Download GOSERELIN in breast cancer

GMMMG Interface Prescribing
Subgroup
Shared Care Protocol
Shared Care Guideline for
Reference Number
GOSERELIN in breast cancer
Version: 2.0
Replaces: SCP for Goserelin April 2010
Author(s)/Originator(s): (please state author name and
department)
Suzanne Frank
Advanced specialist breast cancer pharmacist
The Christie NHS Foundation Trust
Dr Vivek Misra
Consultant Clinical Oncologist
The Christie NHS Foundation Trust
Date approved by Interface Prescribing Group:
09/06/2016
Date approved by Commissioners:
dd/mm/yyyy
Issue date: 21/07/2016
To be read in conjunction
with the following
documents:
Current Summary of Product
characteristics
(http://www.medicines.org.uk)
BNF
Date approved by Greater Manchester
Medicines Management Group:
21/07/2016
Review Date:
21/07/2018
Please complete all sections
1. Name of Drug, Brand
Goserelin 3.6mg implant (Zoladex®)
Name, Form and
Strength
2. Licensed Indications


For advanced breast cancer in pre and perimenopausal women suitable for
hormonal manipulation
As an alternative to chemotherapy in the standard of care for pre/perimenopausal
women with oestrogen receptor (ER) positive early breast cancer (EBC).
3. Criteria for shared
Prescribing responsibility will only be transferred when
care




Treatment is for a specified indication and duration.
Treatment has been initiated and established by the secondary care specialist.
The patient’s initial reaction to and progress on the drug is satisfactory.
The GP has agreed in writing in each individual case that shared care is
appropriate.
The patient’s general physical, mental and social circumstances are such that
he/she would benefit from shared care arrangements

4. Patients excluded
from shared care
Version: 2.0
Date: 21/07/2016
Review: 21/07/2018



Unstable disease state
Patient does not consent to shared care
Patient does not meet criteria for shared care
Shared Care Guideline for Goserelin for Breast Cancer
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
Page 1 of 12
5. Therapeutic use &
Ovarian ablation can be achieved using the LHRH analogue goserelin (Zoladex).
background
Goserelin may be considered for shared care arrangements for the treatment of patients
with breast cancer in the following situations:
- For advanced breast cancer in pre and perimenopausal women suitable for
hormonal manipulation in combination with either tamoxifen or an aromatase
inhibitor.
- As an alternative to chemotherapy in the standard of care for pre/perimenopausal
women with ER positive EBC.
- As an adjunct to existing adjuvant endocrine therapy (tamoxifen/exemestane) in
younger premenopausal women with moderate to high risk tumours who do not
develop amenorrhoea with chemotherapy (unlicensed indication)
- For the preservation of fertility in EBC (unlicensed indication).
NB: NB: Zoladex LA® Safe System (a 10.8mg depot given every 12 weeks in the
treatment of prostate cancer) is NOT licensed for the treatment of breast cancer
and should not be used. Astra Zeneca state that their present LA form does not
provide reliable ovarian suppression for 12 weeks.
References
1. Francis PA et al. Adjuvant Ovarian suppression in premenopausal breast cancer.
NEJM 2015;372:436-46
2. Pagani O et al, Adjuvant Exemestane with Ovarian Suppression in
Premenopausal Breast Cancer NEJM 2014;371(2): 107-118
3. Halle CF et al Goserelin for ovarian protection during breast cancer adjuvant
chemotherapy NEJM 2015;372:923-932
4. Summary of Product Characteristics for goserelin 3.6mg implant
http://www.medicines.org.uk/emc/medicine/7855 (accessed 15.2.16)
5. Breast Cancer Management Guidelines 2016, The Christie Hospital NHS
Foundation Trust
6. Guidance for the management of breast cancer treatment induced bone loss, the
National Osteoporosis Society 2008
https://www.nos.org.uk/NetCommunity/Document.Doc?id=124 (accessed 19.2.16)
6. Contraindications
(please note this does
not replace the SPC or
BNF and should be
read in conjunction
with it).
7. Prescribing in
pregnancy and
lactation
8. Dosage regimen for
continuing care
Hypersensitivity to goserelin or to any of the excipients.
Pregnancy and lactation
This drug cannot be prescribed in the pregnant/breast feeding patient. Under these
circumstances prescribing should be the responsibility of the specialist.
Route of administration
Subcutaneous
Preparations available:
Goserelin is available as a 3.6mg depot injection (Zoladex® Safe System, Astra Zeneca)
in a single dose ready-to-use syringe, with a self activated needle guard to protect from
needlestick injuries.
Please prescribe:
One 3.6 mg depot of goserelin injected subcutaneously into the anterior abdominal wall,
every 28 days.
Is titration required
Version: 2.0
Date: 21/07/2016
Review: 21/07/2018
No
Shared Care Guideline for Goserelin for Breast Cancer
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Check with internet that this printed copy of the latest issue
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Adjunctive treatment regime:
Tamoxifen, Aromatase Inhibitors, Chemotherapy as appropriate depending on the
indication for therapy.
NB: Patients with hormone receptor positive breast cancer should not be prescribed
Hormone Replacement Therapy (HRT).
Conditions requiring dose reduction:
No dosage adjustment is required for hepatic or renal impairment, or in the elderly.
Duration of treatment:
Advanced breast cancer: Dependant on disease response
As alternative to chemotherapy in low risk ER positive EBC: Up to 2 years
In addition to tamoxifen/exemestane in high risk ER positive EBC: Up to 5 years
Fertility preservation in EBC: First dose to be given by specialist up to 1 week prior to
commencement of chemotherapy and throughout duration of chemotherapy
Treatment to be terminated by:
Specialist
NB. All dose adjustments will be the responsibility of the initiating specialist
care unless directions have been specified in the medical letter to the GP.
9.Drug Interactions
Ensure the patient is not using hormonal methods of contraception.
For a comprehensive
list consult the BNF or
Summary of Product
Characteristics
Since androgen deprivation treatment may prolong the QT interval, the concomitant use
of goserelin with medicinal products known to prolong the QT interval or medicinal
products able to induce Torsade de pointes should be carefully evaluated.
A useful resource to identify such medication: www.crediblemeds.org
10. Adverse drug
Specialist to detail below the action to be taken upon occurrence of a particular
adverse event as appropriate. Most serious toxicity is seen with long-term use
and may therefore present first to GPs.
reactions
For a comprehensive list
(including rare and very
rare adverse effects), or if
significance of possible
adverse event uncertain,
consult Summary of
Product Characteristics
or BNF
Adverse event
System – symptom/sign
Menopausal symptoms
Action to be taken Include
whether drug should be stopped prior to
contacting secondary care specialist
Menopausal symptoms to
be treated as appropriate
(see NICE for further
information)
By whom
GP
Refer back to consultant
consultant if patient wishes
to discuss treatment
cessation due to intolerable
adverse effects.
Version: 2.0
Date: 21/07/2016
Review: 21/07/2018
Shared Care Guideline for Goserelin for Breast Cancer
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
Page 3 of 12
Reduced Bone Mineral
Density (BMD)
As appropriate according to
T score – see National
Osteoporosis Society
guidance for the
management of Breast
cancer Treatment Induced
Bone Loss
Consultant
There is an increased risk of
incident depression (which
may be severe) in patients
undergoing treatment with
GnRH agonists, such as
Goserelin
Patients should be informed
accordingly
Consultant
and treated as appropriate if
symptoms occur.
GP
Androgen deprivation
therapy may prolong the QT
interval.
Baseline ECG to ensure no
underlying QT prologation
prior to commencing
therapy.
Consideration of
concomitant medication with
the potential to prolong QT
Consultant
Monitor affected patients for
signs or symptoms of
abdominal haemorrhage.
Consutant/GP
Injection site injury including
events of pain, haematoma,
haemorrhage and vascular
injury.
In very rare cases,
administration error resulted
in vascular injury and
haemorrhagic shock
requiring blood transfusions
and surgical intervention.
During early treatment with
Zoladex some women may
experience vaginal bleeding
of variable duration and
intensity.
Consultant/GP
Extra care should be taken
when administering to
patients with a low BMI
and/or receiving full
anticoagulation medications
If vaginal bleeding occurs it
is usually in the first month
after starting treatment.
Such bleeding probably
represents oestrogen
withdrawal bleeding and is
expected to stop
spontaneously. If bleeding
continues, the reason
should be investigated.
GP
The patient should be advised to report any of the following signs or symptoms to
their GP without delay:
Symptoms of venous thromboembolism.
Other important co morbidities:
Non-applicable
In patients with a history of or risk factors for QT prolongation and in patients receiving
Version: 2.0
Date: 21/07/2016
Review: 21/07/2018
Shared Care Guideline for Goserelin for Breast Cancer
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
Page 4 of 12
concomitant medicinal products that might prolong the QT interval physicians should
assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating
goserelin.
Any adverse reaction to a black triangle drug or serious reaction to an established
drug should be reported to the MHRA via the “Yellow Card” scheme.
11.Baseline
investigations
12. Ongoing
monitoring
requirements to be
undertaken by GP
List of investigations / monitoring undertaken by secondary care
 HBA1c, fasting glucose
 Fasting lipids
 BP and take cardiac history to include cardiac family history
 Document weight and BMI
 DEXA
Is monitoring required?
Monitoring
DEXA scan
13. Pharmaceutical
aspects
14. Responsibilities
of initiating specialist
Frequency









