Barts Health NHS Trust and local GPs Shared Care Guidelines. DENOSUMAB (Prolia) Post menopausal osteoporosis

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1 Barts Health NHS Trust and local GPs Shared Care Guidelines Indication: DENOSUMAB (Prolia) Post menopausal osteoporosis DOCUMENT TO BE SCANNED INTO ELECTRONIC RECORDS AS AND FILED IN NOTES Patient Name : Date of Birth: NHS No: Name of Referring Consultant: Contact number: INTRODUCTION Indication and Licensing Denosumab (Prolia) has been approved by NICE (NICE TA 204). Denosumab is licensed for the treatment of osteoporosis in postmenopausal women at increased risk of fractures. (NB It is also licensed for bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures). The recommended dose of Denosumab is 60mg administered as a single subcutaneous injection once every 6 months into the thigh, abdomen or back of the arm. Patients must be adequately supplemented with calcium and vitamin D. Primary Prevention Denosumab will be recommended as a treatment option for the primary 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 contraindication to, those treatments and who have a combination of T-score, age and number of independent clinical risk factors for fracture. (Independent clinical risk factors for fractures are parental history of hip fracture, alcohol intake of 4 units or more per day, and rheumatoid arthritis). Secondary Prevention Denosumab will be recommended as a treatment option for the 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 contraindication to, those treatments. Exclusions Patients with Stage 5 CKD are not be suitable for shared care

2 PATIENT PATHWAY- brief explanation of why planned arrangements for prescribing and monitoring between primary and secondary care are appropriate Denosumab is a straightforward subcutaneous injection given every 6 months. It does not require monitoring and has a favourable side-effect profile. It is therefore a suitable medication for initiation in secondary care and ongoing treatment in primary care. Patients are usually treated for 3 years in the first instance, but longer-term treatment may be necessary. Clinical Speciality / Indication Osteoporosis Prescribing Initiated by Prescribing Continued by Consultant GP to prescribe second Rheumatologist dose onwards First dose given in To be given at GP Osteoporosis clinic surgery Monitored by There is no specific monitoring required for Denosumab Duration of treatment Usually 3 years in the first instance After 3 years patient will be recalled to osteoporosis clinic automatically for review (follow-up appointment) The GP liase with the osteoporosis clinic after the treatment course or sooner if any concerns. The consultant will then assess and decide it treatment should be ongoing. DOSE AND ADMINISTRATION The recommended dose of denosumab is 60mg administered as a single subcutaneous injection once every 6 months into the thigh, abdomen or back of arm. Patient will receive an appropriate patient information leaflet from the osteoporosis clinic MONITORING STANDARDS FOR MEDICATION AT BARTS HEALTH NHS TRUST Pre-treatment Assessment (performed in secondary care) Hypocalcaemia is a contraindication and must be corrected before administration. Clinical monitoring of calcium levels is recommended for patients predisposed to hypocalcaemia. Check that the patient is calcium and vitamin D replete. Advise patients to seek prompt medical attention if they develop signs or symptoms of cellulitis. There are no other specific monitoring requirements for Denosumab. Before prescribing denosumab or intravenous bisphosphonates (MHRA advice): 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 (eg loose teeth, pain, swelling,non-healing sores or discharge. Monitoring during treatment Monitoring of calcium levels is only recommended for patients predisposed to hypocalcaemia (e.g. severe renal impairment or dialysis patients). Parameter Serum corrected calcium Target level Within normal range Frequency of monitoring Before each injection and 2 weeks after Action If hypocalcaemia to ensure patient is asymptomatic, increase calcium supplementation if

