FIRMAGON 120 mg powder and solvent for solution for injection

  • Name:

    FIRMAGON 120 mg powder and solvent for solution for injection

  • Company:
    info
  • Active Ingredients:

    degarelix acetate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Summary of Product Characteristics last updated on medicines.ie: 10/5/2018
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Ferring Ireland Limited

Ferring Ireland Limited

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1 - 0 of 35 items.Total: Infinity pages

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 10 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 22 December 2014 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 22 December 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2:
Sentence updated to "240 mg administered as two consecutive subcutaneous injections of 120 mg each"

Section 4.8.
New sentence added to Summary of the Safety Profile:
"Serious injection site reactions were very rarely reported such as injection site infection, injection site abscess or injection site necrosis that could require surgical treatment/drainage."

Updated on 22 December 2014 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Free text change information supplied by the pharmaceutical company

Section 4.2:
Sentence updated to "240 mg administered as two consecutive subcutaneous injections of 120 mg each"

Section 4.8.
New sentence added to Summary of the Safety Profile:
"Serious injection site reactions were very rarely reported such as injection site infection, injection site abscess or injection site necrosis that could require surgical treatment/drainage."

Updated on 9 December 2013 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 3:

Text deleted: … (powder for injection and solvent).

 

Section 4.2

Word deleted: Special patient populations


New text deleted/added: There is no relevant use indication for use of FIRMAGON in children and adolescents in the treatment of adult male patients with advanced hormone-dependent prostate cancer.


Text removed:

As with other medicinal products administered by subcutaneous injection,

There is no relevant indication for use of FIRMAGON in women, children and adolescents.

 

Section 4.4:

ECG expanded – electrocardiograms


Text added:

Cardiovascular disease

Cardiovascular disease such as stroke and myocardial infarction has been reported in the medical literature in patients with androgen deprivation therapy. Therefore, all cardiovascular risk factors should be taken into account.

 

Section 4.5:

Deleted:  Cisapride

 

Section 4.7:

Text deleted: No studies on the effects of degarelix on the ability to drive and use machines have been performed. However,….


Text added:
FIRMAGON has no or negligible influence on the ability to drive and use machines

 

 

Section 4.8:

Adverse events replaced by adverse reactions throughout

 

Table 1 heading is updated to reflect that the table now includes reports from post-marketing experience

 

Additional column in Table 1 added: Rare events listing ‘neutropenic fever’, ‘anaphylactic reactions’, ‘myocardial infarction’, ‘cardiac failure’.

 

Text deleted: The following reactions have been reported as being related to treatment in single patients: Febrile neutropenia, myocardial infarction and congestive heart failure. Rare reports of anaphylactic reactions have been received from post-marketing use of FIRMAGON.

 

Text added:

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 preferably through the online reporting option accessible from the IMB homepage. A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’. Alternatively, the traditional post-paid ‘yellow card’ option may also continue to be used.

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O’Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

 

 

Section 5.1:


Title added: Mechanism of action


Text added:

Paediatric population

The European Medicines Agency has waived the obligation to submit the results of studies with FIRMAGON in all subsets of the paediatric population (see section 4.2 for information on paediatric use).

 

 Section 6.5:


Text deleted:

1 pack containing 2 powder vials, 2 solvent pre-filled syringes, 2 plunger rods, 2 vial adapters and 2 needles.


Text added:

Pack-size of 2 trays containing 2 powder vials, 2 solvent pre-filled syringes, 2 plunger rods, 2 vial adapters and 2 needles

 

Section 6.6:

Repeated paragraph deleted (see section 6.3):

Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC. From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

 

Updated on 9 December 2013 PIL

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

Section 3:

Text deleted: … (powder for injection and solvent).

 

Section 4.2

Word deleted: Special patient populations


New text deleted/added: There is no relevant use indication for use of FIRMAGON in children and adolescents in the treatment of adult male patients with advanced hormone-dependent prostate cancer.


Text removed:

As with other medicinal products administered by subcutaneous injection,

There is no relevant indication for use of FIRMAGON in women, children and adolescents.

 

Section 4.4:

ECG expanded – electrocardiograms


Text added:

Cardiovascular disease

Cardiovascular disease such as stroke and myocardial infarction has been reported in the medical literature in patients with androgen deprivation therapy. Therefore, all cardiovascular risk factors should be taken into account.

 

Section 4.5:

Deleted:  Cisapride

 

Section 4.7:

Text deleted: No studies on the effects of degarelix on the ability to drive and use machines have been performed. However,….


