Common use of CLINICAL INFORMATION Clause in Contracts

CLINICAL INFORMATION. i. Prescribed indications Degarelix is a gonadotrophin releasing hormone (GnRH) antagonist indicated for the treatment of adult male patients with advanced hormone-dependant prostate cancer. Degarelix will be prescribed for patients requiring a rapid lowering of testosterone presenting with symptoms such as:  Impending spinal cord compression (as per NICE CG 75)  Treating advanced hormone dependent prostate cancer in people with spinal metastases (as per NICE TA 404)  Renal failure due to ureteric obstruction ii. Therapeutic summary Degarelix is a selective gonadotrophin releasing-hormone (GnRH) antagonist that competitively and reversibly binds to the pituitary GnRH receptors, thereby rapidly reducing the release of the gonadotrophins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), and thereby reducing the secretion of testosterone (T) by the testes. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that removes the source of androgen. Unlike GnRH agonists, GnRH antagonists do not induce a LH surge with subsequent testosterone surge/tumour stimulation and potential symptomatic flare after the initiation of treatment. Patients do not require a course of anti-androgens as no tumour flare is caused by degarelix iii. Dose & Route of administration Starting dose (to be prescribed & administered by secondary care)  240mg administered as two subcutaneous injections of 120mg each Maintenance dose (to be prescribed & administered in primary care)  80mg monthly administered as one subcutaneous injection starting one month after the starting dose & continued monthly MUST BE GIVEN SUBCUTANEOUSLY; INJECTION BY OTHER ROUTES MAY BE HARMFUL iv. Duration of treatment Indefinite v. Adverse effects Very common (≥1/10): Hot flush*, injection site adverse events Common (≥1/100 to <1/10): anaemia*, weight increase*, insomnia, dizziness, headache, diarrhoea, nausea, liver transaminases increased, hyperhidrosis (inc. night sweats)*, rash, musculoskeletal pain & discomfort, gynaecomastia*, testicular atrophy*, erectile dysfunction*, chills, pyrexia, fatigue*, influenza-like illness *known physiological consequence of testosterone suppression vi. Monitoring Requirements Baseline - Specialist  Serum PSA  IP (U+Es, bone profile, liver function test)  Full blood count Every 6 months – GP  PSA Missed dose (by more than 2 weeks)  PSA vii. Action to be taken Patients should be referred back to secondary care if they have any of the following symptoms:  PSA above threshold  Deterioration in lower urinary tract symptoms  Bone pain Patients who have the following symptoms should be re-referred on the same day:  Lower limb neurology  Suspicion of spinal cord compression viii. Clinically relevant 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 (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, cisapride, moxifloxacin, antipsychotics, etc. should be carefully evaluated ix. Contra-indications None. Caution advised diabetes and in patients susceptible to QT-prolongation (see interactions also) x. Supply of ancillary equipment Not required xi. Supply, storage and reconstitution instructions Degarelix should not be mixed with other medicinal products The vials should not be shaken See SPC for instructions on reconstitution & administration Storage conditions after reconstitution Chemical and physical in-use stability has been demonstrated for 2 hours at 25°C. From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user xii. Prepared and or updated by Prepared by The Shared Care Guideline Group, University Hospitals of Derby and ▇▇▇▇▇▇ NHS Foundation Trust Dr ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, Consultant Urologist, University Hospitals of Derby and ▇▇▇▇▇▇ NHS Foundation Trust Updated in consultation with Dr. ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, Consultant Urologist, University Hospitals of Derby and ▇▇▇▇▇▇ NHS Foundation TrustDavid Shipstone, Consultant Urologist, Chesterfield Royal Hospital NHS Foundation Trust ▇▇▇▇ ▇▇▇▇▇▇, Consultant Urologist and prostate cancer lead, Chesterfield Royal Hospital NHS Foundation Trust ▇▇▇▇ ▇▇▇▇▇▇▇, Urology Matron, Chesterfield Royal Hospital NHS Foundation Trust ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇, Urology cancer CNS, Chesterfield Royal Hospital NHS Foundation Trust Sample transfer letter Hospital No: «HOSPITAL_NUMBER» NHS No: «NHS_NUMBER» {Insert date} «GP_TITLE» «GP_INITIALS» «GP_SURNAME» «GP_ADDRESS_1» «GP_ADDRESS_2» «GP_ADDRESS_3» «GP_ADDRESS_4» «GP_POSTCODE» Dear «GP_TITLE» «GP_SURNAME» Your patient was seen on {Insert date} with a diagnosis of {Insert diagnosis}. I have initiated the following medication {Insert drug name} and am writing to ask you to participate in the shared care for this patient. This medication has been accepted as suitable for shared care by the Derbyshire Joint Area Prescribing Committee (JAPC). I agree to the secondary care responsibilities set out in the shared care agreement for this medication (available from ▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇.▇▇/▇▇▇▇▇▇▇▇_▇▇▇▇▇▇▇▇▇▇/▇▇▇▇▇▇_▇▇▇▇_▇▇▇▇▇▇▇▇▇▇). I am therefore requesting your agreement to share the care of this patient. Where preliminary tests are set out in the agreement I have carried these out and results are below. Dose Regimen Date {Insert medicine name} started Date for GP to start prescribing {Insert medicine name} from PSA threshold is: The baseline test results are (if applicable): I confirm I have explained to the patient: the risks and benefits of treatment, the baseline tests conducted the need for monitoring, how monitoring will be arranged, and the roles of the consultant / nurse specialist, GP and the patient in shared care. I confirm the patient has understood and is satisfied with this shared care arrangement at this time. If you do NOT wish to participate in shared care for this patient, usually under clinical grounds, please complete the attached form. Yours sincerely GP RESPONSE TO SHARED CARE (only complete & send if NOT participating in shared care) Shared care is produced by GPs and specialists knowledgeable in the field of that drug usage. The shared care has been approved by the JAPC. This allows a more convenient service to the patient and cost effective use of NHS resources.

CLINICAL INFORMATION. i. Prescribed indications Degarelix is a gonadotrophin releasing hormone (GnRH) antagonist indicated for the treatment of adult male patients with advanced hormone-dependant prostate cancer. Degarelix will be prescribed for patients requiring a rapid lowering of testosterone presenting with symptoms such as:  • Impending spinal cord compression (as per NICE CG 75)  • Treating advanced hormone dependent prostate cancer in people with spinal metastases (as per NICE TA 404)  • Renal failure due to ureteric obstruction ii. Therapeutic summary Degarelix is a selective gonadotrophin releasing-hormone (GnRH) antagonist that competitively and reversibly binds to the pituitary GnRH receptors, thereby rapidly reducing the release of the gonadotrophins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), and thereby reducing the secretion of testosterone (T) by the testes. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that removes the source of androgen. Unlike GnRH agonists, GnRH antagonists do not induce a LH surge with subsequent testosterone surge/tumour stimulation and potential symptomatic flare after the initiation of treatment. Patients do not require a course of anti-anti- androgens as no tumour flare is caused by degarelix iii. Dose & Route of administration Starting dose (to be prescribed & administered by secondary care)  • 240mg administered as two subcutaneous injections of 120mg each Maintenance dose (to be prescribed & administered in primary care)  • 80mg monthly administered as one subcutaneous injection starting one month after the starting dose & continued monthly MUST BE GIVEN SUBCUTANEOUSLY; INJECTION BY OTHER ROUTES MAY BE HARMFUL iv. Duration of treatment Indefinite v. Adverse effects Very common (≥1/10): Hot flush*Pregnancy, injection site adverse events Common (≥1/100 to <1/10): anaemia*, weight increase*, insomnia, dizziness, headache, diarrhoea, nausea, liver transaminases increased, hyperhidrosis (inc. night sweats)*, rash, musculoskeletal pain & discomfort, gynaecomastia*, testicular atrophy*, erectile dysfunction*, chills, pyrexia, fatigue*, influenzapaternal exposure and breastfeeding Pregnancy and breast-like illness *known physiological consequence of testosterone suppression vi. Monitoring Requirements Baseline - Specialist  Serum PSA  IP (U+Es, bone profile, liver function test)  