Technology | Antiplatelet and Anticoagulation Therapies | January 22, 2018

Baxter Announces FDA Approval of Ready-to-Use Cardiovascular Medication Bivalirudin

Approval marks first presentation of bivalirudin in frozen, premixed, ready-to-use formulation

Baxter Announces FDA Approval of Ready-to-Use Cardiovascular Medication Bivalirudin

January 22, 2018 — Baxter International Inc. announced the U.S. Food and Drug Administration (FDA) approval of Bivalirudin in 0.9 percent Sodium Chloride Injection (bivalirudin). Bivalirudin is a specific and direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), a common non-surgical procedure to treat blocked or narrowed blood vessels in the heart.

Bivalirudin will use Baxter's proprietary frozen GALAXY container technology, a non-PVC and non-DEHP system specifically designed to create a ready-to-use format for unstable molecules. Premixed versions of commonly prescribed drugs help simplify the preparation process and can avoid potential errors that may occur when medications are compounded. Compounding is the process of combining different ingredients in specific quantities to fill individualized prescriptions.

Baxter's premixed medications are manufactured to current Good Manufacturing Practice (cGMP) regulations established and monitored by the FDA. Bivalirudin is expected to launch in the United States in early 2018 in two commonly prescribed dosage forms and strengths: 250 mg of bivalirudin per 50 mL (5 mg/mL) and 500 mg of bivalirudin per 100 mL (5 mg/mL).

For more information: www.baxter.com

Related Bivalirudin Content

No Benefit to Prolonging Bivalirudin after PCI

Meta-Analysis Evaluates the Effect of Post-PCI Bivalirudin on Adverse Clinical Events

No Difference in Adverse Events When Comparing Anticoagulants

Bivalirudin, Heparin Achieve Similar Anticoagulation Results in TAVR Patients

Advantages and Disadvantages of Novel Oral Anticoagulants

Questions Remain on DAPT Prolongation

 

Related Content

One-month Clopidogrel Monotherapy After PCI Not Supported in STOPDAPT-2 ACS Trial 
News | Antiplatelet and Anticoagulation Therapies | September 01, 2021
September 1, 2021 — The STOPDAPT-2 ACS trial does not support the use of one month of dual...
The anticoagulant edoxaban (Savaysa) may be just as effective as warfarin for preventing heart attack or stroke in patients with AFib who undergo transcatheter aortic valve replacement (TAVR), according to an ESC late-breaking trial.

The anticoagulant edoxaban (Savaysa) may be just as effective as warfarin for preventing heart attack or stroke in patients with AFib who undergo transcatheter aortic valve replacement (TAVR), according to an ESC late-breaking trial.

News | Antiplatelet and Anticoagulation Therapies | September 01, 2021
September 1, 2021 – The anticoagulant edoxaban (Savaysa) may be just as effective as warfarin for preventing heart at
The ADAPTABLE trial found no significant differences in cardiovascular events or major bleeding in patients with pre-existing cardiovascular disease who were taking 81 milligrams (mg) baby aspirin, versus 325 mg of daily aspirin. Getty Images #ACC #ACC21 #ACC2021

The ADAPTABLE trial found no significant differences in cardiovascular events or major bleeding in patients with pre-existing cardiovascular disease who were taking 81 milligrams (mg) baby aspirin, versus 325 mg of daily aspirin. Getty Images

News | Antiplatelet and Anticoagulation Therapies | May 15, 2021
May 15, 2021 — The ADAPTABLE trial found no significant differences in cardiovascular events or major bleeding in pat
A Chinese registry study found there are higher event rates in patients with shorter dual-antiplatelet therapy (DAPT) after PCI procedures. There has been a lot of movement toward using shorter duration DAPT with newer generation drug-eluting stent technologies, but this study reinforces the need longer DAPT in many patients. The findings were presented as a late-breaking trial at SCAI 2021 today. 

A Chinese registry study found there are higher event rates in patients with shorter dual-antiplatelet therapy (DAPT) after PCI procedures. There has been a lot of movement toward using shorter duration DAPT with newer generation drug-eluting stent technologies, but this study reinforces the need longer DAPT in many patients. The findings were presented as a late-breaking trial at SCAI 2021 today. 

News | Antiplatelet and Anticoagulation Therapies | April 28, 2021
April 28, 2021 — An analysis of the prospective Chinese Fuwai PCI Registry, confirms long-term,...
Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) can potentiate all 3 sides of Virchow’s Triad of coagulopathy, including endothelial dysfunction, blood flow stasis, and hypercoagulability. Angiotensin-converting enzyme-2 (ACE-2)–dependent viral entry and the virus-induced inflammatory response can lead to endothelial dysfunction. Clotting Prevention in COVID-19 Patients, Thrombosis Prevention in COVID-19 Patients, Preventing blood clots in COVID-19 patients

Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) can potentiate all 3 sides of Virchow’s Triad of coagulopathy, including endothelial dysfunction, blood flow stasis and hypercoagulability. Angiotensin-converting enzyme-2 (ACE-2)–dependent viral entry and the virus-induced inflammatory response can lead to endothelial dysfunction. Additional figure included in the JACC article.

Feature | Antiplatelet and Anticoagulation Therapies | March 22, 2021 | By Dave Fornell, Editor
A comprehensive review or more than 80 randomized controlled trials (RCTs) investigating how to best manage optimal a
Tailor PCI trial showed genetic testing may play a role in personalizing antiplatelet therapy after PCI.
News | Antiplatelet and Anticoagulation Therapies | September 02, 2020
September 2, 2020 — An international, first-of-its-kind cardiology trial used personalized genetic testing to reduce