Text added:
FIRMAGON has no or negligible influence on the ability to drive and use machines

 

 

Section 4.8:

Adverse events replaced by adverse reactions throughout

 

Table 1 heading is updated to reflect that the table now includes reports from post-marketing experience

 

Additional column in Table 1 added: Rare events listing ‘neutropenic fever’, ‘anaphylactic reactions’, ‘myocardial infarction’, ‘cardiac failure’.

 

Text deleted: The following reactions have been reported as being related to treatment in single patients: Febrile neutropenia, myocardial infarction and congestive heart failure. Rare reports of anaphylactic reactions have been received from post-marketing use of FIRMAGON.

 

Text added:

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 preferably through the online reporting option accessible from the IMB homepage. A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’. Alternatively, the traditional post-paid ‘yellow card’ option may also continue to be used.

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O’Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

 

 

Section 5.1:


Title added: Mechanism of action


Text added:

Paediatric population

The European Medicines Agency has waived the obligation to submit the results of studies with FIRMAGON in all subsets of the paediatric population (see section 4.2 for information on paediatric use).

 

 Section 6.5:


Text deleted:

1 pack containing 2 powder vials, 2 solvent pre-filled syringes, 2 plunger rods, 2 vial adapters and 2 needles.


Text added:

Pack-size of 2 trays containing 2 powder vials, 2 solvent pre-filled syringes, 2 plunger rods, 2 vial adapters and 2 needles

 

Section 6.6:

Repeated paragraph deleted (see section 6.3):

Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC. From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

 

Updated on 4 September 2013 PIL

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Free text change information supplied by the pharmaceutical company

New sentence added: “No testosterone microsurges were observed after re-injection during degarelix treatment.

 

New sections added:

Testosterone Reversibility

In a study involving patients with rising PSA after localised therapy (mainly radical prostatectomy and radiation) were administered FIRMAGON for seven months followed by a seven months monitoring period. The median time to testosterone recovery (>0.5 ng/mL, above castrate level) after discontinuation of treatment was 112 days (counted from start of monitoring period, i.e 28 days after last injection). The median time to testosterone >1.5 ng/mL (above lower limit of normal range) was 168 days.”

 

Effect on prostate volume

Three months therapy with degarelix (240/80 mg dose regimen) resulted in a 37% reduction in prostate volume as measured by trans-rectal ultrasound scan (TRUS) in patients requiring hormonal therapy prior to radiotherapy and in patients who were candidates for medical castration. The prostate volume reduction was similar to that attained with goserelin plus anti-androgen protection.

 

Text update:

“Anti-degarelix antibodies

Anti-degarelix antibody development has been observed in 10% of patients after treatment with FIRMAGON for one year and 29% of patients after treatment with FIRMAGON for up to 5.5 years. There is no indication that the efficacy or safety of FIRMAGON treatment is affected by antibody formation after up to 5.5 years of treatment.”

Updated on 4 September 2013 SmPC

Reasons for updating

  • 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

New sentence added: “No testosterone microsurges were observed after re-injection during degarelix treatment.

 

New sections added:

Testosterone Reversibility

In a study involving patients with rising PSA after localised therapy (mainly radical prostatectomy and radiation) were administered FIRMAGON for seven months followed by a seven months monitoring period. The median time to testosterone recovery (>0.5 ng/mL, above castrate level) after discontinuation of treatment was 112 days (counted from start of monitoring period, i.e 28 days after last injection). The median time to testosterone >1.5 ng/mL (above lower limit of normal range) was 168 days.”

 

Effect on prostate volume

Three months therapy with degarelix (240/80 mg dose regimen) resulted in a 37% reduction in prostate volume as measured by trans-rectal ultrasound scan (TRUS) in patients requiring hormonal therapy prior to radiotherapy and in patients who were candidates for medical castration. The prostate volume reduction was similar to that attained with goserelin plus anti-androgen protection.

 

Text update:

“Anti-degarelix antibodies

Anti-degarelix antibody development has been observed in 10% of patients after treatment with FIRMAGON for one year and 29% of patients after treatment with FIRMAGON for up to 5.5 years. There is no indication that the efficacy or safety of FIRMAGON treatment is affected by antibody formation after up to 5.5 years of treatment.”

