Eliquis 2.5 mg film-coated tablets
Bristol-Myers Squibb-Pfizer
contact details
Active ingredient
apixaban
Legal Category
POM: Prescription only medicine
Eliquis 2.5 mg film-coated tablets
Each film-coated tablet contains 2.5 mg apixaban.
Excipients with known effect
Each 2.5 mg film-coated tablet contains 51.43 mg lactose (see section 4.4).
For the full list of excipients, see section 6.1.
Film-coated tablet (tablet)
Yellow, round tablets debossed with 893 on one side and 2½ on the other side.
Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.
Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).
Posology
Prevention of VTE (VTEp): elective hip or knee replacement surgery
The recommended dose of apixaban is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery.
Physicians may consider the potential benefits of earlier anticoagulation for VTE prophylaxis as well as the risks of post-surgical bleeding in deciding on the time of administration within this time window.
In patients undergoing hip replacement surgery
The recommended duration of treatment is 32 to 38 days.
In patients undergoing knee replacement surgery
The recommended duration of treatment is 10 to 14 days.
Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF)
The recommended dose of apixaban is 5 mg taken orally twice daily.
Dose reduction
The recommended dose of apixaban is 2.5 mg taken orally twice daily in patients with NVAF and at least two of the following characteristics: age ≥ 80 years, body weight ≤ 60 kg, or serum creatinine ≥ 1.5 mg/dL (133 micromole/L).
Therapy should be continued long-term.
Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt)
The recommended dose of apixaban for the treatment of acute DVT and treatment of PE is 10 mg taken orally twice daily for the first 7 days followed by 5 mg taken orally twice daily. As per available medical guidelines, short duration of treatment (at least 3 months) should be based on transient risk factors (e.g., recent surgery, trauma, immobilisation).
The recommended dose of apixaban for the prevention of recurrent DVT and PE is 2.5 mg taken orally twice daily. When prevention of recurrent DVT and PE is indicated, the 2.5 mg twice daily dose should be initiated following completion of 6 months of treatment with apixaban 5 mg twice daily or with another anticoagulant, as indicated in Table 1 below (see also section 5.1).
Table 1:
