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تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
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Abciximab (United States: Not available): Drug information

Abciximab (United States: Not available): Drug information
(For additional information see "Abciximab (United States: Not available): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • ReoPro [DSC]
Pharmacologic Category
  • Antiplatelet Agent, Glycoprotein IIb/IIIa Inhibitor
Dosing: Adult

Note: Reopro is no longer available in the United States. Initial therapy for acute coronary syndrome includes oral antiplatelet therapy (eg, aspirin plus a P2Y12 inhibitor) and an IV anticoagulant (eg, bivalirudin, heparin). A glycoprotein IIb/IIIa inhibitor is not routinely used due to limited benefit on ischemic outcomes and more bleeding complications; however, use may be considered in high-risk patients (eg, significant thrombus burden) when percutaneous coronary intervention (PCI) is planned (ACC/AHA [Lawton 2022]).

Unstable angina undergoing percutaneous coronary intervention

Unstable angina undergoing percutaneous coronary intervention: IV: 0.25 mg/kg bolus administered at the time of PCI, followed by an infusion of 0.125 mcg/kg/minute (maximum: 10 mcg/minute) continued for up to 12 hours (ACC/AHA [Lawton 2022]).

ST-elevation myocardial infarction or non-ST elevation myocardial infarction undergoing percutaneous coronary intervention

ST-elevation myocardial infarction or non-ST elevation myocardial infarction undergoing percutaneous coronary intervention (off-label use): IV: 0.25 mg/kg bolus administered at the time of PCI, followed by an infusion of 0.125 mcg/kg/minute (maximum: 10 mcg/minute) continued for up to 12 hours (ACC/AHA [Lawton 2022]).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Hemodialysis: Dialyzable: Unknown, but unlikely (NCS/SCCM [Frontera 2016])

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous:

ReoPro: 2 mg/mL (5 mL [DSC]) [contains polysorbate 80]

Generic Equivalent Available: US

No

Product Availability

Reopro is no longer being produced in the US. The last lot expires September 2019.

Administration: Adult

For IV administration. Solution must be filtered using a 0.2 or 5 micron low protein-binding syringe filter during preparation or via a 0.2 to 0.22 micron low protein-binding inline filter during administration. Do not shake 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)

Usual Infusion Concentrations: Adult

IV infusion: 7.2 mg in 250 mL (concentration: 28.8 mcg/mL) or 9 mg in 250 mL (concentration: 36 mcg/mL) of D5W or NS

Use: Labeled Indications

Unstable angina: Prevention of cardiac ischemic complications in patients with unstable angina unresponsive to conventional therapy when percutaneous coronary intervention is scheduled within 24 hours.

Use: Off-Label: Adult

ST-elevation myocardial infarction or non-ST elevation myocardial infarction undergoing percutaneous coronary intervention

Medication Safety Issues
High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs which have a heightened risk of causing significant patient harm when used in error.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. 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%: Abdominal distension, abnormality in thinking, abscess, agitation, allergic reaction (possible), anaphylaxis (possible), anemia, anxiety, arteriovenous fistula, asthenia, bladder pain, bronchitis, bronchospasm, bullous skin disease, cellulitis, cerebrovascular accident, cold extremities, coma, complete atrioventricular block, confusion, diabetes mellitus, diaphoresis, diarrhea, diplopia, dizziness, dyspepsia, dysuria, edema, embolism, gastroesophageal reflux disease, hyperkalemia, hypertonia, hypoesthesia, incisional pain, incomplete atrioventricular block, inflammation, intestinal obstruction, intracranial hemorrhage, leukocytosis, muscle spasm, myalgia, nodal arrhythmia, pain, pallor, palpitations, petechiae, pleural effusion, pleurisy, pneumonia, prostatitis, pruritus, pseudoaneurysm, pulmonary alveolar hemorrhage, pulmonary embolism, rales, renal insufficiency, rhonchi, thrombophlebitis, urinary frequency, urinary incontinence, urinary retention, ventricular tachycardia, visual disturbance, wound, xerostomia

Contraindications

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 residual neurological deficit; bleeding diathesis; administration of oral anticoagulants within 7 days unless prothrombin time (PT) is ≤1.2 times control PT value; thrombocytopenia (<100,000 cells/mcL); recent (within 6 weeks) major surgery or trauma; intracranial tumor, arteriovenous malformation, or aneurysm; severe uncontrolled hypertension; history of vasculitis (presumed or documented); use of dextran before PCI or intent to use dextran during PCI.

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 percutaneous coronary intervention (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: Thrombocytopenia, including severe cases, have been reported. Most severe cases occurred within 24 hours, with some cases occurring up to 2 weeks after administration. Readministration within 30 days or in patients with human antichimeric antibodies at baseline increases the incidence and severity of thrombocytopenia. A history of thrombocytopenia with prior abciximab use increases the risk of recurrence. Monitor platelets at baseline, during, and after treatment and as clinically indicated; immediately discontinue if thrombocytopenia occurs.

