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Ipsen Ltd
190 Bath Road, Slough, Berkshire, SL1 3XE
Telephone: +44 (0)1753 627 777
Fax: +44 (0)1753 627 778
Medical Information Direct Line: +44 (0)1753 627 777
Medical Information e-mail: medical.information.uk@ipsen.com
Customer Care direct line: +44 (0)1753 627 627

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Summary of Product Characteristics last updated on the eMC: 23/01/2012
SPC Decapeptyl SR 22.5mg

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 23/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • 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:   24-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.1 Therapeutic Indications: The following indication has been added:$0        'As adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer.'$0$0$0$0$0In section 5.1 Pharmacodynamic Properties: The following information has been added:$0$0$0'In a phase IIIrandomized clinical trial including 970 patients with locally advanced prostatecancer (mainly T2c-T4 with some T1c to T2b patients with pathologicalregional nodal disease) of whom 483 were assigned to short-term androgensuppression (6 months) in combination with radiation therapy and 487 tolong-term therapy (3 years), a non-inferiority analysis compared the short‑termto long‑term concomitant and adjuvant hormonal treatment with triptorelin(62.2%) or goserelin (30.1%). The 5-year overall mortality was 19.0% and 15.2%,in the short-term and long-term groups, respectively. The observed Hazard Ratioof 1.42 with an upper one-sided 95.71% CI of 1.79 or two-sided 95.71%  CIof 1.09; 1.85 (p = 0.65 for non-inferiority), demonstrate that thecombination of radiotherapy plus 6 months of androgendeprivation therapy provides inferior survival as compared with radiotherapyplus 3 years of androgen deprivation therapy. Overall survival at 5 years of long-term treatment and short-termtreatment shows 84.8% survival and 81.0%, respectively.$0$0Overall quality of life using QLQ-C30 did notdiffer significantly between the two groups (p= 0.37).'$0$0
Updated on 04/10/2011 and displayed until 23/01/2012
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   14-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.4 (Special warnings and precuations for use):

Existing information has been reworded and expanded and new text has been added. Information regarding LHRH agonists reducing bone mineral density has been added; together with a statement that particular caution is necessary in patients with risk factors for, or established osteoporosis. 

A warning has been added that treatment with LHRH agonists may reveal the presence of a previously unknown gonadotroph cell pituitary adenoma and that mood changes, including depression have been reported.  Patients with known depression should be monitored closely during therapy.

The wording regarding the initial transient increase in serum testosterone on initiation of treatment and the subsequent exacerbation of symptoms of prostate cancer has changed slightly. The following wording has been added: “A small number of patients may experience a temporary worsening of signs and symptoms of their prostate cancer (tumour flare) and temporary increase in cancer related pain (metastatic pain), which can be managed symptomatically.”

In section 4.5 (Interaction with other medicinal products and other forms of interaction):

The following information has been added: “When Decapeptyl SR 22.5mg is co-administered with drugs affecting pituitary secretion of gonadotropins, caution should be exercised and it is recommended that the patient’s hormonal status be supervised.”

In section 4.8 (Undesirable effects):
Please refer to the SPC for a full list of changes.

In section 6.6 (Special precautions for disposal):

The following sentence: "The vial should be gently swirled until a homogeneous  suspension is formed, and the mixture then drawn back into the syringe without inverting the vial." has been changed to: "The vial should be shaken from side to side until a homogeneous  suspension is formed, and the mixture then drawn back into the syringe without inverting the vial."

 
Updated on 21/01/2011 and displayed until 04/10/2011
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  triptorelin pamoate