Eliquis 5mg film coated tablets

  • Name:

    Eliquis 5mg film coated tablets

  • Company:
    info
  • Active Ingredients:

    apixaban

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/10/19

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Summary of Product Characteristics last updated on medicines.ie: 17/10/2019

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Bristol-Myers Squibb-Pfizer

Bristol-Myers Squibb-Pfizer

Company Products

Medicine NameActive Ingredients
Medicine Name Eliquis 2.5 mg film-coated tablets Active Ingredients apixaban
Medicine Name Eliquis 5mg film coated tablets Active Ingredients apixaban
1 - 0 of 2 items.Total: Infinity pages

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 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 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients
  • 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

4.4 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 SmPC

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 7 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 SmPC

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 SmPC

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 changes to include 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 SmPC

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 SmPC

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 SmPC

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 5.1EMANATE study information added.

Section 7 – amendment of MAH address

Section 10 – updated date of revision

Updated on 5 June 2018 SmPC

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

  • Change to section 6 - manufacturer

Updated on 22 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 30 October 2017 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Section 4.5: This section has been updated with information on the effects of clarithromycin on apixaban treatment

Section 5.2: Absorption - % correction from 20% to 21%

Updated on 27 February 2017 SmPC

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 28 January 2016 SmPC

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 22 January 2016 PIL

Reasons for updating

  • Change to date of revision
  • Removal of black triangle
  • Improved electronic presentation

Updated on 2 October 2015 SmPC

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 SmPC

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

“Pruritus” as a uncommon ADR has been added to section 4.8 of the SmPC and “Itching” to section 4 of the PIL as part of the PSUR/PBRER n.7. European Commission decision received on 20 Aug 2015

Updated on 27 August 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 17 September 2014 SmPC

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 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

New VTE indication

Updated on 16 September 2014 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 May 2014 SmPC

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 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: A statement that patients can stay on apixaban while being cardioverted
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 10: updated date of revision

Updated on 1 October 2013 SmPC

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 Haemoptysisuncommon (NVAF)  has been corrected

In section 4.8   Undesirable effects

Adverse Event omission of Haemoptysisuncommon (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 11 September 2013 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided