AVONEX 30 micrograms/0.5 ml solution for injection
*Company:
Biogen Idec LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 26 January 2023
File name
leaflet pre-filled syringe for ni.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 4 - possible side effects
Updated on 26 January 2023
File name
spc pre-filled syringe for ni.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 October 2022
File name
leaflet pfs-pdf.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 26 October 2022
File name
spc-pfs-pdf.pdf
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 not be renewed (A)
Updated on 25 February 2021
File name
Avonex_PIL_Feb 2021_IE.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 20 January 2021
File name
Avonex_PFS_PIL_Jan_2020 GB&IE.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 20 September 2019
File name
Avonex PFS_PIL_UK&Ireland_Sept 2019.pdf
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
File name
Avonex PFS_SmPC_UK&Ireland_Sept 2019.pdf
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
File name
Avonex PFS_PIL_UK&Ireland_Aug 2018.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 17 August 2018
File name
Avonex PFS_SmPC_UK&Ireland_Aug 2018.pdf
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
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 June 2017
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
Updated on 14 June 2017
File name
PIL_10360_470.pdf
Reasons for updating
- New PIL for new product
Updated on 14 June 2017
Reasons for updating
- Correction of spelling/typing errors
Updated on 16 March 2016
Reasons for updating
- Change to date of revision
Updated on 06 January 2016
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
Other minor editorial changes are included.
Updated on 05 January 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 06 November 2014
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 17 September 2014
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
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 09 June 2014
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 09 June 2014
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 14 August 2013
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 10 January 2013
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 09 August 2012
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 10 (Date of Revision of Text)- the date has been updated.
Updated on 07 August 2012
Reasons for updating
- Change to date of revision
Updated on 08 November 2011
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 04 November 2011
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 4.8 (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
Reasons for updating
- Change to date of revision
- Change of distributor details
Updated on 12 April 2010
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 06 January 2009
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
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 06 January 2009
Reasons for updating
- Change to further information section
- Change to dosage and administration
Updated on 31 July 2008
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 29 July 2008
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
A summary of the changes are shown below;
2. Qualitative And Quantitative Composition
Using the World Health Organisation (WHO)
7. Marketing Authorisation Holder
BIOGEN IDEC LIMITED
Maidenhead
Berkshire
10. Date of revision of text
06/2008
Updated on 15 May 2008
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
Updated on 25 March 2008
Reasons for updating
- Improved electronic presentation
Updated on 20 March 2008
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
Updated on 14 December 2007
Reasons for updating
- Correction of spelling/typing errors
Updated on 12 December 2007
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 March 2007
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
Updated on 08 March 2007
Reasons for updating
- Change due to user-testing of patient information
Updated on 20 February 2007
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
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
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
Updated on 15 August 2006
Reasons for updating
- Improved electronic presentation
Updated on 17 August 2005
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
Reasons for updating
- New PIL for medicines.ie
Updated on 12 August 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)