Decapeptyl 6 Month 22.5mg

update to variation to add convulsion as warning and AE

Update variation to add convulsion as warning and AE

Change to section 2 – What you need to know before you use Decapeptyl 6-month – warnings and precautions

Change to section 4 – Possible side effects

Change to section 6 – Date of revision

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

The following sections have been updated:

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 the “Men” section.

The following sections have been updated:

4.2 Posology and method of administration 

“Precocious puberty” has been corrected to “Central precocious puberty

4.5 Interaction with other medicinal products and other forms of interaction 

The sub-heading Paediatric populations has been added with information on interaction studies being performed in adults only.

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” section. Information on the long term use of GnRH analogues in combination with radiotherapy has also been included.

(For 11.25 mg strength only) Information under the “General tolerance in children” sub-heading has been updated.

6.5 Nature and contents of the container

Information on the appearance of the vial powder and solvent ampoule has been added.

7. Marketing Authorisation Holder

Ipsen have taken this opportunity to correct the MAH name from “Ipsen Pharmaceuticals Ltd” to “Ipsen Pharmaceuticals Limited”

The following changes have been made to the PIL:

1 What Decapeptyl 6-month is and what it is used for

Section 1: The sentence relating to use in children 2 years of age and older has been re-phrased so that the words 2 years of age and older are at the start of the sentence in line with the approved common RMS text.

2 What you need to know before you use Decapeptyl 6-month

Section 2 has been corrected by inclusion of additional text relating to pregnancy and breast-feeding.

4 Possible side effects

Section 4 has been corrected by moving the information relating to the development of a severe allergic reaction in rare cases from the middle of section 4 up to the top of section 4. The uncommon side effects in children section has been corrected by amending weight increased to overweight. The post-marketing surveillance side effects in children section has also been amended.

The name of the product has been corrected from Decapeptyl 6 Month to Decapeptyl 6-month in line with the approved MAA..

The following changes have been made to the SmPC:

- Section 4.2 has been corrected by the addition of the sentence: Decapeptyl 6-month must be administered under the supervision of a physician.

- Section 4.6 has been corrected by addition of the sentences: Decapeptyl 6-month is indicated for adult men and children. There are very limited data on the use of triptorelin in pregnant women.

- Section 6.6 has been amended to include the words medicinal product in the sentence: Used needles, any unused medicinal product or suspension or other waste materials should be disposed of in accordance with local requirements.

The MAH has also taken this opportunity to correct the name of the product from Decapeptyl 6 Month to Decapeptyl 6-month in line with the approved MAA.

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.
In Section  6.6 Special precautions for disposal and other handling: the text has been updated to differentiate between reconstitution needle and administration needle (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 injection needle (20 G, with safety device) used to administer the product.

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.

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: