Eliquis 2.5 mg film-coated tablets
- Name:
Eliquis 2.5 mg film-coated tablets
- Company:
Bristol-Myers Squibb-Pfizer
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/01/21

XPIL
Package leaflet: Information for the user
Package leaflet: Information for the user
1. What Eliquis is and what it is used for
1. What Eliquis is and what it is used for
2. What you need to know before you take Eliquis
2. What you need to know before you take Eliquis
3. How to take Eliquis
3. How to take Eliquis
4. Possible side effects
4. Possible side effects
5. How to store Eliquis
5. How to store Eliquis
6. Contents of the pack and other information
6. Contents of the pack and other information
Click on this link to Download PDF directly
Bristol-Myers Squibb-Pfizer

Company Products
Medicine Name | Active Ingredients |
---|---|
Medicine Name Eliquis 2.5 mg film-coated tablets | Active Ingredients apixaban |
Medicine Name Eliquis 5mg film coated tablets | Active Ingredients apixaban |
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 18 January 2021 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - use in children and adolescents
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Formatting and editorial changes throughout the SmPC to bring it in line with the current product information (QRD) template
Updated on 18 January 2021 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Updated inline with QRD template and/or excipient guideline
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.6 Fertility, pregnancy and lactation
Pregnancy
There are no data from the use of apixaban in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of apixaban during pregnancy.. Apixaban is not recommended during pregnancy.
Breast-feeding
It is unknown whether apixaban or its metabolites are excreted in human milk. Available data in animals have shown excretion of apixaban in milk (see section 5.3). In rat milk, a high milk to maternal plasma ratio (Cmax about 8, AUC about 30) was found, possibly due to active transport into the milk. A risk to the suckling child newborns and infants cannot be excluded.
A decision must be made whether to either discontinue breast-feeding or to discontinue/abstain from apixaban apixaban therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
5.3 Preclinical safety data:
In rat milk, a high milk to maternal plasma ratio (Cmax about 8, AUC about 30) was found, possibly due to active transport into the milk.
Formatting and editorial changes throughout the SmPC to bring it in line with the current product information (QRD) template
Updated on 17 August 2020 Ed-HCP
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
The risk minimisation materials for Eliquis (apixaban) were developed as a condition of the marketing authorisation for this product. These risk minimisation materials are for Eliquis for all indications. These materials contain important safety information and in particular are aimed at increasing awareness about the potential risk of bleeding with apixaban. The risk minimisation materials have been updated in 2020 and a letter was sent to healthcare professionals summarising the updates made. Please refer to the attached letter for further information on the updates made to the risk minimisation materials in 2020.
Updated on 10 August 2020 PIL
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Date of revision updated to align with SmPC date of revision
Updated on 10 August 2020 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SmPC Update: Addition of angioedema as an adverse drug reaction in the SmPC
Updated on 4 August 2020 Ed-HCP
Reasons for updating
- Replace document
Updated on 14 May 2020 Ed-Ptnt
Reasons for updating
- Replace document
Updated on 29 April 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
- To add Swords Laboratories T/A Bristol-Myers Squibb Pharmaceutical Operations, External Manufacturing as an alternative site responsible for batch release
- To change the name and amend the address of the site responsible for batch release to CATALENT ANAGNI S.R.L.
Updated on 29 April 2020 SPC
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- To add Swords Laboratories T/A Bristol-Myers Squibb Pharmaceutical Operations, External Manufacturing as an alternative site responsible for batch release
- To change the name and amend the address of the site responsible for batch release to CATALENT ANAGNI S.R.L.
The SmPC date of revision has been updated to align with the patient leaflet date of revision (30 March 2020)
Updated on 2 April 2020 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 2 April 2020 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to the product information to reflect the results of study CV185-316 (AUGUSTUS)
Updated on 19 February 2020 PIL
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Date of Revision: 17 February 2020
Updated on 19 February 2020 SPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Periodic Safety Update Report (PSUR) - SmPC section 4.5 Inhibitors of CYP3A4 and P-gp updated with ‘fluconazole’
Updated on 20 January 2020 PIL
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Date of Revision updated (20 December 2019) to align with date of EU Product Information revision - To include updated details from the Maltese list of representatives in the patient leaflet
Updated on 20 January 2020 SPC
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Date of Revision updated (20 December 2019) to align with date of EU Product Information revision - To include updated details from the Maltese list of representatives in the patient leaflet
Updated on 25 November 2019 Ed-HCP
Reasons for updating
- Replace document
Free text change information supplied by the pharmaceutical company
Updated Eliquis Prescriber Guide, Nov 2019
Changes include:
• Harmonisation of the UK/Ireland Eliquis Prescriber Guides into one document
• Update to the contraindication statement on unfractionated heparin co-administration to clarify an exception applies during catheter ablation for atrial fibrillation
• Clarification added on use in patients undergoing cardioversion (with reference to a transesophageal echocardiogram [TEE]-guided approach to exclude left atrial thrombus)
• Availability of a reversal agent, intended for use when reversal of anticoagulation with apixaban is needed due to life-threatening or uncontrolled bleeding
• Editorial modifications
Updated on 17 October 2019 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
To update the product information on the availability of reversal agent, andexanet alfa (Ondexxya).
