ESCA: Denosumab for the treatment of osteoporosis in postmenopausal women.

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1 ESCA: Denosumab for the treatment of osteoporosis in postmenopausal women. Specialist details Patient identifier Name Tel: This effective shared care agreement (ESCA) sets out details for the sharing of care for patients given subcutaneous denosumab. It should be read in conjunction with the Summary of Products Characteristics (SPC; datasheet). The purpose of this document is to assist the provision of denosumab. Initiation of treatment should be the responsibility of a specialist, or a general practitioner who has a specialist interest. Once the patient is stabilised on treatment, it is then appropriate for GP s without a special interest ( a GP who either works with the rheumatologists or is accredited as having a Special interest in rheumatology)to prescribe this drug over the longer term within the guidance of an ESCA. This document sets out the responsibilities of the hospital and the General Practitioner in the provision of shared care. Areas of care for which the hospital will be responsible 1. Assess patient suitability for denosumab in line with NICE TA 204, complete necessary form on Blueteq. 2. Discuss the potential risks, benefits and side effects of treatment with the patient, and advise of shared care process 3. Arrange for appropriate initial haematology/biochemistry 4. Instruct the GP and patient to discontinue bisphosphonates 5. Administer the first two doses of denosumab (at baseline and six months) if not contraindicated. 6. Confirm that the GP is willing to participate in shared care. 7. Advise the GP on when to stop treatment, or consult with the specialist. 8. Report adverse events to the CSM, MHRA and GP. 9. Ensure that clear backup arrangements exist for GPs to obtain advice and support. Areas of care for which the GP will be responsible 1. Reply to the request for shared care as soon as practicable and if happy to continue prescribing in primary care 2. Practice to add denosumab onto Patient Medication Record (PMR), ensuring a recall is set up for the patient at a six month interval, with a flag to have bloods done 2 weeks before the next appointment for each administration. 1

2 3. Prescribe and administer the third and subsequent treatment with denosumab at the dose recommended. 4. Report to and seek advice from the specialist on any aspect of patient care that is of concern to the GP and may affect treatment 5. Refer back to specialist if the patient's condition deteriorates, in particular Fractures occurring at least one year after the initiation of therapy, intolerance to treatment. 6. Stop treatment on the advice of the specialist or immediately if an urgent need to stop treatment arises e.g. Adverse reactions especially hypocalcaemia - Symptoms of hypocalcemia include neuromuscular irritability (including tetany as manifested by Chvostek's sign or Trousseau's sign, bronchospasm), electrocardiographic changes, and seizures. 7. Report adverse events to the specialist and CSM and MHRA. Patients Role 1. Report to the specialist or GP if she does not have a clear understanding of the treatment. 2. Attend as arranged for the administration of the injection 3. Adhere to any calcium and vitamin D supplementation as per formulary recommendations: 4. Share any concerns in relation to treatment with denosumab. 5. Inform specialist or GP of any other medication being taken, including over-thecounter products. 6. Report any other adverse effects or warning symptoms (as per the BNF e.g. Symptoms of hypocalcemia include neuromuscular irritability to the specialist or GP whilst receiving denosumab. Therapeutic Uses and Licensed indications Treatment of postmenopausal osteoporosis in women at increased risk of fractures and bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures Posology 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. Patients must be adequately supplemented with calcium and vitamin D as per formulary recommendations: No dose adjustment is needed in patients with renal impairment, for patients with End Stage Renal Failure with greater risk of hypocalcaemia, treatment may be inappropriate. See Patient Management SOP point 13. The safety and efficacy of denosumab has not been studied in patients with hepatic impairment No dose adjustment is required in elderly patients. Adverse effects, precautions and contraindications Side Effects Infections Urinary tract infection Upper respiratory tract infection Uncommon Diverticulitis 1 Uncommon Cellulitis 1 2

3 Uncommon Ear infection Metabolism and nutrition disorders Very rare Hypocalcaemia 1 Nervous system disorders Sciatica Eye disorders Cataracts 1 Gastrointestinal disorders Constipation Skin and subcutaneous tissue disorders Musculoskeletal and connective tissue disorders Uncommon Rash Eczema Pain in extremity The following convention has been used for the classification of the adverse reactions reported in these phase II and III clinical studies - very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000) and very rare (< 1/10,000) based on 1-year event rates. Within each frequency grouping and system organ class, undesirable effects are presented in order of decreasing seriousness. Precautions for use Calcium & Vitamin D Supplementation Adequate intake of calcium and vitamin D is important in all patients. This is something that should be managed in partnership with Renal Physicians. Secondary Hyperparathyroidism needs to be considered. Hypocalcaemia must be corrected before initiating therapy. Patients with severe renal function or receiving dialysis (End Stage Renal failure egfr<15ml/min or on dialysis) are at greater risk of developing hypocalcaemia. Clinical monitoring of calcium levels is recommended for patients predisposed to hypocalcaemia. A blood test every six months two weeks prior to treatment is good practice. Skin Infections Patients should seek prompt medical attention if they develop signs or symptoms of cellulitis. Osteonecrosis of the Jaw (ONJ) has been reported in patients receiving denosumab. A dental examination by the patient s dentist, with appropriate preventive dentistry should be considered before commencement of treatment. Good oral hygiene measures should be maintained during treatment. Allergy The needle cover of the pre-filled syringe contains dry natural rubber (a latex derivative). Contraindications and cautions for use Denosumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Denosumab is contraindicated in patients with hypocalcaemia. Drug and Other forms of Interaction There is a low potential for drug-drug interactions. Presentations 3

