Decapeptyl (triptorelin) 3-month
*Company:
Ipsen Pharmaceuticals LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 03 December 2024
File name
241126A ie-pl-clean-197_DEC11.25_IE.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update to add convulsion as warning and AE
Updated on 03 December 2024
File name
241126A ie-spc-clean-196_DEC11.25_IE.pdf
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
update to add convulsion as warning and AE
Updated on 01 September 2023
File name
230830A ie-clean-180_DEC11_IE.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 June 2023
File name
230505A ie-pl-clean-171_DEC11.25_IE.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change to section 2 – What you need to know before you use Decapeptyl 3-month – warnings and precautions
Change to section 4 – Possible side effects
Change to section 6 – Date of revision
Updated on 01 June 2023
File name
230505A ie-spc-clean-170_DEC11_IE.pdf
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to section 4.4 - Special warnings and precaution for use
Change to section 4.8 - Undesirable effects
Change to section 10 - Date of revision of the text
Updated on 17 May 2022
File name
220513A ie-pl-clean-164_DEC11.25.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change due to harmonisation of PIL
Free text change information supplied by the pharmaceutical company
1. What Decapeptyl is and what it is used for
- Definition of a very young age for boys and girls
2. What you need to know before you use Decapeptyl
Warnings and precautions
- Addition of the wording for depression monitoring
- Wording amended to "...at the site of the intramuscular injection."
- For women, addition of exemestane as an example of an aromatase inhibitor
- For women, addition of a warning concerning the use of Decapeptyl for underage girls
- Rewording of the paragraph concerning osteoporosis
- For women, addition of a warning for women with submucous fibroids after the bullet point on contraceptive pill
- For men, rewording of the paragraph concerning urinary obstruction and spinal cord compression
- For men, addition of the warning concerning the change in ECG after the bullet point on arrhythmia
- For women, moving of the warning for patients with heart problem to the Breast Cancer paragraph
- Addition of the warning concerning surgical castration and misleading diagnostic tests of gonadal functions or sex organs after the bullet point on benign tumour
- For children, addition of a warning concerning slipped capital femoral epiphysis of the hip
Other medicines and Decapeptyl
- Addition of a warning concerning medication for blood pressure control and management
Decapeptyl contains
- Rewording of the paragraph concerning sodium to comply with EU excipient guidelines
4. Possible side effects
- Addition of angioedema and anaphylactic reaction as examples of allergic reaction
- Addition of dizziness
- Addition of swelling of the ankles, feet or fingers as uncommon side effects
- Rewording of the definition of anaphylactic shock
- For children, rewording of hypersensitivity reactions to allergic reactions
Updated on 02 March 2022
File name
220224A ie-pl-clean-157_DEC11.25.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The following sections have been updated:
2 What you need to know before you use Decapeptyl
Section 2 has been updated to include the updated sodium warning.
4 Possible side effects
Section 4 has been updated to include additional information on side effects in post-marketing surveillance, including information on increased bleeding risk in the case of a pituitary tumour in both the “Men” and “Women” sections.
Information on exacerbated symptoms of endometriosis during the first weeks of treatment has also been added in the “Women” sub section.
Updated on 02 March 2022
File name
220224A ie-spc-clean-156_DEC11.pdf
Reasons for 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.3 - Preclinical safety data
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The following sections have been updated:
4.1 Therapeutic indications
“Precocious puberty” has been corrected to “Central precocious puberty”.
4.2 Posology and method of administration
Section 4.2 has been updated to add a warning for patients treated for endometriosis.
Section 4.2 has been updated to add a warning on co-administration with hormone replacement therapy.
4.4 Special warnings and precautions for use
Section 4.4 has been split into a section detailing special warnings and precautions in men and in women. Information on the loss of bone mineral density in women has been added.
The sub-heading “In paediatric populations” has been added to section 4.4. In addition the sodium content warning has been updated.
4.6 Fertility, pregnancy and lactation
Section 4.6 is being update to remove the information under the “fertility” sub-heading.