Full blood count Every 6 months – GP  PSA Missed dose (by more than 2 weeks)  PSA vii. Action to be taken Patients should be referred back to secondary care if they have any of the following symptoms:  PSA above threshold  Deterioration in lower urinary tract symptoms  Bone pain Patients who have the following symptoms should be re-referred on the same day:  Lower limb neurology  Suspicion of spinal cord compression viii. Clinically feeding There is no relevant drug interactions No formal drug-drug interaction studies have been performed. Since androgen deprivation treatment may prolong the QTc interval, the concomitant indication for use of degarelix with medicinal products known to prolong degarelix. Fertility Degarelix may inhibit fertility as long as the QTc interval or medicinal products able to induce torsades de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, cisapride, moxifloxacin, antipsychotics, etc. should be carefully evaluated ix. Contra-indications None. Caution advised diabetes and in patients susceptible to QT-prolongation (see interactions also) x. Supply of ancillary equipment Not required xi. Supply, storage and reconstitution instructions Degarelix should not be mixed with other medicinal products The vials should not be shaken See SPC for instructions on reconstitution & administration Storage conditions after reconstitution Chemical and physical in-use stability has been demonstrated for 2 hours at 25°C. From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user xii. Prepared and or updated by Prepared by The Shared Care Guideline Group, University Hospitals of Derby and ▇▇▇▇▇▇ NHS Foundation Trust Dr ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, Consultant Urologist, University Hospitals of Derby and ▇▇▇▇▇▇ NHS Foundation Trust Updated in consultation with Dr. ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, Consultant Urologist, University Hospitals of Derby and ▇▇▇▇▇▇ NHS Foundation TrustDavid Shipstone, Consultant Urologist, Chesterfield Royal Hospital NHS Foundation Trust ▇▇▇▇ ▇▇▇▇▇▇, Consultant Urologist and prostate cancer lead, Chesterfield Royal Hospital NHS Foundation Trust ▇▇▇▇ ▇▇▇▇▇▇▇, Urology Matron, Chesterfield Royal Hospital NHS Foundation Trust ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇, Urology cancer CNS, Chesterfield Royal Hospital NHS Foundation Trust Sample transfer letter Hospital No: «HOSPITAL_NUMBER» NHS No: «NHS_NUMBER» {Insert date} «GP_TITLE» «GP_INITIALS» «GP_SURNAME» «GP_ADDRESS_1» «GP_ADDRESS_2» «GP_ADDRESS_3» «GP_ADDRESS_4» «GP_POSTCODE» Dear «GP_TITLE» «GP_SURNAME» Your patient was seen on {Insert date} with a diagnosis of {Insert diagnosis}. I have initiated the following medication {Insert drug name} and am writing to ask you to participate in the shared care for this patient. This medication has been accepted as suitable for shared care by the Derbyshire Joint Area Prescribing Committee (JAPC). I agree to the secondary care responsibilities set out in the shared care agreement for this medication (available from ▇▇▇testosterone is suppressed.▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇.▇▇/▇▇▇▇▇▇▇▇_▇▇▇▇▇▇▇▇▇▇/▇▇▇▇▇▇_▇▇▇▇_▇▇▇▇▇▇▇▇▇▇). I am therefore requesting your agreement to share the care of this patient. Where preliminary tests are set out in the agreement I have carried these out and results are below. Dose Regimen Date {Insert medicine name} started Date for GP to start prescribing {Insert medicine name} from PSA threshold is: The baseline test results are (if applicable): I confirm I have explained to the patient: the risks and benefits of treatment, the baseline tests conducted the need for monitoring, how monitoring will be arranged, and the roles of the consultant / nurse specialist, GP and the patient in shared care. I confirm the patient has understood and is satisfied with this shared care arrangement at this time. If you do NOT wish to participate in shared care for this patient, usually under clinical grounds, please complete the attached form. Yours sincerely GP RESPONSE TO SHARED CARE (only complete & send if NOT participating in shared care) Shared care is produced by GPs and specialists knowledgeable in the field of that drug usage. The shared care has been approved by the JAPC. This allows a more convenient service to the patient and cost effective use of NHS resources.