Reopro

Name: Reopro

Interactions for ReoPro

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

Advice to Patients

  • Risk of serious bleeding or hemorrhage.1 4 5 9

  • Importance of close laboratory monitoring.1

  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., cardiovascular disease).1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of advising patients of other important precautionary information.1 (See Cautions.)

Commonly used brand name(s)

In the U.S.

  • Reopro

Available Dosage Forms:

  • Solution

Therapeutic Class: Platelet Aggregation Inhibitor

Pharmacologic Class: Glycoprotein IIb/IIIa Inhibitor

What are some other side effects of ReoPro?

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.

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 ReoPro, 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 ReoPro. 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 ReoPro.

Review Date: October 4, 2017

Warnings

Bleeding Events

Abciximab has the potential to increase the risk of bleeding events, rarely including those with a fatal outcome, particularly in the presence of anticoagulation, e.g., from heparin, other anticoagulants, or thrombolytics (see ADVERSE REACTIONS: Bleeding).

The risk of major bleeds due to Abciximab therapy is increased in patients receiving thrombolytics and should be weighed against the anticipated benefits.

Should serious bleeding occur that is not controllable with pressure, the infusion of Abciximab and any concomitant heparin should be stopped.

Allergic Reactions (including anaphylaxis)

Allergic reactions, some of which were anaphylaxis (sometimes fatal), have been reported rarely in patients treated with ReoPro. Patients with allergic reactions should receive appropriate treatment. Treatment of anaphylaxis should include immediate discontinuation of ReoPro administration and initiation of resuscitative measures.

PRINCIPAL DISPLAY PANEL - 10 mg/5 mL Vial Box

NDC 57894-200-01

ABCIXIMAB
ReoPro®

10 mg/5 mL vial

Sterile Solution
No Preservatives

1 VIAL

Rx only

For intravenous use

ReoPro 
abciximab injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:57894-200
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
abciximab (abciximab) abciximab 2 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium phosphate  
sodium chloride  
polysorbate 80  
water  
Packaging
# Item Code Package Description
1 NDC:57894-200-01 1 VIAL, SINGLE-USE in 1 BOX
1 5 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103575 01/03/2017
Labeler - Janssen Biotech, Inc. (099091753)
Establishment
Name Address ID/FEI Operations
Janssen Biologics B.V. 409612918 API MANUFACTURE(57894-200)
Establishment
Name Address ID/FEI Operations
Hospira Inc. 030606222 MANUFACTURE(57894-200)
Revised: 06/2017   Janssen Biotech, Inc.

What is ReoPro?

ReoPro is used to lessen the chance of heart attack in people who need percutaneous coronary intervention (PCI), a procedure to open blocked arteries of the heart.

A heart attack may occur when a blood vessel in the heart is blocked by a blood clot. Blood clots can sometimes form during PCI. ReoPro reduces the chance that a harmful clot will form by preventing certain cells in the blood from clumping together. ReoPro is used with aspirin and heparin, which are other medicines used to keep your blood from clotting.

ReoPro is available only with your doctor's prescription, in the following dosage forms:

    Parenteral
  • Injection (U.S. and Canada)

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.[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 (the active ingredient contained in ReoPro) 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 (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.[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 (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%).[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 (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%).[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 (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%).[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 (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%).[Ref]

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.[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 (the active ingredient contained in ReoPro) [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 (the active ingredient contained in ReoPro) 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 ReoPro may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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