Approved by Area Prescribing Committee February 2014 Guideline written by Dr Judith Bubbear Consultant Rheumatologist (Barts)

Review date helliphelliphellip February 2016 Adapted for BHRUT by Tutu Ogunsanwo Rheumatology Liaison Pharmacist

NHS BHR CCGs Barking Havering and Redbridge University Hospitals NHS Trust Shared Care Guidelines

DENOSUMAB (Prolia)

Indication 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 Secretary

INTRODUCTION ndash 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 in line with NICE guidance

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) in line with NICE guidance

T-scores (SD) at (or below) which denosumab is recommended when alendronate and either risedronate or

etidronate are unsuitable

Number of independent clinical risk factors for fracture

Age (years) 0 1 2

65-69 ndash[a]

minus45 minus40

70-74 minus45 minus40 minus35

75 or older minus40 minus40 minus30 [a]

Treatment with denosumab is not recommended

Approved by Area Prescribing Committee February 2014 Guideline written by Dr Judith Bubbear Consultant Rheumatologist (Barts)

Review date helliphelliphellip February 2016 Adapted for BHRUT by Tutu Ogunsanwo Rheumatology Liaison Pharmacist

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 may not be suitable for shared care

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

Prescribing Initiated by Prescribing Continued by

Monitored by Duration of treatment

Osteoporosis Consultant Rheumatologist First dose given in Osteoporosis clinic

GP to prescribe second dose onwards To be given at GP surgery

There is no specific monitoring required for Denosumab

Usually 3 years in the first instance ndash 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 BHRUT 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 Assess the patient to ensure heshe has good oraldental hygiene If necessary advise the patient to see a dentist before proceeding

Approved by Area Prescribing Committee February 2014 Guideline written by Dr Judith Bubbear Consultant Rheumatologist (Barts)

Review date helliphelliphellip February 2016 Adapted for BHRUT by Tutu Ogunsanwo Rheumatology Liaison Pharmacist

Monitoring during treatment Monitoring of calcium levels is only recommended for patients predisposed to hypocalcaemia (eg 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 ndash to ensure patient is asymptomatic increase calcium supplementation if indicated and recheck 2 weeks later

KEY ADVERSE EFFECTS amp ACTIONS

Adverse effects Symptomssigns (specify what would prompt action)

Actions (what action should the GP take if identified in primary care)

Mild transient decreases in serum calcium

Skin infections predominantly cellulitis Red hot inflamed skin Treat with antibioticsrefer to on call medical team if IV treatment required

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

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 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 Drug Interactions (see BNF or SPC) No interaction studies have been performed

Approved by Area Prescribing Committee February 2014 Guideline written by Dr Judith Bubbear Consultant Rheumatologist (Barts)

Review date helliphelliphellip February 2016 Adapted for BHRUT by Tutu Ogunsanwo Rheumatology Liaison Pharmacist

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 If used in premenopausal women then patients will be counselled about contraception and what to do if pregnancy occurs The counselling should be documented in the patient notes

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 ensuring that the patientcarer is an informed recipient in

therapy 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 heshe 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 heshe 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

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

2 Monitor patientrsquos overall health and well-being 3 To ensure that Denosumab is added to the patients drug record 4 To ensure that other osteoporosis treatments (eg alendronate strontium) are stopped and removed from the patients 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 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

Approved by Area Prescribing Committee February 2014 Guideline written by Dr Judith Bubbear Consultant Rheumatologist (Barts)

Review date helliphelliphellip February 2016 Adapted for BHRUT by Tutu Ogunsanwo Rheumatology Liaison Pharmacist

Costs

Drug Product Cost in primary care

Denosumab (Prolia) 60mg sc 6 monthly pound366 per year

Based on BNF edition March 2013

RESOURCES AVAILABLE

BHRUT NHS Trust

Consultant Dr Euthalia Roussou Consultant Rheumatologist Dr Thushani Wickramaratne Consultant Rheumatologist Dr Louise Daniels Consultant Rheumatologist Dr Guy Dabrera Consultant Rheumatologist Dr Myo Lynn Consultant Rheumatologist

Secretary 01708435000 Ext 8188 8311 8190 2721

General Medical Registrar on-call out of hours Aircall via switchboard 01703435000

Rheumatology Nurse Specialist Michelle Barnett Janice Leahy Christine Heron Diana Simeon Margaret Idowu Pat Lewis

01708435000 ext 8408 4821 4820 3219

BHR CCGs Medicines Management Team 0208 822 30746

References Nice Guidance TA 204 httppublicationsniceorgukdenosumab-for-the-prevention-of-osteoporotic-fractures-in-postmenopausal-

women-ta204

Pivotal Fracture study (Freedom trial)