Updated on 17 October 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
To update the product information on the availability of reversal agent, andexanet alfa (Ondexxya):
Updated on 17 October 2019 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.9 - Overdose
- Change to section 6.1 - List of excipients
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
To update the product information on the availability of reversal agent, andexanet alfa (Ondexxya):
4.4 Special warnings and precautions for use
An agent to reverse the anti-factor Xa activity of apixaban is available.
4.9 Overdose
There is no antidote to Eliquis. Overdose of apixaban may result in a higher risk of bleeding. In the event of haemorrhagic complications, treatment must be discontinued and the source of bleeding investigated. The initiation of appropriate treatment, e.g., surgical haemostasis, or the transfusion of fresh frozen plasma or the administration of a reversal agent for factor Xa inhibitors should be considered.
For situations when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding, a reversal agent for factor Xa inhibitors is available (see section 4.4).
If life-threatening bleeding cannot be controlled by the above measures, an agent to reverse the anti-factor Xa activity of apixaban is available. Aa Administration of prothrombin complex concentrates (PCCs) or recombinant factor VIIa may also be considered
6.1 List of excipients (removal of E number)
Film coat:
Lactose monohydrate
Hypromellose (E464)
Titanium dioxide (E171)
Triacetin (E1518)
Yellow iron oxide (E172)
Updated on 16 October 2019 Ed-Ptnt
Reasons for updating
- Replace document
Updated on 5 July 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 5 July 2019 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.2 Posology:
Patients undergoing catheter ablation (NVAF)
Patients can continue apixaban use while undergoing catheter ablation (see sections 4.3, 4.4 and 4.5)
Patients undergoing cardioversion
Apixaban can be initiated or continued in NVAF patients who may require cardioversion.
For patients not previously treated with anticoagulants, exclusion of left atrial thrombus using an image guided approach (e.g. transesophogeal echocardiography (TEE) or computed tomographic scan (CT)) prior to cardioversion should be considered, in accordance with established medical guidelines.
at least 5 doses of apixaban 5 mg twice daily (2.5 mg twice daily in patients who qualify for a dose reduction (see above sections Dose reduction and Renal impairment)) should be given before cardioversion to ensure adequate anticoagulation (see section 5.1). For patients initiating treatment with apixaban, 5 mg should be given twice daily for at least 2.5 days (5 single doses) before cardioversion to ensure adequate anticoagulation (see section 5.1). The dosing regimen should be reduced to 2.5 mg apixaban given twice daily for at least 2.5 days (5 single doses) if the patient meets the criteria for dose reduction (see above sections Dose reduction and Renal impairment).
4.3 Contraindications:
· Concomitant treatment with any other anticoagulant agent e.g., unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc.) except under specific circumstances of switching anticoagulant therapy (see section 4.2), or when UFH is given at doses necessary to maintain an open central venous or arterial catheter or when UFH is given during catheter ablation for atrial fibrillation (see sections 4.4 and 4.5).
4.4 Special Warnings and precuations for use
For patients undergoing catheter ablation for atrial fibrillation, Eliquis treatment does not need to be interrupted (see sections 4.3, 4.4 and 4.5).
4.5 Interaction with other medicinal products and other forms of interactions
Anticoagulants, platelet aggregation inhibitors, SSRIs/SNRIs and NSAIDs
Due to an increased bleeding risk, concomitant treatment with any other anticoagulants is contraindicated except under specific circumstances of switching anticoagulant therapy, when UFH is given at doses necessary to maintain an open central venous or arterial catheter or when UFH is given during catheter ablation for atrial fibrillation (see section 4.3).
