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Dosing and uses of ReoPro (abciximab)

 

Adult dosage forms and strengths

injectable solution

  • 2mg/mL

 

Adjunct to PCI

Prevention of cardiac ischemic complications in patients undergoing PCI

0.25 mg/kg IV bolus over at least 1 min, 10-60 min before start of PCI, THEn

0.125 mcg/kg/min IV continuous infusion for 12 hr; not to exceed infusion rate of 10 mcg/min

 

Unstable Angina

Indicated for prevention of cardiac complications in patients with unstable angina with PCI planned within 24 hr

0.25 mg/kg IV bolus over at least 1 minute, THEn

0.125 mcg/kg/min IV continiuous infusion for 18-24 hr concluding 1 hour post-PCI; not to exceed 10 mcg/min

Stop continuous infusion of abciximab in patients with failed PCIs

 

Other Indications & Uses

Adjunctive therapy during thrombolysis (off-label)

 

Pediatric dosage forms and strengths

Safety and efficacy not established

 

ReoPro (abciximab) adverse (side) effects

>10%

Bleeding, minor (70-82%)

Bleeding, major (17-21%)

Hypotension (14-21%)

Back pain (17.6%)

Nausea (13.6%)

Chest pain (11.4%)

Vomiting (7-11%)

 

1-10%

Headache (6%)

Thrombocytopenia (2-6%)

Bradycardia (5%)

Injection site pain (3.6%)

Extremity pain (3.5%)

Abdominal pain (3%)

UTI (2%)

Dizziness (1.8%)

Peripheral edema (1.6%)

Anemia (1.2%)

Diarrhea (1%)

Hypoesthesia (1%)

 

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

 

Pregnancy and lactation

Pregnancy category: C

Lactation: not known if excreted in breast milk; use caution

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of ReoPro (abciximab)

Mechanism of action

Chimeric monoclonal antibody; prevents binding of fibrinogen, vWF to glycoprotein IIb/IIIa receptor sites on platelets

 

Pharmacokinetics

Half-life: 30 min

Onset: 10 min (<20% of baseline)

Duration: 72 hr

Metabolism: Through proteolytic cleavage

Platelet binding: Remains bound for 15 days

Peak time: ~30 min (platelet inhibition)

 

Administration

IV Compatibilities

Solution: D5W, Ns

Y-site: adenosine, atropine, bivalirudin, diphenhydramine, fentanyl, metoprolol, midazolam

 

IV Preparation

Do not add any other drugs in same IV line

Bolus injection: withdraw through 0.22 micron filter

Infusion: withdraw 4.5 mL (9 mg) through filter into syringe; inject into 250 mL of NS or D5W; final concentration 35 mcg/mL

Do not shake viaL

 

IV Administration

Bolus over at least 1 min

See adult dosing for infusion rate