N Engl J Med 2009 Aug 20361(8)756-65 doi 101056NEJMoa0809493 Epub 2009 Aug 11

Denosumab for prevention of fractures in postmenopausal women with osteoporosis Cummings SR et al

Refer to the relevant BHR CCG website to obtain the latest version of this guideline httpwwwbarkingdagenhamccgnhsukAbout-usMedicines-managementshared-care-guidelineshtm httpwwwhaveringccgnhsukAbout-usmedicines-managementshared-care-guidelineshtm httpwwwredbridgeccgnhsukAbout-usMedicines-managementshared-care-guidelineshtm

Approved by Area Prescribing Committee February 2014 Guideline written by Dr Judith Bubbear Consultant Rheumatologist (Barts)

Review date helliphelliphellip February 2016 Adapted for BHRUT by Tutu Ogunsanwo Rheumatology Liaison Pharmacist

Monitoring during treatment Monitoring of calcium levels is only recommended for patients predisposed to hypocalcaemia (eg 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 ndash to ensure patient is asymptomatic increase calcium supplementation if indicated and recheck 2 weeks later

KEY ADVERSE EFFECTS amp ACTIONS

Adverse effects Symptomssigns (specify what would prompt action)

Actions (what action should the GP take if identified in primary care)

Mild transient decreases in serum calcium

Skin infections predominantly cellulitis Red hot inflamed skin Treat with antibioticsrefer to on call medical team if IV treatment required

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

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 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 Drug Interactions (see BNF or SPC) No interaction studies have been performed

Approved by Area Prescribing Committee February 2014 Guideline written by Dr Judith Bubbear Consultant Rheumatologist (Barts)

Review date helliphelliphellip February 2016 Adapted for BHRUT by Tutu Ogunsanwo Rheumatology Liaison Pharmacist

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 If used in premenopausal women then patients will be counselled about contraception and what to do if pregnancy occurs The counselling should be documented in the patient notes

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 ensuring that the patientcarer is an informed recipient in

therapy 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 heshe 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 heshe 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

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

2 Monitor patientrsquos overall health and well-being 3 To ensure that Denosumab is added to the patients drug record 4 To ensure that other osteoporosis treatments (eg alendronate strontium) are stopped and removed from the patients 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 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

Approved by Area Prescribing Committee February 2014 Guideline written by Dr Judith Bubbear Consultant Rheumatologist (Barts)

Review date helliphelliphellip February 2016 Adapted for BHRUT by Tutu Ogunsanwo Rheumatology Liaison Pharmacist

Costs

Drug Product Cost in primary care

Denosumab (Prolia) 60mg sc 6 monthly pound366 per year

Based on BNF edition March 2013

RESOURCES AVAILABLE

BHRUT NHS Trust

Consultant Dr Euthalia Roussou Consultant Rheumatologist Dr Thushani Wickramaratne Consultant Rheumatologist Dr Louise Daniels Consultant Rheumatologist Dr Guy Dabrera Consultant Rheumatologist Dr Myo Lynn Consultant Rheumatologist

Secretary 01708435000 Ext 8188 8311 8190 2721

General Medical Registrar on-call out of hours Aircall via switchboard 01703435000

Rheumatology Nurse Specialist Michelle Barnett Janice Leahy Christine Heron Diana Simeon Margaret Idowu Pat Lewis

01708435000 ext 8408 4821 4820 3219

BHR CCGs Medicines Management Team 0208 822 30746

References Nice Guidance TA 204 httppublicationsniceorgukdenosumab-for-the-prevention-of-osteoporotic-fractures-in-postmenopausal-

women-ta204

Pivotal Fracture study (Freedom trial)

N Engl J Med 2009 Aug 20361(8)756-65 doi 101056NEJMoa0809493 Epub 2009 Aug 11

Denosumab for prevention of fractures in postmenopausal women with osteoporosis Cummings SR et al

Refer to the relevant BHR CCG website to obtain the latest version of this guideline httpwwwbarkingdagenhamccgnhsukAbout-usMedicines-managementshared-care-guidelineshtm httpwwwhaveringccgnhsukAbout-usmedicines-managementshared-care-guidelineshtm httpwwwredbridgeccgnhsukAbout-usMedicines-managementshared-care-guidelineshtm

Approved by Area Prescribing Committee February 2014 Guideline written by Dr Judith Bubbear Consultant Rheumatologist (Barts)

Review date helliphelliphellip February 2016 Adapted for BHRUT by Tutu Ogunsanwo Rheumatology Liaison Pharmacist

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 If used in premenopausal women then patients will be counselled about contraception and what to do if pregnancy occurs The counselling should be documented in the patient notes