Special populations:

• Older adult: Use with caution in patients >65 years of age; 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 <175 seconds or aPTT <50 seconds. 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 [Lawton 2022]).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Abrocitinib: Agents with Antiplatelet Properties may enhance the antiplatelet effect of Abrocitinib. Management: Do not use antiplatelet drugs with abrocitinib during the first 3 months of abrocitinib therapy. The abrocitinib prescribing information lists this combination as contraindicated. This does not apply to low dose aspirin (81 mg/day or less). Risk X: Avoid combination

Acalabrutinib: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the antiplatelet effect of other Agents with Antiplatelet Properties. Risk C: Monitor therapy

Anticoagulants: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Anticoagulants. Risk C: 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. Risk C: Monitor therapy

Bemiparin: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Bemiparin. Management: Avoid concomitant use of bemiparin with antiplatelet agents. If concomitant use is unavoidable, monitor closely for signs and symptoms of bleeding. Risk D: Consider therapy modification

Caplacizumab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Caplacizumab. Specifically, the risk of bleeding may be increased. Management: Avoid coadministration of caplacizumab with antiplatelets if possible. If coadministration is required, monitor closely for signs and symptoms of bleeding. Interrupt use of caplacizumab if clinically significant bleeding occurs. Risk D: Consider therapy modification

Cephalothin: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Cephalothin. Specifically, the risk for bleeding may be increased. Risk C: 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. Risk C: 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. Risk C: Monitor therapy

Dasatinib: May enhance the anticoagulant effect of Agents with Antiplatelet Properties. Risk C: 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. Risk C: Monitor therapy

Dextran: May enhance the anticoagulant effect of Abciximab. Risk X: Avoid combination

Edoxaban: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Edoxaban. Specifically, the risk of bleeding may be increased. Risk C: Monitor therapy

Enoxaparin: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Enoxaparin. Management: Discontinue antiplatelet agents prior to initiating enoxaparin whenever possible. If concomitant administration is unavoidable, monitor closely for signs and symptoms of bleeding. Risk D: Consider therapy modification

Heparin: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Heparin. Management: Decrease the dose of heparin or agents with antiplatelet properties if coadministration is required. Risk D: Consider therapy modification

Herbal Products with Anticoagulant/Antiplatelet Effects (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Bleeding may occur. Risk C: Monitor therapy

Ibritumomab Tiuxetan: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Ibritumomab Tiuxetan. Both agents may contribute to impaired platelet function and an increased risk of bleeding. Risk C: Monitor therapy

Ibrutinib: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Icosapent Ethyl: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Inotersen: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Lecanemab: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Specifically, the risk of hemorrhage may be increased. Risk C: Monitor therapy

Limaprost: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Lipid Emulsion (Fish Oil Based): May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Multivitamins/Fluoride (with ADE): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Multivitamins/Minerals (with AE, No Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: 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. Risk C: Monitor therapy

Omega-3 Fatty Acids: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: 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. Risk C: Monitor therapy

Pentoxifylline: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Prostacyclin Analogues: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: 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. Risk C: Monitor therapy

Salicylates: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Salicylates. Increased risk of bleeding may result. Risk C: Monitor therapy

Selumetinib: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Thrombolytic Agents: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Thrombolytic Agents. Risk C: Monitor therapy

Tipranavir: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Urokinase: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Urokinase. Risk X: Avoid combination

Vitamin E (Systemic): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Zanubrutinib: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Pregnancy Considerations

In vitro studies have shown only small amounts of abciximab to cross the placenta (Miller 2003). Information related to the use of abciximab in pregnancy is limited (Santiago-Diaz 2009; Sebastian 1998).

Breastfeeding Considerations

It is not known if abciximab is present in breast milk. The manufacturer recommends that caution be exercised when administering abciximab to breastfeeding women.

Monitoring Parameters

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 to 4 hours following bolus infusion, at 24 hours (or prior to discharge, if before 24 hours), and as clinically indicated. To minimize risk of bleeding:

Abciximab initiated 18 to 24 hours prior to percutaneous coronary intervention (PCI): Maintain aPTT between 60 to 85 seconds during the heparin/abciximab infusion period

During PCI: Maintain ACT between 200 to 300 seconds

Following PCI (if anticoagulation is maintained): Maintain aPTT between 50 to 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 if femoral access utilized for percutaneous coronary intervention. 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; examine urine, stool, and emesis for presence of occult or frank blood; gentle care should be provided when removing dressings.

Mechanism of Action

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

Pharmacokinetics

Onset: Rapid; platelet aggregation reduced to <20% of baseline at 10 minutes

Duration: Platelet function recovery: 24 to 48 hours (Tcheng 1994; Mascelli 1998); may be up to 72 hours for restoration of normal hemostasis (Schror 2003). Platelet function may remain abnormal for up to 7 days post infusion based on shear-dependent platelet function testing as opposed to platelet aggregometry (Osende 2001).

Distribution: Vd: 0.07 L/kg (Schror 2003)

Protein binding: Mostly bound to GP IIb/IIIa receptors on platelet surface

Metabolism: Unbound abciximab metabolized via proteolytic cleavage (Schror 2003)

Half-life elimination: 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)

Time to peak: Platelet inhibition: ~30 minutes (Mascelli 1998)

Pricing: US

Solution (ReoPro Intravenous)

2 mg/mL (per mL): $323.56

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Clotinab (KR, PY, TH, TR);
  • ReoPro (AR, AT, AU, BB, BE, BG, BR, CH, CL, CO, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HU, IE, IN, IS, IT, KR, LK, LU, MX, NL, NO, NZ, PE, PK, PL, PT, RU, SE, SG, SI, TH, TW, ZA);
  • Reopro (CN, CR, DO, GT, HN, NI, PA, SV)


For country code abbreviations (show table)
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