Meet APIXA – a new NATIVITA’s medicine

A new direct oral anticoagulant APIXA (apixaban) in tablets of 5 mg and 2.5 mg has shown up in Belarusian pharmacies. Until recently, the promising class of direct oral anticoagulants was represented in our country only by dabigatran and rivaroxaban products, while original and generic apixaban was not available. APIXA, the first apixaban generic, forthcoming was possible due to cooperation with our Indian partner, Natco Pharma Ltd. Bioequivalence of APIXA to the original apixaban according to the FDA criteria was confirmed in a clinical study conducted in the United States and Canada. The results of this study were presented in the registration dossier.

Anticoagulants are broadly used in various, often life-threatening, clinical situations that require blood thinning to prevent blood clots and treat thrombosis if it has occurred. Oral administration of anticoagulants significantly expands the thrombosis treatment and prevention opportunities in both inpatient and outpatient settings and makes it simpler. APIXA is approved for medical use in the following indications:

  1. Prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery.
  2. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, with one or more risk factors, such as prior stroke or transient ischaemic attack; age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure.
  3. Treatment and prevention of recurrent deep vein thrombosis and pulmonary embolism in adults.

The efficacy and safety of apixaban for approved indications have been confirmed in large international randomized clinical trials. The analysеs of medicine’s use in real clinical practice also indicate its high efficacy and favorable safety profile.

Apixaban (APIXA) for outpatient use is included in the “Temporary Recommendations on the Organization of Medical Care for Patients with COVID-19 Infection”, approved by the order of the Ministry of Health of the Republic of Belarus dated 11.11.2021 No. 1424.

Until the end of November 2021, pharmacies in all regions of Belarus will have APIXA.