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 ensuring that the patientcarer is an informed recipient in

therapy 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 heshe 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 heshe 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

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

2 Monitor patientrsquos overall health and well-being 3 To ensure that Denosumab is added to the patients drug record 4 To ensure that other osteoporosis treatments (eg alendronate strontium) are stopped and removed from the patients 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 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

Approved by Area Prescribing Committee February 2014 Guideline written by Dr Judith Bubbear Consultant Rheumatologist (Barts)

Review date helliphelliphellip February 2016 Adapted for BHRUT by Tutu Ogunsanwo Rheumatology Liaison Pharmacist

Costs

Drug Product Cost in primary care

Denosumab (Prolia) 60mg sc 6 monthly pound366 per year

Based on BNF edition March 2013

RESOURCES AVAILABLE

BHRUT NHS Trust

Consultant Dr Euthalia Roussou Consultant Rheumatologist Dr Thushani Wickramaratne Consultant Rheumatologist Dr Louise Daniels Consultant Rheumatologist Dr Guy Dabrera Consultant Rheumatologist Dr Myo Lynn Consultant Rheumatologist

Secretary 01708435000 Ext 8188 8311 8190 2721

General Medical Registrar on-call out of hours Aircall via switchboard 01703435000

Rheumatology Nurse Specialist Michelle Barnett Janice Leahy Christine Heron Diana Simeon Margaret Idowu Pat Lewis

01708435000 ext 8408 4821 4820 3219

BHR CCGs Medicines Management Team 0208 822 30746

References Nice Guidance TA 204 httppublicationsniceorgukdenosumab-for-the-prevention-of-osteoporotic-fractures-in-postmenopausal-

women-ta204

Pivotal Fracture study (Freedom trial)

N Engl J Med 2009 Aug 20361(8)756-65 doi 101056NEJMoa0809493 Epub 2009 Aug 11

Denosumab for prevention of fractures in postmenopausal women with osteoporosis Cummings SR et al

Refer to the relevant BHR CCG website to obtain the latest version of this guideline httpwwwbarkingdagenhamccgnhsukAbout-usMedicines-managementshared-care-guidelineshtm httpwwwhaveringccgnhsukAbout-usmedicines-managementshared-care-guidelineshtm httpwwwredbridgeccgnhsukAbout-usMedicines-managementshared-care-guidelineshtm

Approved by Area Prescribing Committee February 2014 Guideline written by Dr Judith Bubbear Consultant Rheumatologist (Barts)

Review date helliphelliphellip February 2016 Adapted for BHRUT by Tutu Ogunsanwo Rheumatology Liaison Pharmacist

Costs

Drug Product Cost in primary care

Denosumab (Prolia) 60mg sc 6 monthly pound366 per year

Based on BNF edition March 2013

RESOURCES AVAILABLE

BHRUT NHS Trust

Consultant Dr Euthalia Roussou Consultant Rheumatologist Dr Thushani Wickramaratne Consultant Rheumatologist Dr Louise Daniels Consultant Rheumatologist Dr Guy Dabrera Consultant Rheumatologist Dr Myo Lynn Consultant Rheumatologist

Secretary 01708435000 Ext 8188 8311 8190 2721

General Medical Registrar on-call out of hours Aircall via switchboard 01703435000

Rheumatology Nurse Specialist Michelle Barnett Janice Leahy Christine Heron Diana Simeon Margaret Idowu Pat Lewis

01708435000 ext 8408 4821 4820 3219

BHR CCGs Medicines Management Team 0208 822 30746

References Nice Guidance TA 204 httppublicationsniceorgukdenosumab-for-the-prevention-of-osteoporotic-fractures-in-postmenopausal-

women-ta204

Pivotal Fracture study (Freedom trial)

N Engl J Med 2009 Aug 20361(8)756-65 doi 101056NEJMoa0809493 Epub 2009 Aug 11

Denosumab for prevention of fractures in postmenopausal women with osteoporosis Cummings SR et al

Refer to the relevant BHR CCG website to obtain the latest version of this guideline httpwwwbarkingdagenhamccgnhsukAbout-usMedicines-managementshared-care-guidelineshtm httpwwwhaveringccgnhsukAbout-usmedicines-managementshared-care-guidelineshtm httpwwwredbridgeccgnhsukAbout-usMedicines-managementshared-care-guidelineshtm

Approved by Area Prescribing Committee February 2014 Guideline written by Dr Judith Bubbear Consultant Rheumatologist (Barts)

Review date helliphelliphellip February 2016 Adapted for BHRUT by Tutu Ogunsanwo Rheumatology Liaison Pharmacist

Appendix 1

Barking Havering and Redbridge University Hospitals NHS Trust

This form will be completed by the Hospital SpecialistGP and given to the patient

