Prostap SR DCS

  • Name:

    Prostap SR DCS

  • Company:
    info
  • Active Ingredients:

    Leuprorelin Acetate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/08/19

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Summary of Product Characteristics last updated on medicines.ie: 22/8/2019

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Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 22 August 2019 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - dose and frequency
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 22 August 2019 SmPC

Reasons for 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

There has been an update to the Prostap SR and Prostap 3 SmPCs to add new indications of early and advanced breast cancer. Information has been added to sections 4.1, 4.2, 4.3, 4.4, and 4.8 .

Updated on 28 June 2018 SmPC

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

The updated Prostap DCS SmPCs contain additional information in the following section(s):

  • In section 4.8 (undesirable effects), interstitial lung disease has been added as a side effect with unknown frequency.
  • The date of revision is 09/06/2018.

Updated on 28 June 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 24 May 2018 SmPC

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The HPRA has approved the renewal of the licence for Prostap DCS.

Updated on 2 November 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 November 2016 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 7 March 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section

Details of change

4.4 Special warnings and precautions for use

Text in red added:

Postmarketing reports of seizures have been observed in patients treated with leuprorelin acetate and these events have been reported in both children and adults, and in those with or without a history of epilepsy, seizure disorders or risk disorders for seizures.

 

4.8 Undesirable effects

Text in red added

Nervous system disorders:

Common:  headache (occasionally severe)

Rare: dizziness

Very rare: pituitary apoplexy has been reported after administration of both short-and long acting GnRH agonists

Not known: paralysis, seizure

 

 

Nervous system disorders:          

Common: headache

Not known: seizure

 

10. Date of revision of the text

Updated text in red:

 

23 February 2016

Updated on 7 March 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 3 March 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 19 November 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.2, posology and method of administration, the text highlighted in red has been added in the male adults sections:

Male adults: The recommended dose is 3.75mg administered as a single subcutaneous or intramuscular injection every month.  The majority of patients will respond to a 3.75mg dose.  PROSTAP SR therapy should not be discontinued when remission or improvement occurs.

 

Response to PROSTAP SR therapy may be monitored by clinical parameters and by measuring serum levels of testosterone and acid phosphatase.  Clinical studies have shown that testosterone levels increased during the first 4 days of treatment in the majority of non-orchidectomised patients.  They then decreased and reached castrate levels in about 2-4 weeks.  Once attained, castrate levels were maintained as long as drug therapy continued.  Transient increases in acid phosphatase levels sometimes occur early in the treatment period but usually return to normal or near normal values by the 4th week of treatment.

 

In patients treated with GnRH analogues for prostate cancer, treatment is usually continued upon development of castrate-resistant prostate cancer. Reference should be made to relevant guidelines.

  

Updated on 9 October 2015 SmPC

Reasons for 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section

Details of change

4.1. Therapeutic indications

Added:

In children:

Treatment of central precocious puberty (girls under 9 years of age, boys under 10 years of age).

4.2. Posology and method of administration

Added:

Posology

 

Paediatric population:

The treatment of children with leuprorelin acetate should be under the overall supervision of the paediatric endocrinologist.

 

The dosing scheme needs to be adapted individually.

 

The recommended starting dose is dependent on the body weight.

 

Children with a body weight ≥ 20 kg

1 ml (3.75 mg leuprorelin acetate) suspension of 44.1 mg sustained-release microcapsules in 1 ml vehicle solution are administered once a month as a single subcutaneous injection.

 

Children with a body weight < 20 kg

In these rare cases the following dosage should be administered according to the clinical activity of the central precocious puberty:

0.5 ml (1.88 mg leuprorelin acetate) is administered once a month as a single subcutaneous injection.

The remainder of the suspension should be discarded. The child’s weight gain should be monitored.

Depending on the activity of the central precocious puberty, it may be necessary to increase the dosage in the presence of inadequate suppression (clinical evidence e.g. spotting or inadequate gonadotropin suppression in the LHRH test). The minimal effective monthly dose to be administered should then be determined by means of the LHRH test.

Sterile abscesses at the injection site often occurred when leuprorelin acetate was administered intramuscularly at higher than the recommended dosages. Therefore, in such cases, the medicinal product should be administered subcutaneously (see 4.4).

 

It is recommended to use the lowest volumes possible for injections in children in order to decrease the inconvenience which is associated with the intramuscular/subcutaneous injection.

 

The duration of treatment depends on the clinical parameters at the start of treatment or during the course of treatment (final height prognosis, growth velocity, bone age and/or bone age acceleration) and is decided by the treating paediatrician together with the legal guardian and, if appropriate, the treated child. The bone age should be monitored during treatment at 6-12 month intervals.

In girls with bone maturation of older than 12 years and boys with bone maturation of older than 13 years discontinuation of treatment should be considered taking into account the clinical parameters.

In girls, pregnancy should be excluded before the start of treatment. The occurrence of pregnancy during treatment cannot be generally excluded. In such cases, medical advice should be sought.

 

Note:

The administration interval should be 30 ± 2 days in order to prevent the recurrence of precocious puberty symptoms.

Removed:

Children: Safety and effectiveness in children have not been established.

4.3. Contraindications

Added:

In girls with central precocious puberty:

- Pregnancy and lactation

- Undiagnosed vaginal bleeding.

4.4.  Special warnings and precautions for use

 

Added:

In girls with central precocious puberty

Before starting the therapy, a precise diagnosis of idiopathic and/or neurogenic central precocious puberty is necessary.

 

The therapy is a long-term treatment, adjusted individually. PROSTAP SR should be administered as precisely as possible in regular monthly periods. An exceptional delay of the injection date for a few days (30 ± 2 days) does not influence the results of the therapy.

 

In the event of a sterile abscess at the injection site (mostly reported after i.m. injection of higher than the recommended dosage) the absorption of leuprorelin acetate from the depot can be decreased. In this case the hormonal parameters (testosterone, oestradiol) should be monitored at 2-week intervals (see 4.2).

 

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

 

The occurrence of vaginal bleeding, spotting and discharge after the first injection may occur as a sign of hormone withdrawal in girls. Vaginal bleeding beyond the first/second month of treatment needs to be investigated.

 

Bone mineral density (BMD) may decrease during GnRH 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 femoral epiphysis can be seen after withdrawal of GnRH treatment. The suggested theory is that the low concentrations of estrogen during treatment with GnRH agonists weakens 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.

4.8. Undesirable Effects

Added:

In Children:  In the initial phase of therapy, a short-term increase as flare-up of the sex hormone level occurs, followed by a decrease to values within the pre-pubertal range. Due to this pharmacological effect, adverse events may occur particularly at the beginning of treatment.

Immune system disorders:

Very rare: general allergic reactions (fever, rash, e.g. itching, anaphylactic reactions)

Psychiatric disorders:

Common: emotional lability

Nervous system disorders:

Common: headache

As with other medicinal products of this class, very rare cases of pituitary apoplexy have been reported following initial administration in patients with pituitary adenoma.

Gastrointestinal disorders:

Common: abdominal pain / abdominal cramps, nausea/vomiting

Skin and subcutaneous tissue disorders:

Common: acne

Reproductive system and breast disorders:

Common: vaginal bleeding, spotting, discharge

Note:

In general, the occurrence of vaginal spotting with continued treatment (subsequent to possible withdrawal bleeding in the first month of treatment) should be assessed as a sign of potential underdosage. The pituitary suppression should then be determined by an LHRH test.

General disorders and administration site conditions:

Common: injection site reactions.

5.1. Pharmacodynamic properties

Added:

In children:

Reversible suppression of pituitary gonadotropin release occurs, with a subsequent decrease in oestradiol (E2) or testosterone levels to values in the pre-pubertal range. 

Initial gonadal stimulation (flare-up) may cause vaginal bleeding in girls who are already post-menarchal at start of treatment. Withdrawal bleeding may occur at the start of treatment. The bleeding normally stops as treatment continues.

The following therapeutic effects can be demonstrated:

-           Suppression of basal and stimulated gonadotropin levels to pre-pubertal levels.

-           Suppression of prematurely increased sexual hormone levels to pre-pubertal levels and arrest of premature menstruation;

-           Arrest/involution of somatic pubertal development (Tanner stages);

-           Improvement/normalisation of the ratio of chronological age to bone age;

-           Prevention of progressive bone age acceleration;

-           Decrease of growth velocity and its normalization;

-           Increase in final height.

 

Treatment result is the suppression of the pathologically, prematurely activated hypothalamic-pituitary-gonadal axis according to pre-pubertal age.

 

In a long-term clinical trial in children treated with leuprorelin at doses up to 15mg monthly for > 4 years resumption of pubertal progression were observed after cessation of treatment. Follow up of 20 female subjects to adulthood showed normal menstrual cycles in 80% and 12 pregnancies in 7 of the 20 subjects including multiple pregnancies for 4 subjects.

5.2.  Pharmacokinetic properties

Added:

In children:

Figure 1 presents leuprorelin serum levels after a single s.c. administration of leuprorelin acetate depot at a dosage of 30 µg/kg body weight.  Peak serum levels are reached sixty minutes after administration (7.81 ± 3.59 ng/m)l.  The AUC0-672 is 105.78 ± 52.40 ng x hr/ml.

 

 


Figure 1: Leuprorelin serum levels after single s.c. administration of 30 µg/kg body weight of leuprorelin acetate as depot formulation (n=6) (Mean ± SD)

10. DATE OF REVISION OF THE TEXT

 

Changed to:

29th September 2015

Updated on 9 October 2015 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 3 July 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.2       Posology and method of administration

 

In patients treated with GnRH analogues for prostate cancer, treatment is usually continued upon development of castrate-resistant prostate cancer. Reference should be made to relevant guidelines.

 

5.1       Pharmacodynamic properties

Leuprorelin acetate is inactive when given orally.

In patients with metastatic castration resistant prostate cancer, clinical studies have shown benefit from the addition of secondary agents to treatment with LHRH agonists such as leuprorelin. Androgen deprivation therapy (ADT) is generally continued in conjunction with secondary therapies after progression on the initial ADT regimen.

10      DATE OF REVISION OF THE TEXT

                23 June 2015

Updated on 17 November 2014 SmPC

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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section

Details of change

4.4 Special warnings and precautions for use

Addition of text:

 

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 PROSTAP SR.

 

4.5       Interaction with other medicinal products and other forms of interaction

Addition of text:

 

Since androgen deprivation treatment may prolong the QT interval, the concomitant use of PROSTAP SR 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).

 

4.8       Undesirable effects

 

Addition of text:

 

under “Men”:

 

Frequency unknown:, QT prolongation (see sections 4.4 and 4.5)

 

 

10        DATE OF REVISION OF THE TEXT

 

 

31/10/2014

 

Updated on 17 November 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 2 October 2014 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 1 October 2014 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



SECTION 7. MARKETING AUTHORISATION HOLDER


Change of address of Marketing Authorisation Holder to: 
 

Takeda UK Limited

Building 3, Glory Park,

Glory Park Avenue,

Wooburn Green,

BUCKS,

HP10 0DF

 

SECTION 10. DATE OF REVISION OF THE TEXT

 

26/09/2014

Updated on 4 June 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 4 June 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 - how to report a side effect
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

The following highlighted text has been added 

Change to Section 2 an additional word "the" has been added: "For the full list of excipients, see section 6.1"

 

Change to Section 4.2 Additional highlighted text has been added: the word "posology" and the words "Method of"


4.2       Posology and method of administration

Posology

and 

Method of Administration


Change to Section 4.4
additional paragraphs have been added to 4.4 Special warnings and precautions for use, under the subheading "Men"

 

Long-term androgen deprivation either by bilateral orchiectomy or administration of GnRH analogues is associated with increased risk of bone loss which, in patients with additional risk factors, may lead to osteoporosis and increased risk of bone fracture.

 

Epidemiological data have shown that during androgen deprivation therapy changes in the metabolic condition (e.g. reduction in glucose tolerance or aggravation of pre-existing diabetes) as well as an increased risk for cardiovascular diseases may occur. 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 appropriately monitored.

 
Change to section 4.6 There is an
insertion of an additional word, "Fertility": 4.6       Fertility, pregnancy and lactation

Change to section 4.8
insertion of an additional paragraph at the end of section 4.8

 

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 to Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, IRL – Dublin 2. Tel: +353 1 6764971, Fax: +353 1 676 2517, Website: www.imb.ie. e-mail:imbpharmacovigilance@imb.ie. 

Change to section 6.6 insertion of the additional words as highlighted: 6.6       Special precautions for disposal and handling

 

Change to section 10 – date of revision of text is : 26/05/2014

Updated on 26 July 2013 PIL

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 7 May 2013 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes to sections 6.5 and 6.6 to reflect the addition of the new safety device to the Dual Chamber syringe.

6.5       Nature and contents of container

One dual chamber pre-filled syringe containing 11.25 mg leuprorelin acetate in the front chamber and 1 ml of aqueous sterile solvent in the rear chamber.

 

1 x 23 gauge syringe needle fitted with safety device

1 x syringe plunger

6.6       Special precautions for disposal

Always ensure the safety device to prevent needle-stick injury is deployed after injection.  For single use only. Discard any unused content. Any unused product or waste material should be disposed of in accordance with local requirements.

Updated on 22 June 2012 SmPC

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

The IMB has approved new versions of the Prostap DCS SmPCs. The updates are as follows:

 

1.      warning around injection site reactions in section 4.4 (Special warnings and precautions) : “In the rare event of an abscess occurring at the injection site, testosterone level should be monitored as there may be inadequate absorption of leuprorelin from the depot formulation.”

2.      Section 4.8- Undesirable effects have been updated to include the following adverse events:

        Uncommon: as with other medicinal products of this class, anaemia has been reported

        Rare: reactions at the injection site, e.g., induration, erythema, pain, abscesses, swelling, nodules, ulcers and necrosis have been reported rarely

 

Updated on 19 June 2012 SmPC

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

The IMB has approved new versions of the Prostap DCS SmPCs. The updates are as follows:

 

1.      warning around injection site reactions in section 4.4 (Special warnings and precautions) : In the rare event of an abscess occurring at the injection site, testosterone level should be monitored as there may be inadequate absorption of leuprorelin from the depot formulation.”

 

2.      Section 4.8- Undesirable effects have been updated to include the following adverse events:

Uncommon: as with other medicinal products of this class, anaemia has been reported

Rare: reactions at the injection site, e.g., induration, erythema, pain, abscesses, swelling, nodules, ulcers and necrosis have been reported rarely

Updated on 19 June 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 31 August 2011 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 30 August 2011 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided