DIPHERELINE® (triptorelin embonate) 22.5mg Paediatric Product Familiarisation Program (PFP)

Available Samples DIPHERELINE® (triptorelin embonate) 22.5mg Paediatric Product Familiarisation Program (PFP)

Diphereline® 22.5mg Product Familiarisation Program (PFP) - Now closed

As of 1st November 2021, Diphereline® 22.5mg is listed on the Pharmaceutical Benefits Scheme (PBS). The 6-monthly gonadotropin-releasing hormone agonist (GnRHa) has been approved by the Therapeutic Goods Administration (TGA) for the use in children aged two years and over, who have been diagnosed with central precocious puberty.^1,2

The Product Familiarisation Program Ipsen put in place for eligible patients after the product was first approved by the TGA has been closed. Patients who were enrolled in the program can access Diphereline 22.5mg at a subsidised cost if they are eligible to receive benefits under the PBS.

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DIPHERELINE® (triptorelin embonate) 22.5mg Paediatric Product Familiarisation Program (PFP)
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Diphereline® (triptorelin embonate) 22.5mg is now approved as a treatment for children with Central Precocious Puberty (CPP). It is the first and only six-month formulation that is TGA-approved for children with CPP in Australia. Diphereline®...

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How to prescribe Diphereline® (triptorelin embonate) 22.5mg under the PBS for your CPP patients:

Treatment phase	Initial	Grandfathered*	Continuing or switching GnRHa
Code	5297T
Restriction	Restricted benefit for central precocious puberty
Treatment criteria	Must be treated by a paediatric endocrinologist; OR by an endocrinologist specialising in paediatrics	Must be treated by a paediatric endocrinologist; OR by an endocrinologist specialising in paediatrics; OR by a medical practitioner in consultation with a paediatric endocrinologist
Population criteria	Patient must be of an age that is prior to their 12th birthday (female); OR their 13th birthday (male) AND Patient must have had an onset of signs/symptoms of CPP prior to their 9th birthday (female); OR their 10th birthday (male)		Patient must be undergoing continuing treatment with a GnRHa initiated through the PBS for this PBS indication

*Restriction will cease to operate on 31 October 2022. Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 November 2021. Patients may qualify for PBS-subsidised treatment under this restriction.

Please also refer to the PBS Schedule for full information.

Link to the PI & CMI: TGA eBS - Product and Consumer Medicine Information

PBS Information: Restricted Benefit for central precocious puberty.
Refer to PBS Schedule for full authority information.

Before prescribing please refer to full Product Information

which is available from Ipsen Medical Information.

Ph: 1800 317 033 or from

www.guildlink.com.au/gc/ws/ipsen/pi.cfm?product=ispdi

This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.

Diphereline®: Triptorelin embonate 22.5 mg (6-month formulation). Indications: Treatment of children 2 years and older with central precocious puberty. Dose: 22.5 mg triptorelin (1 vial) once every six months. Administration: Single intramuscular injection; 1 vial reconstituted using 2 mL sterile water for injection; injection site should be varied periodically; inadvertent intravascular injection must be strictly avoided (see full PI). Contraindications: Known hypersensitivity to triptorelin or product excipients, GnRH or other GnRH agonist analogues; pregnancy and lactation. Precautions: Children with progressive brain tumours; pseudo-precocious puberty and gonadotropin-independent precocious puberty; mild to moderate vaginal bleeding in first month (girls); decreased bone mineral density during treatment (bone mass accrual preserved after treatment cessation); slipped capital femoral epiphysis after withdrawal of treatment; depression and mood changes; pituitary apoplexy (see full PI). Drug Interactions: Caution with intramuscular injection in patients treated with anticoagulants; caution when administered with other medicines affecting pituitary secretion of gonadotrophins; hyperprolactinaemic agents should not be prescribed concomitantly. Adverse Events: Very common: Vaginal bleeding (including vaginal haemorrhage, withdrawal bleed, uterine haemorrhage, vaginal discharge, bleeding and spotting). Common: abdominal pain, injection site reaction, hypersensitivity, increased weight, headache, acne, hot flushes (see full PI). Storage: Store below 25°C.

IPSEN Pty Ltd. (ABN 47 095 036 909]). Telephone: +61 (3) 8544 8100. Facsimile: +61 (3) 9562 5152. Brandon Office Park, Level 2, Building 4, 540 Springvale Road, Glen Waverley 3150, Victoria, Australia. TRI-AU-000629. Date prepared: November 2021...

Reference

Therapeutic Goods Administration, Diphereline®. Available at https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=PI&q=Diphereline%20. Last accessed November 2021.
Pharmaceutical Benefits Scheme. https://www.pbs.gov.au/medicine/item/10907C-5297T-9378N-9379P. Last accessed November 2021