4 Prolia 60 mg solution for injection in a pre-filled syringe. Store in a refrigerator (2 C 8 C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light. Do not shake excessively. References NHS Wolverhampton Denosumab ESCA Summary of Product Characteristics. Keele Medicines Management ESCA toolkit. SUBCUTANEOUS DENOSUMAB PATIENT MANAGEMENT Standard Operating Procedure (SOP) Rheumatology Department, Dudley Group NHS Foundation Trust 1. Patient seen in Osteoporosis Clinic and decision made to start Denosumab. 2. Doctor will discuss and give patient information leaflet. 3. Doctor will commence Pathway and forward to C8 Medical Day Case Unit. 4. Vitamin D Levels checked within 6 months (and level >60nmol/l) 5. Teeth should be in good condition and no pending dental work 6. Bisphosphonates should be stopped and allergy status recorded. 7. *Vitamin D deficiency treated prior to denosumab, if needs be, SEE TABLE BELOW. 8. TAG form completed, and funding applied for. 9. When funding agreed, patient is booked onto Denosumab/Vitamin D Clinic. Appointment and blood form for bone profile (includes calcium), U and E and FBC (and vitamin D if appropriate) sent to patient in post. 10. Blood to be taken within 2 weeks prior to injection. 11. On day of injection check with Patient they have regular dental check-ups, allergies and check that bisphosphonates have been stopped. Enter patient into database. 12. Check bloods including adjusted Calcium level. Any abnormalities to be discussed with consultant/spr/clinical assistant. 13. Injection given as prescribed usually top of thigh. 14. Give patient 2 blood forms for FBC, bone profile and U and Es bloods to be checked both 2 weeks post injection and 2 weeks before the next injection. 15. Post injection blood results to be checked. This information should be confirmed and recorded on the database. 16. Second injection to take place in Secondary Care as above.repeat points Abnormal bloods at this stage acted upon GP to be kept informed. For small minority of patients, where clinically appropriate e.g. CKD Stage 4, subsequent injections to continue in secondary care. 17. Letter, copy of ESCA and copy of Pathway to be sent to GP within two months following the second injection. 18. Third and subsequent injections to take place in Primary Care if possible (follow points 6-12). 19. Dr Whallett and Injection Clinic available for advice following discharge from the injection clinic. 4

5 Corrected calcium usually reported. If not, it can be adjusted to albumin level. Rule of thumb - add 0.02mmol/l to calcium result for every whole number value below 40g/l so for albumen of 38, add 2 x 0.02mmol/l for example. For albumin more than 40, subtract 0.02 per whole number value of albumin. * Vitamin D level Action >75 nmol/l Give denosumab, keep oral vitamin D intake the same >60 nmol/l Give denosumab, and increase oral vitamin D supplements nmol/l Give a single boost of IM stat followed immediately by vitamin D 300,000 iu rather than waiting 3 months to gradually top up Vitamin D prior to denosumab) <50nmol/L Correct vitamin D level as per guidance below, and recheck levels again before giving denosumab which will be at the end of the course of high dose Vitamin D (usually at 3 months) *Website: *From the guidance the relevant section, which correlates with new ranges is as below: Management of sufficient Vitamin D levels >75nmol/l Reassure and give lifestyle advice Management of Insufficiency Vitamin D levels 25-75nmol/L Recommend that the patient purchases colecalciferol iu (25-50mcg) daily or 10,000iu weekly Treatment of Deficiency*(Vitamin D levels<25nmol/l) Prescribe : Osteocaps D3 20,000iu capsules- Two capsules to be taken weekly for 8-12 weeks. Then switch to maintenance dose of colecalciferol 800iu daily-prescribe Desunin 800iu tablets one daily lifelong. Osteocaps D3 caps- sugar free, gelatine free, peanut oil and soya free. Suitable for vegetarians Desunin tabs- gelatine free, peanut oil and soya free. Suitable for vegetarians Contacts Dr A Whallett/ Dr A Michael Medicines Information (Pharmacy, Russells Hall Hospital) Pharmaceutical Public Health Team (Primary Care) Dudley Group of Hospitals NHS Foundation Trust, NHS Dudley Original: April 2011 Updated: June 2015 Review date: June

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