Abciximab

Name: Abciximab

Cautions for Abciximab

Contraindications

  • Bleeding diathesis, active internal bleeding, or recent (within 6 weeks) clinically important GI or genitourinary bleeding.1

  • Severe uncontrolled hypertension.1

  • Recent (within 6 weeks) major surgery or trauma.1

  • History of cerebrovascular accident (CVA) in preceding 2 years or CVA with serious substantial residual neurologic deficit.1

  • Recent (within previous 7 days) oral anticoagulant therapy unless prothrombin time (PT) is ≤1.2 times control value.1

  • Thrombocytopenia (platelet count <100,000/mm3).1

  • Intracranial neoplasm.1

  • Arteriovenous malformation or aneurysm.1

  • Use of IV dextran prior to or during PCI.1

  • Presumed or documented history of vasculitis.1

  • Known hypersensitivity to any ingredient in the formulation or to murine proteins.1 9

Warnings/Precautions

Warnings

Hematologic Effects

Risk of major bleeding (e.g., intracranial hemorrhage, genitourinary or GI bleeding, bleeding at arterial access site) and minor bleeding (e.g., spontaneous gross hematuria, spontaneous hematemesis); may require blood or platelet transfusions.1 2 4 5 (See Bleeding Precautions and see Laboratory Monitoring under Cautions.)

Pulmonary alveolar hemorrhage reported rarely.1

Increased risk of major bleeding observed in patients weighing ≤75 kg;1 4 5 during concomitant thrombolytic therapy;1 when PCI is performed within 12 hours of onset of symptoms of MI;1 following prolonged (>70 minutes) PCI;1 or following failed PCI.1 9

If bleeding cannot be controlled by pressure, discontinue abciximab and concomitant heparin immediately.1

Sensitivity Reactions

Hypersensitivity Reactions

Possible anaphylaxis.1 If anaphylaxis occurs, discontinue abciximab immediately and initiate appropriate treatment; drugs for treatment of hypersensitivity reactions (e.g., epinephrine, dopamine, theophylline, antihistamines, corticosteroids) should be immediately available.1

Formation of human antichimeric antibody (HACA) reported.1 3 8 16 22 23 54 63 65 Possible hypersensitivity reactions (including anaphylaxis), thrombocytopenia, or diminished antithrombotic effect if abciximab is readministered or if monoclonal antibodies are administered in patients with HACA titers.1

General Precautions

Bleeding Precautions

To reduce risk of bleeding, adhere to strict anticoagulation guidelines; use a short course of low-dose, weight-adjusted heparin; avoid vascular and other trauma; carefully manage vascular (e.g., femoral artery) access site; and monitor all potential bleeding sites during and following treatment.1 44 60

Use caution in the placement, maintenance, and removal of vascular access sheath; avoid femoral vein sheath placement.1 When inserting sheath, puncture only anterior wall of femoral artery; avoid Seldinger (through and through) technique.1 Observe appropriate precautions while sheath is in place (e.g., complete bed rest, elevation of head ≤30°, restrain limb in which sheath is inserted, frequent monitoring of vascular access site and distal pulse in the involved limb).1 Following PCI, discontinue heparin immediately; remove arterial sheath within 6 hours following PCI (at least 2 hours after discontinuation of heparin) if aPTT ≤50 seconds or ACT ≤175 seconds.1 Following sheath removal, apply pressure to femoral artery for at least 30 minutes to achieve hemostasis.1 Measure and monitor hematomas for enlargement.1

To avoid vascular and other trauma, minimize arterial or venous punctures, IM injections, cutdown sites, and use of nasotracheal intubation, nasogastric tubes, urinary catheters, and automatic BP cuffs; avoid establishment of IV access at noncompressible sites (e.g., subclavian or jugular veins); consider using an indwelling venipuncture device (e.g., heparin lock) for drawing blood; document and monitor vascular puncture sites; and remove dressings gently and carefully.1

If emergency surgery is needed, discontinue abciximab.1

Thrombocytopenia

Risk of thrombocytopenia.1 Severe thrombocytopenia (platelet count <20,000/mm3)19 46 66 reported more frequently than with tirofiban.1 32 54 67 68

Determine platelet count prior to treatment, at 2–4 hours following initial IV injection, and at 24 hours following initiation of therapy or prior to discharge, whichever occurs first.1 9 Consider possibility of pseudothrombocytopenia or heparin-induced thrombocytopenia (in patients receiving concomitant heparin therapy).1 14 47 54 59 70 Exclude pseudothrombocytopenia caused by an in vitro anticoagulant interaction by sampling blood in tubes containing edetate disodium (EDTA), citrate, or heparin.1 A low platelet count in the presence of EDTA but not in the presence of heparin and/or citrate supports of a diagnosis of pseudothrombocytopenia.1

If true thrombocytopenia is verified, discontinue abciximab and initiate appropriate treatment and monitoring.1 Platelet transfusions may partially restore platelet function.1

Possible increased incidence and severity of thrombocytopenia following readministration.1

Contraindicated in patients with platelet counts <100,000/mm3.1

Laboratory Monitoring

Prior to administration, obtain platelet count, PT, ACT, and aPTT.1

Monitor platelet count during and after treatment.1 (See Thrombocytopenia under Cautions.)

