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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 Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 2 of 12 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 15. Responsibilities of the GP 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 Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 6 of 12 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 Page 7 of 12 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 Page 8 of 12 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 Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 9 of 12 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 Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 10 of 12 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