Bivalirudin (Angiomax)_Dosage, benefits & legal status
Also known as Angiomax, Angiomax RTU, Angiox, Hirulog, Hirulog-1
A short-acting synthetic anticoagulant that grips thrombin at two sites. FDA-approved since 2000; it wears off within about an hour.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Bivalirudin (Angiomax)?
Plain language first. The technical label stays, but it never stands alone.Overview
During angioplasty and stenting, blood must not clot on the wires and stents. Bivalirudin is given as a bolus then a drip, works at once and fades within about an hour of stopping. Compared with heparin it usually caused less bleeding, but large trials disagree on whether it saves lives, and early stent clotting was more common after heart-attack procedures in older trials. It is also used in people who cannot have heparin because of heparin-induced thrombocytopenia.
Bivalirudin is a linear 20-residue peptide: a D-Phe-Pro-Arg-Pro head that enters the active site of thrombin, a four-glycine linker, and a 12-residue tail modelled on the C-terminal region (residues 53 to 64) of hirudin, the leech anticoagulant, that grips thrombin's exosite I. It inhibits free and clot-bound thrombin (Ki 2.3 nanomolar) without needing antithrombin, and thrombin slowly cuts its Arg3-Pro4 bond, so the block is temporary. Biogen designed it as Hirulog-1; The Medicines Company developed it, and Sandoz has held the US application since 2018.
What it's used for
A hospital-only intravenous anticoagulant for angioplasty and stenting, including in people with heparin-induced thrombocytopenia.
How does Bivalirudin (Angiomax) work?
What it does in the body, and where.Bivalirudin blocks thrombin, the enzyme at the end of the clotting cascade, by clamping it at two places.
- 01Two gripsIts D-Phe-Pro-Arg-Pro head enters thrombin's active site, and its hirudin-derived tail binds exosite I, the groove thrombin uses to recognise fibrinogen. A four-glycine linker joins them.
- 02No helper neededUnlike heparin, it needs no antithrombin and reaches thrombin already bound in clots. It is approved for people with heparin-induced thrombocytopenia, who cannot have heparin.
- 03Built to let goThrombin slowly cuts the Arg3-Pro4 bond, freeing its active site, and the half-life is 25 minutes, so the effect fades within about an hour. That quick fade is the likely reason stent clotting rose when infusions stopped right after heart-attack procedures; in BRIGHT-4, where a high-dose infusion was continued for 2 to 4 hours, stent clotting was lower than with heparin (0.37% against 1.10%).
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
ACUITY
peer-reviewed-human- Human trial13,819 patients: bivalirudin alone matched heparin plus a IIb/IIIa blocker on ischaemic events and cut major bleeding from 5.7% to 3.0%.
HORIZONS-AMI
peer-reviewed-human- Human trial3,602 heart-attack patients: net adverse events 9.2% against 12.1%, and deaths 2.1% against 3.1%.
- No dataAcute stent thrombosis within 24 hours was more common with bivalirudin, now a label warning.
VALIDATE-SWEDEHEART
peer-reviewed-human- Human trial6,006 heart-attack patients treated mostly through the wrist with modern antiplatelet tablets: no difference in death, heart attack or major bleeding (12.3% against 12.8%).
BRIGHT-4
peer-reviewed-human- Human trial6,016 heart-attack patients with a full-dose infusion continued 2 to 4 hours: death or serious bleeding 3.06% against 4.39%, and stent thrombosis 0.37% against 1.10%.
With streptokinase
tested-and-failed- Human trialHERO-2, 17,073 patients: no change in 30-day deaths (10.8% against 10.9%), though fewer repeat heart attacks.
It is synthetic, not taken from leeches: only residues 9 to 20 echo hirudin. Sandoz, not The Medicines Company, has held the US application since August 2018, and products are labelled 'Bivalirudin' rather than Angiomax; the EU brand Angiox was withdrawn in 2018. The 2000 label's dose (1 mg/kg, then 2.5 mg/kg/h, for unstable-angina angioplasty) is obsolete; today's is 0.75 mg/kg, then 1.75 mg/kg/h. 'Reduces deaths' holds only in some trials (HORIZONS-AMI, BRIGHT-4, and as a secondary result in MATRIX); EUROMAX, VALIDATE-SWEDEHEART and HERO-2 showed no difference, and HEAT-PPCI favoured heparin. GSRS shows position 1 as an unknown residue (X) rather than D-phenylalanine; the label gives the weight as 2,180 Da. The US label covers angioplasty only; heart surgery and ECMO use is off-label in the US.
The published record
Papers and trials about Bivalirudin (Angiomax)
461 papers tagged human · 284 not reviews or lab · 95 clinical trial publications
92 registered trials · 14 with posted results
Furthest stage reached: Approved in the US
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count. 497 papers and 92 trials indexed in detail.
