Shared care guidelines are developed when sophisticated or complex treatments that were initiated in secondary care are then prescribed by a GP. They set out the process that needs to be followed for the GP to take on prescribing responsibility. They should be patient specific and encompass all aspects relevant to that particular patient.
Clinical responsibility should be considered for transfer to primary care only where it is agreed that the patient's clinical condition is stable or predictable.
Shared Care Policy And Prescribing Information For Denosumab 120mg injection (Xgeva®) For Treatment Of Bone Metastases From Solid Tumours, Excluding Prostate (Adults Only)Public / Applies to: NHS Grampian / Version: 1 /
Prepared by: / Authorised for issue by: / Document no:
NHSG/SCPa/Xgeva/MGPG765
Pharmacist, ARI / Medicines Guidelines
and Policies Group / Effective date: October 2015
Signature:
Millie Galvin / Signature:
Caroline Hind / Review Date: October 2017
Supersedes: N/A – New
Please keep this document in the patients notes
UNCONTROLLED WHEN PRINTED Review Date: October 2017 (sooner if recommendations change) NHSG/SCPa/Xgeva/MGPG765 - 1 -
SCP and Prescribing Information for Denosumab 120mg (Xgeva®) For Treatment Of Bone Metastases (Adults Only) - Version 1, October 2015
Shared care guidelines are developed when sophisticated or complex treatments that were initiated in secondary care are then prescribed by a GP. They set out the process that needs to be followed for the GP to take on prescribing responsibility. They should be patient specific and encompass all aspects relevant to that particular patient.
Clinical responsibility should be considered for transfer to primary care only where it is agreed that the patient's clinical condition is stable or predictable.
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UNCONTROLLED WHEN PRINTED Review Date: October 2017 (sooner if recommendations change) NHSG/SCPa/Xgeva/MGPG765 - 1 -
SCP and Prescribing Information for Denosumab 120mg (Xgeva®) For Treatment Of Bone Metastases (Adults Only) - Version 1, October 2015
Shared care guidelines are developed when sophisticated or complex treatments that were initiated in secondary care are then prescribed by a GP. They set out the process that needs to be followed for the GP to take on prescribing responsibility. They should be patient specific and encompass all aspects relevant to that particular patient.
Clinical responsibility should be considered for transfer to primary care only where it is agreed that the patient's clinical condition is stable or predictable.
UNCONTROLLED WHEN PRINTED Review Date: October 2017 (sooner if recommendations change) NHSG/SCPa/Xgeva/MGPG765 - 1 -
SCP and Prescribing Information for Denosumab 120mg (Xgeva®) For Treatment Of Bone Metastases (Adults Only) - Version 1, October 2015
Shared care guidelines are developed when sophisticated or complex treatments that were initiated in secondary care are then prescribed by a GP. They set out the process that needs to be followed for the GP to take on prescribing responsibility. They should be patient specific and encompass all aspects relevant to that particular patient.
Clinical responsibility should be considered for transfer to primary care only where it is agreed that the patient's clinical condition is stable or predictable.
The prescriber who prescribes denosumab 120mg injection (Xgeva®) legally assumes clinical responsibility for the drug and the consequences of its use.Subcutaneous denosumab is available as two different preparations Xgeva® 120mg and Prolia® 60mg injection. They are licensed for different indications and are not interchangeable. This shared care policy refers only to Xgeva® 120mg vial and only Xgeva® 120mg should be prescribed under this policy.
THERAPEUTIC INDICATION FOR THIS PATIENT:
Denosumab 120mg (Xgeva®) is included on the Grampian Joint Formulary as an option for preventing skeletal-related events in adults with bone metastases from breast cancer and from solid tumours other than prostate.
DOSAGE/FREQUENCY OF ADMINISTRATION:
120mg subcutaneously every 4 weeks into the thigh, abdomen or upper arm.
SAFE PRACTICE IS THAT THE CLINICIAN WHO ORDERS THE TEST MUST ACT ON THE RESULT
CARE WHICH IS THE RESPONSIBILITY OF THE HOSPITAL CONSULTANT
1. Assess patient and establish need for denosumab 120mg treatment.
2. Provide patient with information including possible adverse events and obtain consent. Provide patient reminder card. Link
3. Baseline Urea and Electrolytes (including creatinine and eGFR), corrected calcium and LFTs.
4. Identify if review by a dentist and or dental work needs to be carried out and refer if necessary.
5. If pre-existing hypocalcaemia this should be corrected prior to recommending denosumab 120mg.
6. Contact the GP to invite shared care for the patient. / CARE WHICH IS THE RESPONSIBILITY OF THE
GENERAL PRACTITIONER (GP)
1. Prescribing of medication under guidance of consultant.
2. Check before prescribing medication that the monitoring is up to date and that results are within the normal range.
3. Urea and Electrolytes (including creatinine and eGFR), corrected calcium and LFTs should be checked prior to each denosumab 120mg administration. Administration should occur within 7 days after taking blood samples. Note for first administration bloods can be up to 14 days old.
4. Calcium should be re-checked 2 weeks after the first dose of denosumab 120mg.
5. Prescribe denosumab 120mg on a GP10 every 4 weeks and arrange for administration at the GP practice.
6. When the patient attends for administration they should be given the patient information leaflet supplied with the vial of denosumab 120mg (Xgeva®) unless they already have a copy.
