

Increased risk of bleeding1

Concomitant use contraindicated1

Dipyridamole

Potential increased risk of bleeding1

Use with caution1

Heparin

Increased risk of bleeding1

Monitor aPTT or ACT during therapy1

NSAIAs

Potential increased risk of bleeding1

Use with caution1

Thrombolytics (e.g., reteplase)

Increased risk of major bleeding1

Weigh risk against anticipated benefit of concomitant therapy1

Ticlopidine

Potential increased risk of bleeding1

Use with caution1

Abciximab Pharmacokinetics

Absorption

Onset

Maximal inhibition of platelet aggregation occurs within 10 minutes following IV administration.1

Duration

Bleeding time returns to ≤12 minutes within 12–24 hours following discontinuance of infusion.1 Platelet function generally recovers within 48 hours.1

Distribution

Extent

Not known whether abciximab is distributed into breast milk or is absorbed systemically after ingestion.1

Elimination

Half-life

Initial half-life is <10 minutes; second phase half-life is about 30 minutes.1 Abciximab remains in circulation for ≥15 days in a platelet-bound state.1

Actions

  • Fab fragment of chimeric human-murine monoclonal immunoglobulin antibody 7E3.1 2 3 4 5 6

  • Binds selectively to platelet GP IIb/IIIa receptors and reversibly inhibits platelet aggregation (by preventing binding of fibrinogen, von Willebrand factor, and other adhesive ligands to GP IIb/IIIa receptors).1 2 4 5

How do I store and/or throw out Abciximab?

  • If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Dosing Adult

Percutaneous coronary intervention (PCI): IV: 0.25 mg/kg bolus administered 10 to 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 [O'Gara 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)

Overdose

There has been no experience of overdosage in human clinical trials.

Pharmacology

Mechanism of Action

Chimeric monoclonal antibody; prevents binding of fibrinogen, vWF to glycoprotein IIb/IIIa receptor sites on platelets

Pharmacokinetics

Half-life: 30 min

Onset: 10 min (<20% of baseline)

Duration: 72 hr

Metabolism: Through proteolytic cleavage

Platelet binding: Remains bound for 15 days

Peak time: ~30 min (platelet inhibition)

Side effects

Bleeding

Abciximab has the potential to increase the risk of bleeding, particularly in the presence of anticoagulation, e.g., from heparin, other anticoagulants or thrombolytics. Bleeding in the Phase 3 trials was classified as major, minor or insignificant by the criteria of the Thrombolysis in Myocardial Infarction study group (16). Major bleeding events were defined as either an intracranial hemorrhage or a decrease in hemoglobin greater than 5 g/dL. Minor bleeding events included spontaneous gross hematuria, spontaneous hematemesis, observed blood loss with a hemoglobin decrease of more than 3 g/dL, or a decrease in hemoglobin of at least 4 g/dL without an identified bleeding site. Insignificant bleeding events were defined as a decrease in hemoglobin of less than 3 g/dL or a decrease in hemoglobin between 3-4 g/dL without observed bleeding. In patients who received transfusions, the number of units of blood lost was estimated through an adaptation of the method of Landefeld, et al. (17).

In the EPIC trial, in which a non-weight-adjusted, longer-duration heparin dose regimen was used, the most common complication during Abciximab therapy was bleeding during the first 36 hours. The incidences of major bleeding, minor bleeding and transfusion of blood products were significantly increased. Major bleeding occurred in 10.6% of patients in the Abciximab bolus plus infusion arm compared with 3.3% of patients in the placebo arm. Minor bleeding was seen in 16.8% of Abciximab bolus plus infusion patients and 9.2% of placebo patients (7). Approximately 70% of Abciximab-treated patients with major bleeding had bleeding at the arterial access site in the groin. Abciximab-treated patients also had a higher incidence of major bleeding events from gastrointestinal, genitourinary, retroperitoneal, and other sites.

Bleeding rates were reduced in the CAPTURE trial, and further reduced in the EPILOG and EPISTENT trials by use of modified dosing regimens and specific patient management techniques. In EPILOG and EPISTENT, using the heparin and Abciximab dosing, sheath removal and arterial access site guidelines described under PRECAUTIONS, the incidence of major bleeding in patients treated with Abciximab and low-dose, weight-adjusted heparin was not significantly different from that in patients receiving placebo.

