Bivalirudin Reig Jofre: Uses, Dosage & Side Effects
Direct thrombin inhibitor for anticoagulation during percutaneous coronary intervention and acute coronary syndrome
Quick facts about Bivalirudin Reig Jofre
Key takeaways about Bivalirudin Reig Jofre
- Hospital-only anticoagulant: Bivalirudin is given exclusively in hospital by intravenous injection and infusion during cardiac procedures – it is not a take-home medication
- Direct thrombin inhibitor: Unlike heparin, bivalirudin directly binds to thrombin and does not require antithrombin III, providing more predictable anticoagulation and lower risk of heparin-induced thrombocytopenia (HIT)
- Short half-life: With a half-life of approximately 25 minutes, bivalirudin’s anticoagulant effect wears off rapidly after the infusion is stopped, allowing better control of bleeding risk
- Used with aspirin and clopidogrel: Bivalirudin must be administered together with aspirin and clopidogrel as part of the standard anticoagulation protocol during PCI
- Renal dose adjustment required: Patients with moderate kidney impairment need a reduced infusion rate; bivalirudin is contraindicated in severe renal impairment (GFR <30 ml/min) and dialysis patients
What Is Bivalirudin Reig Jofre and What Is It Used For?
Bivalirudin Reig Jofre is a direct thrombin inhibitor used as an anticoagulant during percutaneous coronary intervention (PCI) and for the treatment of acute coronary syndrome (ACS). It works by directly binding to thrombin, the key enzyme in the blood clotting cascade, preventing the formation of blood clots during and after cardiac procedures.
Bivalirudin belongs to a class of medications known as direct thrombin inhibitors (DTIs). Thrombin is the central enzyme in the coagulation cascade – it converts fibrinogen to fibrin, activates platelets, and amplifies the coagulation process through positive feedback loops. By directly binding to and inhibiting thrombin, bivalirudin provides potent, predictable anticoagulation that is essential during invasive cardiac procedures where the risk of blood clot formation is high.
The molecule is a synthetic 20-amino acid peptide that is structurally related to hirudin, a natural anticoagulant found in the saliva of medicinal leeches (Hirudo medicinalis). However, unlike hirudin, bivalirudin is a reversible inhibitor of thrombin. It binds to both the catalytic active site and the anion-binding exosite 1 of thrombin. Once bound, thrombin slowly cleaves the bivalirudin peptide at the Arg3-Pro4 bond, which gradually restores the active site function. This built-in “self-cleaving” mechanism gives bivalirudin a predictable and short duration of action, with a half-life of approximately 25 minutes in patients with normal renal function.
An important pharmacological advantage of bivalirudin over heparin is that it inhibits both circulating (free) thrombin and fibrin-bound (clot-bound) thrombin. Unfractionated heparin (UFH) primarily acts on circulating thrombin through antithrombin III and is less effective against clot-bound thrombin. This dual action makes bivalirudin particularly effective during percutaneous coronary intervention, where disrupted atherosclerotic plaques expose tissue factor and generate significant amounts of thrombin directly at the site of vascular injury.
Bivalirudin Reig Jofre is manufactured by Laboratorio Reig Jofre, S.A. (based in Barcelona, Spain) and is approved within the European Economic Area. It is also marketed under the name Bivalirudina Sala in certain European countries. The medicine is supplied as a white to off-white lyophilised powder in glass vials, each containing 250 mg of bivalirudin. It must be reconstituted and diluted before intravenous administration.
Approved indications
Bivalirudin Reig Jofre is indicated for the following clinical situations in adult patients:
- Percutaneous coronary intervention (PCI): As an anticoagulant in patients undergoing PCI, including primary PCI for ST-elevation myocardial infarction (STEMI). PCI is a minimally invasive procedure used to open blocked or narrowed coronary arteries using balloons and stents
- Unstable angina / non-ST-elevation myocardial infarction (UA/NSTEMI): For the treatment of adult patients with acute coronary syndrome who are planned for urgent or early invasive intervention. These patients typically present with chest pain due to reduced blood flow to the heart
In both indications, bivalirudin must be administered together with aspirin (acetylsalicylic acid) and clopidogrel as part of the standard dual antiplatelet therapy protocol.
