Degarelix Shared Care Protocol

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Degarelix subcutaneous injection 80mg, 120mg


Summary of Product Characteristics, available at www.medicines.org.uk.

 

Indication

Advanced hormone-niaive prostate cancer with at least one of the following:

  • symptoms of spinal cord compression
  • severe bony pain requiring opiates.
Dosage and administration

Initially 240mg as two 120mg injections, then 80mg every 28 days. 
Consider changing to 3-monthly LHRH agonist with anti-androgen cover.
No dose adjustment required for the elderly or patients with mild to moderate hepatic or renal impairment.  Patients with severe hepatic or renal impairment have not been studied.
Degarelix is administered as a subcutaneous injection in the abdominal region. 
As with other medicinal products administered by subcutaneous injection, the injection site should vary periodically. 
Give injections in areas where the patient will not be exposed to pressure, eg not close to waistband or belt and not close to the ribs.

Initiation and maintenance of treatment - delineation of responsibilities

Initiation - treatment will be initiated by a Consultant Urologist or Oncologist

  1. Assess patient's appropriateness for treatment with degarelix.
  2. Discuss the benefits and side-effects of treatment with the patient.
  3. Baseline monitoring including LFTs, PSA, serum lipids, glucose and an osteoporosis risk assessment.
  4. Initiation of treatment and administration of 240mg initiation dose.
  5. Report any suspected adverse reactions during initiation period.
  6. Provide the GP with written outline of what monitoring is required and what the review period should be.
  7. Offer the patient a copy of the patient information leaflet.
  8. Advising GP on related issues as required.

Continuation of treatment - GP responsibilities

  1. Prescribing the continuation doses of degarelix and making arrangements for its administration.
  2. Monitoring of PSA every 3 to 6-monthly as directed by the specialist.
  3. Refer back to specialist if the patient's condition deteriorates or intolerance occurs.
Drug interactions

No formal drug-drug interaction studies have been performed.
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, such as class IA (eg disopyramide) or class III (eg amiodarone, sotalol) antiarrhythmic medicinal products, methadone, cisapride, moxifloxacin, antipsychotics, etc, should be carefully evaluated.

Advice to patients

Fatigue and dizziness are common adverse reactions that might influence the ability to drive and use machines.

Editorial Information

Last reviewed: 31 July 2014

Next review: 31 July 2016

Version: 2

Approved By: Formulary Subgroup of ADTC

Reviewer Name(s): Clinical Pharmacist