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Shared Care Agreement Form – Accredited CONSULTANT REQUEST DENOSUMAB 60mg (Prolia®) To: Dr. Your patient: NHS No. (10 digit): was seen on: with a diagnosis of: I recommend that the following drug is continued: This drug has been accepted as suitable for shared care by ABUHB’s MTC. I agree to the responsibilities set out in the protocol SCP No. 27 (copy attached and at: http://www.wales.nhs.uk/sites3/page.cfm?orgid=814&pid=38180). Your practice is accredited to provide pre-assessment and administration of denosumab 60mg (Prolia®) as a Local Enhanced Service. I am therefore requesting your agreement to share the care of this patient. The preliminary tests set out in the Protocol (Section 7) have been carried out. First 60mg dose administered on (date): Baseline renal function: Baseline hydroxyvitamin D (25OHD) level: (Normal/abnormal) Baseline bone profile (Normal/abnormal) (serum calcium, alk phos, phosphate, albumin) Next review with this department: (add date) OR Routine review in hospital is not required. However, the medical staff of the department are available to give you advice. If the patient continues on denosumab 60mg for 5 years, please notify this department so that review can be arranged. Consultant Name: Signature: Department: Hospital: Date: Contact Telephone Nos: NOTE FOR GENERAL PRACTITIONER AS THE PRACTICE IS ACCREDITED TO UNDERTAKE NEAR PATIENT TESTING, IT WILL BE ASSUMED THAT THE PRACTICE WILL WISH TO ACCEPT REFERRALS FOR SHARED CARE. IF FOR ANY REASON THIS IS NOT THE CASE, PLEASE CONTACT THE CONSULTANT URGENTLY SO THAT ARRANGEMENTS CAN BE MADE TO UNDERTAKE THE NECESSARY MONITORING FOLLOWING INITIATION OF THE DRUG. This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics Status: APPROVED Issue Date: January 2014 (updated Jan. 2016 & March 2017) Approved by: ABUHB MTC Page 1 of 6 Review Date: January 2018 Gwent Shared Care Protocol DENOSUMAB 60mg (Prolia®) for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures Protocol No. 27 General guidance 1. Licensed indication PLEASE CHECK http://www.wales.nhs.uk/sites3/page.cfm?orgid=814&pid=38180 FOR THE LATEST VERSION OF THIS PROTOCOL ABUHB’s Medicines and Therapeutics Committee endorsed this protocol in 2014. It outlines shared care arrangements for. This Protocol should be read in conjunction with: The Shared Care Agreement Form (see Page 1). The Summary of Product Characteristics for Prolia® see: http://www.medicines.org.uk/emc/medicine/23127 NICE TA204 (October 2010) http://guidance.nice.org.uk/TA204 – Osteoporotic fractures. Note: This Protocol does NOT cover the prescribing and administration of denosumab: 60mg (Prolia®) in patients with an eGFR <30 or for any patients subsequently developing eGFRs <30. In such cases Secondary Care will retain the responsibility for the prescribing and administration of denosumab. 60mg (Prolia®) for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (NICE is unable to recommend this use). 120mg (▼XGEVA®) for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumours. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In 2014 denosumab (Prolia®) was granted a license extension for treatment of osteoporosis in men at increased risk of fracture and in March 2017 a One Wales Interim Commissioning decision recommended that denosumab be made available within NHS Wales for this indication (see: https://openrepository.awttc.org/app/serve/resource/trpp2722). In Gwent denosumab is considered a third line option after failure of two oral bisphosphonates in patients unsuitable for zoledronic acid or fourth line after failure of zoledronic acid (or the development of severe renal impairment during treatment – this cohort to remain specialist managed). 2. Background information Denosumab (Prolia®) has been prescribed for the treatment of osteoporosis/bone loss for this individual. Denosumab is a human monoclonal antibody (IgG2) that decreases bone resorption in cortical and trabecular bone. When denosumab (Prolia®) is used for the prevention of osteoporotic fractures in postmenopausal women, it should be prescribed in accordance with the recommendations in NICE TA204 (www.nice.org.uk/TA204) i.e. when the following conditions are met: Primary prevention of osteoporotic fragility fractures in postmenopausal women at increased risk of fractures: who are unable to comply with the special instructions for administering alendronate and either risedronate or etidronate, or have an intolerance of, or a contra-indication to, those treatments and who comply with particular combinations of bone mineral density measurement, age, and independent risk factors for fracture, as indicated in NICE TA204. Secondary prevention of osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures: who are unable to comply with the special instructions for administering alendronate and either risedronate or etidronate, or have an intolerance of, or a contra-indication to, those treatments. The first dose should be administered by the specialist team. Thereafter, prescribing and This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics Status: APPROVED Issue Date: January 2014 (updated Jan. 2016 & March 2017) Approved by: ABUHB MTC Page 2 of 6 Review Date: January 2018 administration can be undertaken in primary care in accordance with the shared care agreement. 