Benepali 50 mg solution for injection in pre-filled syringe

  • Name:

    Benepali 50 mg solution for injection in pre-filled syringe

  • Company:
    info
  • Active Ingredients:

    Etanercept

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/05/19

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Summary of Product Characteristics last updated on medicines.ie: 1/8/2019
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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Biogen Idec Ltd

Biogen Idec Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name AVONEX 30 micrograms/0.5 ml solution for injection Active Ingredients Interferon beta-1a
Medicine Name AVONEX 30 micrograms/0.5ml solution for injection, in pre-filled pen Active Ingredients Interferon beta-1a
Medicine Name Benepali 25mg solution for injection in pre-filled syringe Active Ingredients Etanercept
Medicine Name Benepali 50 mg solution for injection in pre-filled pen Active Ingredients Etanercept
Medicine Name Benepali 50 mg solution for injection in pre-filled syringe Active Ingredients Etanercept
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Medicine Name Imraldi 40mg solution for injection in pre-filled pen Active Ingredients adalimumab
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Medicine Name Tecfidera 120mg and 240mg gastro-resistant hard capsules Active Ingredients Dimethyl fumarate
Medicine Name Tysabri 300mg concentrate for solution for infusion Active Ingredients Natalizumab
1 - 0 of 13 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 1 November 2019 Ed-HCP

Reasons for updating

  • Replace document

Free text change information supplied by the pharmaceutical company

Incorrect version uploaded in error

Updated on 1 August 2019 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 1 August 2019 Ed-Ptnt

Reasons for updating

  • Add New Doc

Updated on 1 August 2019 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 1 August 2019 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 23 May 2019 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 23 May 2019 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.6:

Update to align with the reference product to add additional information to this section - the following text has been added:

The effects of etanercept on pregnancy outcomes have been investigated in two observational cohort studies.....In another observational multi‑country registry study comparing the risk of adverse pregnancy outcomes in women exposed to etanercept during the first 90 days of pregnancy (n=425) to those exposed to non-biologic drugs (n=3497), there was no observed increased risk of major birth defects (crude odds ratio [OR]= 1.22, 95% CI: 0.79-1.90; adjusted OR = 0.96, 95% CI: 0.58-1.60 after adjusting for country, maternal disease, parity, maternal age and smoking in early pregnancy). This study also showed no increased risks of minor birth defects, preterm birth, stillbirth, or infections in the first year of life for infants born to women exposed to etanercept during pregnancy.

The following text has been updated to read: Benepali should only be used during pregnancy if clearly needed

Updated on 22 March 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 21 March 2019 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 has been updated to include lichenoid skin reactions as a rare adverse event.

Updated on 16 November 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 16 November 2018 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 not be renewed (A)

Updated on 5 June 2018 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 29 May 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 13 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 February 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 29 January 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 23 August 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

$0$0$07.       MARKETING AUTHORISATION HOLDER$0

Updated on 23 August 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 22 August 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 7 August 2017 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

·         Summary of Product Characteristics (SmPC),

 

Location

Update

SmPC, section 4.8 Undesirable effects

Hepatobiliary disorders:

Uncommon:        Elevated liver enzymes*

Rare:      Elevated liver enzymes, aAutoimmune hepatitis

SmPC, section 4.8 Undesirable effects

Elevated liver enzymes

In the double-blind periods of controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of adverse events of elevated liver enzymes in patients receiving etanercept without concomitant methotrexate was 0.54% (frequency uncommon). In the double-blind periods of controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of adverse events of elevated liver enzymes was 4.18% (frequency common).

PiL, section 4 Possible side effects

·         Uncommon (may affect up to 1 in 100 people):

elevated liver blood tests (in patients also receiving methotrexate treatment, the frequency of elevated liver blood tests is common).

·         Rare (may affect up to 1 in 1,000 people):

elevated liver blood tests;

Updated on 25 July 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 22 June 2017 SmPC

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 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to the SPC due to approval of new strength of this product.

Updated on 13 June 2017 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 10 February 2017 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.1, Juvenile Idiopathic Arthritis, Paediatric plaque psoriasis, enthesitis-related arthritis and Psoriatic Arthritis added. Consequential updates implemented in other impacted sections.

Updated on 9 February 2017 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 11 July 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



In section 4.2 and in Section 4.8, under the subtitle "special populations", "elderly (above 65 years)" was changed to state "elderly".

In Section 4.4 Special warnings and precautions for use, the text highlighted in red was added.

Congestive heart failure
Physicians should use caution when using Benepali in patients who have congestive heart failure (CHF). There have been postmarketing reports of worsening of CHF, with and without identifiable precipitating factors, in patients taking Etanercept.
There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known pre-existing cardiovascular disease. Some of these patients have been under 50 years of age. Two large clinical trials evaluating the use of Etanercept in the treatment of CHF were terminated early due to lack of efficacy. Although not conclusive, data from one of these trials suggest a possible tendency toward worsening CHF in those patients assigned to Etanercept treatment.

In section 4.8 Undesirable effects: "Worsening of congestive heart failure" was changed to "Congestive heart failure".

Section 5.1, under the subheader "Adult patients with non-radiographic axial spondyloarthritis" was updated due to new originator etanercept data as indicated below. The strike through text was deleted and purple text added.

 

MRIs  of  the  sacroiliac joint and spine were obtained to assess inflammation at  baseline  and  at  week  12.  The double-blind period was followed by an open- label period during which all patients receive etanercept 50 mg weekly for up to an additional 92 weeks.  

MRIs of the sacroiliac joint and spine were obtained to assess inflammation at baseline and at weeks 12 and 104.

 

 

 

 

 

 

 

 

 

 

 

 

In Section 5.2, formatting changes only occurred to introduce a line space was added between text and subheaders

 

 

 

Updated on 7 July 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 10 May 2016 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 4 May 2016 PIL

Reasons for updating

  • New PIL for new product