The following risk minimisation materials have been developed for Eliquis(apixaban) for the 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):
•Prescriber Guide – for healthcare professionals
•Patient Alert Card – for patients (to be given by the healthcare professional)
•Summary of Product Characteristics (SmPC, 5mg and 2.5mg) – for healthcare professionals
Please ensure that you are familiar with these educational materials before prescribing Eliquis as they contain important safety information. In particular, they are aimed at increasing awareness about the potential risk of bleeding during treatment with Eliquis and providing guidance on how to manage that risk.
Please click on this link to view the materials.
Table of Contents

1. Name of the medicinal product
2. Qualitative and quantitative composition
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. Pharmacological properties
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
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Eliquis 5 mg film-coated tablets
1. Name of the medicinal product
Eliquis 5 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 5 mg apixaban.
Excipients with known effect:
Each 5 mg film-coated tablet contains 51.43 mg lactose (see section 4.4).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet)
Yellow, round tablets debossed with 893 on one side and 2½ on the other side.
4. Clinical particulars
4.1 Therapeutic indications
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).
4.2 Posology and method of administration
Posology
Prevention of VTE (VTEp): elective hip or knee replacement surgery
The recommended dose of Eliquis 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 Eliquis is 5 mg taken orally twice daily.
Dose reduction
The recommended dose of Eliquis 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 &