Subgroup analyses in the EPIC and CAPTURE trials showed that non-CABG major bleeding was more common in Abciximab patients weighing ≤ 75 kg. In the EPILOG and EPISTENT trials, which used weight-adjusted heparin dosing, the non-CABG major bleeding rates for Abciximab-treated patients did not differ substantially by weight subgroup.

Although data are limited, Abciximab treatment was not associated with excess major bleeding in patients who underwent CABG surgery. (The range among all treatment arms was 3-5% in EPIC, and 1-2% in the CAPTURE, EPILOG, and EPISTENT trials.) Some patients with prolonged bleeding times received platelet transfusions to correct the bleeding time prior to surgery. (see PRECAUTIONS: Restoration of Platelet Function)

The rates of major bleeding, minor bleeding and bleeding events requiring transfusions in the CAPTURE, EPILOG, and EPISTENT trials are shown in Table 4. The rates of insignificant bleeding events are not included in Table 4.

Cases of fatal bleeding have been reported rarely during post-marketing use of Abciximab (see WARNINGS: Bleeding Events).

Pulmonary alveolar hemorrhage has been rarely reported during use of Abciximab. This can present with any or all of the following in close association with ReoPro administration: hypoxemia, alveolar infiltrates on chest x-ray, hemoptysis, or an unexplained drop in hemoglobin.

Table 4: NON-CABG BLEEDING IN TRIALS OF PERCUTANEOUS CORONARY INTERVENTION (EPILOG, EPISTENT and CAPTURE) Number of Patients with Bleeds (%)

  Placeboc
(n= 1748)
Abciximab + Low-dose Heparind
(n=2525)
Abciximab + Standard-dose Heparine
(n=918)
EPILOG and EPISTENT:
Majora 18 (1.0) 21 (0.8) 17 (1.9)
Minor 46 (2.6) 82 (3.2) 70 (7.6)
Requiring transfusionb 15 (0.9) 13 (0.5) 7 (0.8)
CAPTURE:
  Placebof
(n=635)
  Abciximabf
(n=630)
Majora 12 (1.9)   24 (3.8)
Minor 13 (2.0)   30 (4.8)
Requiring transfusionb 9 (1.4)   15 (2.4)
a Patients who had bleeding in more than one classification are counted only once according to the most severe classification. Patients with multiple bleeding events of the same classification are also counted once within that classification.
b Patients with major non-CABG bleeding who received packed red blood cells or whole blood transfusion.
c Standard-dose heparin with or without stent (EPILOG and EPISTENT)
d Low-dose heparin with or without stent (EPILOG and EPISTENT)
e Standard-dose heparin (EPILOG)
f Standard-dose heparin (CAPTURE)

Intracranial Hemorrhage And Stroke

The total incidence of intracranial hemorrhage and non-hemorrhagic stroke across all four trials was not significantly different, 9/3023 for placebo patients and 15/4680 for Abciximab-treated patients. The incidence of intracranial hemorrhage was 3/3023 for placebo patients and 7/4680 for Abciximab patients.

Thrombocytopenia

In the clinical trials, patients treated with Abciximab were more likely than patients treated with placebo to experience decreases in platelet counts. Among patients in the EPILOG and EPISTENT trials who were treated with Abciximab plus low-dose heparin, the proportion of patients with any thrombocytopenia (platelets less than 100,000 cells/μL) ranged from 2.5 to 3.0%. The incidence of severe thrombocytopenia (platelets less than 50,000 cells/μL) ranged from 0.4 to 1.0% and platelet transfusions were required in 0.9 to 1.1%, respectively. Modestly lower rates were observed among patients treated with placebo plus standard-dose heparin. Overall higher rates were observed among patients in the EPIC and CAPTURE trials treated with Abciximab plus longer duration heparin: 2.6 to 5.2% were found to have any thrombocytopenia, 0.9 to 1.7% had severe thrombocytopenia, and 2.1 to 5.5% required platelet transfusion, respectively.