Updated on 26 June 2013 PIL

Reasons for 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

Free text change information supplied by the pharmaceutical company

Section 4.2:

-          ‘Elderly’ is changed to ‘Older’

 

Section 4.4:

-          Sentence deleted: The data available on efficacy and safety experience with degarelix is limited to a one year treatment.

 

-          Sentence inserted: A thorough QT study showed that there was no intrinsic effect of degarelix on QT/QTc interval (see section 4.8).

 

Section 4.6:

-          Sentence inserted: FIRMAGON may inhibit male fertility as long as the testosterone is suppressed.

 

Section 4.8:

-          Sentence inserted:  Rare reports of anaphylactic reactions have been received from post-marketing use of FIRMAGON.

 

-          Additional information inserted under ‘Changes in ECG measurement’: The lack of intrinsic effect of degarelix on cardiac repolarisation (QTcF), heart rate, AV conduction, cardiac depolarisation, or T or U wave morphology was confirmed in a thorough QT study in healthy subjects (N=80) receiving an i.v. infusion of degarelix over 60 min, reaching a mean Cmax of 222 ng/mL, approx. 3-4-fold the Cmax obtained during prostate cancer treatment.

 

-          New section in relation to adverse event reporting:

 

                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 via the national reporting system as follows:

                Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace,  Dublin 2

                Tel: +353 1 6764971; Fax: +353 1 6767836; Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie

 

 

Section 5.2:

-          Sentence updated to: Cmax degarelix plasma concentration decreases in a biphasic fashion, with a mean terminal half-life (t½) of 29 days for the maintenance dose.

 

Updated on 26 June 2013 SmPC

Reasons for 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2:

-          ‘Elderly’ is changed to ‘Older’

 

Section 4.4:

-          Sentence deleted: The data available on efficacy and safety experience with degarelix is limited to a one year treatment.

 

-          Sentence inserted: A thorough QT study showed that there was no intrinsic effect of degarelix on QT/QTc interval (see section 4.8).

 

Section 4.6:

-          Sentence inserted: FIRMAGON may inhibit male fertility as long as the testosterone is suppressed.

 

Section 4.8:

-          Sentence inserted:  Rare reports of anaphylactic reactions have been received from post-marketing use of FIRMAGON.

 

-          Additional information inserted under ‘Changes in ECG measurement’: The lack of intrinsic effect of degarelix on cardiac repolarisation (QTcF), heart rate, AV conduction, cardiac depolarisation, or T or U wave morphology was confirmed in a thorough QT study in healthy subjects (N=80) receiving an i.v. infusion of degarelix over 60 min, reaching a mean Cmax of 222 ng/mL, approx. 3-4-fold the Cmax obtained during prostate cancer treatment.

 

-          New section in relation to adverse event reporting:

 

                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 via the national reporting system as follows:

                Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace,  Dublin 2

                Tel: +353 1 6764971; Fax: +353 1 6767836; Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie

 

 

Section 5.2:

-          Sentence updated to: Cmax degarelix plasma concentration decreases in a biphasic fashion, with a mean terminal half-life (t½) of 29 days for the maintenance dose.

 

Updated on 30 April 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 - 'Special patient populations' added
Section 6.5 - Contents of the container updated to reflect a new prefilled syringe for the solution
Section 6.6 - Reconstitution instructions updated to reflect a new prefilled syringe for the solution

Updated on 30 April 2013 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

Section 4.4 - 'Special patient populations' added
Section 6.5 - Contents of the container updated to reflect a new prefilled syringe for the solution
Section 6.6 - Reconstitution instructions updated to reflect a new prefilled syringe for the solution

Updated on 30 January 2012 PIL

Reasons for updating

  • Addition of legal category

Free text change information supplied by the pharmaceutical company

Legal Category updated to: Product subject to medical prescription which may not be renewed (A)

Updated on 30 January 2012 SmPC

Reasons for updating

  • Addition of legal category

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Legal Category updated to: Product subject to medical prescription which may not be renewed (A)

Updated on 20 April 2011 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Introduction of new reconstitution method

Updated on 20 April 2011 PIL

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

Free text change information supplied by the pharmaceutical company

Introduction of new reconstitution method

Updated on 13 August 2009 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 4.8:  undesirable effects updated to include those reported during phase II and phase III trials (instead of phase III only)

Updated on 13 August 2009 SmPC

Reasons for updating

  • 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 4.8:  undesirable effects updated to include those reported during phase II and phase III trials (instead of phase III only)

Updated on 8 June 2009 PIL

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided

Updated on 8 June 2009 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided