BETHESDA, MD 02 January 2013—FDA on December 28 approved apixaban oral tablets to reduce the risk of stroke and systemic embolism in patients with nonvavular atrial fibrillation.
The factor Xa inhibitor will be marketed as Eliquis by Bristol-Myers Squibb. The company expects the product to be widely available by the end of this month.
The labeling (PDF) for apixaban includes a boxed warning about the increased risk of stroke in patients who use the drug and then stop taking it without having an alternative anticoagulant. For patients who discontinue apixaban for any reason other than pathological bleeding, strong consideration should be given to the use of another anticoagulant drug, according to the warning.
The labeling warns that apixaban can cause serious and potentially deadly bleeding. Patients treated with the drug who show signs of blood loss require prompt evaluation.
Patients with prosthetic heart valves should not be treated with apixaban.
These and other risks are also described in a medication guide that is part of the drug's labeling.
The recommended dosage of apixaban for most patients is 5 mg taken twice daily with or without food.
For patients who meet two at least two of three specific criteria— age 80 years or older, weight 60 kg or less, or serum creatinine level of ≥1.5 mg/dL—the recommended dosage is 2.5 mg taken twice daily.
This reduced dosage is also recommended for patients who take both apixaban and one or more drugs that strongly inhibit both cytochrome P-450 (CYP) isoenzyme 3A4 and P-glycoprotein.
Patients who are already taking 2.5 mg of apixaban twice daily should not begin therapy with a strong dual inhibitor of CYP3A4 and P-glycoprotein.
According to Bristol-Myers Squibb, apixaban is the only oral anticoagulant to outperform warfarin in clinical trials that evaluated the occurrence of stroke, systemic embolism, major bleeding, and all-cause mortality in patients with nonvalvular atrial fibrillation.
In clinical trials, the most commonly reported adverse events associated with apixaban were related to bleeding, according to FDA.
No therapy is known to reverse the effects of apixaban.
Apixaban will be supplied in 2.5- and 5-mg tablets in bottles of 60 and 180 tablets each and single-unit packages of 100 tablets for hospital use. The tablets should be stored at controlled room temperature.