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Decapeptyl SR 22.5mg

Last Updated on eMC 06-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 06-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 06-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 4.2 - Posology and method of administration
  • 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: 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:

$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.

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, 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. $0

Updated on 23-Jan-2012 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: 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-Oct-2011 and displayed until 23-Jan-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-Jan-2011 and displayed until 04-Oct-2011

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO

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 pamoate

Legal categories

POM - Prescription Only Medicine

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