Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Ipsen Limited, 190 Bath Road, Slough SL1 3XE, United Kingdom
Treatment of patients with locally advanced, non-metastatic prostate cancer, as an alternative to surgical castration.
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 central precocious puberty (CPP) in children 2 years and older with an onset of CPP before 8 years in girls and 10 years in boys).
The recommended dose of Decapeptyl SR 22.5 mg is 22.5 mg of triptorelin (1 vial) administered every six months (twenty four weeks) as a single intramuscular injection.
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.
Decapeptyl is also available as a 1-month treatment (Decapeptyl SR 3 mg) and as a 3-month treatment (Decapeptyl SR 11.25 mg).
No dosage adjustment is necessary for patients with renal or hepatic impairment.
The treatment of children with Decapeptyl SR 22.5 mg should be under the overall supervision of a paediatric endocrinologist or of a paediatrician or an endocrinologist with expertise in the treatment of central precocious puberty.
Treatment should be stopped around the physiological age of puberty in boys and girls and should not be continued in girls with a bone maturation of more than 12-13 years. There are limited data available in boys relating to the optimum time to stop treatment based on bone age, however it is advised that treatment is stopped in boys with a bone maturation age of 13-14 years.
As with other medicinal products administered by injection, the injection site should be varied periodically.
Once reconstituted, the suspension of Decapeptyl SR 22.5 mg should be intramuscularly injected relatively rapidly and uninterrupted manner in order to avoid any potential blockage of the needle.
Decapeptyl SR 22.5 mg is only intended for intramuscular use.
Since Decapeptyl SR 22.5 mg is a suspension of microparticles, inadvertent intravascular injection must be strictly avoided.
Decapeptyl SR 22.5 mg must be administered under the supervision of a physician.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
The pharmaceutical properties of Decapeptyl SR 22.5 mg and its mode of administration make accidental or intentional overdose unlikely. There is no experience of overdose from clinical trials. Animal tests suggest that no effect other than the intended therapeutic effects on sex hormone concentration and on the reproductive tract will be evident with higher doses of Decapeptyl SR 22.5 mg. If overdose occurs, this should be managed symptomatically.
3 years.
Do not store above 25°C. Keep the container in the outer carton. The reconstituted suspension for injection should be used immediately.
6 mL septum vial with bromobutyl stopper and aluminium flip-off cap.
Ampoule containing 2 mL of sterile solvent for suspension.
Box of: 1 vial, 1 ampoule and 1 blister containing 1 injection syringe and 2 injection 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.
Any unused medicinal product, needles or other waste material should be disposed of in accordance with local requirements.
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