The landmark HORIZONS-AMI trial (2008) compared bivalirudin monotherapy to unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor in over 3,600 patients with STEMI undergoing primary PCI. Bivalirudin was associated with significantly lower rates of major bleeding (4.9% vs 8.3%) and net adverse clinical events at 30 days and one year. However, there was an early increase in acute stent thrombosis with bivalirudin, particularly within the first 24 hours. Subsequent trials, including EUROMAX and HEAT-PPCI, have refined the evidence base, and current ESC and ACC/AHA guidelines recommend bivalirudin as an acceptable alternative to heparin during PCI, particularly when the risk of bleeding is a primary concern.
What Should You Know Before Using Bivalirudin Reig Jofre?
Before receiving bivalirudin, your medical team must be aware of any bleeding disorders, recent surgery, kidney problems, history of allergic reactions to hirudins, current use of blood-thinning medications, pregnancy or breastfeeding status. Bivalirudin is contraindicated in patients with active bleeding, severe uncontrolled hypertension, severe renal impairment, or infective endocarditis.
Because bivalirudin is administered in a hospital setting by trained healthcare professionals, your medical team will conduct a thorough assessment before treatment. However, it is essential that you inform them of your complete medical history, all medications you are taking, and any allergies you have to ensure that bivalirudin is safe for you.
Contraindications
You must not receive bivalirudin if you have any of the following conditions:
- Hypersensitivity: Known allergy to bivalirudin, any of its excipients, or to hirudins (other thrombin inhibitors derived from leech proteins)
- Active bleeding: Ongoing bleeding from the stomach, intestines, urinary tract or other organs, or increased bleeding risk due to disorders of haemostasis and/or irreversible coagulation disorders (menstrual bleeding is excluded)
- Severe uncontrolled hypertension: Severely elevated blood pressure that is not adequately controlled with medication
- Subacute bacterial endocarditis: Infection of the heart valves, which significantly increases the risk of embolic complications
- Severe renal impairment: Glomerular filtration rate (GFR) below 30 ml/min, including patients requiring dialysis, due to the renal clearance of bivalirudin and the risk of drug accumulation
Warnings and precautions
Inform your medical team before receiving bivalirudin if any of the following apply to you:
- Bleeding occurs during treatment: Your doctor will monitor you closely throughout the procedure and will stop bivalirudin immediately if significant bleeding develops. Because of its short half-life, the anticoagulant effect resolves relatively quickly after discontinuation
- Previous treatment with similar medicines: If you have previously received lepirudin (another hirudin-derived anticoagulant) or other direct thrombin inhibitors, inform your medical team as cross-sensitivity reactions may occur
- Allergic reactions: Hypersensitivity reactions, including anaphylaxis, can occur but are uncommon (affecting 1 to 10 in every 1,000 patients). Your doctor will be prepared to treat any allergic reaction before starting the infusion
- Brachytherapy: If you are receiving radiation therapy (beta or gamma brachytherapy) to a coronary artery, special caution is required as the combination may increase the risk of complications
After receiving bivalirudin following a cardiac event, you must remain in hospital for at least 24 hours and be monitored for signs or symptoms that resemble those you experienced during the cardiac event that led to your hospitalisation.
Clinical trials have identified an increased risk of acute stent thrombosis (blood clot formation within a newly placed coronary stent) within the first 24 hours after bivalirudin treatment, particularly when the infusion is stopped immediately after PCI. To mitigate this risk, current guidelines recommend continuing the high-dose infusion (1.75 mg/kg/hour) for at least 4 hours after the procedure, or transitioning to a lower-dose infusion (0.25 mg/kg/hour) for 4 to 12 hours post-PCI.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, tell your doctor before receiving bivalirudin. There are no adequate clinical studies of bivalirudin in pregnant women. The medicine should not be used during pregnancy unless the treating physician determines that the potential benefit clearly outweighs the potential risk to the foetus. Given the emergency nature of the cardiac procedures for which bivalirudin is indicated, the clinical decision will be made on a case-by-case basis.