UNCONTROLLED WHEN PRINTED Review Date: October 2017 (sooner if recommendations change) NHSG/SCPa/Xgeva/MGPG765 - 1 -
SCP and Prescribing Information for Denosumab 120mg (Xgeva®) For Treatment Of Bone Metastases (Adults Only) - Version 1, October 2015
CARE WHICH IS THE RESPONSIBILITY OF THE HOSPITAL CONSULTANT7. Assess the continued appropriateness for denosumab 120mg (usually clinic reviews every 3-6 months), this should be specified in the clinic letter.
8. Review any concerns from the GP regarding disease progression within 2 weeks.
9. Ensure that all other professionals in the shared care team are kept informed of any changes in the patient’s circumstances. / CARE WHICH IS THE RESPONSIBILITY OF THE GENERAL PRACTITIONER (GP)
7. Calcium and vitamin D supplements should be prescribed for all patients unless hypercalcaemic. The usual dose is 1-2 tablets daily of Accrete D3 or another equivalent alternative.
8. If corrected calcium is below the normal range (less than 2.2 mmol/L) denosumab 120mg should be withheld until calcium is within the normal range (between 2.2-2.6 mmol/L).
9. If corrected calcium is above the normal range (more than 2.6 mmol/L) denosumab 120mg can be prescribed but the GP should consider withholding calcium supplements and reviewing at the next administration. Other causes for hypercalcaemia should be excluded.
10. Refer back to the hospital consultant for review if there are signs of disease progression.
11. Ensure that all other professionals in the shared care team are kept informed of any changes in the patient’s circumstances.
When writing laboratory request forms always include details of the patient’s medication
NOTE: In addition to absolute values for haematological indices a rapid fall or a consistent downward trend in any value should prompt caution and extra vigilance.
If something unexpected occurs contact consultant.
Notify the consultant if the drug is stopped.
Abnormal Monitoring Results / Action To Be Taken
· Corrected calcium less than 2.2 mmol/L. / Withhold denosumab 120mg until corrected calcium within the normal range (2.2-2.6 mmol/L). Ensure patient prescribed calcium and vitamin D supplement.
· Corrected calcium greater than 2.6 mmol/L / Consider withholding calcium supplements (as above) and review at next administration. Exclude other causes for hypercalcaemia.
· Liver function test abnormalities changed from baseline. / Consider referring back to consultant if suspected signs of disease progression.
· eGFR less than 30mL/min. / At higher risk of hypocalcaemia – monitor calcium closely.
For specific product information please consult the current summary of product characteristics (http://emc.medicines.org.uk/) and the BNF http://www.bnf.org/bnf/)
Other information
· All patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with denosumab 120mg (Xgeva®). While on treatment, patients should avoid invasive dental procedures if possible due to the risk of osteonecrosis of the jaw.
· Patients being treated with denosumab 120mg (Xgeva®) should not be treated concomitantly with other denosumab containing medicinal products (for osteoporosis indications).
· Patients being treated with denosumab 120mg (Xgeva®) should not be treated concomitantly with bisphosphonates.
· There are no significant drug interactions.
· Caution in patients with eGFR less than 30mL/min as these patients are at higher risk of hypocalcaemia, monitor calcium closely in these patients.
· Possible side effects of treatment:
· Hypocalcaemia
· Hypophosphataemia
· Dyspnoea
· Diarrhoea
· Osteonecrosis of the jaw (ONJ)
· Hypersensitivity
· Skin infection at administration site
· Hyperhydrosis.
Denosumab 120mg (Xgeva®) should be given once every 4 weeks. If a dose is missed please give at the earliest opportunity. There must always be a minimum 4 week interval between doses.
Pregnancy
Contra-indicated in pregnancy. Refer back to consultant.
Breast-feeding
Should be avoided. Refer back to consultant.
Responsibilities of GPs undertaking monitoring
A GP agreeing to monitor denosumab 120mg (Xgeva®) should:
· Ensure that the relevant monitoring requirements are undertaken at the correct frequency.
· Ensure that the test results are checked for any abnormality as soon as the results are available.
· Ensure abnormal results are acted upon.
· Only continue to prescribe denosumab 120mg (Xgeva®) if it is being satisfactorily monitored.
· Contact the consultant in the event of a drug reaction or monitoring abnormality or anything you are unhappy about.
· Be alert for any of the known adverse reactions.
** The patient should be encouraged to ensure blood tests are taken at the correct intervals. **
Storage:
Store in a refrigerator (+2°C to + 8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Once removed from the refrigerator it must be used within 30 days
Reference:
Grampian Medicines Management Website, Shared Care Policies webpage - http://www.nhsgrampian.org/nhsgrampian/GJF_general_new.jsp?pContentID=4382&pMenuID=464&pElementID=470&p_service=Content.show
Electronic Medicines Compendium denosumab (Xgeva®)
https://www.medicines.org.uk/emc/medicine/24755 [accessed 30/10/2015]
UNCONTROLLED WHEN PRINTED Review Date: October 2017 (sooner if recommendations change) NHSG/SCPa/Xgeva/MGPG765 - 1 -
SCP and Prescribing Information for Denosumab 120mg (Xgeva®) For Treatment Of Bone Metastases (Adults Only) - Version 1, October 2015