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Leeds Denosumab (Prolia®): Amber Drug Guidance for the treatment of Osteoporosis in; postmenopausal women and men at increased risk of fractures Amber Drug Level 3 (amber drug with monitoring requirements) Amber Level 3 ‘Medicines that should be initiated by a specialist, and which require specific drug related monitoring on an ongoing basis. After a successful initiation period, including assessment of efficacy, a transition to GP care can take place. Relevant disease monitoring should be undertaken. The amber drug guidance will outline the specialist and GP responsibilities (including monitoring requirements and specific details of follow up) and basic prescribing information’, this can be accessed via Leeds Health Pathways. We have started your patient on Denosumab for the treatment of osteoporosis in postmenopausal women or men at increased risk of fractures. We will continue to see the patient and prescribe Denosumab until the patient (and their condition) is stable. After this period the GP will be asked to take over prescribing and monitoring responsibilities within this amber drug protocol. This drug requires ongoing monitoring which does include blood tests. This guideline outlines the specific responsibilities of the Specialist, GP, and patient when Denosumab is prescribed. The link to Denosumab on the Leeds formulary can be found here The link to the protocol for rapid Vitamin D replacement before scheduled IV bisphosphonate and SC denosumab in osteoporosis can be found here The link to the advice on the management of adults over 18 years with Vitamin D deficiency or insufficiency in primary and secondary care can be found here Indication for therapy: Osteoporosis in postmenopausal women and men at increased risk of fractures Classification: Amber Level 3 Monitoring: Required The advice in the following alerts have been incorporated into our guidance MHRA Drug Safety Update September 2014 Link and Drug Safety Update on denosumab July 2015 - link Baseline Tests: Prior to treatment each patient will have: A DXA bone scan, spinal x-ray (right lateral mid dorsal and lumbar spine), Denosumab Amber Drug Guideline Date prepared: October 2015 1 Review date: October 2018 Leeds Vitamin D (if low correct before administration) PTH, Ca bone profile (if hypocalcaemia correct before administration), U&Es, , CRP, FBC fasting plasma b-CTX (a specific indicator of bone resorption) Prior to starting treatment the hospital specialist will evaluate the patient for risks of osteonecrosis of the jaw. The specialist will recommend the patient has a dental examination and preventative dentistry prior to treatment in patients who have concomitant risk factors for osteonecrosis of the jaw. If the patient hasn’t had a dental check up in the last year they will also advise they get one before starting treatment The specialist will provide patients they see in hospital with a reminder card from the manufacturer of denosumab which contains information about the risk of osteonecrosis of the jaw with denosumab and the precautions to take before and during treatment - these cards can be obtained directly from the manufacturer, and the information in these can be found in the following link Patients will receive their first and second doses of their six monthly injections at LTHT Routine Tests/Monitoring: In patients who are pre-disposed to hypocalcaemia (e.g. severe renal impairment, creatinine clearance <30mL/min). calcium levels will be re-checked within 2 weeks of the initial dose by the hospital At three months: fasting plasma b-CTX will be done at LTHT. This is to monitor if bone turnover has been suppressed, which would indicate a positive treatment response. Six monthly : Calcium vitamin D Low levels must be corrected prior to each dose of denosumab. This would be done by the hospital prior to the first 2 doses for subsequent doses this will be the responsibility of the GP Denosumab Amber Drug Guideline Date prepared: October 2015 2 Review date: October 2018 Leeds Calcium levels should be re-checked if the patient presents with suspected symptoms of hypocalcaemia at any time during treatment with denosumab®. The specialist will review the patient at 6 months, and issue advice at that time to the GP about further management, and the follow up they recommend for each patient. Disease Monitoring: For patients discharged to primary care the specialist will advise the GP on recommendations regarding duration of treatment, monitoring of bone bone density and criteria for re-referral To monitor the osteoporosis a repeat DXA bone scan may be advised in some patients at 18 to 24 months Prescribing Information The following is a summary of prescribing information only. Consult the BNF and SPC for full and current prescribing information. Dose: the usual dose is 60mg administered as a single subcutaneous injection once every 6 months into the thigh, abdomen or upper arm. Formulation: Adverse drug reactions: Denosumab 60mg/mL solution for injection in a prefilled syringe Denosumab should be stored at 2ºC to 8ºC (in a refrigerator). To avoid discomfort at injection site, allow the injection to come to room temperature prior to injection. Denosumab may be stored at room temperature (up to 25ºC) for up to 30 days in its original container. Once removed from the refrigerator it must be used within this 30 day period. Musculoskeletal pain, pain in extremity, constipation, hypocalcaemia, UTI, upper respiratory tract infection, sciatica, cataracts, rash, eczema, abdominal discomfort, less commonly; diverticulitis, cellulitis (urgent medical attention required), ear infection, rarely; osteonecrosis of the jaw, atypical femoral fractures Cautions/Contra-indications: Hypocalcaemia, hypersensitivity to any of the ingredients. Precautions for use: Hypocalcaemia and vitamin D insufficiency / deficiency must be corrected by adequate intake of calcium and vitamin D before initiating therapy. For further information on hypocalcaemia see the monitoring section. 