At a glance
Four things to know about Bivalirudin (Angiomax)
Evidence
FDA-approved
Category
Healing and recovery
Common vial
Varies
Half-life
About 25 minutes (3.5 hours on dialysis)
How much, and do you cycle it?
The range, and whether you take breaks.0.75 mg/kg bolus, then 1.75 mg/kg/h during the procedure (label), infusion for the procedure, sometimes up to 4 hours after. One course per procedure FDA label
Given only for the procedure, and up to 4 hours after it in heart-attack cases, then stopped.
How long does it stay in the body?
The half-life, and where the figure comes from.About 25 minutes (3.5 hours on dialysis)FDA label
34 minutes with moderate and 57 minutes with severe kidney impairment. Cleared by enzymes cutting the peptide and by the kidneys; haemodialysis removes about 25%. It binds no plasma protein except thrombin.
Source: Angiomax US prescribing information, section 12.3
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How is it given?
Dosing context and source notes.0.75 mg/kg intravenous bolus, then 1.75 mg/kg per hour for the length of the procedure, with an extra 0.3 mg/kg bolus if clotting time is short 5 minutes after. After a heart-attack procedure the infusion may continue for up to 4 hours. Kidney impairment: no change to the bolus; infusion 1 mg/kg per hour below creatinine clearance 30 mL/min and 0.25 mg/kg per hour on dialysis. Supplied as a 250 mg powder vial, mixed with 5 mL water and then diluted to 5 mg/mL; a separate ready-to-use solution (Angiomax RTU, MAIA) is approved under its own application. Hospital use only; dosed by body weight, so the calculator cannot produce a draw.
How do you store it?
Before mixing, and after.Given in hospital or a trial clinic, so the pharmacy stores it.
Bivalirudin (Angiomax) goes into a vein and is prepared by hospital, clinic or trial pharmacy staff, following the product label or the trial protocol. Some products like this are ready-made solutions and others are powders mixed just before use, often with hours rather than weeks of shelf life once prepared. It is not a medicine people store at home.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 40% charged residues, 35% hydrophobic. Water usually sufficient.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- Active major bleeding
- Allergy to bivalirudin or its ingredients
Stop and get help
- Any serious bleeding, including from the access site, in urine or stool, or a sudden severe headache
- Chest pain or new symptoms soon after a stent, a possible stent thrombosis
Common effects
- Major bleeding 3.7% against 9.3% with heparin in the original angioplasty trial (BAT)
- Major bleeding 3.0% against 5.7% with heparin plus a IIb/IIIa blocker in ACUITY, and 4.9% against 8.3% in HORIZONS-AMI
- Acute stent thrombosis after primary angioplasty for heart attack: 1.2% against 0.2% with heparin
- Antibodies in 2 of 494 patients, with no allergic reactions
- Clots, some fatal, have formed during gamma brachytherapy of the arteries (a label warning)
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Bivalirudin (Angiomax) approved?
And where the numbers on this page come from.Yes. Bivalirudin (Angiomax) is FDA approved and available on prescription in the United States. It is also approved in Canada.
- Approval statusFDA-approved
- RouteInto a vein (bolus, then infusion)
- Checked15 October 2026
- Approved outside the USCanada: Approved in Canada, including for heart surgery in heparin-induced thrombocytopenia; Sandoz bought the Canadian rights in 2019. The EU brand Angiox, authorised on 20 September 2004, was withdrawn on 21 June 2018, and EU generic status was not confirmed. Also approved in the US.This does not change the United States position above.
- DoseFrom the drug label. The manufacturer tested this range and a regulator reviewed it.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesAngiomax US prescribing information (2019)Drugs@FDA, NDA 020873Original Angiomax label (2000)The Medicines Company, 2018 annual report (10-K)EMA, Angiox EPARFDA GSRS substance record, bivalirudin (UNII TN9BEX005G)Maraganore JM et al., Biochemistry 1990;29:7095-7101Lincoff AM et al., JAMA 2003;289:853-863 (REPLACE-2)Stone GW et al., New England Journal of Medicine 2006;355:2203-2216 (ACUITY)Stone GW et al., New England Journal of Medicine 2008;358:2218-2230 (HORIZONS-AMI)Steg PG et al., New England Journal of Medicine 2013;369:2207-2217 (EUROMAX)Valgimigli M et al., New England Journal of Medicine 2015;373:997-1009 (MATRIX)Erlinge D et al., New England Journal of Medicine 2017 (VALIDATE-SWEDEHEART)Li Y et al., Lancet 2022;400:1847-1857 (BRIGHT-4)ClinicalTrials.gov, HEAT-PPCI posted results (NCT01519518)HERO-2 Trial Investigators, Lancet 2001;358:1855-1863
What has happened recently
FDA-approved on 15 December 2000 (NDA 020873) as Angiomax for angioplasty in unstable angina; the indication widened to all angioplasty in June 2005, based on REPLACE-2, and to heparin-induced thrombocytopenia in November 2005. US generics arrived in July 2015. The Medicines Company sold the US Angiomax rights to Sandoz on 22 August 2018; Sandoz's product is listed on DailyMed simply as 'Bivalirudin', though Drugs@FDA still names it Angiomax. A separate ready-to-use solution, Angiomax RTU, was approved for MAIA Pharmaceuticals on 25 July 2019 under its own application (NDA 211215). The EU authorised it as Angiox on 20 September 2004 and the brand was withdrawn on 21 June 2018 for commercial reasons; generic competition in Europe began in August 2015, but which EU generics remain authorised was not confirmed. Canada also approved it, including for heart surgery in heparin-induced thrombocytopenia.
