| Section 4.1 Therapeutic indications
The onset age for boys for precocious puberty has changed from 9 years to 10 years.
Section 4.2 Posology and method of administration
Prostate cancer
The following wording has been added:
Decapeptyl is also available as a 1-month treatment (Decapeptyl SR 3mg) and as a 6-month treatment (Decapeptyl SR 22.5mg) for prostate cancer.
Endometriosis
Wording altered slightly as follows:
A further course of treatment by Decapeptyl SR 3mg or by other GnRH agonists beyond 6 months should not be undertaken due to concerns about bone density losses.
The following wording added:
Decapeptyl is also available as a 1-month treatment (Decapeptyl SR 3mg) for endometriosis.
Precocious puberty
A reminder that treatment should be before 8 years in girls and 10 years in boys has been added, as well as a statement that the treatment of children with Decapeptyl SR 11.25mg should be under the overall supervision of a paediatric endocrinologist or of a paediatrician or endocrinologist with expertise in the treatment of central precocious puberty.
Section 4.3 Contraindications
The contra-indication to treatment in patients presenting with spinal cord compression or evidence of spinal metastases has been removed and this information has instead been included under Section 4.4 Special warnings and precautions for use. Pregnancy and lactation have been included as a contra-indication to treatment.
Section 4.4 Special warnings and precautions for use
This section has a number of changes. Existing information has been reworded and expanded and new text has been added.
Information regarding GnRH agonists reducing bone mineral density has been added; together with a statement that particular caution is necessary in patients with risk factors for, or established osteoporosis.
A warning that it should be confirmed that the patient is not pregnant before prescribing Decapeptyl SR has been added, as well as the fact that treatment with GnRH agonists may reveal the presence of a previously unknown gonadotroph cell pituitary adenoma and that mood changes, including depression have been reported. Patients with known depression should be monitored closely during therapy.
Prostate cancer
The wording regarding the initial transient increase in serum testosterone on initiation of treatment has changed slightly. The recommendation to use an anti-androgen for 3 days prior to Decapeptyl has been altered to:
During the initial phase of treatment, consideration should be given to the additional administration of a suitable anti-androgen….
The following wording has been added to the precautions regarding patients with spinal cord compression or urethral obstruction:
If spinal cord compression or renal impairment develops, standard treatment of these complications should be instituted, and in extreme cases an immediate orchidectomy (surgical castration) should be considered.
The following additional wording regarding bone loss has been added:
Long-term androgen deprivation either by bilateral orchidectomy or administration of GnRH agonists is associated with increased risk of bone loss and may lead to osteoporosis and increased risk of bone fracture.
An additional precaution for patients at high risk for metabolic or cardiovascular diseases has been added as follows:
In addition, from epidemiological data, it has been observed that patients may experience metabolic changes (e.g. glucose intolerance), or an increased risk of cardiovascular disease during androgen deprivation therapy. 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 carefully assessed before commencing treatment and their glucose, cholesterol and blood pressure adequately monitored during androgen deprivation therapy.
Metabolic changes may be more severe in these high risk patients. Patients at high risk of metabolic or cardiovascular disease and receiving androgen deprivation therapy should be monitored at appropriate intervals not exceeding 3 months.
Endometriosis
Additional information regarding GnRH treatment resulting in reduced bone mineral density increased fracture risk has been added.
The statement regarding use of non-hormonal contraception during the first month of treatment has been removed and the following statement added:
A non-hormonal method of contraception should be used throughout treatment including for 3 months after the duration of the last injection.
Precocious puberty
The following data has been added:
Treatment of children with progressive brain tumours should follow a careful individual appraisal of the risks and benefits.
In girls, initial ovarian stimulation at treatment initiation, followed by the treatment-induced oestrogen withdrawal, may lead, in the first month, to vaginal bleeding of mild or moderate intensity.
After discontinuation of treatment the development of puberty characteristics will occur.
Information with regards to future fertility is still limited. In most girls, regular menses will start on average one year after ending the therapy.
Pseudo-precocious puberty (gonadal or adrenal tumour or hyperplasia) and gonadotropin-independent precocious puberty (testicular toxicosis, familial Leydig cell hyperplasia) should be precluded.
Bone mineral density may decrease during GnRH agonist 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 capital femoral epiphysis can be seen after withdrawal of GnRH agonist treatment. The suggested theory is that the low concentrations of oestrogen during treatment with GnRH agonists weaken 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.
Section 4.5 Interactions with other medicinal products and other forms of interaction
The following data has been added:
When Decapeptyl SR 11.25mg is co-administered with drugs affecting pituitary secretion of gonadotropins, caution should be exercised and it is recommended that the patient’s hormonal status be supervised.
Section 4.6 Pregnancy and lactation
The following data has been added:
Triptorelin should not be used during pregnancy since concurrent use of GnRH agonists is associated with a theoretical risk of abortion or foetal abnormality. Prior to treatment, potentially fertile women should be examined to exclude pregnancy. Non-hormonal methods of contraception should be employed during therapy until menses resume.
Section 4.7 Effects on ability to drive and use machines
The following data has replaced the existing statement that there is no evidence that Decapeptyl SR has any effect on the ability to drive or operate machinery:
No studies on the effects on the ability to drive and use machines have been performed. 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 Undesirable effects
The format of this section has been updated to bring it in line with regulatory recommendations, in that it now lists undesirable effects according to their frequency. The updated SPC contains a more exhaustive list of undesirable effects reported during clinical trials and post-marketing use as compared with the previous document.
Please refer to the updated SPC for the full list of undesirable effects which have been reported with Decapeptyl SR 11.25mg.
Section 6.6 Special precautions for disposal
This section has been updated with an instruction that the vial should be shaken from side to side, rather than ‘gently swirled’ as in the previous SPC.
Section 8 Marketing authorisation number(s)
The product licence number has changed:
Decapeptyl SR 11.25mg - PL 34926/0003
Section 10 Date of revision of the text
Changed to 18 November 2010
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