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Biogen Idec Ltd
Innovation House, 70 Norden Road, Maidenhead, Berkshire, SL6 4AY, UK
Telephone: +44 (0)1628 501 000
Fax: +44 (0)1628 501 010
Medical Information Direct Line: 0800 008 7401
Medical Information e-mail: biogenidec@professionalinformation.co.uk
Medical Information Fax: +44(0)1748 828801
Out of Hours Telephone: 0800 008 7401

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Summary of Product Characteristics last updated on the eMC: 03/11/2011
SPC AVONEX 30 micrograms powder and solvent for solution for injection

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 03/11/2011 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   01-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.2 (Posology and Method of Administration): Inclusion of two possible titration regimens to reduce the incidence and severity of flu-like symptoms 
In section 4.8 (Undesirable Side Effects): Information on titration and reduction and severity in flu-like symptoms included
In section 10 (Date of Revision of the Text): Date amended
Updated on 18/05/2010 and displayed until 03/11/2011
Reasons for adding or updating:
  • 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
  • change to paediatric information
Date of revision of text on the SPC:   01-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

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.

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 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.

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.

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 31/07/2008 and displayed until 18/05/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   01-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 2 Qualitative And Quantitative Composition has been updated with a standard reference variation as follows

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.

Section 7. Marketing Authorisation Holder address has been updated as follows

BIOGEN IDEC LIMITED

5 Roxborough Way Innovation House

Foundation Park 70 Norden Road

Maidenhead

Berkshire

SL6 4AY SL6 3UD
Updated on 26/03/2008 and displayed until 31/07/2008
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   03/2008
Legal Category:   POM
Black Triangle (CHM):   NO

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 12/12/2007 and displayed until 26/03/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 08/03/2007 and displayed until 12/12/2007
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 Inclusion of paediatrics indication
 
5 year renewal
Updated on 13/09/2006 and displayed until 08/03/2007
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 

Section 4.3 Contraindication " 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 20/06/2006 and displayed until 13/09/2006
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   03/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Date of revision changed to March 2006
Updated on 03/10/2005 and displayed until 20/06/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 01/10/2004 and displayed until 03/10/2005
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  interferon beta-1a