In a readministration registry study of patients receiving a second or subsequent exposure to Abciximab (see PRECAUTIONS: Readministration) the incidence of any degree of thrombocytopenia was 5%, with an incidence of profound thrombocytopenia of 2% ( < 20,000 cell/μL). Factors associated with an increased risk of thrombocytopenia were a history of thrombocytopenia on previous Abciximab exposure, readministration within 30 days, and a positive HACA assay prior to the readministration.

Among 14 patients who had thrombocytopenia associated with a prior exposure to Abciximab, 7 (50%) had recurrent thrombocytopenia. In 130 patients with a readministration interval of 30 days or less, 25 (19%) developed thrombocytopenia. Severe thrombocytopenia occurred in 19 of these patients. Among the 71 patients who had a positive HACA assay at baseline, 11 (15%) developed thrombocytopenia, 7 of which were severe.

Allergic Reactions

There have been rare reports of allergic reactions, some of which were anaphylaxis (see WARNINGS: Allergic Reactions).

Other Adverse Reactions

Table 5 shows adverse events other than bleeding and thrombocytopenia from the combined EPIC, EPILOG and CAPTURE trials which occurred in patients in the bolus plus infusion arm at an incidence of more than 0.5% higher than in those treated with placebo.

Table 5 : ADVERSE EVENTS AMONG TREATED PATIENTS IN THE EPIC, EPILOG, AND CAPTURE TRIALS

Event Placebo
(n=2226)
Bolus + Infusion
(n=3111)
Number of Patients (%)
Cardiovascular system
  Hypotension 230 (10.3) 447 (14.4)
  Bradycardia 79 (3.5) 140 (4.5)
Gastrointestinal system
  Nausea 255 (11.5) 423 (13.6)
  Vomiting 152 ( 6.8) 226 (7.3)
  Abdominal pain 49 ( 2.2) 97 (3.1)
Miscellaneous
  Back pain 304 (13.7) 546 (17.6)
  Chest pain 208 (9.3) 356 (11.4)
  Headache 122 (5.5) 200 (6.4)
  Puncture site pain 58 (2.6) 113 (3.6)
  Peripheral edema 25 (1.1) 49 (1.6)

The following additional adverse events from the EPIC, EPILOG and CAPTURE trials were reported by investigators for patients treated with a bolus plus infusion of Abciximab at incidences which were less than 0.5% higher than for patients in the placebo arm.

Cardiovascular System: ventricular tachycardia (1.4%), pseudoaneurysm (0.8%), palpitation (0.5%), arteriovenous fistula (0.4%), incomplete AV block (0.3%), nodal arrhythmia (0.2%), complete AV block (0.1%), embolism (limb)(0.1%); thrombophlebitis (0.1%);

Gastrointestinal System: dyspepsia (2.1%), diarrhea (1.1%), ileus (0.1%), gastroesophogeal reflux (0.1%);

Hemic and Lymphatic System: anemia (1.3%), leukocytosis (0.5%), petechiae (0.2%);

Nervous System: dizziness (2.9%), anxiety (1.7%), abnormal thinking (1.3%), agitation (0.7%), hypesthesia (0.6%), confusion (0.5%) muscle contractions (0.4%), coma (0.2%), hypertonia (0.2%), diplopia (0.1%);

Respiratory System: pneumonia (0.4%), rales (0.4%), pleural effusion (0.3%), bronchitis (0.3%) bronchospasm (0.3%), pleurisy (0.2%), pulmonary embolism (0.2%), rhonchi (0.1%);

Musculoskeletal System: myalgia (0.2%);

Urogenital System: urinary retention (0.7%), dysuria (0.4%), abnormal renal function (0.4%), frequent micturition (0.1%), cystalgia (0.1%), urinary incontinence (0.1%), prostatitis (0.1%);

Miscellaneous: pain (5.4%), sweating increased (1.0%), asthenia (0.7%), incisional pain (0.6%), pruritus (0.5%), abnormal vision (0.3%), edema (0.3%), wound (0.2%), abscess (0.2%), cellulitis (0.2%), peripheral coldness (0.2%), injection site pain (0.1%), dry mouth (0.1%), pallor (0.1%), diabetes mellitus (0.1%), hyperkalemia (0.1%), enlarged abdomen (0.1%), bullous eruption (0.1%), inflammation (0.1%), drug toxicity (0.1%).