When abciximab is initiated 18–24 hours prior to PCI, maintain aPTT between 60–85 seconds.1 During PCI, maintain ACT ≥200 seconds.1 10 12 16 19 45 46 77 If anticoagulation is continued following PCI, maintain aPTT between 55–75 seconds.1

Monitor aPTT or ACT prior to arterial sheath removal; do not remove sheath unless aPTT ≤50 seconds or ACT is 150–180 seconds (approximately 6 hours after PCI).1

Specific Populations

Pregnancy

Category C.1

Lactation

Not known whether abciximab is distributed into milk.1 Use with caution.1 9

Pediatric Use

Safety and efficacy not established in children <18 years of age.1 9

Geriatric Use

No substantial differences in safety and efficacy in patients 65–74 years of age relative to younger adults.1 Insufficient experience in patients ≥75 years of age to determine whether these patients respond differently than younger adults.1

Common Adverse Effects

Bleeding, back pain, hypotension, nausea, chest pain, vomiting, headache, bradycardia, puncture site pain, abdominal pain, peripheral edema.1

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Abciximab

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IV use

2 mg/mL (10 mg)

ReoPro

Lilly

Pronunciation

(ab SIK si mab)

Brand Names U.S.

  • ReoPro

Drug Interactions

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

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: Administration may result in human antichimeric antibody formation that can cause hypersensitivity reactions (including anaphylaxis [rare], sometimes fatal).

• Bleeding: The most common complication is bleeding, including retroperitoneal, pulmonary, and spontaneous GI and/or GU bleeding; monitor closely for bleeding, especially the arterial access site for the cardiac catheterization. Use with extreme caution in patients with platelet counts <150,000/mm3, 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, use of urinary catheters, nasogastric tubes, and automatic blood pressure cuffs. Increased risk of hemorrhage during or following angioplasty is associated with unsuccessful PCI, PCI procedure >70 minutes duration, or PCI performed within 12 hours of symptom onset for acute myocardial infarction. When attempting IV access, avoid noncompressible sites (eg, subclavian or jugular veins). If serious uncontrolled bleeding or the need for emergency surgery arises, discontinue abciximab.

• Thrombocytopenia: Administration may result in human antichimeric antibody formation that can cause thrombocytopenia, including severe cases; immediately discontinue if thrombocytopenia occurs. Readministration within 30 days or in patients with human antichimeric antibodies (HACA) increases the incidence and severity of thrombocytopenia.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Use with caution in patients >65 years; may have increased risk of bleeding.

• Low weight patients: Use with caution in patients weighing <75 kg; may have increased risk of bleeding.

Other warnings/precautions:

• Diminished efficacy: Administration may result in human antichimeric antibody formation that can cause diminished efficacy upon readministration.

• Sheath removal: Discontinuation of heparin immediately upon completion of the procedure and removal of the sheath within 6 hours is strongly recommended as long as ACT <150 to 180 seconds or aPTT <50 seconds (ACCF/AHA/SCAI [Levine 2011]). Use standard compression techniques after sheath removal. Monitor the site closely afterwards for further bleeding.

• Surgery: Discontinue ≥12 hours prior to coronary artery bypass graft surgery (ACC/AHA [Amsterdam 2014]).

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.

Side Effects of Abciximab

Common side effects of abciximab include bleeding, low blood pressure, and nausea.

This is not a complete list of abciximab side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Warnings

Contraindications

Hypersensitivity

Active major bleeding, thrombocytopenia, history of CVA (within 2 years)

Peptic ulcer disease

Recent surgery of trauma, intracranial neoplasm, uncontrolled HTN, vasculitis

Oral anticoagulant use within 7 days increases bleeding risk

Cautions

Intended for use with aspirin and heparin, and has only been studied in that setting

Increased bleeding risk when used with thrombolytic agents

Monitor for thrombocytopenia

Abciximab Pregnancy Warnings

Abciximab has been assigned to pregnancy category C by the FDA. Animal reproduction studies have not been conducted with abciximab. It is also not known whether abciximab can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Abciximab should only be given during pregnancy when benefit outweighs risk.

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