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What else is like Bivalirudin (Angiomax)?
Others in Healing and recovery, side by side.If you're weighing Bivalirudin (Angiomax), it's worth reading Calcitonin (salmon), Canvuparatide, and Cerluten in the same class.
A short-acting synthetic anticoagulant that grips thrombin at two sites. FDA-approved since 2000; it wears off within about an hour.
- Dose
- 0.75 mg/kg bolus, then 1.75 mg/kg/h during the procedure (label)
- How often
- Infusion for the procedure, sometimes up to 4 hours after
A bone hormone borrowed from salmon, and the weakest option in its own category.
- Dose
- Set by the label
- How often
- Daily, by spray or injection
Parathyroid hormone fitted with fatty tails and a self-releasing cap so one injection lasts a week. Phase 3 started in August 2026.
- Dose
- 400 to 1,600 mcg once weekly (phase 3 range; 600 mcg for the first 4 weeks)
- How often
- Once weekly
A bioregulator for brain and nerve support, with thin evidence.
- Dose
- Varies (course-based)
- How often
- Courses
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
Sources
- Angiomax US prescribing information (2019)(2019)Current dose and kidney adjustments; half-life 25 minutes (3.5 hours on dialysis); stent thrombosis 1.2% against 0.2%; BAT and AT-BAT data.
- Drugs@FDA, NDA 020873(2026)Approved 15 December 2000; Sandoz is the sponsor; PCI and HIT supplements in 2005.
- Original Angiomax label (2000)(2000)Original unstable-angina angioplasty indication and dose, now obsolete; BAT bleeding 3.7% against 9.3%.
- The Medicines Company, 2018 annual report (10-K)(2019)US Angiomax rights sold to Sandoz on 22 August 2018; Canadian rights in 2019; generic entry in 2015.
- EMA, Angiox EPAR(2018)EU authorisation 20 September 2004; withdrawn 21 June 2018.
- FDA GSRS substance record, bivalirudin (UNII TN9BEX005G)(2026)CAS 128270-60-0; sequence shown with X at position 1 in place of D-phenylalanine.
- Maraganore JM et al., Biochemistry 1990;29:7095-7101(1990)Hirulog-1 design; Ki 2.3 nM for thrombin; no inhibition of factor Xa, plasmin or trypsin.
- Lincoff AM et al., JAMA 2003;289:853-863 (REPLACE-2)(2003)6,010 patients: non-inferior to heparin plus a IIb/IIIa blocker; major bleeding 2.4% against 4.1%.
- Stone GW et al., New England Journal of Medicine 2006;355:2203-2216 (ACUITY)(2006)13,819 patients: ischaemic events 7.8% against 7.3%; major bleeding 3.0% against 5.7%.
- Stone GW et al., New England Journal of Medicine 2008;358:2218-2230 (HORIZONS-AMI)(2008)3,602 heart-attack patients: net adverse events 9.2% against 12.1%; fewer deaths; more early stent thrombosis.
- Steg PG et al., New England Journal of Medicine 2013;369:2207-2217 (EUROMAX)(2013)2,218 patients given it in the ambulance: death or major bleeding 5.1% against 8.5%; stent thrombosis 1.1% against 0.2%.
- Valgimigli M et al., New England Journal of Medicine 2015;373:997-1009 (MATRIX)(2015)7,213 patients: no difference in the main endpoints (10.3% against 10.9%).
- Erlinge D et al., New England Journal of Medicine 2017 (VALIDATE-SWEDEHEART)(2017)6,006 heart-attack patients with modern care: death, heart attack or major bleeding 12.3% against 12.8%.
- Li Y et al., Lancet 2022;400:1847-1857 (BRIGHT-4)(2022)6,016 Chinese heart-attack patients with a 2 to 4 hour post-procedure infusion: death or serious bleeding 3.06% against 4.39%; less stent thrombosis.
- ClinicalTrials.gov, HEAT-PPCI posted results (NCT01519518)(2015)1,829 patients: major adverse events 8.7% against 5.7%, favouring heparin.
- HERO-2 Trial Investigators, Lancet 2001;358:1855-1863(2001)17,073 patients given streptokinase: 30-day deaths 10.8% against 10.9%.
Beyond these, 589 records are indexed. Browse the records