Source: Pharmaceutical Benefits Scheme (AU) Revision Year: 2022 Publisher: Ipsen Pty Ltd, Level 2, Building 4, Brandon Office Park, 540 Springvale Road, Glen Waverley Victoria 3150 Telephone: 1800 317 033
Diphereline is indicated for the treatment of hormone-dependent locally advanced or metastatic prostate cancer.
Diphereline 22.5mg 6 month formulation only: Diphereline 22.5 mg is indicated for the treatment of children 2 years and older with central precocious puberty (CPP).
Diphereline 3.75mg – 1month formulation: The recommended dose of Diphereline is 3.75 mg triptorelin (1 vial) administered once a month as a single intramuscular injection.
Diphereline 11.25mg – 3 month formulation: The recommended dose of Diphereline is 11.25 mg triptorelin (1 vial) administered every three months as a single intramuscular injection.
Diphereline 22.5mg – 6 month formulation: The recommended dose of Diphereline is 22.5 mg triptorelin (1 vial) administered every six months as a single intramuscular injection.
The lyophilised microgranules are to be reconstituted using 2 mL sterile water for injection (see METHOD OF ADMINISTRATION). The injection site should be varied periodically.
Since Diphereline is a suspension of microgranules, inadvertent intravascular injection must be strictly avoided.
No dosage adjustment is necessary for patients with renal or hepatic impairment (see also section 5.2 PHARMACOKINETIC PROPERTIES). Diphereline must be administered under the supervision of a physician.
Precocious puberty (before 8 years in girls and 9 years in boys):
Prior to initiation of treatment a clinical diagnosis of CPP should be confirmed by measurement of blood concentrations of LH (basal or stimulated with a GnRH analogue), sex steroids, and assessment of bone age versus chronological age. Baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumour), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumours), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumour), and adrenal steroid measurements to exclude congenital adrenal hyperplasia.
The treatment of children with Diphereline 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.
The solvent for suspension should be drawn into the injection syringe and transferred to the vial containing the powder. The vial should be gently shaken to thoroughly disperse particles and obtain a uniform suspension. The suspension will appear milky. The suspension obtained should be drawn back into the injection syringe. The injection needle has to be changed and the produced suspension for injection should be administered immediately.
The suspension should be discarded if not used immediately after reconstitution.
Diphereline contains no antimicrobial agent. The product is for treatment of one patient only on one occasion. Discard any remaining contents. Used injection needles should be disposed in a designated sharp container. Any remaining product should be discarded.
Diphereline must be administered under the supervision of a healthcare professional.
The pharmaceutical properties of Diphereline and its route 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 Diphereline.
In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
After opening:
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, the prepared suspension should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C.
Contains no antimicrobial preservative. Use each ampoule in one patient on one occasion only. Discard any residue.
Store below 25°C.
For storage conditions after first opening of the medicinal product, see Section 6.3 SHELF LIFE.
Diphereline 3.75 mg 1 month formulation: 6 mL type I brown tint glass vial with grey bromobutyl stopper and purple aluminium flip-off capsule.
Diphereline 11.25 mg 3 month formulation: 6 mL type I brown tint glass vial with grey bromobutyl stopper and yellow green aluminium flip-off capsule.
Diphereline 22.5 mg 6 month formulation: 6 mL type I brown tint glass vial with grey bromobutyl stopper and dark green aluminium flip-off capsule.
Solvent: Type I glass ampoule containing 2 mL of sterile solvent for suspension.
Each box contains 1 vial, 1 ampoule and 1 blister containing 1 empty polypropylene injection syringe and 2 injection needles.
In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.
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