At baseline,
3/12 after
commencing
treatment and 2
yearly
thereafter
Results
Action
By whom
As appropriate
Consultant
according to T
score – see
National
Osteoporosis
Society
guidance for
the
management of
Breast cancer
Treatment
Induced Bone
Loss
The depot must be injected subcutaneously into the anterior abdominal wall.
The depot injections must not be stored above 25°C.

Version: 2.0
Date: 21/07/2016
Review: 21/07/2018
Yes – but no specific monitoring required by GP other
than observation of any side-effects as detailed above
and disease response.
T score
Initiate treatment and prescribe until dose is stable
Administration of at least first dose.
Undertake baseline monitoring.
Dose adjustments.
Monitor patient’s initial reaction to and progress on the drug.
Ensure that the patient has an adequate supply of medication until GP supply can
be arranged.
Patients will be considered suitable for transfer to GP prescribing ONLY when
they meet the criteria listed in section 3 above.
The consultant team will write formally to the GP to request shared care using the
Shared Care Agreement Form (Appendix 2) which must be fully completed.
Failure to supply all the required information will result in the refusal of the request
until all information has been supplied.
Patients will only be transferred to the GP once the GP has agreed via signing
copies of the Shared Care Agreement Form (Appendix 2).
Continue to monitor and supervise the patient according to this protocol, while the
Shared Care Guideline for Goserelin for Breast Cancer
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
Page 5 of 12
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15. Responsibilities
of the GP





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





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Version: 2.0
Date: 21/07/2016
Review: 21/07/2018
patient remains on this drug, and agree to review the patient promptly if contacted
by the GP
Provide GP with diagnosis, relevant clinical information and baseline results,
treatment to date and treatment plan, duration of treatment before consultant
review.
Provide patient with relevant drug information to enable Informed consent to
therapy.
Provide patient/carer with relevant drug information to enable understanding of
potential side effects and appropriate action.
Provide patient/care with relevant drug information to enable understanding of the
role of monitoring.
Provide GP with details of outpatient consultations, ideally within 14 days of
seeing the patient or inform GP if the patient does not attend appointment.
Provide GP with advice on when to stop this drug.
Act upon communication from the GP in a timely manner.
Provide patient with relevant drug information to enable Informed consent to
therapy.
Provide patient with relevant drug information to enable understanding of potential
side effects and appropriate action.
Provide patient with relevant drug information to enable understanding of the role
of monitoring.
Be available to provide patient specific advice and support to GPs as necessary.
Continue treatment as directed by the specialist.
Act upon communication from the specialist in a timely manner.
Ensure no drug interactions with concomitant medicines.
To monitor and prescribe in collaboration with the specialist according to this
protocol.
Symptoms or results are appropriately actioned, recorded and communicated to
secondary care when necessary.
Formally reply to the consultant’s request to shared care within 14 days of receipt,
using the shared care agreement forms (Appendix 2). NB the GP should only
agree to the transfer of prescribing if all details of the form have been completed.
If the GP does not feel it is appropriate to take on the prescribing then the
prescribing responsibilities will remain with the specialist. The GP should indicate
the reason for declining.
Enter a READ code (e.g. 8BM5.00) on to the patient record to highlight the
existence of shared care for the patient.
Undertake more frequent tests if there is evidence of clinical deterioration,
abnormal results, or other risk factors. Contact consultant team for advice on
monitoring in these circumstances if required.
Check all monitoring results prior to issuing a repeat prescription to ensure it is
safe to do so.
Monitor the patient’s general wellbeing.
Inform the consultant immediately if a patient has become pregnant or is planning
to become pregnant for treatment options to be considered
Seek urgent advice from secondary care if:
 Toxicity is suspected
 Non-compliance is suspected
 The GP feels a dose change is required
 There is marked deterioration in the patient’s condition
 The GP feels the patient is not benefiting from the treatment
The shared care agreement will cease to exist, and prescribing responsibility will
return to secondary care, where:
Shared Care Guideline for Goserelin for Breast Cancer
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Check with internet that this printed copy of the latest issue
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
The clinical situation deteriorates such that the shared care criterion of
stability is not achieved.
 The clinical situation requires a major change in therapy.
 The patient is a risk to self or others
 GP feels it to be in the best stated clinical interest of the patient for
prescribing responsibility to transfer back to the Consultant. The
Consultant will accept such a transfer within a timeframe appropriate to
the clinical circumstances.
There must be discussion between the consultant team and GP on this matter
and agreement from the consultant team to take back full prescribing
responsibility for the treatment of the patient. The consultant team should be
given 14 days’ notice in which to take back prescribing responsibilities from
primary care.
16. Responsibilities
of the patient




