Bivalirudin: uses, dosing, side effects & brands
Bivalirudin is an anti-coagulant sold in the U.S. under 3 brand and generic names, for unstable angina. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Anti-Coagulant
- Treats (across its forms)
- Unstable Angina
- Available as
- Injectable · Powder · Solution
- Sold as
- 3 products — Bivalirudin, Angiomax and Angiomax Rtu
- Prescription?
- Prescription only
- Generic available?
- Yes
How bivalirudin is dosed
From the FDA label for Bivalirudin (application ANDA205962). Other bivalirudin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The recommended dosage is a 0.75 mg/kg intravenous bolus dose followed immediately by a 1.75 mg/kg/h intravenous infusion for the duration of the procedure. Five minutes after the bolus dose has been administered, an activated clotting time (ACT) should be performed and an additional bolus dose of 0.3 mg/kg should be given if needed. Extending duration of infusion post-procedure up to 4 hours should be considered in patients with ST segment elevation MI (STEMI). ( 2.1 ) 2.1 Recommended Dosage Bivalirudin for injection has been studied only in patients receiving concomitant aspirin. The recommended dose of bivalirudin for injection is an intravenous bolus dose of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h for the duration of the procedure. Five minutes after the bolus dose has been administered, an activated clotting time (ACT) should be performed and an additional bolus of 0.3 mg/kg should be given if needed. Extended duration of infusion following PCI at 1.75 mg/kg/h for up to 4 hours post-procedure should be considered in patients with ST segment elevation MI (STEMI). 2.2 Dose Adjustment in Renal Impairment Bolus Dose No reduction in the bolus dose is needed for any degree of renal impairment. Maintenance Infusion In patients with creatinine clearance less than 30 mL/min (by Cockcroft Gault equation), reduce the infusion rate to 1 mg/kg/h. Monitor…
Bivalirudin side effects
Most common adverse reaction (>2%) was bleeding. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the BAT trials, 79 of the 2161 (3.7%) patients undergoing PCI for treatment of unstable angina and randomized to bivalirudin experienced major bleeding events which consisted of: intracranial bleeding, retroperitoneal bleeding, and clinically overt bleeding with a decrease in hemoglobin >3 g/dL or leading to a transfusion of >2 units of blood. 6.2 Immunogenicity As with all peptides, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to bivalirudin in the studies described below with the…
Who shouldn’t take bivalirudin
Bivalirudin for injection is contraindicated in patients with: Active major bleeding; Hypersensitivity (e.g., anaphylaxis) to bivalirudin for injection or its components [see Adverse Reactions (6.3) ]. Active major bleeding (4) Hypersensitivity to bivalirudin or its components (4)
Bivalirudin drug interactions
In clinical trials in patients undergoing PCI/ percutaneous transluminal coronary angioplasty (PTCA), co-administration of bivalirudin with heparin, warfarin, thrombolytics, or GPIs was associated with increased risks of major bleeding events compared to patients not receiving these concomitant medications. Heparin, warfarin, thrombolytics, or GPIs: Increased major bleeding risk with concomitant use. (7)
Every bivalirudin product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Injectable | No data | — | View → | |
| 2 | 68/100 | Prescription | Injectable | No data | — | View → | |
| 3 | Not yet rated | Prescription | Injectable | No data | — | View → |
Bivalirudin and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for bivalirudin: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the use of bivalirudin during breastfeeding. Because the drug is absorbed orally, an alternate drug is preferred.
National Institute of Child Health and Human Development, record revised July 15, 2023. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about bivalirudin
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,120 reports naming bivalirudin, and the FDA flagged 91% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- haemorrhage94 reports
- heparin-induced thrombocytopenia78 reports
- thrombosis52 reports
- gastrointestinal haemorrhage50 reports
- thrombosis in device50 reports
- hypotension47 reports
- acute myocardial infarction44 reports
- vascular stent thrombosis42 reports
Read these as a signal, not a rate. A report does not mean bivalirudin caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is bivalirudin?
Bivalirudin is an anti-coagulant used to treat Unstable Angina.
What kind of drug is bivalirudin?
The FDA classifies bivalirudin as an anti-coagulant. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take bivalirudin with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run bivalirudin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is bivalirudin sold under?
We track 3 bivalirudin-containing products in the U.S.: Bivalirudin, Angiomax and Angiomax Rtu. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does bivalirudin come in?
Across the brands we track, bivalirudin is currently marketed as injectable, powder and solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic bivalirudin?
Yes. Our catalog lists 1 generic bivalirudin product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Bivalirudin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/bivalirudin
- MLA
- “Bivalirudin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/bivalirudin.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for bivalirudin on DailyMed (NIH) ↗.