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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

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 21/06/2011
SPC Decapeptyl SR 3mg

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 21/06/2011 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:   09-May-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 wording has been added:

As adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer.


In section 5.1 Pharmacodynamic properties:

Data on the efficacy of triptorelin as adjuvant treatment to radiotherapy has been added.
Updated on 07/01/2011 and displayed until 21/06/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2 Posology and method of administration

 

Prostate cancer

The following wording has been added:

Decapeptyl is also available as a 3-month treatment (Decapeptyl SR 11.25mg) and as a 6-month treatment (Decapeptyl SR 22.5mg) for prostate cancer.

 

Endometriosis and uterine fibroids

Wording altered slightly as follows:

A further course of treatment by Decapeptyl SR 3mg or by other GnRH agonists beyond 6 months should not be undertaken due to concerns about bone density losses.

The following wording added:

Decapeptyl is also available as a 3-month treatment (Decapeptyl SR 11.25mg) for endometriosis.

  

Section 4.3 Contraindications

The contra-indication to treatment in patients presenting with spinal cord compression or evidence of spinal metastases has been removed and this information has instead been included under Section 4.4 Special warnings and precautions for use. Pregnancy and lactation have been included as a contra-indication to treatment.

Section 4.4 Special warnings and precautions for use

This section has a number of changes. Existing information has been reworded and expanded and new text has been added.

Information regarding GnRH 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 that it should be confirmed that the patient is not pregnant before prescribing Decapeptyl SR has been added, as well as the fact that treatment with GnRH 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.

Prostate cancer

The wording regarding the initial transient increase in serum testosterone on initiation of treatment has changed slightly. The recommendation to use an anti-androgen for 3 days prior to Decapeptyl has been altered to:

 During the initial phase of treatment, consideration should be given to the additional administration of a suitable anti-androgen…..

The following wording has been added to the precautions regarding patients with spinal cord compression or urethral obstruction:

If spinal cord compression or renal impairment develops, standard treatment of these complications should be instituted, and in extreme cases an immediate orchidectomy (surgical castration) should be considered.

The following additional wording regarding bone loss has been added:

Long-term androgen deprivation either by bilateral orchidectomy or administration of GnRH agonists is associated with increased risk of bone loss and may lead to osteoporosis and increased risk of bone fracture.

An additional precaution for patients at high risk for metabolic or cardiovascular diseases has been added as follows:

In addition, from epidemiological data, it has been observed that patients may experience metabolic changes (e.g. glucose intolerance), or an increased risk of cardiovascular disease during androgen deprivation therapy. However, prospective data did not confirm the link between treatment with GnRH analogues and an increase in cardiovascular mortality. Patients at high risk for metabolic or cardiovascular diseases should be carefully assessed before commencing treatment and their glucose, cholesterol and blood pressure adequately monitored during androgen deprivation therapy.

Metabolic changes may be more severe in these high risk patients. Patients at high risk of metabolic or cardiovascular disease and receiving androgen deprivation therapy should be monitored at appropriate intervals not exceeding 3 months.

Endometriosis and Uterine Fibromyomas

Additional information regarding GnRH treatment resulting in reduced bone mineral density and increased fracture risk has been added.

The statement regarding use of non-hormonal contraception during the first month of treatment has been removed and the following statement added:

A non-hormonal method of contraception should be used throughout treatment including for 1 month after the duration of the last injection.

A recommendation that the size of the fibroid is determined regularly during treatment of uterine fibroids has been added. 
 

Section 4.5  Interactions with other medicinal products and other forms of interaction

The following data has been added:

When Decapeptyl SR 3mg 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.

 

Section 4.6  Pregnancy and lactation

The following data has been added:

Triptorelin should not be used during pregnancy since concurrent use of GnRH agonists is associated with a theoretical risk of abortion or foetal abnormality. Prior to treatment, potentially fertile women should be examined to exclude pregnancy. Non-hormonal methods of contraception should be employed during therapy until menses resume.

 

Section 4.7  Effects on ability to drive and use machines

The following data has replaced the existing statement that there is no evidence that Decapeptyl SR has any effect on the ability to drive or operate machinery:

No studies on the effects on the ability to drive and use machines have been performed. However, the ability to drive and use machines may be impaired should the patient experience dizziness, somnolence and visual disturbances (being possible undesirable effects of treatment), or resulting from the underlying disease.

 

Section 4.8  Undesirable effects

The format of this section has been updated to bring it in line with regulatory recommendations, in that it now lists undesirable effects according to their frequency. The updated SPC contains a more exhaustive list of undesirable effects reported during clinical trials and post-marketing use as compared with the previous document. 

Please refer to the updated SPC for the full list of undesirable effects which have been reported with Decapeptyl SR 3mg.

 

Section 6.3 Shelf life

The shelf life for Decapeptyl SR 3mg has been extended from 18 months to 3 years. 


Section 6.6 Special precautions for disposal

This section has been updated with an instruction that the vial should be shaken from side to side, rather than ‘gently swirled’ as in the previous SPC. 

 

Section 8 Marketing authorisation number(s)

The product licence number has changed:

 

Decapeptyl SR 3mg - PL 34926/0002

Section 10 Date of revision of the text

 

Changed to 18 November 2010 
Updated on 30/03/2010 and displayed until 07/01/2011
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • 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:   13-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 6.5 the following text has been added:  Box containing 1 vial and 1 ampoule with 1 syringe and 2 needles.

In section 6.6 the following text has been added: 

The suspension for injection must be reconstituted using an aseptic technique and only using the ampoule of mannitol solution 0.8% for injection that is provided as the suspension vehicle for DECAPEPTYL SR 3mg.

The suspension vehicle should be drawn into the syringe provided using one of the injection needles and transferred to the vial containing the powder for injection. 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. The injection needle should then be changed and the second needle used to administer the injection. As the product is a suspension, the injection should be administered immediately after reconstitution to prevent sedimentation. To ensure patients receive the correct dose, each vial of DECAPEPTYL contains a small overage to allow for predictable losses on reconstitution and injection.

The vial is intended for single use only and any remaining product should be discarded.
Updated on 25/06/2008 and displayed until 30/03/2010
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   01-Oct-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 6.5, the inclusion of the safety shield on the injection needle has been added.
Updated on 20/03/2007 and displayed until 25/06/2008
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
  section 4.1  wordings for existing prostate cancer indication has been revised.
 
 section 5.1 additional information from clinical studies conducted on prostate cancer has been included.
Updated on 14/03/2007 and displayed until 20/03/2007
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
 section 4.1 the existing indication wordings for prostate cncer has been revised.
 section 5.1 detailed information of the outcome of clinical studies on prostate cancer is included.
Updated on 14/03/2007 and displayed until 14/03/2007
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
  Section 4.1 existing indication wordings for prostate cancer has been revised.
 
 Section 5.1 more detailed information of clinical studies conducted for prostate cancer indication has been added.
Updated on 23/09/2005 and displayed until 14/03/2007
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.3 - Contra-indications
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Improved Electronic Presentation
Updated on 19/09/2003 and displayed until 23/09/2005
Reasons for adding or updating:
  • Change to section 1 - trade name
Updated on 23/05/2002 and displayed until 19/09/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 21/05/2002 and displayed until 23/05/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 13/08/2001 and displayed until 21/05/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 04/02/2000 and displayed until 13/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 04/02/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  triptorelin acetate