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. In the EPIC, EPILOG, and CAPTURE trials, positive HACA responses occurred in approximately 5.8% of these patients receiving a first exposure to Abciximab. No increase in hypersensitivity or allergic reactions was observed with Abciximab treatment (see WARNINGS: Allergic Reactions).

In a study of readministration of Abciximab to patients (see PRECAUTIONS: Readministration) the overall rate of HACA positivity prior to the readministration was 6% and increased post-readministration to 27%. Among the 36 subjects receiving a fourth or greater Abciximab exposure, HACA positive assays were observed postreadministration in 16 subjects (44%). There were no reports of serious allergic reactions or anaphylaxis (see WARNINGS: Allergic Reactions). HACA positive status was associated with an increased risk of thrombocytopenia (see PRECAUTIONS: Thrombocytopenia).

The data reflect the percentage of patients whose test results were considered positive for antibodies to Abciximab using an ELISA assay, and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Abciximab with the incidence of antibodies to other products may be misleading.

Read the entire FDA prescribing information for ReoPro (Abciximab)

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For Healthcare Professionals

Applies to abciximab: intravenous solution

Hematologic

There was no significant increase in bleeding between patients who received abciximab and those who received aspirin, heparin, or placebo among the 58 patients from the EPIC trial who underwent emergency coronary artery bypass grafting (CABG) after PTCA. The authors concluded that surgery can be performed after treatment with abciximab with acceptable mortality and bleeding complications. These data are supported by data from the Thrombolysis and Angioplasty in Myocardial Infarction (TAMI) 8 pilot study.

In the EPILOG trial, use of weight-adjusted abciximab infusion and low-dose weight-adjusted heparin, early removal of the femoral sheath, and arterial access guidelines reduced the incidence of major bleeding in patients receiving abciximab and heparin to rates similar to patients receiving placebo.

Immediate discontinuation of abciximab (and heparin) is recommended in the event of serious bleeding that cannot be controlled by compression.

The first and second most common sites of bleeding are the femoral artery access site and the gastrointestinal (GI) tract, respectively. Great care should be exercised when placing the femoral artery introducer. Indwelling arterial and venous lines should be in place prior to administration of abciximab, and recent puncture sites should be monitored closely.

In clinical trials, the incidence of intracranial hemorrhage in treated patients was similar to placebo, but the incidence of major bleeding events from GI, genitourinary, retroperitoneal, and other sites was higher in treated patients.

The incidence of hematologic side effects such as bleeding increases when abciximab is given following full dose thrombolytic therapy. In a Canadian study involving 147 acute myocardial infarction (AMI) patients, the researchers reported a 2-fold increase in bleeding risk in patients who had received full dose thrombolytics followed by adjunctive abciximab (plus low dose heparin) therapy during rescue or urgent PTCA. The patients were treated with full dose thrombolytics within the first 12 hours following the onset of AMI symptoms. Abciximab was given to 57 patients as adjunctive therapy during rescue (PTCA within 12 hours of AMI) or urgent (PTCA within 48 hours of AMI) angioplasty. The remaining 90 patients did not receive abciximab, and served as the control group. The authors reported that the risk of intracranial or fatal bleeding events was the same for both treated and non-treated groups, however, the risk for minor bleeding was doubled for the abciximab-treated group.

Major bleeding events were increased in patients receiving abciximab within 24 hours of full dose thrombolytic therapy according to a study conducted between July 1995 and March 1999. Of the 214 total patients studied, 50 (23%) experienced major bleeding episodes. A total of 34 patients required transfusions. Intracranial bleeding occurred in 3 (1.4%) patients. The authors concluded that major bleeding occurs in about 20% to 25% of patients when abciximab is used within 24 hours of full-dose thrombolytic therapy.

