ReoPro Side Effects

Generic Name: abciximab

Note: This document contains side effect information about abciximab. Some of the dosage forms listed on this page may not apply to the brand name ReoPro.

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

For the Consumer

Applies to abciximab: intravenous solution

Along with its needed effects, abciximab (the active ingredient contained in ReoPro) 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:

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 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:

More Common
  • Back pain
Less common
  • 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

For Healthcare Professionals

Applies to abciximab: intravenous solution

Hematologic

There was no significant increase in bleeding between patients who received abciximab (the active ingredient contained in ReoPro) 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.

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.

Hypersensitivity

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 (the active ingredient contained in ReoPro) (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.

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.

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 (the active ingredient contained in ReoPro) 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.

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 (the active ingredient contained in ReoPro) than for patients who received placebo: dyspepsia (2.1%), diarrhea (1.1%), ileus or gastroesophageal reflux or enlarged abdomen or dry mouth (0.1%).

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 (the active ingredient contained in ReoPro) 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%).

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 (the active ingredient contained in ReoPro) 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%).

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.

Genitourinary

Genitourinary side effects that have occurred at incidences less than 1% higher for patients who received abciximab (the active ingredient contained in ReoPro) 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%).

Dermatologic

Dermatologic side effects that have occurred at incidences equal to or less than 0.5% in patients who received abciximab (the active ingredient contained in ReoPro) 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.

Endocrine

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

Local

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

Other

Drug toxicity has occurred in 0.1% of patients receiving abciximab (the active ingredient contained in ReoPro)

Immunologic

Readministration of abciximab (the active ingredient contained in ReoPro) 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.

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.

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