It is not known whether bivalirudin or its metabolites are excreted in human breast milk. If you are breastfeeding, your doctor will decide whether to discontinue breastfeeding or to withhold the medication, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.
Children and adolescents
Bivalirudin Reig Jofre is not recommended for use in children and adolescents under 18 years of age. There is insufficient clinical data on the safety and efficacy of bivalirudin in the paediatric population.
Driving and operating machinery
The effect of bivalirudin is short-lived and it is only administered to patients in hospital. It is therefore unlikely that your ability to drive or use machines will be affected after discharge.
Sodium content
Bivalirudin Reig Jofre contains less than 23 mg sodium per vial and can therefore be considered essentially “sodium-free”. This is relevant for patients on a controlled sodium diet.
How Does Bivalirudin Reig Jofre Interact with Other Drugs?
Bivalirudin has clinically significant interactions with all anticoagulants and antiplatelet agents, including warfarin, heparin, direct oral anticoagulants (DOACs), aspirin, clopidogrel, prasugrel and ticagrelor. These combinations increase bleeding risk. Additionally, certain IV medications are physically incompatible and must not be mixed with bivalirudin in the same infusion line.
Tell your medical team about all medicines you are currently taking, have recently taken, or might take – including prescription medicines, over-the-counter medicines and herbal products. Because bivalirudin is a potent anticoagulant, combining it with other blood-thinning or antiplatelet medications significantly increases the risk of bleeding.
Major interactions
The following drug interactions are considered clinically significant and may require dose adjustment, additional monitoring, or careful timing of administration:
| Drug / Class | Interaction | Clinical Significance | Recommendation |
|---|---|---|---|
| Warfarin | Additive anticoagulant effect; bivalirudin may falsely elevate INR test results | Significantly increased bleeding risk and unreliable INR monitoring | Avoid concurrent use; monitor INR carefully during transition |
| Heparin (UFH, LMWH) | Additive anticoagulant effect through different mechanisms | Major increase in bleeding risk | Discontinue heparin before starting bivalirudin; do not co-administer |
| Direct oral anticoagulants (dabigatran, rivaroxaban, apixaban) | Additive anticoagulation through complementary pathways | Significantly increased bleeding risk | Avoid combination; consider timing of last DOAC dose before procedure |
| Aspirin & Clopidogrel | Increased antiplatelet and anticoagulant effect (intended therapeutic combination) | Increased bleeding risk, but required per protocol | Use together as indicated; monitor for signs of bleeding |
| Prasugrel, Ticagrelor | More potent platelet inhibition than clopidogrel combined with anticoagulation | Higher bleeding risk compared to clopidogrel combination | Use with caution; close monitoring for bleeding required |
| Thrombolytics (alteplase, streptokinase, reteplase) | Additive effects on clot dissolution and anticoagulation | Major increase in bleeding risk | Avoid concurrent use; also physically incompatible in same IV line |
Physical incompatibilities
Bivalirudin must not be mixed in the same intravenous line with the following medications, as they cause cloudiness, microparticle formation, or heavy precipitation:
- Alteplase, reteplase and streptokinase (thrombolytics)
- Amiodarone hydrochloride (antiarrhythmic)
- Amphotericin B (antifungal)
- Chlorpromazine hydrochloride (antipsychotic)
- Diazepam (benzodiazepine)
- Prochlorperazine edisylate (antiemetic)
- Vancomycin hydrochloride (antibiotic)
Additionally, the following medicines are incompatible with bivalirudin at higher concentrations: dobutamine hydrochloride, famotidine, haloperidol lactate, labetalol hydrochloride, lorazepam and promethazine hydrochloride. If these medications are needed, they must be administered through a separate intravenous line.
