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Royal Wolverhampton NHS Trust Wolverhampton City Clinical Commissioning Group Wolverhampton Shared Care Agreement Black Country Cluster Bicalutamide 50mg (Casodex®) ESCA: For the treatment of advanced prostate cancer combined with castration or LHRH SECONDARY CARE SECTION TO BE COMPLETED BY INITIATING DOCTOR Patient’s Name: NHS Number: Date of Birth: Date Treatment Started: (Add Date) One copy of information leaflet given to patient One copy of agreement sent to general practitioner One copy filed in patients notes Name of Initiating Doctor: Consultant: Speciality: Fax Number: PRIMARY CARE SECTION TO BE COMPLETED BY GENERAL PRACTITIONER I agree*/don’t agree* to enter into a shared care arrangement for the treatment of the above patient with this medicine (*delete as appropriate) GP Name: Signature: Date: Once signed please detach this sheet and fax to the number shown above. BACK-UP ADVICE AND SUPPORT Contact details Telephone No. Specialist: Dr Sayers Bleep Fax Email 695220 695624 [email protected] Specialist: Dr Koh 695201 695624 [email protected] Specialist: Dr Tirmazy 695204 695624 [email protected] Hospital Pharmacy Dept: Sandra Tang 695139 1717 [email protected] This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for bicalutamide 50mg (Casodex®)) and the Midland Therapeutic Review and Advisory Committee (MTRAC) verdict and summary sheets (VS & SS 03/17). Original template developed by MTRAC in April 2004 Date approved: January 2013 Last Reviewed: June 2016 Expiry date: June 2019 Royal Wolverhampton NHS Trust Wolverhampton City Clinical Commissioning Group Wolverhampton Shared Care Agreement Black Country Cluster Bicalutamide 50mg (Casodex®) ESCA: For the treatment of advanced prostate cancer combined with castration or LHRH Patient’s Name: Date treatment commenced: AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE This shared care agreement outlines suggested ways in which the responsibilities for managing the prescribing of bicalutamide for men with prostate cancer can be shared between the specialist and general practitioner (GP). GPs are invited to participate. If the GP is not confident to undertake these roles, then he or she is under no obligation to do so. In such an event, the total clinical responsibility for the patient for the diagnosed condition remains with the specialist. If a specialist asks the GP to prescribe this drug, the GP should reply to this request as soon as practicable. Sharing of care assumes communication between the specialist, GP and patient. The intention to share care should be explained to the patient by the doctor initiating treatment. It is important that patients are consulted about treatment and are in agreement with it. Patients with prostate cancer should be under regular specialist follow-up, which provides opportunities to discuss drug therapy. The doctor who prescribes the medication legally assumes clinical responsibility for the drug and the consequences of its use. RESPONSIBILITIES and ROLES 1. 2. 3. 4. 5. 6. 7. 1. 2. 3. 4. 1. 2. 3. Specialist responsibilities Discuss the benefits and side effects of treatment with the patient. Initiate treatment, ask the GP whether he or she is willing to participate in shared care, and agree with the GP as to who will discuss the shared care arrangement with the patient. Monitor the response to treatment and communicate promptly with the GP when treatment changes. Monitor liver function (LFTs) and PSA levels. Stop treatment when indicated, or advise the GP as to when to stop treatment. Report adverse events to the MHRA. Ensure clear backup arrangements exist for GPs for advice and support. General Practitioner responsibilities Reply to the request for shared care as soon as practicable. Refer promptly to the specialist when any loss of clinical efficacy is suspected (e.g. worsening of diseaserelated symptoms, new symptoms suggestive of disease progression such as bone pain) or if intolerance to therapy occurs. Report adverse events to the specialist and MHRA. Stop treatment on the advice of the specialist, or immediately if intolerable side effects occur e.g. gynaecomastia, clinically significant hepatic changes. Patient's role Report to the specialist or GP if he does not have a clear understanding of the treatment. Share