Shared Care Agreement Denosumab (Prolia )

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Carmel Harrison
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1 Shared Care Agreement Denosumab (Prolia ) Licensed Indication Treatment of osteoporosis in postmenopausal women. Use in male patients for primary osteoporosis would be outside of the product license, however many of the treatments used for primary osteoporosis in men are used outside of the product licence. (Note: denosumab is licensed for use in men with cancer of the prostate who develop osteoporosis on hormone ablation therapy). Countess of Chester prescribing guidelines To be used as an alternative to bisphosphonate therapy for patients who are unable to comply with the special instructions for bisphosphonates, or have an intolerance to, or a contraindication to those treatments. Dose and administration 60mg given by subcutaneous injection every 6 months. The initial dose will be given whilst the patient is in hospital. Subsequent injections will be given in primary care. The patient should be assessed prior to each injection to ensure that bisphosphonate therapy is not appropriate. Patients should be adequately supplemented with calcium and vitamin D. Adverse effects The most common adverse effects reported with denosumab are constipation, urinary tract infection, upper respiratory tract infection, pain in extremities, sciatica, cataracts* and rash (between 1 in 10 and 1 in 100). Other less commonly reported adverse effects include diverticulitis, cellulitis, ear infection, eczema (between 1 in 100 and 1/1000). Osteonecrosis of the jaw (ONJ) has been reported rarely with denosumab. Hypocalcaemia has been reported very rarely with denosumab. See contraindications and warnings. * In a single phase III placebo-controlled clinical trial in patients with prostate cancer receiving androgen deprivation therapy (ADT) an imbalance in cataract adverse events was observed (4.7% denosumab, 1.2% placebo). No imbalance was observed in postmenopausal women with osteoporosis or in women undergoing aromatase inhibitor therapy for non-metastatic breast cancer.

2 Contraindications and warnings ONJ has been reported rarely with denosumab. Most cases have been reported in cancer patients; however some have occurred in patients with osteoporosis. A dental examination with appropriate preventive dentistry should be considered prior to treatment with denosumab in patients with concomitant risk factors for ONJ. During treatment, these patients should avoid invasive dental procedures if possible. Good oral hygiene practices and routine dental checkups should be maintained during treatment. o Risk factors for ONJ: Cancer Concomitant chemotherapy, corticosteroids, radiotherapy Poor oral hygiene or pre-existing dental disease Coagulopathy Smokers Denosumab is contraindicated in hypocalcaemia, which should be corrected by adequate intake of calcium and vitamin D before initiating therapy. Patients with severe renal impairment (creatinine clearance < 30 ml/min) or receiving dialysis are at greater risk of developing hypocalcaemia with denosumab. Clinical monitoring of calcium levels is recommended for patients predisposed to hypocalcaemia. Patients receiving denosumab may develop skin infections, predominantly cellulitis. Patients should be advised to seek prompt medical attention if they develop signs or symptoms of cellulitis. The needle cover of the pre-filled 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. Denosumab is contraindicated in patients with hypersensitivity to the active substance or any excipients. Drug Interactions There are no known pharmacodynamic or pharmacokinetic drug interactions. Monitoring requirements Calcium levels should be monitored in patients predisposed to hypocalcaemia, including those with severe renal impairment (CrCl < 30ml/min) or receiving dialysis. In such patients calcium levels should be checked 4 weeks after starting denosumab, then at 3 months and annually thereafter. Preparations available Denosumab 60mg/ml pre-filled syringe for subcutaneous injection. Cost For 12 months treatment: 366 (plus VAT)

3 RESPONSIBILITIES Specialist responsibilities 1. Identify patients who may benefit from denosumab treatment as per COCH guidelines above. 2. Discuss the benefits and side effects of treatment with the patient to enable them to make informed choices about their treatment. 3. Initiate treatment, giving initial dose while patient in hospital. Treatment should continue at 6 month intervals, unless circumstances change and an oral bisphosphonate becomes suitable. 4. Ask the GP whether he/she is willing to participate in shared care arrangements. 5. To report all adverse events to the MHRA. GP responsibilities 1. To prescribe denosumab at the dosage recommended by the specialist at COCH, unless patient circumstances change and an oral bisphosphonate becomes suitable. 2. If patient develops hypocalcaemia then to inform the specialist. 3. To report all adverse events to the specialist and the MHRA. Additional information This document should be read in conjunction with the Summary of Product Characteristics (SPC). The doctor who prescribes the medication assumes legal responsibility for the drug. Contacts Dr Frank Joseph, Consultant Endocrinologist, COCH Rebecca Houston, Orthopaedic Pharmacist, COCH References 1. Summary of Product Characteristics. Prolia (denosumab). Amgen. September NICE Technology Appraisal Guidance 204. Denosumab for the prevention of osteoporotic fractures in postmenopausal women. October BNF60. September 2010.

4 Shared care protocol GP return form: Please return within 14 days Part 1 : To be completed by specialist Patient Name DOB Date Address CC No Dear Dr NHS No I request that you prescribe denosumab in accordance with the enclosed shared care agreement. Reason for prescribing: Unable to comply with instructions for oral bisphosphonates [ ] e.g. swallowing difficulties, unable to sit upright Intolerance to bisphosphonates [ ] Consider weekly risedronate if GI side effects with alendronic acid Compliance issues, e.g. forgets weekly dose, dementia (unless in nursing care) [ ] Consider weekly Alendronic acid with compliance chart where appropriate e.g. forgets weekly dose, dementia (unless in nursing care) Contraindication to oral bisphosphonates [ ] e.g. oesophageal abnormality, delayed oesophageal emptying Signed (Specialist COCH) Part 2: to be completed by GP I have read the enclosed share care agreement and agree/disagree* (delete as appropriate) to prescribe denosumab for the above patient on a long term basis. Signed Date Print name Address

5 Please sign both copies and return one to : insert name and address of contact here

Drug treatment pathway for Osteoporosis in Postmenopausal Women

Drug treatment pathway for Osteoporosis in Postmenopausal Women Version 1.0 Ratified by: East Sussex HEMC Date ratified: 26.01.2011 Job title of originator/author Gillian Ells, East Sussex HEMC Pharmacist