Effect on laboratory tests
Bivalirudin prolongs the activated partial thromboplastin time (aPTT), activated clotting time (ACT), thrombin time (TT) and prothrombin time (PT/INR). This is an expected pharmacological effect and is used to confirm that the patient is receiving adequate anticoagulation. However, the effect on INR may lead to falsely elevated results in patients who are also receiving warfarin, potentially complicating the transition between anticoagulants.
What Is the Correct Dosage of Bivalirudin Reig Jofre?
Bivalirudin dosing is weight-based and depends on the clinical indication. For PCI, the standard dose is a 0.75 mg/kg IV bolus followed by an infusion of 1.75 mg/kg/hour. For ACS managed medically, a lower dose of 0.1 mg/kg bolus and 0.25 mg/kg/hour infusion is used. All doses are determined and administered by your medical team.
Bivalirudin Reig Jofre is always prepared and administered by trained healthcare professionals in a hospital cardiac catheterisation laboratory or intensive care setting. You will not need to calculate or manage the dosing yourself. The dose is based on your body weight and the specific clinical scenario. Your doctor will determine the appropriate regimen and monitor your response using clotting tests such as the activated clotting time (ACT).
Patients undergoing PCI (including primary PCI for STEMI)
Standard PCI dosing
- Bolus dose: 0.75 mg/kg body weight, given as a rapid intravenous injection immediately before the procedure
- Maintenance infusion: 1.75 mg/kg/hour as a continuous intravenous infusion for the duration of the PCI procedure (minimum)
- Post-procedure: The infusion at 1.75 mg/kg/hour may continue for up to 4 hours after PCI when clinically indicated. It may then be followed by a reduced infusion of 0.25 mg/kg/hour for an additional 4 to 12 hours if clinically warranted
Patients with acute coronary syndrome (UA/NSTEMI)
ACS initial medical management
- Bolus dose: 0.1 mg/kg body weight as an intravenous injection
- Maintenance infusion: 0.25 mg/kg/hour as a continuous intravenous infusion, which may continue for up to 72 hours during medical management
ACS patients proceeding to PCI
- Additional bolus: An extra 0.5 mg/kg bolus is administered before the PCI procedure
- Infusion increase: The infusion rate is increased from 0.25 mg/kg/hour to 1.75 mg/kg/hour for the duration of the procedure
- Post-PCI: The infusion may continue at 1.75 mg/kg/hour for up to 4 hours, then optionally reduced to 0.25 mg/kg/hour for 4 to 12 hours
ACS patients proceeding to CABG surgery
- Off-pump CABG: Continue bivalirudin infusion until surgery. Immediately before the operation, administer a 0.5 mg/kg bolus followed by a 1.75 mg/kg/hour infusion throughout the operation
- On-pump CABG: Continue bivalirudin infusion until 1 hour before surgery. Then discontinue bivalirudin and switch to unfractionated heparin (UFH) for the procedure
Dose adjustments for renal impairment
| Renal Function | GFR (ml/min) | Bolus Dose | Infusion Rate (PCI) | Infusion Rate (ACS) |
|---|---|---|---|---|
| Normal / Mild impairment | ≥60 | No adjustment | 1.75 mg/kg/hour | 0.25 mg/kg/hour |
| Moderate impairment | 30–59 | No adjustment | 1.4 mg/kg/hour (reduced) | 0.25 mg/kg/hour (no change) |
| Severe impairment / Dialysis | <30 | Contraindicated – bivalirudin must not be used | ||
Hepatic impairment
No dose adjustment is required for patients with liver impairment. Bivalirudin is primarily cleared by proteolytic cleavage and renal excretion, with the liver playing a minimal role in its elimination.
Elderly patients
No specific dose adjustment is needed based on age alone. However, because renal function often declines with age, elderly patients should have their kidney function assessed and may require the reduced infusion rate if moderate renal impairment is present.
