Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Ipsen Limited, 190 Bath Road, Slough, Berkshire, SL1 3XE, United Kingdom
Treatment of patients with locally advanced, non-metastatic prostate cancer, as an alternative to surgical castration (see section 5.1).
Treatment of metastatic prostate cancer.
As adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer.
As neoadjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced prostate cancer.
As adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression.
Treatment of endometriosis.
Treatment of uterine fibroids prior to surgery or when surgery is not appropriate.
As adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine responsive early stage breast cancer in women at high risk of recurrence who are confirmed as pre-menopausal after completion of chemotherapy (see sections 4.3, 4.4, 4.8 and 5.1).
One intramuscular injection should be administered every 4 weeks (28 days). No dosage adjustment is necessary in the elderly.
Decapeptyl is also available as a 3-month treatment (Decapeptyl SR 11.25 mg) and as a 6-month treatment (Decapeptyl SR 22.5 mg) for prostate cancer.
In patients treated with GnRH analogues for metastatic prostate cancer, treatment is usually continued upon development of castrate-resistant prostate cancer.
Reference should be made to relevant guidelines.
One intramuscular injection every 28 days. For the treatment of endometriosis and uterine fibroids the treatment must be initiated in the first five days of the cycle. The maximum duration of treatment should be 6 months. For patients with uterine fibroids Decapeptyl SR 3 mg should be administered for a minimum of 3 months.
A further course of treatment by Decapeptyl SR 3 mg or by other GnRH agonists beyond 6 months should not be undertaken due to concerns about bone density losses.
Decapeptyl is also available as a 3-month treatment (Decapeptyl SR 11.25 mg) for endometriosis.
One intramuscular injection every 4 weeks in combination with tamoxifen or an aromatase inhibitor.
Triptorelin should be commenced after completion of chemotherapy, once pre-menopausal status has been confirmed (see section 4.4).
The treatment with triptorelin must be initiated at least 6-8 weeks before starting aromatase inhibitor treatment. A minimum of two injections of triptorelin (with an interval of 4 weeks between injections) should be administered before commencement of aromatase inhibitor treatment.
During treatment with an aromatase inhibitor, triptorelin must not be interrupted to avoid rebound increases in circulating oestrogens in premenopausal women.
The recommended treatment duration for adjuvant treatment in combination with other hormonotherapy is up to 5 years.
Since triptorelin P.R. 3 mg is a suspension of microparticles, inadvertent intravascular injection must be strictly avoided.
There is no human experience of overdosage. Animal data do not predict any effects other than those on sex hormone concentration and consequent effect on the reproductive tract. If overdosage occurs, symptomatic management is indicated.
3 years.
The product should be used immediately after reconstitution.
Do not store above 25°C. Keep the container in the outer carton.
A type I, 5 mL capacity glass vial with an elastomer stopper and an aluminium cap containing the powder.
Type I, 3 mL capacity glass ampoule containing 2 mL of the suspension vehicle.
Box containing 1 vial and 1 ampoule with 1 syringe and 2 needles.
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.
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