Download Protocol for the use of degarelix

Protocol for use of degarelix injection
Approved use
Degarelix is a gonadotrophin releasing hormone (GnRH) antagonist licensed for treatment of adult
male patients with advanced hormone-dependent prostate cancer.
It has been approved for use locally in line with NICE (Drug TA404 Aug 2016) and 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.
Dose
Starting dose
240 mg administered as two deep
subcutaneous injections of 120 mg each
Maintenance dose – monthly administration
80 mg administered as one deep
subcutaneous injection
Degarelix does not induce a testosterone surge it is not necessary to add an anti-androgen such
as cyproterone at initiation of therapy.
Specialist responsibilities
 Baseline and on-going blood tests o PSA, U&E, LFT prior to each clinic visit.
o Give patients a blood form at each appointment to have bloods done 1-2 weeks
before next appointment. No additional requests for GP to instigate blood tests

Administer the starting dose

Ask GP to prescribe and administer on-going treatment with degarelix and on coprescription of calcium and vitamin D for bone protection as appropriate.

Monitor response to therapy
o using patient’s symptoms and regular blood tests (PSA, U&E, LFT, occasionally
testosterone)

Follow up in clinic
o every 3 months for first year, then every 6 months. May be possible to have annual
hospital appointments if prolonged response

Advise the GP when treatment should be stopped
o according to PSA and/or symptom progression
Degarelix protocol
Version 1 October 2016
Written by : Mr R Wilson (Consultant Urologist) / Jane Crewe (Pharmacist)
Approved by : York and Scarborough Medicines Commissioning Committee
GP responsibilities
 Administer the monthly maintenance dose as advised by the specialist
 Prescribe calcium and vitamin D for bone protection as advised by the specialist
 Stop treatment on the advice of the specialist
 Specialist will be responsible for all blood test and monitoring and patient will remain under
their care for the duration of treatment.
Drug interactions
Since androgen deprivation treatment may prolong the QTc interval. Take care with concomitant
use of degarelix with drugs known to prolong the QTc interval or induce torsades de pointes.
Adverse effects
The most commonly observed adverse reactions during degarelix therapy are :
 Hot flushes (25% patients treated for 1 year) – due to testosterone suppression
 Weight increase (7% of patients treated for 1 year)- due to testosterone suppression
 Injection site adverse reactions (site rotation is recommended)
 Transient chills, fever or influenza like illness - reported to occur hours after dosing.
Affected patients should be advised to take paracetamol.
 Reduced level of testosterone may cause a reduction in bone calcium and osteoporosis.
Drug monitoring
 Liver function tests - The manufacturer advises monitoring of liver function in patients with
known or suspected hepatic disorder. This will be performed by secondary care
 Diabetes - Worsening or onset of diabetes may occur.
The manufacturer does not recommend any other routine drug monitoring during treatment. In
clinical trials changes in laboratory values seen during one year of treatment were in the same
range for degarelix and leuprorelin. These include abnormal liver function tests (including mild
transient increase in transaminases), decreases in haemoglobin, raised potassium and raised
creatinine.
For further information consult the summary of product characteristics
https://www.medicines.org.uk/emc/medicine/21701
Degarelix protocol
Version 1 October 2016
Written by : Mr R Wilson (Consultant Urologist) / Jane Crewe (Pharmacist)
Approved by : York and Scarborough Medicines Commissioning Committee