Overdose
If an overdose of bivalirudin occurs, the infusion will be stopped immediately. There is no specific antidote for bivalirudin. However, because of its short half-life (approximately 25 minutes), the anticoagulant effect will diminish rapidly after discontinuation. Your medical team will monitor you closely for signs of bleeding and provide supportive treatment as needed. Bivalirudin is haemodialysable, meaning it can be removed by dialysis in severe cases.
What Are the Side Effects of Bivalirudin Reig Jofre?
Like all medicines, bivalirudin can cause side effects, although not everybody gets them. The most common side effect is minor bleeding, which occurs in more than 1 in 10 patients. Major bleeding, anaemia and bruising at the injection site are common. Allergic reactions and blood clot formation (stent thrombosis) are uncommon but potentially serious.
Because bivalirudin is used during invasive cardiac procedures, it can be difficult to distinguish side effects of the drug from complications of the procedure itself. Your medical team will monitor you continuously during and after treatment and will manage any adverse events promptly. If you experience any of the following serious symptoms while still in hospital, inform your doctor or nurse immediately. If you have been discharged and develop concerning symptoms, seek immediate medical attention.
Very Common
Affects more than 1 in 10 patients
- Minor bleeding (at puncture sites, gums, or other minor locations)
Common
Affects up to 1 in 10 patients
- Major bleeding (internal bleeding from the stomach, gastrointestinal tract, groin, lungs, urinary tract, heart, eyes, ears, nose or brain)
- Anaemia (low red blood cell count)
- Haematoma (bruising, particularly at the groin puncture site)
Uncommon
Affects up to 1 in 100 patients
- Thrombocytopenia (low platelet count, which may worsen bleeding)
- Nausea and/or vomiting
- Allergic/hypersensitivity reactions (itching, redness, rash, small bumps on the skin)
- Thrombosis (blood clot formation), including arterial thrombosis and stent thrombosis
- Bleeding at the injection site after PCI (may be painful)
Rare
Affects up to 1 in 1,000 patients
- Increased INR (may affect warfarin monitoring results)
- Angina pectoris (chest pain)
- Bradycardia (slow heart rate)
- Tachycardia (fast heart rate)
- Dyspnoea (shortness of breath)
- Reperfusion injury (slow or no reflow – impaired blood flow in coronary arteries after reopening)
- Catheter thrombosis (blood clot in the catheter)
- Groin surgical complications (arteriovenous fistula, pseudoaneurysm – may require surgical repair)
- Severe anaphylactic reactions (very rare but potentially fatal; may present with throat tightness, facial/lip/tongue swelling, wheezing, difficulty breathing, low blood pressure)
Contact your medical team or go to the nearest emergency department immediately if you experience any of the following after discharge: swelling in the groin or arm, unexplained pain in the groin, arm or back, blood in urine (pink or red), blood in vomit or stool, unusual bruising, sudden severe headache, dizziness, excessive sweating, feeling faint, difficulty breathing, facial swelling, or any symptoms resembling those of your original cardiac event. These may indicate internal bleeding, allergic reaction, or recurrent cardiac ischaemia.
The risk of bleeding is increased when bivalirudin is used in combination with other anticoagulants or antiplatelet agents (see the drug interactions section above). Your medical team will carefully weigh the benefits of combination therapy against the increased bleeding risk.
Reporting side effects
If you experience any side effects, including those not listed above, report them to your doctor, pharmacist or nurse. You can also report side effects directly to your national medicines regulatory authority. Reporting helps to continuously monitor the benefit-risk balance of medicines after they have been authorised.
How Should Bivalirudin Reig Jofre Be Stored?
Bivalirudin Reig Jofre is stored and handled by hospital pharmacy staff. The dry powder has no special storage requirements. Once reconstituted, the concentrate must be refrigerated (2–8°C) and used within 24 hours. The diluted solution must be stored below 25°C and used within 24 hours. It must never be frozen.
