Fibanix

Approved Indications:

• Acute Coronary Syndrome (ACS):
• Unstable angina (UA)
• Non-ST elevation myocardial infarction (NSTEMI)
• In patients undergoing percutaneous coronary intervention (PCI), including balloon angioplasty or stenting, to reduce thrombotic cardiovascular events.

Off-Label (Clinically Accepted) Uses:

• ST-elevation myocardial infarction (STEMI) in selected patients undergoing primary PCI.
• Bridge therapy in patients at high risk of thrombosis during temporary interruption of oral antiplatelets before surgery.
• Peripheral arterial disease with angioplasty in select high-risk cases (under clinical discretion).

Adult Dose (Intravenous use only):

• Initial Bolus (for ACS with PCI):
• 25 mcg/kg IV bolus over 3 minutes.
• Maintenance Infusion:
• 0.15 mcg/kg/min continuous IV infusion for up to 18–24 hours post-procedure.

Alternate Dosing for Medical Management of ACS (without PCI):

• 0.4 mcg/kg/min for 30 minutes followed by 0.1 mcg/kg/min maintenance infusion for up to 108 hours.

Elderly (≥65 years):

• Same dose, but increased monitoring is recommended due to increased bleeding risk.

Renal Impairment (CrCl <60 mL/min):

• Reduce infusion rate by 50%.

Hepatic Impairment:

• Use with caution; data are limited.

Pediatric Use:

• Safety and efficacy not established; not recommended.

Administration Route:

• Intravenous only.
• Administer via dedicated line or Y-site with compatible fluids (e.g., normal saline or D5W).

Tirofiban Hydrochloride is a non-peptide, selective antagonist of the glycoprotein (GP) IIb/IIIa receptor on activated platelets. By reversibly inhibiting this receptor, it blocks the final common pathway for platelet aggregation, preventing fibrinogen binding and cross-linking of platelets. This action effectively reduces thrombus formation in coronary arteries during acute ischemic events, particularly in unstable angina and myocardial infarction.

• Absorption: Not applicable (IV only).
• Distribution: Volume of distribution ~30–40 L.
• Protein Binding: ~65%.
• Onset of Action: Within minutes of bolus administration.
• Peak Effect: 5–10 minutes post-bolus.
• Half-Life: Terminal elimination half-life is approximately 2 hours.
• Metabolism: Minimal hepatic metabolism.
• Elimination: Primarily renal (~66%) as unchanged drug; remainder via feces.
• Clearance: Reduced in renal impairment; dose adjustment necessary.

• Pregnancy Category (FDA): Category B
  (No adequate and well-controlled studies in pregnant women; use only if clearly needed.)
• Lactation:
• Unknown whether Tirofiban is excreted in human milk.
• Due to potential for serious adverse effects in nursing infants, breastfeeding is not recommended during treatment.

• Primary Class: Antiplatelet Agent
• Subclass: Glycoprotein IIb/IIIa Inhibitor

• Known hypersensitivity to Tirofiban or any formulation component.
• Active internal bleeding or history of bleeding diathesis.
• Severe uncontrolled hypertension.
• Major surgery or trauma within the past 4–6 weeks.
• History of hemorrhagic stroke or active intracranial disease.
• Severe renal failure not on dialysis.
• Thrombocytopenia (platelets <90,000/mm³).
• Recent gastrointestinal bleeding or active peptic ulcer disease.

• Bleeding Risk: High; monitor hemoglobin, hematocrit, platelets, and signs of bleeding.
• Thrombocytopenia: Monitor platelets within 2–6 hours after initiation and daily thereafter.
• Use in Renal Impairment: Dose adjustment is essential; accumulation increases bleeding risk.
• Use with Anticoagulants/Other Antiplatelets: Increases bleeding risk; monitor closely.
• Coronary Artery Disease Patients Not Undergoing PCI: May have increased bleeding risk without added benefit.

Common Adverse Effects:

• Hematologic:
• Bleeding (epistaxis, hematuria, gastrointestinal bleeding)
• Thrombocytopenia
• Cardiovascular:
• Bradycardia
• Hypotension
• Gastrointestinal:
• Nausea
• Vomiting

Serious/Rare Adverse Effects:

• Major bleeding (retroperitoneal, intracranial hemorrhage)
• Severe thrombocytopenia (<20,000/mm³)
• Anaphylactic reactions (rare)
• Hypersensitivity reactions (rash, pruritus)

• With Heparin or LMWH: Increased risk of bleeding; requires close coagulation monitoring.
• With ASA, Clopidogrel, or other antiplatelets: Synergistic antiplatelet effect increases bleeding risk.
• Warfarin or Direct Oral Anticoagulants (DOACs): Additive anticoagulant effects.
• Interaction Mechanism: Not significantly metabolized by CYP450 enzymes, but caution advised when used with drugs affecting hemostasis.

• ESC and ACC/AHA Guidelines (recent years):
• GPIIb/IIIa inhibitors like Tirofiban are recommended in high-risk ACS patients undergoing PCI, particularly when there is large thrombus burden.
• De-emphasized in routine pre-treatment of all NSTEMI/UA patients without planned PCI.
• FDA Labeling Update:
• Enhanced safety labeling for dose adjustments in renal impairment.
• Guidance Update:
• Stronger emphasis on platelet monitoring during therapy (esp. first 24 hours).

• Temperature: Store between 2°C to 25°C. Do not freeze.
• Light Sensitivity: Protect from light; keep in original carton.
• Humidity: Keep vial sealed until ready for use.
• Handling:
• Inspect visually for particulate matter or discoloration before use.
• Discard if solution is cloudy or discolored.
• Dilution Stability: Once diluted, use within 24 hours if stored at room temperature.