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

The Diphereline® 22.5mg PFP for CPP provides healthcare professionals the opportunity to familiarise themselves with, and gain experience using, Diphereline® 22.5mg.

For eligible patients who may benefit from Australia’s first and only six-month GnRHa CPP treatment¹, the PFP provides access to Diphereline® at no charge. The program will remain available until 31 March 2022 or until Diphereline® 22.5mg is listed on the PBS, whichever occurs first*.

PBS information: Diphereline® 22.5mg for Central Precocious Puberty is not listed on the Pharmaceutical Benefits Scheme (PBS).

Please ensure that enrolled patients/carers understand the Program and document their consent to the terms of the PFP. Should you have any questions, please do not hesitate to contact Ipsen.

*If Diphereline® is not listed on the PBS on 1 April 2022, or if participants are ineligible to receive Diphereline® treatment via the PBS, Ipsen reserves the right to revise ongoing supply. In this instance, Diphereline® may only be available with a private prescription.

Eligibility Criteria

Patients eligible for the Paediatric Diphereline® (triptorelin) 22.5mg PFP are:

• Girls with a documented diagnosis of CPP with a date of onset of < 8 years of age and who will not be older than 9 years and 3 months on 1 August 2021 when commencing treatment
• Boys with a documented diagnosis of CPP with a date of onset of < 9 years of age and who will not be older than 10 years and 3 months on 1 August 2021 when commencing treatment
• Naïve to any prior therapies for CPP

These criteria have been put in place specifically to allow all patients participating in the program the opportunity to use an alternative GnRHa should Diphereline® 22.5mg (triptorelin) not be PBS-listed by 1 April 2022.

One Diphereline® 22.5mg PFP Welcome pack contains:

• One vial of Diphereline 22.5mg (6-month formulation) for reconstitution
• Diphereline Product Information
• Diphereline Consumer Medicines Information
• The Diphereline 22.5mg reconstitution leaflet

The pack(s) will be shipped to the address you registered within 24-48 hours of the order being placed.

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

Terms & Conditions

• I have read the Diphereline® Product Information*
• I will enrol eligible patients to the Diphereline 22.5mg PFP and confirm that the patient/carer understands the program and consents to the terms of the PFP*
• I will order and use Diphereline® 22.5mg 6-month as per TGA-approval and eligibility criteria listed above*
• I will provide the Consumer Medicines Information to my eligible patient(s)/carer(s); and I will only commence treatment with Diphereline® 22.5mg after consultation with my eligible patient(s)/carer(s)*
• I will report any adverse events that occur in my patients during the use of Diphereline 22.5mg to Ipsen (medinfo.australia@ipsen.com) or directly to the TGA (aems.tga.gov.au)*
• I agree to receive communications from Ipsen via email, print and/or SMS about Ipsen’s products in the following areas: Medical and Scientific Updates, Event Notifications, Corporate Information and Branded Product Information (optional).
• If you no longer wish to receive communications from us, you can manage your preferences and unsubscribe using the link at the bottom of our emails and SMS’s. Alternatively, you can contact the privacy officer at privacyofficer.au@ipsen.com.

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® Australian Minimum Product Information

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-000584. Date prepared: August 2021.

 

Reference

1. 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 August 2021.