Because Bivalirudin Reig Jofre is a hospital-only medication, the responsibility for proper storage lies with the hospital pharmacy and nursing staff. Patients do not need to store this medicine at home. However, the following information is provided for completeness and for healthcare professionals:
- Shelf life: 30 months from the date of manufacture (check the expiry date on the label and carton, marked “EXP”)
- Lyophilised powder (unopened): No special storage conditions are required for the dry powder in the sealed vial
- Reconstituted concentrate: After reconstitution with 5 ml of sterile water for injection, the concentrate (50 mg/ml) is chemically and physically stable for 24 hours at 2–8°C. Must be refrigerated. Must not be frozen
- Diluted solution: After further dilution to a final concentration of 5 mg/ml (with 5% glucose or 0.9% sodium chloride), the solution is chemically and physically stable for 24 hours at up to 25°C. Must not be frozen
- Microbiological considerations: From a microbiological standpoint, the reconstituted and diluted solutions should be used immediately unless reconstitution and dilution have been performed under validated aseptic conditions
The solution should be a clear or slightly opalescent, colourless to slightly yellow liquid. Healthcare professionals will inspect the solution before administration and discard it if it contains particles or is discoloured. Keep this medicine out of the sight and reach of children.
What Does Bivalirudin Reig Jofre Contain?
Each vial of Bivalirudin Reig Jofre contains 250 mg of bivalirudin as the active substance. The other ingredients are mannitol and sodium hydroxide (for pH adjustment). The reconstituted concentrate contains 50 mg/ml bivalirudin, and the final diluted infusion solution contains 5 mg/ml bivalirudin.
Active substance
The active substance is bivalirudin, a synthetic 20-amino acid peptide with the sequence D-Phe-Pro-Arg-Pro-Gly-Gly-Gly-Gly-Asn-Gly-Asp-Phe-Glu-Glu-Ile-Pro-Glu-Glu-Tyr-Leu. Each glass vial contains 250 mg of bivalirudin as a lyophilised (freeze-dried) white to off-white powder.
After reconstitution with 5 ml of sterile water for injection, 1 ml of the concentrate contains 50 mg of bivalirudin. After further dilution (mixing 5 ml of the reconstituted concentrate with additional diluent to a total volume of 50 ml), the final infusion solution contains 5 mg/ml of bivalirudin.
Other ingredients (excipients)
- Mannitol: A sugar alcohol used as a bulking agent for the lyophilised powder, helping to maintain the structural integrity of the cake during freeze-drying and ensuring proper reconstitution
- Sodium hydroxide: Used for pH adjustment to ensure the reconstituted solution is at the appropriate pH for intravenous administration
Reconstitution and dilution
Bivalirudin Reig Jofre must be prepared under aseptic conditions. The powder is reconstituted by adding 5 ml of sterile water for injection to the vial and gently swirling until fully dissolved. The reconstituted concentrate is then further diluted to a total volume of 50 ml using either 5% glucose solution or 0.9% sodium chloride (normal saline) solution, yielding a final concentration of 5 mg/ml for intravenous administration.
Packaging
Bivalirudin Reig Jofre is supplied in glass vials and is available in pack sizes of 2 or 10 vials. Not all pack sizes may be marketed in all countries.
Frequently Asked Questions About Bivalirudin Reig Jofre
Bivalirudin is a direct thrombin inhibitor used as an anticoagulant (blood thinner) during percutaneous coronary intervention (PCI), a procedure to open blocked coronary arteries using balloons and stents. It is also used in patients with acute coronary syndrome (unstable angina or heart attack without ST elevation) who are planned for urgent or early intervention. Bivalirudin prevents blood clots from forming during and shortly after these cardiac procedures and is always given together with aspirin and clopidogrel.