4.8 - Alopecia added as an AE
Updated on 10 June 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 7 June 2019 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
To include warning regarding thromboembolic risk in patients with antiphospholipid syndrome.
Updated on 14 March 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 14 March 2019 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 7: MAH address change
Updated on 16 August 2018 Ed-HCP
Reasons for updating
- Replace document
Free text change information supplied by the pharmaceutical company
Prescriber guide updated in line with SPC updates to include information on the following:
- posology recommendations in Non-valvular Atrial Fibrillation (NVAF) patients undergoing cardioversion
- drug interaction with selective serotonin reuptake inhibitors (SSRIs) / serotonin norepinephrine reuptake inhibitors (SNRIs) leading to an increased risk of bleeding
Updated on 16 August 2018 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 15 August 2018 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 1 August 2018 Ed-Ptnt
Reasons for updating
- Add New Doc
Updated on 27 June 2018
Updated on 12 June 2018 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 12 June 2018 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 8 June 2018 PIL
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 7 June 2018 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.2 - ‘Patients undergoing cardioversion’ subsection - Text amended to state that ‘Apixaban can be initiated or continued in NVAF patients who may require cardioversion’. Section also updated to include detail on dosage in relation to cardioversion.
Section 5.1 – EMANATE study information added.
Section 7 – amendment of MAH address
Section 10 – updated date of revision
Updated on 5 June 2018 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Type II variation - to assign a frequency to all adverse drug reactions for each indication.
-
-
-
- SmPC Section 4.8 Undesirable effects (Table 2)
-
-
Updated on 5 June 2018 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 26 April 2018 Ed-HCP
Reasons for updating
- Add New Doc
Updated on 22 February 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 22 February 2018 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 30 October 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 30 October 2017 SPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.5: This section has been updated with information on the effects of clarithromycin on apixaban treatment
Updated on 27 February 2017 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.2 Posology and method of administration
- Update of section 4.2 of the SmPC to clarify the wording about the dose in patients with renal impairment.
Section 9 Date of first authorisation/renewal of the authorisation
- Updated to include the date of the latest renewal
Section 10 Date of Revision of the Text
- Updated to include the current date of revision to the text
Updated on 21 February 2017 PIL
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 15 December 2016 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 22 January 2016 PIL
Reasons for updating
- Change to date of revision
- Removal of black triangle
- Improved electronic presentation
Updated on 22 January 2016 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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.
4.2 Posology and method of administration
Prevention of VTE (VTEp): elective hip or knee replacement surgery
The recommended dose of Eliquis apixaban is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery.
Switching
Switching treatment from parenteral anticoagulants to Eliquis (and vice versa) can be done at the next scheduled dose (see section 4.5). These medicinal products agents should not be administered simultaneously.
Switching from vitamin K antagonist (VKA) therapy to Eliquis
When converting patients from vitamin K antagonist (VKA) therapy to Eliquis, warfarin or other VKA therapy should be discontinued and start Eliquis started when the international normalised ratio (INR) is < 2.0.
4.4 Special warnings and precautions for use
There is no clinical experience with the use of apixaban with indwelling intrathecal or epidural catheters. In case there is such need and based on the general PK characteristics of apixaban, a time interval of 20‑30 hours (i.e., 2 x half-life) between the last dose of apixaban and catheter withdrawal should elapse, and at least one dose should be omitted before catheter withdrawal. The next dose of apixaban may be given at least 5 hours after catheter removal. As with all new anticoagulant medicinal products agents, experience with neuraxial blockade is limited and extreme caution is therefore recommended when using apixaban in the presence of neuraxial blockade.
Common adverse reactions event were haemorrhage, contusion, epistaxis, and haematoma (see Table 2 for adverse reaction profile and frequencies by indication).
In the VTEp studies, in total, 11% of the patients treated with apixaban 2.5 mg twice daily experienced adverse reactions. The overall incidence of adverse reactions related to bleeding with apixaban was 10% in the apixaban vs enoxaparin studies.