4.8 Undesirable effects
Information on the frequency of undesirable effects has been updated to include the frequency “not known (cannot be estimated from the available data)”.
The adverse event “pituitary apoplexy” has been added under “Endocrine disorders” with a frequency not known in the “General tolerance in men” and “General tolerance in women”. Information on the long term use of GnRH analogues in combination with radiotherapy has also been included.
Information under the “General tolerance in children” sub-heading has been updated.
4.9 Overdose
Section 4.9 has been updated to remove information related to animal data related to overdose.
5.3 Preclinical safety data
Section 5.3 has been updated to include information on mutagenicity in animal studies.
7. Marketing Authorisation Holder
Ipsen have taken this opportunity to correct the MAH name from “Ipsen Pharmaceuticals Ltd” to “Ipsen Pharmaceuticals Limited”
Updated on 18 February 2022
File name
ie-pl-clean_78.2_DEC11.25_IE_160106A.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - duration of treatment
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Reupload of the Decapeptyl 3-month PIL
Updated on 10 February 2022
File name
201112A ie-pl-clean- 139_DEC3.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - duration of treatment
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 10 May 2018
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 January 2016
File name
PIL_11295_595.pdf
Reasons for updating
- New PIL for new product
Updated on 21 January 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 January 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 4.2 Posology and Method of Administration
The following (bold) text was added:
Male Adults only: one intramuscular or subcutaneous injection every three months.
Endometriosis:
Female adults only: one intramuscular injection every three months.
Decapeptyl 3-month 11.25 mg must not be injected intravascularly.
Subcutaneous administration has not been studied in women and children.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
In Section 4.3 Contraindications -the text has been updated to read:
Hypersensitivity to GnRH (gonadotropin releasing hormone), its analogues or to any of the excipients listed in section 6.1.
In Section 4.8 Undesirable effects: The adverse events tables have been extensively updated. The most common undesirable effects now are:
Prostate cancer: Very common: Libido decreased, erectile dysfunction, asthenia, hyperhidrosis, back pain, paraesthesia in lower limbs and hot flush. Common: Hypersensitivity, hypertension, dry mouth, nausea, injection site reaction (including erythema, inflammation, pain), oedema, weight increased, musculoskeletal pain, pain in extremity, pelvic pain, dizziness, headache, depression, mood change and loss of libido. Endometriosis and uterine fibroids: Very common: Headache, libido decreased, sleep disorder (including insomnia), mood disorder, breast disorder, dyspareunia, genital bleeding (including vaginal bleeding, withdrawal bleed), ovarian hyperstimulation syndrome, ovarian hypertrophy, pelvic pain, vulvovaginal dryness, asthenia, acne, seborrhoea, hyperhidrosis and hot flush. Common: Hypersensitivity, nausea, abdominal pain, abdominal discomfort, injection site reaction (including erythema, inflammation, swelling, pain), oedema peripheral, weight increased, arthralgia, muscle spasms, pain in extremities, depression, nervousness, dizziness and breast pain. Precocious puberty: Very common: Vaginal bleeding (including discharge, spotting, haemorrhage, withdrawal bleed, uterine haemorrhage). Common: Abdominal pain, acne, injection site reaction (including erythema, inflammation, pain), headache, hot flush, weight increased and hypersensitivity.
Section 5.1 Pharmacodynamic Properties was updated with technical information surmising that:
In men, administration via subcutaneous route or intramuscular route achieved similar results (about 20 days to achieve castration level and castration still maintained 3 months after administration).
In Section 5.2 Pharmacokinetic Properties:
The following text was added:
The pharmacokinetic properties following subcutaneous injection of Decapeptyl
3-month11.25 mg in men are similar to those observed after intramuscular injection: the plasma concentration peak of triptorelin is rapidly achieved after the administration (median Tmax ranged from 2.0 to 4.5 h, whatever the route of administration subcutaneous or intramuscular) and triptorelin is continuously released over the 91-day period. Three months after subcutaneous or intramuscular administration, the residual levels of triptorelin (Cmin) were similar (0.062 ng/ml for subcutaneous route, 0.032-0.063 ng/ml for intramuscular route).
