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Amgen Ltd
240 Cambridge Science Park, Milton Road, Cambridge, CB4 0WD
Telephone: +44 (0)1223 420 305
Fax: +44 (0)1223 426 314
Medical Information Direct Line: +44 (0)1223 436 441
Medical Information e-mail: gbinfoline@amgen.com
Customer Care direct line: +44 (0)808 0100 321
Medical Information Fax: +44 (0)1223 426 314
Need to contact this company?
Summary of Product Characteristics last updated on the eMC: 23/12/2009
SPC Aranesp SureClick

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 23/12/2009 and displayed until Current
Reasons for adding or 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
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   28-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.2, paediatric patients with chronic renal failure, maintenance phase: clarification of dosing.
In section 4.4, removal of duplicate mention of epilepsy warning.
In section 4.8 dyspnoea changed to allergic bronchospasm.
In section 5.1, section on chronic renal failure added.
Updated on 10/12/2008 and displayed until 23/12/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.4, additional statement that in some clinical situations, blood transfusion is the preferred method of treatment for the management of anaemia.
Updated on 03/11/2008 and displayed until 10/12/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4: rearrangement of text, addition of vascular access thrombosis as a warning arising from clinical studies.
Section 4.8: amended details regarding clinical trials in CRF patients and in cancer patients, revision of wording regarding adverse events and theiir incidence.
Updated on 27/03/2008 and displayed until 03/11/2008
Reasons for adding or 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
Date of revision of text on the SPC:   02/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Target Hb reduced in line with EMEA request as per all erythropoietins.
Section 4.4 - information on survival outcomes in off-license studies
Updated on 24/01/2008 and displayed until 27/03/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 05/11/2007 and displayed until 24/01/2008
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   08/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Extension of the licence to include paediatric patients
Updated on 31/07/2007 and displayed until 05/11/2007
Reasons for adding or updating:
  • Introduction of new strength
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Introduction of 130mcg solution
Updated on 14/01/2007 and displayed until 31/07/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 recommended initial dose for oncology patients is fixed dose 500mcg once every three weeks.  Removal of dose doubling requirement on weekly dose in oncology patients.
Section 5.1 inclusion of text to support once every three week fixed dosing in oncology patients.  Removal of text re; long term surveillance.
Updated on 28/08/2006 and displayed until 14/01/2007
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MA number
Date of revision of text on the SPC:   07/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Updates to sections 6.5 and 8 with new 4-pack availability
Updated on 21/07/2006 and displayed until 28/08/2006
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   05/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Removal of Black Triangle
Updated on 14/06/2006 and displayed until 21/07/2006
Reasons for adding or updating:
  • No reasons supplied
Date of revision of text on the SPC:   05/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Section 4.4 Special Warnings & Precautions for Use

The additional text states that the needle cover of SureClick contains dry natural rubber which may cause allergic reactions. This text is repeated in section 6.5 as well.

Addition of text specifically for CRF patients - Aranesp should be used in caution in patients with epilepsy. Convulsions have been reported in patients with CRF receiving Aranesp.

Section 4.8 Undesirable Effects

The rare cases of convulsion in CRF patients is repeated in this section.

Section 6.4 Special Precautions for storage
If the drug has been removed from the fridge and has reached room temperature it must be used within 7 days or disposed of.
Updated on 22/03/2006 and displayed until 14/06/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 28/10/2005 and displayed until 22/03/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 25/07/2005 and displayed until 28/10/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 4.8 - Undesirable Effects
Updated on 13/06/2005 and displayed until 25/07/2005
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  darbepoetin alfa


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