Mid Essex Locality Degarelix Subcutaneous Injection (Firmagon ) Treatment Guideline Contents FlowChart 2 Summary... 3 Key points... 3 Introduction... 3 Pharmacology... 3 Product information... 4 Place in therapy... 4 Initiation of therapy... 5 Responsibilities of the hospital... 5 Responsibilities of the General Practitioner... 5 References... 6
Flow Chart for Degarelix initiation Patient has an acute need for immediate testosterone suppression, e.g. impending spinal cord compression, renal failure due to ureteric obstruction or impending urinary retention, or patient has severe symptoms Yes Hospital consultant initiates degarelix No Hospital consultant initiates bicalutamide and writes to GP asking them to start LHRH analogue and continue bicalutamide Initial dose administered in hospital outpatient clinic (2x120mg subcutaneously into the abdominal region) Hospital consultant writes to GP asking to continue to prescribe and administer degarelix maintenance dose (80mg subcutaneously every month thereafter) Patient is retained under the care of the hospital specialist who will communicate any changes in therapy to the GP Treatment is continued until disease progression, unacceptable toxicity, or patient/ clinical decision. 2
Summary This treatment guideline has been written to enable the continuation of care by primary care clinicians of patients initiated on degarelix (gonadotrophin releasing hormone (GnRH) antagonist) by the Urology and Oncology team at Mid Essex Hospitals NHS Trust. Primary care will only be requested to take over prescribing of degarelix within its licensed indication after it has already been initiated in secondary care (similar to the LHRH agonists). Key points Degarelix is gonadotrophin releasing hormone (GnRH) antagonist indicated for the treatment of adult male patients with advanced hormone-dependent prostate cancer. NICE TA404 has recommended degarelix as an option for treating advanced hormone-dependent prostate cancer (see detail below). Prescribing will be shared between hospital consultants and GPs. Degarelix should be administered as a 240mg dose (as 2 x 120mg doses) initially followed by a dose of 80mg (as 1 x 80mg dose) monthly thereafter. 1 Administration is by subcutaneous injection into the abdominal area. Degarelix must be reconstituted prior to administration. 1 Patients will be monitored at routine hospital clinic visits where the on-going suitability and efficacy of the treatment will be reviewed. Degarelix can be prescribed on an FP10. The cost of therapy is 260 for 2 x 120mg vials (with diluent) and 129.37 for 1x 80mg vial (with diluent). 2 Introduction Prostate cancer depends on the male hormone testosterone for its growth. Hormone therapy aims to reduce or stop the body making testosterone to slow down or stop the growth of the cancer. There are different types of hormone therapy, including luteinising hormone (LH) blockers, anti-androgens and gonadotrophin releasing hormone (GnRH) blockers. NICE TA404 published 24 th August 2016 3 : Degarelix is recommended as an option for treating advanced hormone-dependent prostate cancer in people with spinal metastases, only if the commissioner can achieve at least the same discounted drug cost as that available to the NHS in June 2016. This guidance is not intended to affect the position of patients whose treatment with degarelix was started within the NHS before this guidance was published. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published. Note. Patients who are not eligible for treatment in accordance with the NICE guidelines may be considered for Degarelix therapy on an individual basis. Pharmacology 3
Degarelix is a selective gonadotrophin releasing-hormone (GnRH) antagonist that competitively and reversibly binds to the pituitary GnRH receptors, thereby rapidly reducing the release of the gonadotrophins, luteinizing hormone (LH) and follicle stimulating hormone (FSH). This subsequently reduces the secretion of testosterone by the testes. Unlike GnRH agonists, GnRH antagonists do not induce a LH surge with subsequent testosterone surge/tumor stimulation and therefore there is no symptomatic flare after the initiation of treatment. Product information Administration Degarelix is a monthly injection administered subcutaneously in to the abdominal region. Degarelix must be reconstituted using the diluent provided prior to administration. The initial dose is 240mg administered as two subcutaneous injections of 120mg each. Maintenance doses of 80mg are administered as a single subcutaneous injection monthly (every 28 days). Cautions/Contraindications Degarelix should not be administered to any patients with a known hypersensitivity to the active substance or any of the excipients listed in the summary of product characteristics. Degarelix has not been studied in patients with severe renal or hepatic impairment proceed with caution in these patient groups. Side effects Very common: Injection Site Reactions - including pain and erythemia, Hot Flushes Common: Anaemia, Weight Increase, Insomnia, Dizziness & Headache, Diarrhoea, Nausea, Increase liver transaminases, Hyperhydrosis, Rash, Musculoskeletal pain and discomfort, Gynaecomastia, Erectile dysfunction, Testicular atrophy, Flu-like Illness: chills, pyrexia, fatigue. Monitoring The therapeutic effect of degarelix should be monitored by clinical parameters and prostate specific antigen (PSA) serum levels. In case the patient's clinical response appears to be sub-optimal, it should be confirmed that serum testosterone levels are remaining sufficiently suppressed. Interactions Since androgen deprivation treatment may prolong the QTc interval, the concomitant use of degarelix with medicinal products known to prolong the QTc interval or medicinal products able to induce torsades de pointes should be carefully evaluated. Note. For more product details go to the summary of product characteristics for Firmagon available via the electronic medicines compendium website: www.medicines.org.uk Place in therapy Degarelix should be used first line in restricted cases where there is an acute need for immediate testosterone suppression. These include impending spinal cord compression, renal failure due to ureteric obstruction (where nephrostomy is likely to be indicated) or 4