Safety information for Denosumab (Proliareg)

You have been prescribed Denosumab for osteoporosis Your GP has been given all the necessary information regarding your condition and treatment Like all medicines this drug is associated with a range of side effects although not everybody gets them The success and safety of your treatment also depends on youhellip

Please tell your doctor immediately if you develop a swollen red area of skin most commonly in the lower leg that feels hot and tender (cellulitis) and possibly with symptoms of fever while being on treatment with Prolia

Please tell your doctor if you have an allergy to latex (the needle cover on the pre-filled syringe contains a derivative of latex)

Tell your doctor if you have or have ever had severe kidney problems kidney failure or have needed dialysis which may increase your risk of getting low blood calcium if you do not take calcium supplements

You should also take calcium and vitamin D supplements while being on treatment with Prolia Your doctor will discuss this with you

A dental examination should be considered before you start treatment with Prolia if you have cancer are undergoing chemotherapy or radiotherapy are taking steroids do not receive routine dental care or have gum disease

If you are under dental treatment or will undergo dental surgery tell your dentist that you are being treated with Prolia

It is important to maintain good oral hygiene while on treatment with Prolia

If a dose of Prolia is missed the injection should be administered as soon as possible Thereafter injections should be scheduled every 6 months from the date of the last injection

To get the most benefit from your treatment it is important to use Prolia for as long as your doctor prescribes it for you Please talk to your doctor before you consider stopping the treatment

Contact your doctor if you experience new or unusual pain in your hip groin or thigh while being on treatment with Prolia as this may be an early indication of a possible fracture of the thigh bone

If you feel you have any concerns about your treatment contact your GP or the hospital The direct-dial telephone numbers for the department are 01708435000 ext 8408 4821 4820 3219

Approved by Area Prescribing Committee February 2014 Guideline written by Dr Judith Bubbear Consultant Rheumatologist (Barts)

Review date helliphelliphellip February 2016 Adapted for BHRUT by Tutu Ogunsanwo Rheumatology Liaison Pharmacist

Appendix 2

Barking Havering and Redbridge University Hospitals NHS Trust

Denosumab (Prolia) SHARED CARE AGREEMENT LETTER

Name of GP helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip Address helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip

helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip Dear GP Re Patientrsquos Namehelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip

Date of Birthhelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip

Hospital Numberhelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip

Indication for - Osteoporosis RoutehelliphelliphellipSubcutaneous Dosehelliphellip60 mg 6 monthly Enclosed is a copy of the shared care guidelines for Denosumab (Prolia) to be retained in the patientrsquos notes Should you agree to shared care we will send a letter containing the details of the patientrsquos 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 Signaturehelliphelliphelliphelliphelliphelliphelliphellip Signaturehelliphelliphelliphelliphelliphelliphelliphellip Name helliphelliphelliphelliphelliphelliphelliphellip Name helliphelliphelliphelliphelliphelliphelliphelliphellip Datehelliphelliphelliphelliphelliphelliphelliphelliphellip Datehelliphelliphelliphelliphelliphelliphelliphelliphellip

If you are not taking on shared care for this patient please state the reason why and return this letter to the Hospital Specialist helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip

Approved by Area Prescribing Committee February 2014 Guideline written by Dr Judith Bubbear Consultant Rheumatologist (Barts)

Review date helliphelliphellip February 2016 Adapted for BHRUT by Tutu Ogunsanwo Rheumatology Liaison Pharmacist

Appendix 2

Barking Havering and Redbridge University Hospitals NHS Trust

Denosumab (Prolia) SHARED CARE AGREEMENT LETTER

Name of GP helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip Address helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip

helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip Dear GP Re Patientrsquos Namehelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip

Date of Birthhelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip

Hospital Numberhelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip

Indication for - Osteoporosis RoutehelliphelliphellipSubcutaneous Dosehelliphellip60 mg 6 monthly Enclosed is a copy of the shared care guidelines for Denosumab (Prolia) to be retained in the patientrsquos notes Should you agree to shared care we will send a letter containing the details of the patientrsquos 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 Signaturehelliphelliphelliphelliphelliphelliphelliphellip Signaturehelliphelliphelliphelliphelliphelliphelliphellip Name helliphelliphelliphelliphelliphelliphelliphellip Name helliphelliphelliphelliphelliphelliphelliphelliphellip Datehelliphelliphelliphelliphelliphelliphelliphelliphellip Datehelliphelliphelliphelliphelliphelliphelliphelliphellip

If you are not taking on shared care for this patient please state the reason why and return this letter to the Hospital Specialist helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip