AVONEX 30 micrograms/0.5 ml solution for injection

  • Name:

    AVONEX 30 micrograms/0.5 ml solution for injection

  • Company:
    info
  • Active Ingredients:

    Interferon beta-1a

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/09/19

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Summary of Product Characteristics last updated on medicines.ie: 20/9/2019

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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
Medicine Name Fampyra 10 mg prolonged-release tablets Active Ingredients Fampridine
Medicine Name Flixabi 100 mg powder for concentrate for solution for infusion Active Ingredients Infliximab
Medicine Name Imraldi 40 mg solution for injection in pre-filled syringe Active Ingredients adalimumab
Medicine Name Imraldi 40mg solution for injection in pre-filled pen Active Ingredients adalimumab
Medicine Name Plegridy 63 mcg, 94 mcg and 125mcg solution for injection in pre-filled pen Active Ingredients peginterferon beta-1a
Medicine Name Spinraza 12 mg solution for injection Active Ingredients Nusinersen sodium
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 20 September 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

 Removal of contraindication related to pregnancy, Inclusion of statement regarding batch traceability, Updated guidance on pregnancy and breastfeeding

Updated on 20 September 2019 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 4.3: Removal of contraindication related to pregnancy

Section 4.4: Inclusion of statement regarding batch traceability

Section 4.6: Updated guidance on pregnancy and breastfeeding following closure of INF pregnancy registry.

Updated on 17 August 2018 PIL

Reasons for updating

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

Updated on 17 August 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)

Free text change information supplied by the pharmaceutical company

Update MAH to Biogen Netherlands B.V.

Updated on 26 June 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 26 June 2017 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Minor editorial changes associated with QRD v10 only.

Updated on 14 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 June 2017 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 16 March 2016 PIL

Reasons for updating

  • Change to date of revision

Updated on 6 January 2016 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 class labeling (PAH).
Other minor editorial changes are included.

Updated on 5 January 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 6 November 2014 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 17 September 2014 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 16 September 2014 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 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

  • In Section 4.4, information has been added on the occurrence of thrombotic microangiopathy in multiple sclerosis patients treated with interferon beta products, including diagnosis of the condition and subsequent patient management
  • In Section 4.8, thrombotic microangiopathy including thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome has been added as a rare adverse reaction (class label for interferon beta products)
  • In Section 4.8, the contact details for the Irish Regulatory Agency have been updated, following their change of name from IMB to HPRA
  • In Section 10, the date of revision of the text has been changed to August 2014

Updated on 9 June 2014 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 9 June 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.3 - Shelf life
  • 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

In Section 4.4 (Special warnings and precautions for use), the following text has been added:

Nephrotic Syndrome: Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon-beta products. Events were reported at various time points during treatment and may occur after several years of treatment with interferon-beta. Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease. Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with Avonex should be considered.

In Section 4.6 (Fertility, pregnancy and lactation), the following text has been added:

Fertility

Fertility and developmental studies in rhesus monkeys have been carried out with a related form of interferon beta 1a. At very high doses, anovulatory and abortifacient effects in test animals were observed (see section 5.3).

No information is available on the effects of interferon beta 1a on male fertility.

In Section 4.8 (Undesirable effects), nephrotic syndrome and glomerulosclerosis have been added as renal and urinary disorders reported rarely, and the following text has been added:

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:

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

 

Ireland

IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

 

In Section 6.3, the shelf life has been increased from 2 years to 3 years.

Updated on 14 August 2013 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 10 January 2013 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 9 August 2012 SmPC

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

In Section 5.2 (Pharmacokinetic Properties)- the following statement has been removed. Intramuscular bioavailability is three-fold higher than subcutaneous bioavailability.
In Section 10 (Date of Revision of Text)- the date has been updated.

Updated on 7 August 2012 PIL

Reasons for updating

  • Change to date of revision

Updated on 8 November 2011 PIL

Reasons for updating

  • Change of manufacturer
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration
  • Change of distributor details

Updated on 4 November 2011 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

In section 4.2: (Posology and Method of Administration)- An alternative titration strategy has been included.  Further information on the manual titration devices is provided.
In section 4.8 (Undesirable Effects)- Information on titration and a reduction in incidence and severity of flu-like symptoms is now included.
In section 10 (Date of Revision of Text)- Date is amended.

Updated on 20 June 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change of distributor details

Updated on 12 April 2010 SmPC

Reasons for updating

  • Change to paediatric information
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Previous Text
4.2 Posology and method of administration

Children and adolescents: No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents. However, limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving AVONEX 30 micrograms IM once per week is similar to that seen in adults.

There is no information on the use of AVONEX in children under 12 years of age and therefore AVONEX should not be used in this population.