In the NVAF studies, the overall incidence of adverse reactions related to bleeding with apixaban was 24.3% in the apixaban vs warfarin study and 9.6% in the apixaban vs acetylsalicylic acid aspirin study. In the apixaban vs warfarin study the incidence of ISTH major gastrointestinal bleeds (including upper GI, lower GI, and rectal bleeding) with apixaban was 0.76%/year. The incidence of ISTH major intraocular bleeding with apixaban was 0.18%/year.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation:- 18 May 2011
Date of latest renewal: 14 January 2016
10. DATE OF REVISION OF THE TEXT
January 2016
Updated on 2 October 2015 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
EMEA/H/C/002148/II/0030 - crushed
Type II variation C.I.4, to update sections 4.2 and 5.2 of the SmPC to include recommendations in the labelling regarding the use of alternative methods of administration of apixaban tablets (crushed tablets)
Approval date (CHMP Opinion): 24 Sept 2013
EMEA/H/C/002148/II/0029 - PCC
Type II variation, C.I.4, to provide the final study results from study CV185156 evaluating the ability of prothrombin complex concentrates (PCCs) to reverse the anticoagulant effect of apixaban in healthy subjects and to propose use recommendations in sections 4.9 and 5.1 of the SmPC based on the study results (PfLEET 2015-0010043).
Approval date (CHMP Opinion): 17 Sept 2015
Updated on 1 October 2015 PIL
Reasons for updating
- Change to dosage and administration
Updated on 28 August 2015 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 27 August 2015 PIL
Reasons for updating
- Change to side-effects
Updated on 17 September 2014 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 12 May 2014 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4: to replace the term ‘Rotachrom anti-FXa assay’ with ‘a calibrated quantitative anti-FXa assay’
Section 5.1: to include the apixaban plasma concentration data (ng/mL) along with the already approved anti-Xa activity data
Section 8: New License number
Section 10: new revision date
Updated on 6 May 2014 PIL
Reasons for updating
- Change to date of revision
- Introduction of new pack/pack size
- Individual presentations superseded by joint PIL
Updated on 1 October 2013 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of black triangle and 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.”
- Section 4.4 Special warnings and precautions for use
Addition of the text:
Patients with prosthetic heart valves
Safety and efficacy of Eliquis have not been studied in patients with prosthetic heart valves, with or without atrial fibrillation. Therefore, the use of Eliquis is not recommended in this setting.
- Section 4.8 Undesirable effects
Adverse Event omission of Haemoptysis - uncommon (NVAF) has been corrected
In section 4.8 Undesirable effects
Adverse Event omission of Haemoptysis - uncommon (NVAF) has been corrected
Addition of the below text:
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
- In section 4.9 Overdose
Addition of the below text:
Haemodialysis decreased apixaban AUC by 14% in subjects with end stage renal disease, when a single dose of apixaban 5 mg was administered orally. Therefore, haemodialysis is unlikely to be an effective means of managing apixaban overdose.
- In section 5.2 Pharmacokinetic properties
Addition of text:
In section 5.2 Addition of text:
In subjects with end-stage renal disease (ESRD), the AUC of apixaban was increased by 36% when a single dose of apixaban 5 mg was administered immediately after hemodialysis, compared to that seen in subjects with normal renal function. Hemodialysis, started two hours after administration of a single dose of apixaban 5 mg, decreased apixaban AUC by 14% in these ESRD subjects, corresponding to an apixaban dialysis clearance of 18 mL/min. Therefore, haemodialysis is unlikely to be an effective means of managing apixaban overdose.
- In section 10 Date of Revision of text
19 September 2013
Updated on 1 October 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Addition of information on reporting a side effect.
- Addition of black triangle
Updated on 11 September 2013 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 4.3 (Contraindications)
The second bullet has been updated to:
Clinically significant aActive clinically significant bleeding.
The fourth bullet point has been updated to:
- Lesion or condition if considered a
atsignificant risk factor forofmajor bleeding. This may includesuch ascurrent or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
The fifth bullet point to:
- Concomitant treatment with any other anticoagulant agent e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc.) except under the circumstances of switching therapy to or from apixaban (see section 4.2) or when UFH is given at doses necessary to maintain an open
patentcentral venous or arterial catheter (see section 4.5).
Addition of the below text:
Depending on local availability, a consultation of a coagulation expert should be considered in case of major bleedings.
In section 10 (Revision of text)
26 August 2013
Updated on 21 February 2013 SPC
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Inclusion of Pharmacotherapeutic Group “direct factor Xa inhibitors” in section 5.1.Minor editorial and typographical corrections have also been introduced.
Updated on 20 February 2013 PIL
Reasons for updating
- Change to date of revision
- Correction of spelling/typing errors
Updated on 29 January 2013 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 25 January 2013 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to how the medicine works
- Change to date of revision
- Change to dosage and administration
- Changes to therapeutic indications
Updated on 21 August 2012 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 15 August 2012 PIL
Reasons for updating
- New PIL for new product
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