Product Code Database
Apixaban, sold under the brand name Eliquis, is an anticoagulant medication used to treat and prevent blood clots and to prevent stroke in people with nonvalvular atrial fibrillation through directly inhibiting factor Xa. (2025). 9780857113382, Pharmaceutical Press. ISBN 9780857113382 It is used as an alternative to warfarin to prevent blood clots following hip replacement or knee replacement and in those with a history of prior clots and does not require monitoring by blood tests or dietary restrictions. It is taken by mouth.
Common side effects include bleeding and nausea. Other side effects may include spinal hematoma and allergic reactions. Use is not recommended during pregnancy or breastfeeding. Use appears to be relatively safe in those with mild kidney problems. Compared to warfarin it has fewer drug interaction. It is a direct factor Xa inhibitor.
In 2007, Pfizer and Bristol-Myers Squibb began the development of apixaban as an anticoagulant. Apixaban was approved for medical use in the European Union in May 2011, and in the United States in December 2012. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. It is on the World Health Organization's List of Essential Medicines. In 2023, it was the 28th most commonly prescribed medication in the United States, with more than 19million prescriptions. It is available as a generic medication, although not in the United States.
In the EU, apixaban is indicated for the prevention of venous thromboembolic events (VTE) in adults who have undergone elective hip or knee replacement surgery, the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation (NVAF) with one or more risk factors, for the treatment of deep vein thrombosis and pulmonary embolism in adults, and for the prevention of recurrent DVT and PE in adults.
Apixaban and other direct oral anticoagulants (DOACs) (dabigatran, edoxaban and rivaroxaban) are at least as effective as warfarin in preventing stroke or systemic embolism in people with atrial fibrillation not caused by moderate-to-severe mitral stenosis or mechanical heart valves. Compared to warfarin, DOACs are associated with a significantly lower risk of intracranial hemorrhage, with apixaban demonstrating both superior efficacy and safety.
While data are limited for the use of apixaban in people with severely decreased kidney function and those on hemodialysis, studies are investigating its potential as an alternative to standard therapy, vitamin K antagonists. However, optimal dosing in these populations is yet to be determined.
Andexanet alfa is a US Food and Drug Administration (FDA) approved antidote for apixaban in people with uncontrolled and life-threatening bleeding events.
A new drug application (NDA) for the approval of apixaban was submitted to the US Food and Drug Administration (FDA) by Bristol-Myers Squibb (BMS) and Pfizer jointly after the conclusion of the ARISTOTLE clinical trial in 2011. Apixaban was approved for the prevention of stroke in people with atrial fibrillation in December 2012. In March 2014, it was approved for the additional indication of preventing deep vein thrombosis and pulmonary embolism in people who have recently undergone knee or hip replacement. In August 2014, the FDA approved apixaban for the additional indication of the treatment of recurring deep vein thrombosis and pulmonary embolism. During its development the drug was known as BMS-562247-01. By late 2019, sales of the product by BMS accounted for thirty percent of their quarterly revenue.
In July 2022, the Canadian generic drug company, Apotex Inc., obtained approval for marketing of apixaban.
Pfizer reported revenue of for Eliquis in 2023.
Apixaban is one of ten medications covered by price negotiations in the US under the Inflation Reduction Act. The negotiations, conducted by the Centers for Medicare & Medicaid Services, apply to pricing for Medicare recipients. The results of the negotiations were announced in August 2024, and Medicare's negotiated price for a 30-day supply of Eliquis is $231, a 56% decrease from the 2023 list price of $521. The pricing is set to take effect in 2026.
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