Unlike heparin, which works indirectly by enhancing antithrombin III activity, bivalirudin directly binds to and inhibits thrombin. Key advantages include: more predictable anticoagulation with a linear dose-response, a shorter half-life (about 25 minutes vs hours for heparin), no risk of heparin-induced thrombocytopenia (HIT), effectiveness against both free and clot-bound thrombin, and no reversal by platelet factor 4. Clinical trials have shown bivalirudin is associated with lower bleeding rates during PCI, though with a slightly higher early risk of acute stent thrombosis.
The most common side effect is minor bleeding, affecting more than 1 in 10 patients. This typically occurs at the puncture site (usually the groin or wrist) used for the cardiac catheter. Common side effects (up to 1 in 10 patients) include major bleeding, anaemia and haematoma (bruising). Uncommon effects include nausea, thrombocytopenia, allergic reactions and stent thrombosis. Rare effects include chest pain, abnormal heart rate and breathing difficulty. Your medical team monitors you closely and can manage these complications promptly.
Bivalirudin can be used with caution in patients with mild to moderate kidney impairment, but it is contraindicated in severe renal impairment (GFR below 30 ml/min) and in patients on dialysis. For patients with moderate impairment (GFR 30–59 ml/min) undergoing PCI, the infusion rate is reduced from 1.75 mg/kg/hour to 1.4 mg/kg/hour, while the bolus dose remains unchanged. For the ACS dosing regimen (0.25 mg/kg/hour infusion), no dose adjustment is needed for mild or moderate impairment. Your doctor will check your kidney function before treatment.
Bivalirudin is only used during hospital-based cardiac procedures and is not a long-term medication. For PCI, the infusion continues for the duration of the procedure and can be maintained for up to 4 hours afterwards at the full rate, then optionally at a reduced rate for another 4 to 12 hours. For medically managed ACS, the infusion can continue for up to 72 hours. Because of its very short half-life (about 25 minutes), the anticoagulant effect wears off quickly after the infusion is stopped. Patients remain in hospital for at least 24 hours after treatment for monitoring.
Bivalirudin should not be used during pregnancy unless clearly necessary and the potential benefit justifies the risk. There are no adequate studies in pregnant women. However, given the emergency nature of the cardiac procedures for which bivalirudin is used (heart attack, severe angina), the decision is made on a case-by-case basis by the treating physician. It is also not known whether bivalirudin passes into breast milk, so breastfeeding mothers should discuss the risks and benefits with their doctor.
References & Sources
This article is based on the following international medical guidelines, clinical trials and peer-reviewed sources:
- European Medicines Agency (EMA). Bivalirudin – Summary of Product Characteristics. Available at: www.ema.europa.eu
- Stone GW, Witzenbichler B, Guagliumi G, et al. Bivalirudin during primary PCI in acute myocardial infarction (HORIZONS-AMI). N Engl J Med. 2008;358(21):2218-2230. doi:10.1056/NEJMoa0708191
- Steg PG, van’t Hof A, Hamm CW, et al. Bivalirudin started during emergency transport for primary PCI (EUROMAX). N Engl J Med. 2013;369(23):2207-2217. doi:10.1056/NEJMoa1311096
- Shahzad A, Kemp I, Mars C, et al. Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): an open-label, single centre, randomised controlled trial. Lancet. 2014;384(9957):1849-1858. doi:10.1016/S0140-6736(14)60924-7
- Byrne RA, Rossello X, Coughlan JJ, et al. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023;44(38):3720-3826. doi:10.1093/eurheartj/ehad191
- Lawton JS, Tamis-Holland JE, Bangalore S, et al. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization. J Am Coll Cardiol. 2022;79(2):e21-e129. doi:10.1016/j.jacc.2021.09.006
- Bivens MB, Bhatt DL. Direct thrombin inhibitors in acute coronary syndromes and percutaneous coronary intervention. Expert Opin Drug Saf. 2019;18(6):483-492.
- British National Formulary (BNF). Bivalirudin – drug monograph. Available at: bnf.nice.org.uk
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. Available at: www.who.int
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