impending urinary retention or where patients are experiencing severe symptoms e.g. severe bone pain which warrant hospitalisation. It may be considered for patients with high volume and/or high PSA metastatic disease and, at the physician s discretion, other conditions such as severe cardiac disease. Treatment will continue until disease progression, unacceptable toxicity or patient/clinical decision. Patients will be reviewed after 1 year of degarelix therapy to assess whether it is suitable for them to be switched to an alternative LHRH analogue. If switched to an alternative therapy bridging with bicalutamide (Casodex ) will not be required. LHRH analogues goserelin or leuprorelin remain the first line treatments of choice for all other cases. Initiation of therapy Patients will be commenced on degarelix in the outpatient clinic and will receive their first dose in secondary care. The patient s GP will then be asked to continue the supply. The patient will be retained under the care of the specialist who will communicate any changes in therapy to the GP. Degarelix is given as a subcutaneous (SC) injection only in the abdominal region. The starting dose given in secondary care is: 240mg administered as two SC injections of 120mg (3ml each). Maintenance doses are then given in primary care at a dose of 80mg (4ml) administered as one subcutaneous injection every month thereafter. 2 As above treatment will continue until disease progression, unacceptable toxicity or patient/clinical decision. Responsibilities of the hospital To initiate degarelix in appropriate patients. To discuss benefits and side effects of treatment with the patient/carer and obtain informed consent. To prescribe and initiate the first month s supply of treatment of degarelix. To continue monitoring of initial response to treatment in secondary care. To contact patient s GP to request prescribing of maintenance doses. To advise the GP regarding continuation / discontinuation of treatment after hospital clinic reviews. To discuss any concerns with the GP regarding the patient s therapy. The patient is to remain under the care of the hospital consultant while they continue to be prescribed degarelix. Responsibilities of the General Practitioner To refer appropriate patients to secondary care for assessment. To agree to prescribe maintenance degarelix therapy for patients as recommended by the hospital consultant. To report any adverse reactions to the MHRA and the referring consultant. To continue to prescribe maintenance degarelix therapy for the patient as advised by the consultant. To inform the consultant if the patient discontinues treatment for any reason. 5
To seek the advice of the consultant if any concerns with the patient s therapy. To conduct an annual medication review. In the event that the GP is not able to prescribe, they will communicate this to the referring consultant. References 1. Ferring Pharmaceuticals Ltd. Summary of Product Characteristics and Patient Information Leaflets - Firmagon 120mg SC injection and Firmagon 80mg SC injection; Last updated on the emc 18 th December 2013. Accessed 04 November 2016 at 15:30 via http://www.medicines.org.uk/emc/ 2. Royal Pharmaceutical Society of Great Britain, BNF September 2016 (online) version accessed 04 November 2016 at 15:30 via www.medicinescomplete.com 3. National Institute for Health and Care Excellence. Degarelix for treating advanced hormone-dependent prostate cancer. TA404, 24th August 2016. Accessed 03 November 2016 at 15:30 via https://www.nice.org.uk/guidance/ta404. See next page for appendix GP template letter Title Document reference Author Consulted with Approved by Date approved March 2017 Next review date March 2019 Degarelix treatment guideline DegarelixGUI201702V1.0FINAL Sophie Wahlich Principal Clinical Pharmacist Oncology Haematology MEHT Angela Bell Senior Pharmacist- Quality, Governance and Performance MECCG Dr Isabella Maund MEHT Mid Essex Area Prescribing Committee Previous version New document Key Changes N/A 6
Consultant Name Consultant Address Date GP name GP address Degarelix (Firmagon ) Therapy Patient Name:- Patient NHS Number:- Patient Hospital Number:- Patient Address:- Dear Dr, Your patient has been commenced on: Degarelix (Firmagon ) subcutaneous injection It would be appropriate for this patient s therapy to be shared between primary and secondary care. Degarelix has now been approved as a yellow drug on the Mid Essex formulary traffic light system. Please sign both copies of this letter to indicate your agreement and return one copy to my office; the other should be placed in the patient s notes at your practice. I confirm that they have received their first dose of therapy in our outpatient clinic on <insert date> and therefore their first dose of maintenance therapy (80mg) will be due with you a month later. Yours sincerely, <Insert Consultant Name> To be signed by GP upon receipt of letter: GP signature Print Name Date *Return one copy of this letter to the hospital, and retain one copy in your own patient records. 7