DENOSUMAB SHARED CARE GUIDLINES

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1 DENOSUMAB LICENSING Denosumab (PROLIA ) is licensed for the treatment of osteoporosis in postmenopausal women at increased risk of fractures and for bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. Denosumab has been approved by NICE (NICE TA204). 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. NB: Another preparation of denosumab (XGEVA ) is licensed for bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. This is outside of the scope of this guideline. LOCAL ENHANCED SERVICES FOR SHARED CARE DRUG MONITORING This drug has been assessed as level 2 shared care and will be commissioned as per LES and in accordance with the supporting local shared care prescribing documentation. For further guidance on commissioning levels and for referral letters see guidance document at Mid Essex website: For product information see SPC: 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: and REFERRAL CRITERIA AND PATIENT SELECTION 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 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) and patients who have had bisphosphonate treatment for over 10 years. 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. Or if patients continue to have fractures while on bisphosphonates. DenosumabSCG201510v1.0.final Page 1 of 5

2 Use outside NICE guidelines Where NICE TA 204 is not applicable, i.e. because the patient is a man or a pre-menopausal woman, the specialist should affirm in the referral letter that the estimated 10-year fracture risk, or lifetime risk where life expectancy may be shorter than 10 years, is at least equivalent to, if not greater than, that envisaged in NICE TA 204. In such cases, patients may be managed under this shared care guideline and associated LES. INITIATION and MAINTENANCE Medication history is checked to ensure there are no contraindications to denosumab Hypocalcaemia must be corrected by adequate intake of calcium and vitamin D before initiating therapy Assess the patient to ensure he/she has good oral/dental hygiene. If necessary advise the patient to see a dentist before proceeding The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions Advise patients to seek prompt medical attention if they develop signs or symptoms of cellulitis Refer patients for prompt medical attention if they develop signs or symptoms of hypocalcaemia (i.e. altered mental status, tetany, seizures, and QTc prolongation) In line with MHRA drug safety update (February 2013) all patients newly initiated on denosumab therapy will be advised to report new or unusual thigh, hip or groin pain Doses are administered 6 monthly. The first dose will be administered in secondary care, after which the patient will be transferred to the GP for administration and monitoring of remaining injections 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. Calcium and vitamin D levels must be checked before each dose is administered. Before administration, the denosumab solution should be inspected Do not inject the solution if it contains particles, or is cloudy or discoloured Do not shake excessively To avoid discomfort at the site of injection, allow the pre-filled syringe to reach room temperature (up to 25 C) before injecting a single subcutaneous injection into the thigh, abdomen or back of arm Inject slowly Inject the entire contents of the pre-filled syringe Any unused product or waste material should be disposed of in accordance with local requirements Corrected calcium (monitored prior to each dose unless advised otherwise by specialist) Vitamin D levels (monitored prior to each dose unless advised otherwise by specialist) egfr (monitored prior to each dose unless advised otherwise by specialist) ADMINISTRATION and DOSAGE 2.2 mmol/l despite patient adherence with supplementation < 50 nmol/l despite patient adherence with supplementation <30 ml/min/1.73m 2 or receiving dialysis team for advice team for advice team for advise on frequency of Ca 2+ monitoring (suggested pre and post injection monitoring) It is essential that the dosing frequency of every six months plus or minus two weeks is maintained for the duration of therapy DenosumabSCG201510v1.0.final Page 2 of 5

3 On-going Advise patients to seek prompt medical attention if they develop signs or symptoms of cellulitis Refer patients for prompt medical attention if they develop signs or symptoms of hypocalcaemia (i.e. altered mental status, tetany, seizures, and QTc prolongation). Hypocalcaemia with denosumab most commonly occurs within the first 6 months of dosing, but it can occur at any time during treatment Secondary care will retain responsibility for any further diagnostic tests e.g. DXA and/or bone turnover markers as deemed appropriate for the patient and will communicate any change in the treatment plan as a result of these tests with the GP in a timely way Other Adverse effects: MONITORING Below are some of the more common side effects, note that this list is NOT exhaustive and that it is recommended that the SPC (Link: ) and BNF should be consulted for a more comprehensive list. Common side effects include: urinary tract infection, upper respiratory tract infection, sciatica, cataracts, constipation, rash, pain in extremities Responsibilities of the Hospital To assess the suitability of the patient for denosumab To discuss the benefits and side effects of treatment with the patient Explain to the patient that the treatment is 6 monthly injections Advise the patient that their other osteoporosis treatments should stop but that they should continue with their calcium and vitamin D supplements; even normo-calcaemic patients could be at risk of hypocalcaemia following administration of denosumab if they are Vitamin D deficient 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 Explain to the patient that the GP will refer them back for a review on completion of the treatment course (as specified by the specialist) 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 If concerned about oral health, advise patient to seek dental assessment and remedial dental care. Instruct patients under dental treatment or undergoing dental surgery, to tell their dentist that they are being treated with denosumab Administer first denosumab injection Report any adverse events to the MHRA Supply GP with a summary of the patient review including link to local guidelines on use of denosumab [The specialist should always state the rationale for prescribing denosumab in preference to other alternative bone protection drugs in the clinic letter] To determine need and frequency of monitoring of any further diagnostic tests e.g. DXA and/or bone turnover markers and to organise such tests and communicate any resulting change in treatment plan with the patient and their GP in a timely way DenosumabSCG201510v1.0.final Page 3 of 5

4 Responsibilities of the GP To ensure that denosumab is added to the patient's drug record To ensure that other osteoporosis treatments (e.g. alendronate, strontium) are stopped and removed from the patient's repeat prescription To ensure that calcium and vitamin D supplements are continued [Supplementation should be with at least calcium 700 mg daily and at least 800 units vitamin D daily] To ensure that advice is sought should hypocalcaemia develop despite adequate supplementation To ensure that additional monitoring (as advised by specialist) of serum calcium levels is conducted in patients with severe renal impairment (creatinine clearance < 30 ml/min) or receiving dialysis 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 supplied at least 2 weeks prior to planned injection date Advise patient that they may sign up to the company s patient support programme online should they wish to receive alerts and reminders 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. Prescribe and administer the denosumab injection at six monthly intervals for time period as specified by the initiating specialist (a protocol on how to administer the injection is available from the company if required) Report any adverse events to the MHRA and discuss with the consultant if action is uncertain Refer patient back to the consultant for review on completion of the treatment course, or sooner if any concerns (such as anti-resorptive related osteonecrosis of the jaw, altered mental health, tetany, seizures, or QTc prolongation which may indicate severe hypocalcaemia) Refer back to the specialist if a new fracture occurs after 1 year of treatment (i.e. 2 doses) and especially if the fractures are multiple, e.g. multi-level vertebral fractures or multiple rib fractures as treatment failure may be suspected In line with MHRA drug safety update (February 2013) all patients newly initiated on denosumab therapy will be advised to report new or unusual thigh, hip or groin pain. Patients presenting with such symptoms to the GP should be referred for prompt medical attention for evaluation of an incomplete femoral fracture. Contacts - Consultants Details to be included in specialist s letter Pharmacy Medicines Information, Broomfield Hospital (Mon Fri 9am 5pm) DenosumabSCG201510v1.0.final Page 4 of 5

5 Title Denosumab Shared Care Guidelines Document reference DenosumabSCG201510v1.0.final Author Catherine Hamilton, Deputy Chief Pharmacist, MECCG Consulted with Dr Arul Srinivasan, Consultant Rheumatologist, MEHT Reference: n/a Approved by Mid Essex Medicines Management Committee Date approved October 2015 Next review date October 2017 Previous Version New Document Updates DenosumabSCG201510v1.0.final Page 5 of 5

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