3 indicated and recheck 2 weeks later. KEY ADVERSE EFFECTS & ACTIONS Adverse effects Mild, transient decreases in serum calcium. Skin infections predominantly cellulitis. (Mechanisms uncertain) Other common undesirable effects (incidence of 1-10%) were urinary tract infection, upper respiratory tract infection, cataracts, constipation, sciatica, rash, pain in extremity. There have been no reports of anaphylaxis with the injection of Denosumab to date. Symptoms/signs (specify what would prompt action) Red, hot, inflamed skin Actions (what action should the GP take if identified in primary care) Treat with antibiotics/refer to on call medical team if IV treatment required Contra-indications (see BNF or SPC) Hypocalcaemia Hypersensitivity to the active substance or to any of the excipients Cautions (see BNF or SPC) Hypocalcaemia must be corrected by adequate intake of calcium and vitamin D before initiating therapy. Patients receiving Denosumab may develop skin infections (predominantly cellulitis). Patients must seek prompt medical attention if they develop signs of cellulitis. Osteonecrosis of the jaw (ONJ) has been reported (rare). A dental examination with appropriate preventive dentistry should be considered prior to starting Denosumab in patients with concomitant risk factors (a diagnosis of cancer with bone lesions, concomitant therapies {chemotherapy, corticosteroids, anti angiogenic biologics, radiotherapy to head and neck}, poor oral hygiene, dental extractions, and co-morbid disorders {pre-existing dental disease, anaemia, coagulopathy, infection} and previous treatment with bisphosphonates). While on Denosumab treatment patients should avoid invasive dental procedures and maintain good oral hygiene. There is no evidence to show when dental procedures should be performed if a patient is on treatment. Emergency dental treatment may be required during treatment, however if dental treatment can be planned it would be reasonable to plan this for the end of a 6 month treatment period and delay the next injection until the dental work has healed. Atypical femoral fractures have been reported in patients receiving Deonsumab. Atypical femoral fractures 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 arthritis, hypophosphatasia) and with use of certain pharmaceutical agents (e.g. bisphosphonates, glucocorticoids, proton pump inhibitors). These events have also occurred without antiresorptive therapy. 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. Discontinuation of Denosumab therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient based on an individual benefit risk assessment. During Denosumab treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Patients presenting with such symptoms should be evaluated for an incomplete femoral fracture. The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. Patients with rare hereditary problems of fructose intolerance should not use Denosumab.

4 Drug Interactions (see BNF or SPC) No interaction studies have been performed. This only lists the key important ADRs-For comprehensive information on cautions, contra-indications and interactions, please refer to the current British National Formulary and Summary of Product Characteristics. PREGNANCY AND BREAST FEEDING Denosumab(Prolia) is licenced for post-menopausal women only. For comprehensive information please refer to the current British National Formulary and Summary of Product Characteristics. SHARED CARE Role of Consultant 1. To assess the suitability of the patient for Denosumab. 2. To discuss the benefits and side effects of treatment with the patient, including guidance over dental surgery, ensuring that the patient/carer is an informed recipient in therapy and give the patient information leaflet (Appendix 1). 3. Ensure baseline investigations are normal before commencing treatment. 4. Explain to the patient that the treatment is 6 monthly injections for up to 3 years in the first instance. 5. Discuss the shared care arrangement with the patient and ensure he/she understands the plan for their follow-up 6 monthly injections at their GP surgery. 6. Explain to the patient that they will be recalled for follow-up in the osteoporosis clinic after 3 years of treatment and arrange that this happens. 7. Send a letter to the GP requesting shared care for this patient. 8. Ensure that the patient is taking calcium supplements (or has sufficient dietary calcium) and vitamin D supplements. 9. Assess the patient to ensure he/she has good oral hygiene and use clinical judgement to determine if dental examination is required prior to initiating therapy. 10. Initiate first Denosumab injection. 11. Evaluation of any reported adverse effects by GP or patient. 12. Report any adverse events to the MHRA. 13. Supply GP with a summary of the patient review and a copy of the local guidelines on use of Denosumab. 14. Ensure that backup advice is available at all times. 15. Identify patients that require monitoring for hypocalcaemia who will continue to receive prescribing,administration and monitoring from the hospital. 6.0 Role of General Practitioner 1. Reinforce the patients understanding of the nature, effect and potential side effects of the drug before prescribing it as part of the shared care programme and contact the specialist for clarification where appropriate, including guidance over dental surgery. 2. Monitor patient s overall health and well-being. 3. To ensure that Denosumab is added to the patient's drug record. 4. To ensure that other osteoporosis treatments (eg, alendronate, strontium) are stopped and removed from the patient's repeat prescription. 5. To ensure that calcium and vitamin D supplements are continued if appropriate. 6. Ensure an account is set up to order Denosumab and determine if it will come direct to the practice (more straightforward scenario for the patient). Alternatively, if the patient will need to collect their prescription from the pharmacy ensure an FP10 is written. 7. Ensure that prior to injection the Denosumab prefilled syringe must be kept in its outer carton, in order to protect from light, and stored in a refrigerator. 8. Prescribe and administer the Denosumab injection at six monthly intervals for time period as specified by the initiating specialist. 9. Report any adverse events to the MHRA and discuss with the consultant if action is uncertain. Role of Patient 1. To report any adverse events to the doctor who last administered the injection.