3. Contraindications & cautions Contraindications: 1. Hypocalcaemia. 2. Hypersensitivity to the active substance or to any of the excipients of denosumab (Prolia®) Cautions: Hypocalcaemia – (note contraindication) must be corrected by adequate intake of calcium and vitamin D before initiating therapy. Patients with severe renal impairment (eGFR <30) or receiving dialysis are at greater risk of developing hypocalcaemia. Clinical monitoring of calcium levels is recommended for patients predisposed to hypocalcaemia. Skin Infections – Patients receiving denosumab may develop cellulitis leading to hospitalisation. Patients should be advised to seek prompt medical attention if they develop signs or symptoms of cellulitis. Osteonecrosis of the jaw (ONJ) – Although most cases have been in cancer patients; ONJ has been reported rarely in clinical studies in patients receiving 60mg of denosumab every 6 months for osteoporosis. Known risk factors for ONJ include a diagnosis of cancer with bone lesions, concomitant therapies (e.g., chemotherapy, antiangiogenic biologics, corticosteroids, radiotherapy to head and neck), poor oral hygiene, dental extractions, and co-morbid disorders (e.g., pre-existing dental disease, anaemia, coagulopathy, infection) and previous treatment with bisphosphonates. Atypical femoral fractures – have been reported in patients receiving 60mg of denosumab and they may occur with little or no trauma in the subtrochanteric and diaphyseal regions of the femur. Specific radiographic findings characterize these events. Atypical femoral fractures have also been reported in patients with certain comorbid conditions (e.g. vitamin D deficiency, rheumatoid arthiritis, hypophosphatasia) and with use of certain medicines (e.g. bisphosphonates, glucocorticoids, PPIs). Similar fractures reported in association with bisphosphonates are often bilateral; therefore the contralateral femur should be examined in denosumab-treated patients who have sustained a femoral shaft fracture. 4. Dosage regimen POSTMENOPAUSAL WOMEN AND MEN AT INCREASED RISK OF FRACTURES: 60mg every 6 months by subcutaneous injection into the thigh, abdomen or upper arm. Note. No dose adjustment is required in the elderly or patients with renal impairment. DURATION OF TREATMENT: review therapy by specialist team after 5 years. 5. Drug Interactions Patients being treated with denosumab (Prolia®) should not be treated concomitantly with other denosumab-containing medicinal products (for prevention of skeletal-related events in adults with bone metastases from solid tumours). 6. Adverse drug reactions Common (≥1/100 to <1/10) adverse effects listed in the denosumab SmPC include urinary tract infection, upper respiratory tract infection, sciatica, cataracts, eczema, rash, constipation and cataracts. The only very commonly (≥1/10) associated adverse effect in the SmPC is pain in extremity. All serious adverse events should be reported to MHRA/CHM using the Yellow Card. Adverse event Cellulitis Atypical femoral fractures (i.e. new or unusual thigh, hip, or groin pain) ONJ Good oral hygiene practices Frequency Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 Rare ≥1/10,000 to <1/1,000 Management Standard clinical management Evaluate for an incomplete femoral fracture and if fracture confirmed consider stopping drug and discuss If ONJ occurs during treatment with use clinical judgment and guide the management This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics Status: APPROVED Issue Date: January 2014 (updated Jan. 2016 & March 2017) Approved by: ABUHB MTC Page 3 of 6 Review Date: January 2018 should be maintained during treatment. plan of each patient based on individual benefit/risk evaluation. Note dental surgery may exacerbate the condition. 7. Baseline investigations To be undertaken by specialist in secondary care: Ensure calcium and vitamin D replete (vitamin D deficiency and hypocalcaemia must be corrected before initiation of therapy) i. Renal function, bone profile (serum calcium, alkaline phosphatase, phosphate, albumin) and serum vitamin D. ii. A dental examination with appropriate preventive dentistry should be considered in patients with concomitant risk factors. While on treatment, these patients should avoid invasive dental procedures if possible. 