any concerns in relation to treatment with bicalutamide. Report any adverse effects to the specialist or GP whilst taking bicalutamide. This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for bicalutamide 50mg (Casodex®)) and the Midland Therapeutic Review and Advisory Committee (MTRAC) verdict and summary sheets (VS & SS 03/17). Original template developed by MTRAC in April 2004 Date approved: January 2013 Last Reviewed: June 2016 Expiry date: June 2019 Royal Wolverhampton NHS Trust Wolverhampton City Clinical Commissioning Group Wolverhampton Shared Care Agreement Black Country Cluster Bicalutamide 50mg (Casodex®) ESCA: For the treatment of advanced prostate cancer combined with castration or LHRH SUPPORTING CLINICAL INFORMATION Indications Bicalutamide 50mg is indicated for the treatment of advanced prostate cancer in combination with luteinising hormone releasing hormone (LHRH) analogue therapy or surgical castration. Dosage and Administration The recommended dose of bicalutamide is one tablet taken once daily. Contraindications Bicalutamide is contra-indicated in women, children, and patients who have shown a hypersensitivity reaction to its use. Side Effects The most frequently reported adverse events with bicalutamide 50mg are gynaecomastia and breast pain. Hepatic changes (elevated transaminase levels, cholestasis and jaundice) have been seen in patients taking bicalutamide (see Monitoring). Refer to the SPC for a full list of adverse effects. Monitoring Parameter Liver function test due to the possibility of hepatic changes. (Most cases are expected to occur within the first 6 months of therapy see SPC). Frequency of monitoring As indicated according to the individual patient's requirements, or as recommended by the specialist (can be measured at the same time as PSA levels). Action Depends on the profile of results. It may be necessary to repeat test, monitor more frequently, or discontinue treatment. Consult with specialist if uncertain about threshold for discontinuing treatment. (The SPC notes that changes seen with bicalutamide therapy were frequently transient, resolving or improving with continued therapy or following withdrawal of therapy.) Prostate Specific Antigen (PSA) levels. According to specialist's recommendation (can be measured at the same time as LFTs). Consult with specialist. High or increasing levels may indicate disease progression, and the need to re-evaluate patient's treatment needs. Drug Interactions In vitro studies show that bicalutamide inhibits enzymes of the cytochrome P450 system, and may displace warfarin from plasma protein binding sites. Concomitant use of other enzyme inhibitors, e.g. cimetidine, could theoretically increase plasma concentrations of bicalutamide with the potential for increased adverse effects. In clinical practice, drug interactions are not generally seen (expert opinion). Caution is advised when drugs with a narrow therapeutic index are given with bicalutamide e.g. ciclosporin, where dose reductions and monitoring of plasma levels may be necessary. Acknowledgements Refer to MTRAC VS & SS 03/17. Version Control Version Date of Issue Author/s Brief Description of Changes This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for bicalutamide 50mg (Casodex®)) and the Midland Therapeutic Review and Advisory Committee (MTRAC) verdict and summary sheets (VS & SS 03/17). Original template developed by MTRAC in April 2004 Date approved: January 2013 Last Reviewed: June 2016 Expiry date: June 2019 Royal Wolverhampton NHS Trust Wolverhampton City Clinical Commissioning Group Wolverhampton Shared Care Agreement Black Country Cluster Bicalutamide 50mg (Casodex®) ESCA: For the treatment of advanced prostate cancer combined with castration or LHRH 1.0 1.1 25/06/2013 R Eardley Removal of pharmacy fax numbers 2.0 20/06/2016 S Tang Updated contact details and confirmed no changes to clinical content References MTRAC guidance VS03/17. AstraZeneca. Casodex. Summary of Product Characteristics 2004. This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for bicalutamide 50mg (Casodex®)) and the Midland Therapeutic Review and Advisory Committee (MTRAC) verdict and summary sheets (VS & SS 03/17). Original template developed by MTRAC in April 2004 Date approved: January 2013 Last Reviewed: June 2016 Expiry date: June 2019