Risk factors for bleeding events in patients treated with glycoprotein (GP) IIb/IIIa inhibitors undergoing percutaneous coronary intervention (PCI) have been identified and include advanced age, renal dysfunction, female gender, peripheral vascular disease, lower body weight, duration of GP IIb/IIIa inhibitor infusion, baseline platelet count, lower baseline hemoglobin, diabetes, and elevated peak activated clotting time. According to one study (CRUSADE trial) involving patients with non-ST-segment elevation acute coronary syndrome (NSTEACS) treated with a GP IIb/IIIa inhibitor, women are at a greater risk of bleeding than men, primarily because of excessive dosing. Results of another study indicate that among patients with NSTEACS undergoing a PCI, compared with men, women experienced a greater incidence of major and minor bleeding complications and required more transfusions of blood products.[Ref]

Hematologic complications are the most common and potentially life-threatening side effects of abciximab. Thrombocytopenia (less than 100,000 cells/mcL) associated with abciximab and standard dose heparin occurred at a rate of 2.5% to 6% (1% to 2% had platelet counts less than 50,000 cells/mcL.). Thrombocytopenia (less than 100,000 cells/mcL) associated with abciximab and low-dose weight-adjusted heparin (EPILOG) occurred at a rate of 2.5% (less than 0.5% had platelet counts less than 50,000 cells/mcL).

Pseudothrombocytopenia, which is considered a benign laboratory condition that does not increase bleeding, stroke, need for transfusion or repeat revascularization, has been reported as the cause of more than one third of low platelet counts in patients undergoing coronary interventions treated with abciximab. Compared with placebo, the incidence of pseudothrombocytopenia in four trials using abciximab was 0.6% vs 2.1%, respectively.

Major bleeding, defined as either an intracranial hemorrhage or a decrease in hemoglobin greater than 5 g/dL, has been reported in 2% to 11% of patients receiving abciximab and standard-dose heparin. Major bleeding was reported in 1% of patients receiving abciximab and low-dose heparin (EPILOG). Minor bleeding, including spontaneous gross hematuria, spontaneous hematemesis, observed blood loss with a hemoglobin decrease of greater than 3 g/dL, or a decrease in hemoglobin of at least 4 g/dL without an identified bleeding site, has been reported in 4% to 17% of patients receiving abciximab and standard-dose heparin. Minor bleeding was reported in 4% of patients receiving abciximab and low-dose heparin (EPILOG).

Excess spontaneous major organ bleeding has occurred primarily in abciximab treated patients weighing 75 kg or less. In addition, patients who experienced a greater incidence of major bleeding episodes have included: patients greater than 65 years old; those who had a prior history of GI disease; those who had received thrombolytics; those who were administered heparin; those who received PTCA within 12 hours of the onset of AMI symptoms; those whose PTCA procedure was greater than 70 minutes in length; and those who failed PTCA.

Anemia, leukocytosis, and petechiae have been reported in 1.3%, 0.5%, and 0.2% of patients, respectively.[Ref]

Hypersensitivity

Hypersensitivity reactions (which may be anticipated whenever protein solutions such as abciximab are administered) may present as anaphylaxis, and may require epinephrine, dopamine, theophylline, antihistamine, and corticosteroid therapy. To date, anaphylaxis has not been reported with abciximab therapy.[Ref]

Abciximab can induce the formation of human anti-chimeric antibodies (HACA) and can produce allergic reactions, including anaphylaxis and thrombocytopenia. These antibodies may diminish the potential benefit of readministration of abciximab (not recommended by manufacturer). Human anti-chimeric antibodies to abciximab may appear at approximately 14 days after initiating therapy and peak at 4 to 6 weeks.[Ref]

Cardiovascular

Cardiovascular side effects have included hypotension in 14% of patients (often related to hemorrhagic complications) and bradycardia in 5% of patients. Chest pain has been reported in 11% of patients and peripheral edema has been reported in 2% of patients. The following cardiovascular side effects have occurred at incidences less than 0.5% higher for patients who received abciximab than for patients who received placebo: ventricular tachycardia (1.4%), pseudoaneurysm (0.8%) , palpitation (0.5%), arteriovenous fistula (0.4%), incomplete AV block (0.3%), nodal arrhythmia (0.2%), peripheral coldness (0.2%), complete AV block (0.1%), embolism (limb) (0.1%), and thromboembolism (0.1%).

