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Decapeptyl SR 11.25mg

Last Updated on eMC 05-May-2016 View document  | Ipsen Ltd Contact details

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 05-May-2016 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 29-Apr-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.3: change to warning relating to excipients
Section 4.8: inclusion of wording and update to AE table based on clinical data
Section 6.6: revision of reconstitution instructions folowing introduction of safety device for needle for injection

Updated on 04-Jun-2015 and displayed until 05-May-2016

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 - how to report a side effect
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 15-May-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

$0In section 4.4 Special Warnings and Precautions for Use – The following information has been added to the prostate cancer subsection:$0$0“Androgen deprivation therapy may prolong the QT interval. $0$0In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval (see section 4.5) physicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating Decapeptyl SR 3 mg.”$0$0In section 4.5 Interaction With Other Medicinal Products and Other Forms of Interaction – The following information has been added:$0$0“Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Decapeptyl SR 3 mg with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide ) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated (see section 4.4).”$0$0In section 4.8 Undesirable Effects – In the general tolerance in men subsection, the following AE has been added to the Additional post-marketing AEs column under cardiac disorders: “QT prolongation (frequency unknown) (see sections 4.4 and 4.5)”$0$0The MHRA Yellowcard website address has been added to the reporting of suspected adverse drug reactions subsection.$0

Updated on 20-May-2014 and displayed until 04-Jun-2015

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC: 01-May-2014

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) under the subheading Prostate Cancer, the following information has been added:

In patients treated with GnRH analogues for metastatic prostate cancer, treatment

is usually continued upon development of castrate-resistant prostate cancer.

Reference should be made to relevant guidelines.


In section 4.8 (Undesirable effects) the following information 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:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Updated on 17-May-2013 and displayed until 20-May-2014

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: 02-May-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

$0$0$0$0$0$0$0In section 4.1 TherapeuticIndications: Thefollowing text has been added:$0$0Asneoadjuvant treatment prior to radiotherapy in patients with high-risklocalised or locally advanced prostate cancer.$0$0As adjuvanttreatment to radical prostatectomy in patients with locally advanced prostatecancer at high risk of disease progression.$0$0In section 5.1 PharmacodynamicProperties: Thefollowing text has been added:$0$0Neoadjuvant triptorelin prior toradiotherapy has been shown to significantly reduce prostate volume.$0Theuse of a GnRH agonist may be considered after radical prostatectomy in selectedpatients considered at high risk of disease progression. There are nodisease-free survival data or survival data with triptorelin in this setting.$0$0$0$0$0$0

Updated on 07-Mar-2013 and displayed until 17-May-2013

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • 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: 21-Aug-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

$0$0In section 4.4 Special warnings andprecautions for use:$0$0$0The following information has been added - "There is an increasedrisk of incident depression (which may be severe) in patients undergoingtreatment with GnRH agonists, such as triptorelin. Patients should be informedaccordingly and treated as appropriate if symptoms occur."$0$0The following sentence has been removed - "Mood changes, includingdepression have been reported."$0$0$0In section 4.8 Undesirable effects:$0$0$0In the AE table for men, depression has moved from an uncommon to commonAE. Mood swings has been removed from the uncommon AE column and mood changeshas been added as a common AE. In the AE table for women, depression has beenadded as an uncommon AE for short-term use and as a common AE for long-termuse.$0

Updated on 21-Jun-2011 and displayed until 07-Mar-2013

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-Jan-2011 and displayed until 21-Jun-2011

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 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. 4 - Special Precautions for Storage
  • 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 4.1 Therapeutic indications

The onset age for boys for precocious puberty has changed from 9 years to 10 years.

 

Section 4.2 Posology and method of administration

Prostate cancer

The following wording has been added:

Decapeptyl is also available as a 1-month treatment (Decapeptyl SR 3mg) and as a 6-month treatment (Decapeptyl SR 22.5mg) for prostate cancer.

 

 

Endometriosis

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 1-month treatment (Decapeptyl SR 3mg) for endometriosis.

 

Precocious puberty

A reminder that treatment should be before 8 years in girls and 10 years in boys has been added, as well as a statement that the treatment of children with Decapeptyl SR 11.25mg should be under the overall supervision of a paediatric endocrinologist or of a paediatrician or endocrinologist with expertise in the treatment of central precocious puberty.

 

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

Additional information regarding GnRH treatment resulting in reduced bone mineral density 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 3 months after the duration of the last injection. 

 

Precocious puberty

The following data has been added:

Treatment of children with progressive brain tumours should follow a careful individual appraisal of the risks and benefits.