3 Denosumab Amber Drug Guideline Date prepared: October 2015 Review date: October 2018 Leeds Patients receiving denosumab may develop skin infections (predominantly cellulitis) leading to hospitalisation. Patients should be advised to seek prompt medical attention if they develop symptoms of cellulitis . Osteonecrosis of the jaw has been reported with denosumab. Appropriate pre-treatment dental examinations and preventative dental treatment is recommended prior to treatment in patients who have concomitant risk factors. Atypical fractures have been reported with denosumab. Discontinuation of therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient based on an individual risk benefit assessment The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex) which may cause allergic reactions. Communication Interactions: No interactions have been identified by the manufacturer of Prolia®, though there have only been a small number of interaction studies undertaken with denosumab. Pregnancy/breast-feeding: Used in postmenopausal women only Contact Names and Details Leeds Teaching Hospitals NHS Trust Medicines Information phone number and e-mail: 0113 2064344 [email protected] Medicines Information Patient Helpline phone number: 0113 2064376 Specialist who makes request via switchboard: LGI 0113 2432799 SJUH 0113 2433144 Prepared by: Responsibilities of Specialist Nicola Butler and Claire Sanderson Dr Afroze Abbas Responsibilities specific to Denosumab for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures Diagnosis of the condition and ensuring other treatment options have been fully explored To assess the suitability of the patient for this treatment To discuss the benefits and side effects of treatment with the patient/carer and Denosumab Amber Drug Guideline Date prepared: October 2015 4 Review date: October 2018 Leeds Responsibilities of GP where applicable the need for long term monitoring Checking for allergies, interactions and contra-indications To perform baseline tests and correct any hypocalcaemia and evaluate the risk of osteonecrosis of the jaw in patients prior to starting therapy The specialist will provide patients they see in hospital with a reminder card from the manufacturer of denosumab which contains information about the risk of osteonecrosis of the jaw with denosumab and the precautions to take before and during treatment (see page 2 for a link to this) To advise patients on the symptoms of hypocalcaemia and inform them to report symptoms that may indicate hypocalcaemia Patients will be advised to seek prompt medical attention if they develop symptoms of cellulitis To initiate treatment To advise that the medication should be prescribed by brand. Only the Prolia® brand of denosumab is licensed for treatment of osteoporosis To assess and monitor the patients response to treatment for 6 months To ask the GP whether they are willing to take over the prescribing and monitoring responsibilities under this amber drug guidance To advise the GP on the dose to be prescribed To advise GP what routine monitoring will be completed by the specialist and what monitoring the GP will be responsible for To forward results of monitoring to GP Outlining to the GP when therapy may be stopped assuming no relapse in patient’s condition. Review periods to be agreed Responding to issues raised by GP To monitor the patient for adverse events and report to the GP and where appropriate Commission on Human Medicines/MHRA (Yellow card scheme) To check for allergies To ensure all required monitoring is up to date before prescribing To provide patients who are prescribed denosumab by their GP with a reminder card from the manufacturer of denosumab which contains information about the risk of osteonecrosis of the jaw with denosumab and the precautions to take before and during treatment (see page 2 for a link to this), if this has not already been done by the hospital. To prescribe and arrange for administration of denosumab injection (the Prolia brand)following initiation and stabilisation by the specialist To perform routine monitoring as agreed with specialist Calcium levels and vitamin D levels should be checked by the GP surgery , and any low levels corrected prior to each dose of denosumab after the GP has taken over the prescribing of it If a patient presents with suspected symptoms of hypocalcaemia during treatment to check their calcium levels To refer back to the specialist if the patient’s condition deteriorates, and in line with specialist recommendations To identify adverse events if the patient presents with any signs and symptoms and liaise with the hospital specialist where necessary. To report adverse events to the specialist and where appropriate the Commission on Human Medicines/MHRA (Yellow card scheme). To stop treatment on the advice of the specialist Denosumab Amber Drug Guideline Date prepared: October 2015 5 Review date: October 2018 Leeds Responsibilities of patient/carer To tell their doctor if they have any problems with their mouth or teeth before starting treatment; and if they wear dentures they should make sure their dentures fit properly before starting treatment To take responsibility for having denosumab injected as prescribed. To attend for blood tests/disease monitoring on time (if appropriate). To understand potential for adverse events and report these to the Specialist and/or GP. To seek medical attention if they develop signs of cellulitis (skin infections) To maintain good oral hygiene and get routine dental check-ups during treatment To inform dentists and other healthcare professionals that they are on denosumab To 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) To contact the GP, Specialist or Medicines Information patient helpline if further information or advice is needed about denosumab. Denosumab Amber Drug Guideline Date prepared: October 2015 6 Review date: October 2018