In Section 6.6 Special precautions for disposal and other handling: the text has been updated to differentiate between reconstitution needle and administration needle(s) (with safety device):
The suspension for injection must be reconstituted using an aseptic technique and only using the ampoule of solvent for injection.
The instructions for reconstitution hereafter and in the leaflet must be strictly followed.
The solvent should be drawn into the syringe provided using the reconstitution needle (20 G, without safety device) and transferred to the vial containing the powder. The suspension should be reconstituted by swirling the vial gently from side to side for long enough until a homogeneous, milky suspension is formed. Do not invert the vial.
It is important to check there is no unsuspended powder in the vial. The suspension obtained should then be drawn back into the syringe, without inverting the vial. The reconstitution needle should then be changed and the suspension should be injected immediately using the specific injection needle:
- The 38 mm length needle (20 G) with safety device for intramuscular injection in the gluteal muscle (patients treated for prostate cancer, endometriosis or central precocious puberty)
- The 25 mm length needle (20 G) with safety device for subcutaneous injection in abdomen or thigh (only patients treated for prostate cancer).
As the product is a suspension, the injection should be administered immediately after reconstitution to prevent precipitation.
For single use only.
Used needles, any unused suspension or other waste materials should be disposed of in accordance with local requirements.
Updated on 21 January 2016
Reasons for updating
- Change to side-effects
- Change to dosage and administration
- Change to improve clarity and readability
Updated on 20 February 2015
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 Addition of:
Androgen deprivation therapy may prolong the QT interval.
In 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 6 month
Section 4.5 Addition of:
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Decapeptyl 6 Month 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).
Section 4.8 Addition of QT prolongation in AE table as an Adverse Event - SOC Cardiac Disorders - Frequency unknown as below:
|
System Organ Class |
Very Common AEs |
Common AEs |
Uncommon AEs |
Rare AEs |
Additional post-marketing AEs |
|
|
≥10% |
≥1% -<10% |
≥0.1% -<1% |
≥0.01% -<0.1% |
Frequency Unknown |
|
|
|
|
|
||
|
Cardiac Disorders |
|
|
|
|
QT prolongation (see sections 4.4 and 4.5) |
Updated on 17 February 2015
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 24 October 2013
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 17 May 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about driving or using machinery
- Change to MA holder contact details
- Change due to user-testing of patient information
Updated on 07 May 2013
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 25 January 2012
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 27 June 2011
Reasons for updating
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 21 June 2011
Reasons for updating
- Change to improve clarity and readability
Updated on 26 April 2011
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
2 Qualitative and quantitative composition
Excipients:
Sodium < 1mmol (23mg)
4.4 Special warnings and special precautions for use
Excipients:
This medicinal product contains less than 1mmol sodium (23mg) per dose and is considered essentially ‘sodium-free’.
Updated on 05 April 2011
Reasons for updating
- Change of inactive ingredient
Updated on 27 May 2010
Reasons for updating
- Improved electronic presentation
Updated on 26 May 2010
Reasons for updating
- Change to appearance of the medicine
- Change to dosage and administration
- PIL retired pending re-submission
Updated on 23 July 2009
Reasons for updating
- Change to dosage and administration
Updated on 16 July 2009
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The shelf life expiry date of the powder for injection shall not exceed three years from the date of its manufacture.
The shelf life expiry date of the solvent shall not exceed five years from the date of its manufacture.
The product should be used immediately after reconstitution.
Updated on 27 August 2008
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 27 August 2008
Reasons for updating
- Change to date of revision
Updated on 25 January 2007
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 25 August 2006
Reasons for updating
- Correction of spelling/typing errors
Updated on 23 August 2006
Reasons for updating
- New PIL for medicines.ie
Updated on 19 May 2005
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 August 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)