8. Ongoing monitoring & administration To be undertaken by GP following administration of the first dose of denosumab: (a) Blood monitoring Prior to each denosumab injection: Renal profile vitamin D and bone profile (serum calcium, alkaline phosphatase, phosphate, albumin). Do not administer denosumab if patient has hypocalcaemia or low vitamin D levels; refer to initiating consultant for advice. In patients with calcium or vitamin D deficiency at first injection, administration of the second dose of denosumab (at 6 months) is also the responsibility of initiating consultant. (b) Clinical monitoring Assess for adverse effects prior to each injection (see cautions in Section 3) If denosumab is considered for patients with eGFR < 30, administration should remain in the hospital setting. Do not administer denosumab if eGFR < 30; refer to specialist clinic for advice. Irrespective of who administered the injection: if a patient becomes acutely unwell such that renal function may be impaired, clinicians should consider the risk of hypocalcaemia and the need to check calcium/renal function. During denosumab treatment, patients presenting with new or unusual thigh, hip or groin pain should be evaluated for an incomplete femoral fracture. Delay administration of denosumab while the patient is evaluated. 9. Pharmaceutical aspects Denosumab (Prolia®) is a fridge item so store between 2 and 8°C. Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light. Do not shake excessively. Denosumab (Prolia®) may be stored at room temperature (up to 25°C) for up to 30 days in the original container. Once removed from the refrigerator, it must be used within this 30-day period. 10. Specialist contact details If stopping the medication or needing advice please contact Rheumatology Helpline: 01633 656251 In an emergency a Clinical Nurse can be bleeped via the Nevill Hall Hospital Switchboard on the number 432. Rheumatology Intranet homepage: http://howis.wales.nhs.uk/sitesplus/866/page/55676 Care of the elderly: Dr Inder Singh (secretary): 01443 802212 (YYF) Dr Muhammad Usman: 01873 732770 (NHH) Dr Amit Sah: 01633 234387 (RGH) 11. Criteria for shared care All Wales criteria for Shared Care can be found at: http://www.awmsg.org/docs/awmsg/medman/Criteria%20for%20Shared%20Care.pdf GMC guidance on Shared Care (2013) states: Decisions about who should take responsibility for continuing care or treatment after initial diagnosis or assessment should be based on the patient’s best interests, rather than on convenience or the cost of the medicine and associated monitoring or follow-up. This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics Status: APPROVED Issue Date: January 2014 (updated Jan. 2016 & March 2017) Approved by: ABUHB MTC Page 4 of 6 Review Date: January 2018 Shared care requires the agreement of all parties, including the patient. Effective communication and continuing liaison between all parties to a shared care agreement are essential. 12. Responsibilities of Specialists (Secondary Care) i. 13. Responsibilities of patients i. To attend hospital and GP clinic appointments. ii. To maintain an adequate intake of calcium and vitamin D. iii. To maintain good dental health and report any dental problems or invasive dental procedures/extractions to the GP prior to the administration of 60mg denosumab. iv. Whilst on treatment, to report the development of new or unusual thigh, hip, or groin pain or episodes of cellulitis to their specialist, GP or practice nurse. 14. Responsibilities of Primary Care i. See also Local Enhanced Service Specification To provide a patient information leaflet indicating the risks and benefits associated with denosumab 60mg. ii. To advise the patient on potential side effects and the action to be taken should they occur; particularly the risk and signs of atypical femoral fractures (new or unusual thigh, hip, or groin pain) and the need for good oral hygiene (questioning about dental health or a basic dental examination should be undertaken). Patients should be specifically advised to: a. seek prompt medical attention if they develop signs or symptoms of cellulitis and b. maintain good oral hygiene, receive routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain, or swelling to a doctor and dentist. iii. To undertake baseline monitoring of calcium and vitamin D (as detailed in Section 7), correcting levels as required. Patient’s ability to tolerate calcium supplements should be established before the first dose of denosumab is administered. Adequate intake of calcium and vitamin D is important in all patients receiving 60mg denosumab. iv. To