The information within this section of the website is intended for UK Healthcare Professionals. Members of the public, Prostap DCS prescribed patients and UK Practice Managers should follow the relevant links.

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The pick of the bunch in prostate cancer

Prostap DCS at a glance

Prostap DCS (leuprorelin acetate):

  • Has treated over 24 million patients globally since 1996, across all indications1
  • Benefits from 30 years of experience with leuprorelin2,3
  • Has been shown to provide long-term survival for prostate cancer patients, when combined with radiotherapy4
  • Has a well-established tolerability: majority of adverse events are related to androgen deprivation; most common events are hot flushes, increased sweating and decreased libido4-8
  • Includes a device which is easy to administer7,8
  • Helps protect HCPs from needle stick injuries. Prostap DCS is fitted with a safety device that complies with the latest EU sharps directive and UK legislation7-9
  • Can be used whenever an LHRH agonist is required for the management of prostate cancer, including neo-adjuvant to radiotherapy4,7,8,10

*Men receiving LHRH agonists are at an increased risk of developing diabetes and cardiovascular disease. Patients at high risk should be appropriately monitored and managed according to current clinical practice. For a full list of adverse events, please refer to the summary of product characteristics.7,8

About Prostap DCS7-8

  • Dual Chamber Syringe (DCS) system delivering leuprorelin7,8

abriefproductoverview-figure1

Therapeutic indications7,8

Prostate cancer

  • Metastatic prostate cancer
  • Locally advanced prostate cancer, as an alternative to surgical castration
  • As an adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer
  • As an adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression
  • As neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced prostate cancer

Breast cancer

  • Treatment in pre- and perimenopausal women with advanced breast cancer suitable for hormonal manipulation
  • Adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine responsive early stage breast cancer in pre- and perimenopausal women at higher risk of disease recurrence (young age, high grade tumour, lymph node involvement)

Note: In women who have received chemotherapy, premenopausal status must be confirmed after completion of chemotherapy

Endometriosis

  • Management of endometriosis, including pain relief and reduction of endometriotic lesions
  • Endometrial preparation prior to intrauterine surgical procedures including endometrial ablation or resection (Prostap SR DCS only)
  • Preoperative management of uterine fibroids to reduce their size and associated bleeding (Prostap SR DCS only)

Preservation of ovarian function

  • Use in pre-menopausal women with neoplastic disease undergoing chemotherapy treatment that can cause premature ovarian insufficiency (Prostap SR DCS only)

NOTE: Treatment with a GnRH analogue should only be proposed after careful risk/benefit evaluation in each patient. Not a replacement for standard fertility-preservation methods.

Central precocious puberty

  • Central precocious puberty in girls under 9 years of age and boys under 10 years of age

Administration overview7,8

Intramuscular (IM) or subcutaneous (SC) administration available, depending on indication and dose

Dosage form

Released from micro particles that are 20µm in diameter abriefproductoverview-figure13

Needle size

Fine gauge needle abriefproductoverview-figure14 Image not to scale

Dosing – Prostap SR DCS7

Dosing – Prostap 3 DCS8

Contact

If you are a healthcare professional and have a query about Prostap DCS, please call Medical Information on:

01628 537 900

If you would like to find out more about how Prostap DCS can help your practice save money, or to order, please call CLARITYpharma on:

0845 080 5190

If you are a healthcare professional and would like to be contacted about Prostap DCS, please enter your details in the short form below

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Takeda UK Ltd will NOT share any of your details with any other parties. If at any time you wish to unsubscribe from receiving information about Prostap DCS, please call Takeda UK Ltd on 01628 537 900.

References

  1. Takeda UK Ltd. Data on file, DF120604(2).
  2. The Leuprolide Study Group. N Eng J Med 1984;311(20):1281–6.
  3. Sharifi R, Ratanawong C et al. Adv Drug Deliv Rev 1977;28(1):121–38.
  4. D’Amico AV et al. Chen M et al. JAMA 2008;299(3):289–95.
  5. Kienle E & Lübben G. Urol Int 1996;56(Suppl 1):23–30.
  6. Tunn UW & Wiedey K. Prostate Cancer Prostatic Dis 2009;12(1):83–7.
  7. Prostap SR DCS. Summary of Product Characteristics.
  8. Prostap 3 DCS. Summary of Product Characteristics.
  9. Health and Safety Sharp Instruments in Healthcare Regulations 2013. Available at: http://www.hse.gov.uk/pubns/hsis7.pdf. (last accessed July 2019).
  10. National Institute for Health and Care Excellence (NICE). Clinical guideline NG131. May 2019.
  11. Abdouelfadel Z & Crawford D. Therapeut Clin Risk Manag 2008;4(2):513–26.
  12. Barnes R et al. Study M86-049 Report.
  13. MHRA Prostap® SR DCS UKPAR, 2014. Available at: http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con120
    442.pdf     (last accessed July 2019).
  14. PharmaTimes online. Takeda launches new presentation of Prostap, 2011. Available at:
    http://www.pharmatimes.com/news/takeda_launches_new_presentation_of_prostap_980760 (last accessed July 2019).
  15. Jocham D. Urol Int 1998;60:18–24.
  16. Mottet N et al. European Association of Urology Guidelines on Prostate Cancer. Update 2018.
  17. D’Amico AV et al. JAMA 2004;292(7):821–7.
  18. Mottet N et al. Eur Urol 2012;62(2):213–9.
  19. Wechsel HW et al. Eur Urol 1996;30(Suppl 1):7–14.
  20. Zoladex 3.6mg. Summary of Product Characteristics. Available at: http://www.medicines.org.uk/.
  21. Zoladex LA 10.8mg. Summary of Product Characteristics. Available at: http://www.medicines.org.uk/.
  22. Decapeptyl SR 3mg. Summary of Product Characteristics. Available at: http://www.medicines.org.uk/.
  23. Decapeptyl SR 11.25mg. Summary of Product Characteristics. Available at: http://www.medicines.org.uk/.
  24. Decapeptyl SR 22.5mg. Summary of Product Characteristics. Available at: http://www.medicines.org.uk/.
  25. Lutrate 3.75mg. Summary of Product Characteristics. Available at: http://www.medicines.org.uk/.
  26. Lutrate 22.5mg. Summary of Product Characteristics. Available at: http://www.medicines.org.uk/.
  27. Takeda UK Ltd. Data on file. DF121104.
  28. Takeda UK Ltd. Data on file. DF121106.

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About these calculations

The table provides a worked example of the PA allowance calculation for a GP in a non-dispensing practice in England.
The dispensing fees and clawback rates are based on the smallest non-dispensing practice:
• Clawback rate: 3.17% represents total basic price per month £1-2,000
• Dispensing Fee: £2.405 represents total prescriptions calculated separately for each individual non-dispensing practitioner up to 449

Clawback rates and dispensing fees current as of October 2016, please refer to http://www.dispensingdoctor.org for the latest clawback rates and dispensing fees.

This part of the Prostap® DCS (leuprorelin acetate) online resource is specifically for Practice Managers. If you are not a Practice Manager, please select the appropriate area of this website from the welcome page.

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This part of the Prostap® DCS (leuprorelin acetate) online resource is specifically for Healthcare Professionals.

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This part of the Prostap® DCS (leuprorelin acetate) online resource is specifically for patients who have been prescribed Prostap DCS.

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