Fulvestrant Shared Care Protocol: Treatment in Metastatic Breast Cancer

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Fulvestrant solution for injection 250mg (specialist use only)


NHS Circular 1992 (GEN11) gives guidance on the responsibility for prescribing at the hospital/GP interface. Where a consultant considers a patient's condition is stable, the agreement of the patient's GP may be sought to ‘share’ the patient's care.  
This shared care protocol is intended to facilitate the sharing of care between the Cancer Centre and Primary Care for a defined group of patients.

Background
Breast cancer is the most common female malignancy in the UK.  Patients with oestrogen receptor positive (ER+ve) or progesterone receptor positive (PgR+ve) tumours should be offered hormonal therapy either in the adjuvant or metastatic setting.

Note
This protocol applies to those patients who are prescribed fulvestrant in combination with palbociclib.Fulvestrant monotherapy can be prescribed in primary care without reference to this shared care protocol, after recommendation by the specialist.

Indication

Fulvestrant is licensed and approved for use in Scotland for the treatment of postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer who have had disease relapse on or after oral anti-oestrogen therapy.

In 2018, the Scottish Medicines Consortium approved a new class of oral treatment for metastatic breast cancer, Cyclin-dependent kinase (CDK) 4 and 6 inhibitors.  CDK4/6 inhibitors reduce cellular proliferation by blocking progression of the cell from G1 into S phase of the cell cycle and can be used in combination with fulvestrant in patients who have already received at least one line of endocrine therapy for metastatic breast cancer.  CDK4/6 inhibitors (CDK4/6i) currently approved for use in Scotland are abemaciclib, palbociclib and ribociclib.  Within NHS Highland, the majority of patients currently receive palbociclib concurrently with fulvestrant.

Dose and Administration

The recommended dose for fulvestrant is 500 mg every 4 weeks, with an additional 500 mg dose given two weeks after the initial dose for the first month only.  Fulvestrant should be administered as two consecutive 5 mL injections by slow intramuscular injection (1 to 2 minutes/injection), one in each buttock.  Due to the proximity of the underlying sciatic nerve, injections should be administered in the upper outer region of the buttock. 

See Summary of Product Characteristsics for further details if needed: https://www.medicines.org.uk/emc/product/68/smpc#USEHANDLING

Duration of treatment

Given monthly until disease progression.  Patients will normally have CT scans (computerised tomography scan) every 3 months to assess response to treatment. 

Contraindications and Cautions

Fulvestrant is contraindicated in patients with known hypersensitivity to the active substance or any of the excipients, pregnancy, in breast-feeding and in patients with severe hepatic impairment. It should be used with caution in mild to moderate hepatic impairment and in severe renal impairment. As it is an intramuscular injection it should be used with caution in patients with clotting abnormalities.

Adverse Effects
The most commonly reported adverse reactions (more than 1 in 100) are: Hot flushes, nausea, vomiting, diarrhoea, anorexia, rash, urinary tract infections, venous thromboembolism, headache, back pain, injection site reactions.

Monitoring

All monitoring for fulvestrant +/- CDK4/6i drug therapy will take place within NHS Highland Oncology Team.  There are no monitoring requirements for the Primary Care team.

Information for patients

Patients will receive treatment information from Macmillan before starting treatment, as part of informed consent to cancer treatment:  https://www.macmillan.org.uk/cancer-information-and-support/treatments-and-drugs/fulvestrant

Storage information for Primary Care and Patients

Store and transport in a refrigerator (2°C to 8°C).  Store the pre-filled syringe in the original package in order to protect from light.

Responsibilities of health care professionals

Consultant Oncologist

  • Initiates treatment plan
  • Provides the patient with relevant written and verbal patient information about planned treatment
  • Obtains informed patient consent to treatment
  • Prescribes appropriate treatment
  • Liaises with GP to agree shared care
  • Informs oncology pharmacy team of treatment plan
  • Continued review of patient for treatment toxicity and disease response
  • Organises CT scan when appropriate
  • Authorises treatment delay
  • Authorises discontinuation of treatment
  • Informs GP of any change to treatment plan
  • Provides advice to Primary Care team if required

Specialist Doctor / Non-medical prescriber in Oncology team

  • Continued review of patient for treatment toxicity and disease response
  • Refers to Consultant Oncologist if any treatment concerns
  • Requests appropriate blood tests and reviews test results
  • Provides advice to Primary Care team if required

Oncology Pharmacy Team

  • Clinical verification of prescription
  • Organises dispensing of Day 1 and Day 14 treatment for the first cycle from Raigmore Hospital Pharmacy Department
  • Liaises with GP surgery when treatment is initiated, to arrange continuation of prescribing of fulvestrant and administration via primary care nursing team.
  • Provides advice to Primary Care Team if required

GPs / Non-medical prescribers in Primary Care

  • Prescribe fulvestrant treatment every 4 weeks in accordance with treatment plan from oncology
  • Refer to Oncology services if required

Primary Care Nursing Staff

Patient

  • Reports any adverse treatment effects via the Cancer Treatment Helpline
  • Organises administration of fulvestrant injections with Primary Care Nursing team in a timely manner.
  • Attends hospital clinics (virtually or in person) for review of cancer treatment
  • Stores any dispensed doses of fulvestrant as per storage conditions above.

Glossary

Abbreviation Meaning
CDK Cyclin-dependent kinase
CT Computerized tomography

Last reviewed: 01 June 2021

Next review: 01 June 2024

Author(s): Lead Cancer Care Pharmacist

Approved By: TAM subgroup of ADTC

Reviewer Name(s): Lead Cancer Care Pharmacist

Document Id: TAM466