New Approved Text

 

 

4.2 Posology and method of administration
Paediatric population: The safety and efficacy of AVONEX in adolescents aged 12 to 16 years have not yet been established. Currently available data are described in section 4.8 and 5.1 but no recommendation on a posology can be made.

 

 

 

The safety and efficacy of AVONEX in children below 12 years of age have not yet been established.

No data are available.

4.8 Undesirable effects
Paediatric population: Limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving AVONEX 30 micrograms IM once per week is similar to that seen in adults.

5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Paediatric population: Limited data of the efficacy/safety of AVONEX 15 micrograms IM once per week (n=8) as compared to no treatment (n=8) with follow up for 4 years showed results in line to those seen in adults, although the EDSS scores increased in the treated group over the 4 year follow-up thus indicating disease progression. No direct comparison with the dose currently recommended in adults is available.

10. DATE OF REVISION OF THE TEXT
03/2010 
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu

 

Updated on 6 January 2009 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

The following information has been added in section 4.2.
4.2 (posology and method of administration)

At the initiation of treatment, patients may either be started on a full dose of 30 micrograms (0.5 ml solution) or on approximately half the dose once a week to help them to adjust to treatment and thereafter increased to the full dose of 30 micrograms (0.5 ml solution). In order to obtain adequate efficacy, a dose of 30 micrograms (0.5 ml solution) once a week should be reached and maintained after the initial titration period. A manual titration device to enable delivery of approximately half the dose is available for patients initiating AVONEX treatment.

Updated on 6 January 2009 PIL

Reasons for updating

  • Change to further information section
  • Change to dosage and administration

Updated on 31 July 2008 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 29 July 2008 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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)

Free text change information supplied by the pharmaceutical company

Changes

A summary of the changes are shown below;
Summary of Product Characteristics

2. Qualitative And Quantitative Composition

Using the World Health Organisation (WHO) natural interferon beta standard, Second International Standard for Interferon, Human Fibroblast (Gb-23-902-531), 30 micrograms of AVONEX contains 6 million IU of antiviral activity. The activity against other standards is not known.

7. Marketing Authorisation Holder

BIOGEN IDEC LIMITED
5 Roxborough Way Innovation House
Foundation Park 70 Norden Road
Maidenhead
Berkshire
SL6 4AY SL6 3UD

10. Date of revision of text
06/2008

Updated on 15 May 2008 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 6.3 Shelf life has been extended from 18 months to2 years
Section 10. Date of revision of text 04/2008

Updated on 25 March 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 20 March 2008 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Biogen Idec submitted an update to the therapeutic indication (section 4.1) and pharmacodynamic properties (section 5.1) in order to align them with the current medical practice, taking into account the McDonald criteria for the diagnosis of multiple sclerosis.

Updated on 14 December 2007 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 12 December 2007 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 8 March 2007 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 8 March 2007 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

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

Free text change information supplied by the pharmaceutical company

inclusion of paediatric indication
 5 year renewal

Updated on 20 February 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to information about pregnancy or lactation

Updated on 18 September 2006 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation

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

Free text change information supplied by the pharmaceutical company

 

Section 4.3 Contraindication

Patients with a history of hypersensitivity to natural or recombinant interferon-b or to any excipients

 

" pregnant patients" removed from being in the contraindications section

 

Section 4.4  Special warnings and Special Precautions for Use  " or other mood disorders, conditions that are common with MS . Depression has been reported in association with Avonex use and it may occur at any time during treatment" removed from the section

 

“Patients with current severe depression and / or suicidal ideation” added to the above section

 

“ Epileptic patients with a history of seizures not adequately controlled by treatment” removed from the above section

 

 

“Patients with a history of hypersensitivity to natural or recombinant interferon - b or to any excipient “ added

 

"Caution should be exercised when administering AVONEX to patients  with pre existing seizure disorder. For patients without a pre existing seizure disorder who develop seizures during therapy with AVONEX, an etiologic basis should be established and appropriate anti-convulsant therapy instituted prior to resuming AVONEX treatment" removed from the above section

 

Section 4.6  - Pregnancy and Lactation “Because of the potential hazards to the foetus, AVONEX  is contraindicated in pregnancy. There are no studies of interferon beta 1a in pregnant women. At high doses, in rhesus monkeys, abortifacient effects were observed. It cannot be excluded that such side effects will be observed in humans" - removed

 

"Fertile women receiving AVONEX should take appropriate contraceptive measures. Patients planning for pregnancy and those becoming pregnant should be informed of the potential hazards and AVONEX should be discontinued" - removed

 

" Breast feeding " Changed to Lactation .

“Breast fed”  - removed

“to discontinue” = removed

 

Updated on 15 August 2006 SmPC

Reasons for updating

  • 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

Change to section 10 of the SPC - Date of revision of the text to 22 March 2006

Updated on 15 August 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 17 August 2005 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 17 August 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 August 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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