5 2. To seek prompt medical attention if they develop signs or symptoms of cellulitis. 3. To avoid invasive dental procedures and maintain good oral hygiene whilst on Denosumab treatment. 4. To continue the calcium and vitamin D supplement. 5. To attend the GP surgery every 6 months for the Denosumab injection. Costs Drug Product Denosumab (Prolia) 60mg sc injection Based on BNF edition March 2015 Cost in primary care 183 /syringe RESOURCES AVAILABLE Barts Health NHS Trust Consultant General Medical Registrar on-call out of hours Clinical Nurse Specialist Secretary at Whipps Cross (Mile End) Osteoporosis Office Mobile via switchboard Aircall via switchboard bleep via switchboard Whipps Cross bleep switchboard Mile End Rheumatology Pharmacist / bleep 975 Barts Health Medicines Information Pharmacist ext Prescribing Advice for Tower Hamlets CCG Prescribing Advice for Newham CCG Prescribing Advice for Waltham Forest CCG Prescribing Advice for Redbridge CCG /6 References Nice Guidance TA Pivotal Fracture study (Freedom trial) N Engl J Med Aug 20;361(8): doi: /NEJMoa Epub 2009 Aug 11. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. Cummings SR et al MHRA Drug Safety Update vol 12: Refer to the local CCG website to obtain the latest version of this guideline Updated template approved by Barts Health Joint Prescribing Group August 2015 (based on the document approved bybhr CCGMedicine Management Committee in July 2011) Guideline written by Dr Judith Bubbear, Consultant Rheumatologist, Review date: September 2018

6 Appendix 1 Patient Information Leaflet This reminder card contains important safety information that you need to be aware of before and during treatment with denosumab (Prolia). Your doctor has recommended that you receive denosumab (Prolia), which is used to treat osteoporosis and bone loss. These diseases involve thinning and weakening of the bones so they may break more easily. A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported rarely (may affect up to 1 in 1,000 people) in patients receiving Prolia for osteoporosis. ONJ can also occur after stopping treatment. It is important to try to prevent ONJ developing as it may be a painful condition that can be difficult to treat. In order to reduce the risk of developing ONJ, there are some precautions you should take. Before starting treatment: Tell your doctor/nurse (health care professional) if you have any problems with your mouth or teeth. Your doctor may ask you to undergo a dental examination if you: were previously treated with a bisphosphonate are taking medicines called corticosteroids (such as prednisolone or dexamethasone) are a smoker have cancer have not had a dental check up for a long time have problems with your mouth or teeth While being treated: You should maintain good oral hygiene and receive routine dental check-ups. If you wear dentures you should make sure these fit properly. If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor and tell your dentist that you are being treated with Prolia. Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw Please read the package leaflet that comes with your medicine for further information. Reporting of side effects If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet, You can also report side effects directly via the Yellow Card Scheme at By reporting side effects you can help provide more information on the safety of Prolia Electronic link to this leaflet below

7 Appendix 1 Barts Health NHS Trust (Chingford Osteoporosis Unit) Denosumab (Prolia) SHARED CARE AGREEMENT LETTER Name of GP. Address Dear GP Re: Patient s Name.. Date of Birth. Hospital Number... Indication for - Osteoporosis Route Subcutaneous Dose...60 mg 6 monthly. Enclosed is a copy of the shared care guidelines for Denosumab (Prolia) to be retained in the patient s notes. Should you agree to shared care, we will send a letter containing the details of the patient s treatment plan, the dose to be prescribed and all relevant blood results. Please sign below and return this letter to the Hospital Specialist if you agree to the shared care arrangements for this patient. Many thanks Hospital Specialist GP Signature... Signature... Name..... Name... Date... Date If you are not taking on shared care for this patient please state the reason why and return this letter to the Hospital Specialist..

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