Abciximab

B01A - Antithrombotic agents ATC B01AC13 Antibody approved 1993 Parenteral

JFDA label: Clotinab Vial

Mechanism of Action

Inhibitor of Integrin alpha-IIb/beta-3 — Integrin alpha-IIb/beta-3 inhibitor; Inhibitor of Integrin alpha-V/beta-3 — Integrin alpha-V/beta-3 inhibitor

Target	Action	Gene / class
Integrin alpha-IIb/beta-3 efficacy	INHIBITOR
Integrin alpha-V/beta-3 efficacy	INHIBITOR

Indications

Approved

NSTEMI
Percutaneous coronary intervention
Unstable angina/non-ST-elevation myocardial infarction

Off-label

ST-elevation myocardial infarction (STEMI) undergoing primary PCI

Contraindications

Source: Lexicomp

Hypersensitivity to abciximab, murine proteins, or any component of the formulation Absolute
active internal hemorrhage or recent (within 6 weeks) clinically-significant GI or GU bleeding Absolute
administration of oral anticoagulants within 7 days unless prothrombin time (PT) is ≤1.2 times control PT value Absolute
bleeding diathesis Absolute
history of cerebrovascular accident within 2 years or with significant residual neurological deficit Absolute
thrombocytopenia ( Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Cardiac disorders (4)

Very Common chest pain · Hypotension

Common Bradycardia · peripheral edema

Blood and lymphatic system disorders (3)

Very Common major hemorrhage · Minor hemorrhage

Common Thrombocytopenia: 3; 3

Gastrointestinal disorders (2)

Very Common Nausea

Common Abdominal pain

Musculoskeletal and connective tissue disorders (1)

Very Common Back pain

General disorders and administration site conditions (2)

Very Common Antibody development

Common Pain at injection site

Dosing

Source: Lexicomp

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)

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer's labeling. Hemodialysis: Dialyzable: Unknown, but unlikely (NCS/SCCM [Frontera 2016])

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

Warnings & Precautions

Source: Lexicomp

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

Pregnancy & Lactation

Pregnancy

FDA category C

Animal reproduction studies have not been conducted. 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).

Lactation

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

LactMed: monitor the infant.

Monitoring

Clinical pearl	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, and at 24 hours (or prior to discharge, if before 24 hours). To minimize risk of bleeding: Abciximab initiated 18 to 24 hours prior to 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

Clinical pearl

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, and at 24 hours (or prior to discharge, if before 24 hours). To minimize risk of bleeding: Abciximab initiated 18 to 24 hours prior to 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

Biology & Pharmacokinetics

Pharmacokinetics

Half-life	4.0 h

Drug–drug interactions (100+, DDInter)

Interacting drug	Severity	Management
Acalabrutinib	major
Alteplase	major
Anagrelide	major
Anisindione	major
Anistreplase	major
Apixaban	major
Ardeparin	major
Argatroban	major
Avapritinib	major
Betrixaban	major
Cabozantinib	major
Cangrelor	major
Caplacizumab	major
Clopidogrel	major
Dalteparin	major
Danaparoid	major
Dasatinib	major
Deferasirox	major
Defibrotide	major
Desirudin	major
Dextran (low molecular weight)	major
Dicoumarol	major
Dipyridamole	major
Drotrecogin alfa	major
Edoxaban	major
Enoxaparin	major
Eptifibatide	major
Fondaparinux	major
Heparin	major
Ibritumomab tiuxetan	major
Ibrutinib	major
Inotersen	major
Lepirudin	major
Omacetaxine mepesuccinate	major
Panobinostat	major
Ponatinib	major
Prasugrel	major
Ramucirumab	major
Regorafenib	major
Reteplase	major

Showing 40 of 100+.

Registered Products (1)

Brand	Form / strength	Pack	Agent	Citizen (JOD)
Clotinab Vial	Vial 10 mg/5 ml	one vial	MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN	—