Analysis of one study (TARGET trial) indicates that patients with renal dysfunction undergoing PCI and receiving a GP IIb/IIIa inhibitor (i.e., tirofiban, abciximab) are at a higher risk of developing ischemic complications (30-day death, myocardial infarction,urgent revascularization) than patients with normal creatinine clearance.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting in 14% and 7% of patients, respectively and abdominal pain in 3% of patients. The following GI system side effects have occurred at incidences less than 0.5% higher for patients who received abciximab than for patients who received placebo: dyspepsia (2.1%), diarrhea (1.1%), ileus or gastroesophageal reflux or enlarged abdomen or dry mouth (0.1%).[Ref]

Nervous system

Nervous system side effects are unusual, but have included headache in 6.4%, hyperesthesia or increased sweating in 1% and confusion in 0.6% of patients. The following nervous system side effects have occurred at incidences less than 0.5% higher for patients who received abciximab than for patients who received placebo: abnormal vision (0.3%), dizziness (2.9%), anxiety (1.7%), abnormal thinking (1.3%), agitation (0.7%), hypesthesia (0.6%), confusion (0.5%), muscle contractions (0.4%), coma (0.2%), hypertonia (0.2%), and diplopia (0.1%).[Ref]

Respiratory

Respiratory side effects have rarely included pulmonary hemorrhage (0.19%), with fatalities reported in 6 cases. All patients presented with acute myocardial infarction and abnormal chest X-ray at baseline. Five patients presented with a history of COPD. The following respiratory side effects have occurred at incidences less than 0.5% higher for patients who received abciximab than for patients who received placebo: pneumonia or rales (0.4%), pleural effusions or bronchitis or bronchospasm (0.3%), pleurisy or pulmonary embolism (0.2%), and rhonchi (0.1%).[Ref]

Musculoskeletal

Musculoskeletal pain, primarily back pain, has been reported in up to 18% of patients. Asthenia has been report in 0.7% and myalgias in less than 0.2% of patients.[Ref]

Genitourinary

Genitourinary side effects that have occurred at incidences less than 1% higher for patients who received abciximab than for patients who received placebo include: urinary retention (0.7%), dysuria or abnormal renal function (0.4%), frequent micturition or cystalgia or urinary incontinence or prostatitis (0.1%).[Ref]

Dermatologic

Dermatologic side effects that have occurred at incidences equal to or less than 0.5% in patients who received abciximab include: pruritus (0.5%), wound or cellulitis (0.2%), injection site pain or bullous eruption or inflammation or pallor (0.1%). These side effects occurred at an equal or greater frequency in patients receiving a placebo.[Ref]

Endocrine

Endocrine side effects are unusual and have included diabetes mellitus and hyperkalemia (0.1%).[Ref]

Local

Pain at the puncture site or incision pain has occurred in 3.6% and 0.6% of patients, respectively.[Ref]

Other

Drug toxicity has occurred in 0.1% of patients receiving abciximab.[Ref]

Immunologic

Abciximab can induce the formation of human anti-chimeric antibodies (HACA). Most patients develop IgG rather than IgE immune globulins (associated with anaphylaxis) that do not appear to interfere with abciximab binding to GP IIb/IIIa receptors. Human anti-chimeric antibodies to abciximab may appear at approximately 14 days after initiating therapy and peak at 4 to 6 weeks.[Ref]

Readministration of abciximab to 29 healthy volunteers who did not develop a human anti-chimeric antibody (HACA) response following the initial dose did not alter the pharmacokinetic disposition of abciximab or reduce its antiplatelet activity. However, results in this group indicate that the incidence of HACA formation may be increased after readministration. The clinical significance of a positive HACA titer remains to be determined.[Ref]

Some side effects of abciximab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Abciximab Breastfeeding Warnings

There are no data on the excretion of abciximab into human milk. The manufacturer recommends that caution be used when administering abciximab to nursing women.

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