17.Additional
Responsibilities
e.g. Failure of patient to
attend for monitoring,
Intolerance of drugs,
Monitoring
parameters
outside
acceptable
range, Treatment failure,
Communication failure
To use medication as directed by the prescriber, or to contact the GP if not using
medication
To attend hospital and GP clinic appointments, bring monitoring booklet (if issued)
Failure to attend will result in medication being stopped (on specialist advice).
To report adverse effects to their Specialist or GP.
List any special
considerations
Action required
By whom
Date
Non-applicable
18. Supporting
documentation
The SCG must be accompanied by a patient information leaflet. (Available from
http://www.medicines.org.uk/emc OR http://www.mhra.gov.uk/spc-pil/)
19. Patient monitoring
Non-applicable
booklet
(may not be applicable
for all drugs)
20. Shared care
agreement form
Attached below
21. Contact details
See Appendix 1
Version: 2.0
Date: 21/07/2016
Review: 21/07/2018
Shared Care Guideline for Goserelin for Breast Cancer
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
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Appendix 1 – Local Contact Details
Lead author contact
information
Name: Suzanne Frank
Email: [email protected]
Contact number: 0161 446 3443
Organisation: The Christie NHS Foundation Trust
Commissioner contact
information
Name: [insert text here]
Email: [insert text here]
Contact number: [insert text here]
Organisation: [insert text here]
Secondary care contact
information
If stopping medication or needing advice please contact:
Name Dr Vivek Misra
Contact number: 01614463000
Email: [email protected]
Hospital: The Christie NHS Foundation Trust
Version: 2.0
Date: 21/07/2016
Review: 21/07/2018
Shared Care Guideline for Goserelin for Breast Cancer
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
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Shared Care Agreement Form
Specialist request
*IMPORTANT: ACTION NEEDED
Dear Dr
[insert Doctors name here]
Patient name: [insert Patients name here]
Date of birth: [insert date of birth]
NHS Number: [insert NHS Number]
Diagnosis:
[insert diagnosis here]
This patient is suitable for treatment with [insert drug name] for the treatment of
[insert indication]
This drug has been accepted for Shared Care according to the enclosed protocol
(as agreed by Trust / CCG / GMMMG). I am therefore requesting your agreement
to share the care of this patient.
The patient has been fully counselled on the medication.
Treatment was started on [insert date started] [insert dose].
If you are in agreement, please undertake monitoring and treatment from [insert
date]
NB: date must be at least 1 month from initiation of treatment.
Baseline tests:
[insert information]
Next review with this department:
[insert date]
You will be sent a written summary within 14 days. The medical staff of the
department are available at all times to give you advice. The patient will not be
discharged from out-patient follow-up while taking [insert text here].
Please use the reply slip overleaf and return it as soon as possible.
Thank you.
Yours
[insert Specialist name]
Version: 2.0
Date: 21/07/2016
Review: 21/07/2018
Shared Care Guideline for Goserelin for Breast Cancer
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Check with internet that this printed copy of the latest issue
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Shared Care Agreement Form
GP Response
Dear Dr [insert Doctors name]
Patient
[insert Patients name]
NHS Number [insert NHS Number]
Identifier
[insert patient date of birth/address]
I have received your request for shared care of this patient who has been
advised to start [insert text here]
A
I am willing to undertake shared care for this patient as set out in the
protocol
B
I wish to discuss this request with you
C
I am unable to undertake shared care of this patient.
My reasons for not accepting are:
(Please complete this section)
GP signature
Date
GP address/practice stamp
Version: 2.0
Date: 21/07/2016
Review: 21/07/2018
Shared Care Guideline for Goserelin for Breast Cancer
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Check with internet that this printed copy of the latest issue
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Shared Care Guideline Summary:
GOSERELIN for the treatment of BREAST CANCER
Drug
Indication
Overview
Specialist’s
Responsibilities
Goserelin 3.6mg implant (Zoladex®)
Goserelin may be considered for shared care arrangements for the treatment of patients
with breast cancer in the following situations:
 For advanced breast cancer in pre and perimenopausal women suitable for
hormonal manipulation in combination with either tamoxifen or an aromatase
inhibitor.
 As an alternative to chemotherapy in the standard of care for pre/perimenopausal
women with ER positive EBC.
 As an adjunct to existing adjuvant endocrine therapy (tamoxifen/exemestane) in
younger premenopausal women with moderate to high risk tumours who do not
develop amenorrhoea with chemotherapy.
 For the preservation of fertility in EBC.
Initial investigations: Assess suitability of patient for treatment. Discuss benefits and sideeffects of treatment with the patient. Undertake baseline investigations (HBA1c, fasting
glucose, fasting lipids, BP, cardiac history, weight, BMI, DEXA).
Initial regimen: Goserelin 3.6mg depot subcutaneous injection every 28 days.
Safety monitoring: DEXA scan at baseline, 3/12 after commencing treatment and 2 yearly
thereafter. Monitoring for response and adverse drug reactions (ADRs) during initiation
period. Evaluating ADRs raised by the GP and evaluating any concerns arising from reviews
undertaken by GP
Prescribing details: Hospital initiated. Transferred to GP once stabilised. To stop the drug
or provide GP with advice on when to stop this drug.
GP’s
Responsibilities
Documentation: Patients will only be transferred to the GP once the GP has agreed via
signing copies of the Shared Care Agreement Form
Provide GP with diagnosis, relevant clinical information, treatment plan, duration of
treatment within 14 days of seeing the patient or inform GP if the patient does not attend
appointment
Maintenance prescription: Goserelin 3.6mg depot subcutaneous injection every 28 days.
Clinical & Safety monitoring: No specific monitoring is required other than observation of
any side-effects and disease response.
Duration of treatment: as specified by consultant
Re-referral criteria: Seek urgent advice from secondary care if:
 Toxicity is suspected
 Non-compliance is suspected
 The GP feels a dose change is required
 There is marked deterioration in the patient’s condition
 The GP feels the patient is not benefiting from the treatment
Documentation: Formally reply to the consultant’s request to shared care within 14 days of
receipt
Version: 2.0
Date: 21/07/2016
Review: 21/07/2018
Shared Care Guideline for Goserelin for Breast Cancer
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
Page 11 of 12
Adverse Events
Contraindications
Cautions
Drug
Interactions
Other
Information
Contact Details
Adverse events
Menopausal symptoms
Reduced Bone Mineral Density (BMD)
Action
Refer back to consultant
As appropriate according to T score – see
National Osteoporosis Society guidance for
the management of Breast cancer
Treatment Induced Bone Loss
Please refer to the BNF and/or SPC for information
The depot must be injected subcutaneously into the anterior abdominal wall.
The depot injections must not be stored above 25°C.
Name: [insert text here]
Address: [insert text here]
Telephone: [insert text here]
Version: 2.0
Date: 21/07/2016
Review: 21/07/2018
Shared Care Guideline for Goserelin for Breast Cancer
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
Page 12 of 12