confirm patient’s understanding and consent to treatment. v. Initiate treatment by administering the first dose of denosumab. In patients with calcium or vitamin D deficiency at first injection, administration of the second dose of denosumab (at 6 months) is also the responsibility of initiating consultant. vi. To retain the responsibility for prescribing and administering 60mg denosumab in patients with an eGFR <30 (or for any patients subsequently developing eGFRs <30). vii. To send the GP a Shared Care Agreement Form – Accredited (Page 1) requesting them to provide continued monitoring and 6 monthly administration of denosumab. viii. Further administration of denosumab should not be undertaken if an atypical femur fracture is suspected, while the patient is evaluated. ix. Monitor patient’s initial reaction to the drug. x. Continue to monitor and supervise the patient according to this protocol, while the patient remains on this drug. xi. To advise GP on when to stop denosumab (see 14 v. below). ii. iii. iv. v. vi. 15. Responsibilities of all prescribers To monitor (Section 8), prescribe and administer denosumab (Prolia®) every 6 months following initial dose from specialist according to this protocol. To ensure that the monitoring and dosage record is kept up to date. Prescribing records should demonstrate that denosumab has been administered within the last 6 months. To ensure that symptoms or results are appropriately actioned, recorded and communicated to secondary care when necessary. To refer any patient subsequently developing an eGFR <30 back to the specialist in Secondary Care (for continued administration of denosumab 60mg). To notify specialist once patient has received a total of 10 doses (5 years treatment) of denosumab so that a review can be arranged. To reinforce advice on importance of maintaining good oral hygiene and to report immediately if they have any problems with their mouth or teeth during treatment. Any suspected serious adverse reaction to an established drug should be reported to MHRA via the “yellow card scheme.” http://yellowcard.mhra.gov.uk/ This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics Status: APPROVED Issue Date: January 2014 (updated Jan. 2016 & March 2017) Approved by: ABUHB MTC Page 5 of 6 Review Date: January 2018 16. Supporting documentation / information BNF Section 6.6.2 Bisphosphonates and other drugs affecting bone metabolism Patient information leaflet for Prolia: http://www.medicines.org.uk/emc/medicine/23128/XPIL/Prolia/ MHRA advice: Drug Safety Update (Oct 2012): Denosumab: fatal cases of severe symptomatic hypocalcaemia, and risk of hypocalcaemia at any time during treatment – monitoring recommended. Drug Safety Update (Feb. 2013): Denosumab 60 mg (Prolia®): rare cases of atypical femoral fracture with long-term use. Drug Safety Update (Sept. 2014): Denosumab: minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia—updated recommendations. Drug Safety Update (July 2015): Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk. Osteonecrosis of the jaw The following precautions are now recommended to reduce the risk of ONJ: Before prescribing denosumab: give patients the patient reminder card for their medicine explain the risk of osteonecrosis of the jaw and advise patients on precautions to take—advise patients to: o tell their doctor if they have any problems with their mouth or teeth before starting treatment; if they wear dentures they should make sure their dentures fit properly before starting treatment o maintain good oral hygiene and get routine dental check-ups during treatment o tell their doctor and dentist that they are receiving denosumab or an intravenous bisphosphonate if they need dental treatment or dental surgery o tell their doctor and dentist immediately if they have any problems with their mouth or teeth during treatment (e.g. loose teeth, pain, swelling, non-healing sores or discharge) do not prescribe denosumab 120 mg (cancer indication) to patients with unhealed lesions from dental or oral surgery Hypocalcaemia Calcium levels should now be monitored as follows: Denosumab 60 mg (osteoporosis indication) Check calcium levels: before each dose within two weeks after the initial dose in patients with risk factors for hypocalcaemia (e.g. severe renal impairment, creatinine clearance <30 ml/min) if suspected symptoms of hypocalcaemia occur. Tell all patients to report symptoms of hypocalcaemia to their doctor (eg, muscle spasms, twitches, or cramps; numbness or tingling in the fingers, toes, or around the mouth). This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics Status: APPROVED Issue Date: January 2014 (updated Jan. 2016 & March 2017) Approved by: ABUHB MTC Page 6 of 6 Review Date: January 2018