In girls, initial ovarian stimulation at treatment initiation, followed by the treatment-induced oestrogen withdrawal, may lead, in the first month, to vaginal bleeding of mild or moderate intensity.

After discontinuation of treatment the development of puberty characteristics will occur.

Information with regards to future fertility is still limited. In most girls, regular menses will start on average one year after ending the therapy.

Pseudo-precocious puberty (gonadal or adrenal tumour or hyperplasia) and gonadotropin-independent precocious puberty (testicular toxicosis, familial Leydig cell hyperplasia) should be precluded.

Bone mineral density may decrease during GnRH agonist therapy for central precocious puberty. However, after cessation of treatment subsequent bone mass accrual is preserved and peak bone mass in late adolescence does not seem to be affected by treatment.

Slipped capital femoral epiphysis can be seen after withdrawal of GnRH agonist treatment. The suggested theory is that the low concentrations of oestrogen during treatment with GnRH agonists weaken the epiphysial plate. The increase in growth velocity after stopping the treatment subsequently results in a reduction of the shearing force needed for displacement of the epiphysis.

 

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

The following data has been added:

When Decapeptyl SR 11.25mg 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 11.25mg.

  

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 11.25mg - PL 34926/0003


Section 10 Date of revision of the text
Changed to 18 November 2010 

 

Updated on 23-Mar-2010 and displayed until 07-Jan-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 (Nature and contents of container) the following text has been added: Box containing 1 vial and ampoule with 1 syringe and 2 needles.

In section 6.6 (Special precautions for disposal) 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 11.25mg. 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 16-Sep-2009 and displayed until 23-Mar-2010

Reasons for adding or updating:

  • 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: 16-Mar-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Sections 9 (Date of first authorisation/renewal of the authorisation) and 10 (date of revision of the text) updated following licence renewal.

No changes to other sections.

Updated on 25-Jun-2008 and displayed until 16-Sep-2009

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 a safety shield on the injection needle has been added.

Updated on 20-Mar-2007 and displayed until 25-Jun-2008

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications

Date of revision of text on the SPC: 01-Feb-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

 section 4.1 wordings for prostate cancer has been revised.
 section 5.1 additional information from clinical studies conducted on prostate cancer is included in this section.

Updated on 20-Mar-2007 and displayed until 20-Mar-2007

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications

Date of revision of text on the SPC: 01-Feb-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

 section 4.1 the wordings for existing prostate cancer indication has been revised.
 
 section 5.1 additional information from the clinical studies conducted on prostate cancer has been included in this section.

Updated on 14-Mar-2007 and displayed until 20-Mar-2007

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications

Date of revision of text on the SPC: 01-Feb-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

 section 4.1 existing prostate cancer indication wordings has been revised.
 section 5.1 additional information of clinical studies on prostate cancer indication has been added.

Updated on 09-Jun-2006 and displayed until 14-Mar-2007

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 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text

Date of revision of text on the SPC: 05-Feb-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.1 - Addition of precocious puberty as a therapeutic indication.
 
Section 4.2 - Posology and method of administration for precocious puberty.
 
Section 4.4 - Special warnings and precaution for use with precocious puberty.
 
Section 4.8 - Undersirable effects re: precocious puberty.
 
Section 5.1 - Pharmacodynamic properties - addition of precocious puberty.
 
Section 10 - Amendment to date of revision of text.

Updated on 08-Jun-2006 and displayed until 09-Jun-2006

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
  • Change to section 10 (date of (partial) revision of the text
  • Change to section 4.1 - Therapeutic Indications

Date of revision of text on the SPC: 05-Feb-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.1  (Therapeutic Indications).  Addition of treatment of precocious puberty (onset before 8 years in girls and 9 years in boys).
 
Section 4.2  Addition of paragraph on precocious puberty. 
 
Section 4.4 Addition of paragraph on precocious puberty in girls.
 
Section 4.8 Additional paragraph on precocious puberty.
 
Section 5.1 Additional paragraph on precocious puberty.
 
Section 10  Revision of date of text.
 

Updated on 31-Jan-2005 and displayed until 08-Jun-2006

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 4.3 - Contra-indications
  • 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 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties

Updated on 19-Jan-2004 and displayed until 31-Jan-2005

Reasons for adding or updating:

  • New SPC for new product

Company contact details

Ipsen Ltd

Company image
Address

190 Bath Road, Slough, Berkshire, SL1 3XE

Fax

+44 (0)1753 627 778

Medical Information e-mail
Telephone

+44 (0)1753 627 777

Medical Information Direct Line

+44 (0)1753 627 777

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?

Active ingredients

triptorelin acetate

Legal categories

POM - Prescription Only Medicine

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