REOPRO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for REOPRO (REOPRO).
Reopro (abciximab) is a chimeric monoclonal antibody Fab fragment that binds to the glycoprotein IIb/IIIa receptor on activated platelets, thereby inhibiting platelet aggregation by blocking the binding of fibrinogen and von Willebrand factor.
| Metabolism | Reopro is not metabolized; it is cleared by the reticuloendothelial system and proteolysis. No significant renal or hepatic metabolism. |
| Excretion | Renal (primarily via proteolytic degradation into small peptides and individual amino acids); <5% excreted unchanged in urine. Fecal elimination negligible. |
| Half-life | Terminal half-life approximately 30 minutes (initial phase) with a second phase of about 4 hours due to slow dissociation from platelet glycoprotein IIb/IIIa receptors; clinical effect persists for platelet inhibition up to 24-48 hours after infusion cessation. |
| Protein binding | <5% bound to plasma proteins; primarily unbound in circulation. |
| Volume of Distribution | Approximately 0.06 L/kg (small volume, consistent with distribution primarily in plasma and extracellular fluid). |
| Bioavailability | Only administered intravenously; bioavailability 100% by IV route. |
| Onset of Action | Intravenous bolus: immediate inhibition of platelet aggregation within minutes; continuous infusion maintains effect. |
| Duration of Action | Platelet function returns to normal within 48 hours after discontinuation; clinical hemostasis may be prolonged for up to 24 hours. |
| Action Class | Glycoprotein IIb/IIIa inhibitors |
| Brand Substitutes | Abcixirel 10mg Injection, Faximab 10mg Injection |
0.25 mg/kg intravenous bolus over 5 minutes, followed by 0.125 mcg/kg/min (maximum 10 mcg/min) continuous intravenous infusion for 12 hours.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment required; abciximab is not renally eliminated. Use caution if severe renal impairment, but no formal guidelines. |
| Liver impairment | No specific dose adjustment required; abciximab is not hepatically metabolized. Use caution in severe hepatic impairment, but no formal guidelines. |
| Pediatric use | Safety and efficacy not established in pediatric patients; no standard dosing recommendations. |
| Geriatric use | Higher risk of bleeding, particularly in patients >65 years; consider weight-based dosing, but no routine dose adjustment. Monitor for bleeding complications. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for REOPRO (REOPRO).
| Breastfeeding | It is not known whether abciximab is excreted in human milk. M/P ratio: not determined. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants (e.g., bleeding), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. |
| Teratogenic Risk | Abciximab (ReoPro) is a Fab fragment of a chimeric monoclonal antibody that inhibits platelet aggregation. No adequate and well-controlled studies in pregnant women. In animal studies, abciximab administered IV during organogenesis in rabbits at doses up to 5 mg/kg (about 0.7 times the human daily dose based on mg/kg) showed no evidence of fetal harm. However, due to the potential for placental transfer and bleeding risk, use during pregnancy only if clearly needed. First trimester: limited data, theoretical risk of bleeding. Second/third trimester: may increase maternal bleeding risk during delivery; use only if potential benefit justifies potential risk to fetus. |
■ FDA Black Box Warning
Bleeding: Reopro increases the risk of bleeding, particularly at the site of arterial access during PCI. Use with caution in patients with recent surgery, trauma, or other conditions associated with bleeding risk. Avoid concomitant use with other anticoagulants or thrombolytics unless necessary.
| Serious Effects |
["Active internal bleeding","Recent gastrointestinal or genitourinary bleeding (within 6 weeks)","History of stroke within 2 years","Major surgery or trauma within 6 weeks","Intracranial neoplasm, arteriovenous malformation, or aneurysm","Severe uncontrolled hypertension","Thrombocytopenia (< 100,000 cells/μL)","Use of dextran before PCI or intent to use dextran during PCI","Known hypersensitivity to abciximab or any component"]
| Precautions | ["Increased risk of bleeding, especially at arterial puncture sites","Thrombocytopenia: monitor platelet counts before and during therapy","Hypersensitivity reactions (including anaphylaxis)"] |
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| Fetal Monitoring | Monitor prothrombin time, activated clotting time, platelet count, hemoglobin/hematocrit, and signs of bleeding. During pregnancy, additional monitoring for fetal well-being (e.g., fetal heart rate monitoring) if used near delivery. Assess for placental abruption or other hemorrhagic complications. |
| Fertility Effects | No human data on fertility effects. In animal studies, no significant impairment of fertility in male or female rats at doses up to 5 mg/kg (about 0.7 times human daily dose). However, given its antiplatelet activity, potential effects on implantation bleeding or reproductive outcomes cannot be excluded. |