Gonapeptyl Depot 3.75 mg powder and solvent for suspension for injection

Update to Section 6.6 to include new Instructions for Use to include new adapter.

This product is being discontinued in Ireland and therefore this change will not be implemented for the Irish packs.

Section 4.4:
New text added:
"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 GONAPEPTYL."

Section 4.5:
New text added:
"Since androgen deprivation treatment may prolong the QT interval, the concomitant use of GONAPEPTYL 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:
'Not known' AE added: "QT prolongation (see section 4.4 and 4.5)"

- Reporting of side effects information added

Section 4.4:
New text added:
"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 GONAPEPTYL."

Section 4.5:
New text added:
"Since androgen deprivation treatment may prolong the QT interval, the concomitant use of GONAPEPTYL 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:
'Not known' AE added: "QT prolongation (see section 4.4 and 4.5)"

- Reporting of side effects information added

Section 4.4: 

There is an increased risk of incident depression (which may be severe) in patients undergoing treatment with GnRH agonists, such as triptorelin.  Patients should be informed accordingly and treated as appropriate if symptoms occur.

 

Mood changes, including depression have been reported. Patients with known depression should be monitored closely during therapy.

 

Section 4.8:

General tolerance in men:
- Common: "Depressed mood, sleep disorder" updated to "Mood changes, depressed mood, depression, sleep disorder"

General tolerance in women:
- Introductory paragraph: "mood altered" updated to "mood changes"
- Very common: "mood altered" updated to "mood changes"
- Common: "Depressed mood" updated to "Depressed mood, depression" 

General tolerance in children:
- Common: new text, "Mood changes, depression"

Section 4.4: 

There is an increased risk of incident depression (which may be severe) in patients undergoing treatment with GnRH agonists, such as triptorelin.  Patients should be informed accordingly and treated as appropriate if symptoms occur.

 

Mood changes, including depression have been reported. Patients with known depression should be monitored closely during therapy.

 

Section 4.8:

General tolerance in men:
- Common: "Depressed mood, sleep disorder" updated to "Mood changes, depressed mood, depression, sleep disorder"

General tolerance in women:
- Introductory paragraph: "mood altered" updated to "mood changes"
- Very common: "mood altered" updated to "mood changes"
- Common: "Depressed mood" updated to "Depressed mood, depression" 

General tolerance in children:
- Common: new text, "Mood changes, depression"

Section 4.2: New statement "The treatment of children with triptorelin should be under the overall supervision of the paediatric endocrinologist or of a paediatrician or endocrinologist with expertise in the treatment of central precocious puberty."

Section 4.4: Full section update.

 

Section 4.5: New statement, “No formal drug-drug interaction studies have been performed. The possibility of interactions with commonly used medicinal products, including histamine liberating products, cannot be excluded.”

Statement deleted “Estrogen containing medicinal products should not be used during treatment with GONAPEPTYL Depot.”

 

Section 4.6: New statement: “Prior to treatment, potentially fertile women should be examined carefully to exclude pregnancy.”

 

Section 4.7: New statement: “However, the ability to drive and use machines may be impaired should the patient experience dizziness, somnolence and visual disturbances being possible undesirable effects of treatment, or resulting from the underlying disease”

 

Section 4.8: full section update

Section 4.2: New statement "The treatment of children with triptorelin should be under the overall supervision of the paediatric endocrinologist or of a paediatrician or endocrinologist with expertise in the treatment of central precocious puberty."

Section 4.4: Full section update.

 

Section 4.5: New statement, “No formal drug-drug interaction studies have been performed. The possibility of interactions with commonly used medicinal products, including histamine liberating products, cannot be excluded.”

Statement deleted “Estrogen containing medicinal products should not be used during treatment with GONAPEPTYL Depot.”

 

Section 4.6: New statement: “Prior to treatment, potentially fertile women should be examined carefully to exclude pregnancy.”

 

Section 4.7: New statement: “However, the ability to drive and use machines may be impaired should the patient experience dizziness, somnolence and visual disturbances being possible undesirable effects of treatment, or resulting from the underlying disease”

 

Section 4.8: full section update

Section 6.1:  Excipient updated to 'propyleneglycol dicaprylocaprate'

Section 6.1:  Excipient updated to 'propyleneglycol dicaprylocaprate'

  error in date of revision of text section 10-updated to June 2007

  error in date of revision of text section 10-updated to June 2007

SPC updated following Renewal

SPC updated following Renewal

Date of authorisation was missing-SPC updated

Date of authorisation was missing-SPC updated