Clinical beta
FMBM is currently in clinical beta. Content is for professional review/testing and must not replace local protocols, senior clinical judgment, or official prescribing references.
Drug Monograph
Bivalirudin
Parenteral direct thrombin inhibitor
Indication
PCI β’ HIT PCI alternative β’ selected STEMI pathways (institution)
INDICATIONS (CORE USE)
**PCI** anticoagulation (often with GPI/heparin allergy contexts); **renal** clearance β **ACT** monitoring in lab.
ADULT DOSE (STANDARD)
Bolus + infusion **mg/kg/h** β reduce if CrCl <30 per PCI label
MAX DOSE
PCI protocol maximum
Route
IV
PEDIATRIC DOSE
Not standard
Must-not-miss safety points
Major warning
- **Renal failure** prolongs effect β reduce infusion - **Bleeding** at access site and systemic - Stent thrombosis risk if anticoagulation inadequate β protocol-driven
USE IF: PCI when cath lab selects bivalirudin. AVOID IF: Active bleeding, uncontrolled severe hypertension per PCI exclusion criteria.
Primary
STANDARD (ADULT PO)
0.75 mg/kg bolus + 1.75 mg/kg/h infusion β reduce maintenance if CrCl <30
ADULT DOSE
Post-PCI infusion continuation per label (0.25 mg/kg/h) β time-limited.
PEDIATRIC DOSE
N/A
MAX DOSE
Per protocol
Practical Note
ACT monitoring during PCI per lab standard.
Clinical warnings
Adverse effects
Pediatrics
Not standard
Pregnancy
PCI emergency only β specialist
Lactation
See lactation references and product labeling.
Renal impairment
**CrCl <30** β reduce infusion rate; dialysis removes partially β pharmacy **CrCl scaffold (FMBM β titrate to FDA/SFDA label + pharmacy / anticoagulation clinic):** - **CrCl β₯50** β **Argatroban:** hepatic clearance dominant β Child-Pugh adjustment; **Bivalirudin:** renal clearance significant - **CrCl 10β50** β **Bivalirudin** β reduce infusion rate per PCI label; monitor ACT - **CrCl <10** β **Bivalirudin** β further dose reduction / specialist PCI protocol; **Argatroban** if hepatic failure β major dose reduction
Hepatic impairment
Less hepatic than argatroban
Elderly
Renal estimate for dose
IV cath lab only
Clinical Picture
β’ **No bleed:** Supratherapeutic **aPTT** (argatroban) or **ACT** (bivalirudin) β titrate infusion β’ **Minor bleed:** Reduce rate + mechanical hemostasis β’ **Major bleed:** Stop infusion β supportive; **PCC** refractory-only per protocol + **ICU**
Immediate Actions
β’ **No bleed:** Lab-guided rate β/brief stop β retitrate β’ **Minor bleed:** Hold/β rate + local control β’ **Major bleed:** Stop infusion β resuscitation β source control; offset short but **organ failure prolongs**
Antidote
**No specific antidote** β stop drug/supportive care; **major bleed** β institutional reversal pathway; anaphylaxis β **epinephrine** per ACLS
Decontamination
β’ **N/A**
Escalation
β’ **Major:** **ICU** + hematology β’ **HIT β oral overlap:** Follow **institutional INR transition** rules
Common mistakes, resistance logic, and bedside traps
**PCI + ACT** β not aPTT. β **Renal** prolongs effect. β Cath lab drug.
Compare to heparin PCI β know which protocol your STEMI center uses. *Anticoagulation (all agents):* **A/B/C bleed tiers** β no bleed (hold/adjust) vs minor (hold/protocol) vs major (reversal + ICU/heme). **Warfarin:** high INR without bleed **β ** major-bleed pathway; **PCC + IV K** for life-threatening bleed. **Bridging:** warfarin **slow on/off**; **parenteral overlap** when indicated for acute VTE; **no routine bridge** low-risk AF; **DOACβwarfarin** table-specific. **Neuraxial:** explicit **last-dose β procedure** documentation. Never extend therapy without indication review.
Proteolytic cleavage + renal elimination; prolonged in renal failure.
Direct thrombin inhibitor (bivalent).
Saudi Arabia
Angiomax
Global
(placeholder β verify local prefilled syringe / vial)
Common trade names are curated examples only β formulations and availability vary. Verify the exact product name with your local pharmacy and national regulator before prescribing or dispensing.
Saudi Arabia
International