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Reduced Shared Care Protocol –remains open to review in light of any new evidence Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up prescribing by primary care. Once medical condition and drug dosage is stable, there is no specific requirement for ongoing monitoring. Dapagliflozin (Forxiga®) / Dapagliflozin/Metformin (Xigduo®) / Canagliflozin (Invokana®) / Canagliflozin/Metformin (Vokanamet®) Reduced Shared Care Guideline for Dapagliflozin (Forxiga®), Dapagliflozin/Metformin (Xigduo®), Canagliflozin (Invokana®) and Canagliflozin/Metformin (Vokanamet®) Introduction Indication/Licensing information Dapagliflozin and Canagliflozin are licensed for use in type 2 diabetes as monotherapy (if metformin not tolerated), or in combination with insulin or other antidiabetic drugs (if existing treatment fails to achieve adequate glycaemic control). However, NICE guidance recommend these for the indications listed below. For patients established on dapagliflozin 5mg and metformin 850mg or 1000mg, a combination product is available in two different strengths: dapagliflozin 5mg/metformin 850mg or dapagliflozin 5mg/metformin 1000mg (Xigduo®). This may be a more cost-effective option for those patients who are already stabilised on the above doses of the individual drugs. For patients established on canagliflozin 100mg daily and metformin 850mg twice daily or canagliflozin 100mg daily and metformin 1g twice daily, then a combination preparation is available in two different strengths: canagliflozin 50mg/metformin 850mg and canagliflozin 50mg/metformin 1g (Vokanamet®). This may be a more cost-effective option for those patients who are already stabilised on the above doses of the individual drugs. NICE Guidance Dapagliflozin: TA2881 - NICE guidance states the following: 1. Dual therapy regimen in combination with metformin as an option for treating type 2 diabetes, only if it is used as described for dipeptidyl peptidase-4 (DPP-4) inhibitors in Type 2 diabetes: the management of type 2 diabetes (NICE clinical guideline 87). NICE Clinical Guideline 872 advises the following in relation to the use of a DPP-4 inhibitor: Consider adding as a second-line therapy instead of a sulfonylurea to first-line metformin when control of blood glucose remains or becomes inadequate: o if the person is at significant risk of hypoglycaemia or its consequences or, o the person does not tolerate a sulfonylurea or a sulfonylurea is contraindicated. Only continue if the person has had a beneficial metabolic response [reduction of at least 56mmols/mol in HbA1c in 6 months (0.5%)]. 2. In combination with insulin with or without other anti-diabetic drugs for treating type 2 diabetes. 3. Triple therapy regimen in combination with metformin and a sulfonylurea is not recommended for treating type 2 diabetes, except as part of a clinical trial. 4. Dapagliflozin should not be used in combination with GLP-1 receptor agonists or with pioglitazone. 5. People currently receiving dapagliflozin in a dual or triple therapy regimen that is not recommended for them as above, should be able to continue treatment until they and their clinician consider it appropriate to stop. Page 1 of 6 Dapagliflozin/Canagliflozin Shared care Guideline Date Prepared: September 2014 Review Date: September 2016 Reduced Shared Care Protocol –remains open to review in light of any new evidence Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up prescribing by primary care. Once medical condition and drug dosage is stable, there is no specific requirement for ongoing monitoring. Canagliflozin: TA3153 – NICE Guidance states the following: 1. Canagliflozin in a dual therapy regimen in combination with metformin is recommended as an option for treating type 2 diabetes, only if: a sulfonylurea is contraindicated or not tolerated or the person is at significant risk of hypoglycaemia or its consequences. 2. Canagliflozin in a triple therapy regimen is recommended as an option for treating type 2 diabetes in combination with: metformin and a sulfonylurea or metformin and a thiazolidinedione. 3. Canagliflozin in combination with insulin with or without other antidiabetic drugs is recommended as an option for treating type 2 diabetes. 4. People currently receiving treatment initiated within the NHS with canagliflozin that is not recommended for them by NICE in this guidance should be able to continue treatment until they and their NHS clinician consider it appropriate to stop. What does this mean in practice? NICE do not specify place in therapy for these drugs other than as an option in patients uncontrolled on metformin alone, where a sulfonylurea is not suitable. Other treatment options at this stage are summarised: DPP-4 inhibitors (gliptins) Thiazolidinediones (pioglitazone) – The use of pioglitazone may be decreasing due to safety concerns relating to a possible increased risk of bladder cancer. (Drug Safety Update. MHRA. August 2011 available at: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON125962 Liraglutide or exenatide can be used as part of dual therapy in line with NICE guidance4.5 if: Treatment with metformin or a sulfonylurea is contraindicated or not tolerated and Treatment with a thiazolidinediones or a dipeptidylpeptidase-4 inhibitor is contraindicated or not tolerated. Responsibilities of the specialist* initiating treatment *Specialist refers to either Consultant, Diabetes Specialist Nurse or a GP with specialist interest and training. Summary To assess the suitability of the patient for treatment. To discuss the benefits and side effects of treatment with the patient/carer. To perform baseline tests (HbA1c, weight and renal function). To prescribe until the patient is stabilised. Review the patient approximately 4 weeks after starting therapy. Continue prescribing and monitoring for a further 4 weeks. The GP can be asked to take on prescribing by week 7/8, provided the patient is stable. Adjust dose of concomitant insulin or drugs that stimulate insulin secretion where applicable. To ask the GP whether they are willing to participate in shared care. To provide the GP with a summary of information relating to the individual patient to support the GP in undertaking reduced shared care (See Appendix A). Provide the GP with a starting HbA1c, weight and renal function. To advise the GP of any dosage adjustments required, when to refer back, when and how to stop treatment (if appropriate) and when the patient will next be reviewed by the specialist. To monitor the patient for adverse events and report to the GP and where appropriate Commission on Human Medicines/MHRA (Yellow card scheme). To provide the GP with contact details in case of queries. Page 2 of 6 Dapagliflozin/Canagliflozin Shared care Guideline Date Prepared: September 2014 Review Date: September 2016 Reduced Shared Care Protocol –remains open to review in light of any new evidence Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up prescribing by primary care. Once medical condition and drug dosage is stable, there is no specific requirement for ongoing monitoring. Baseline Tests Baseline HbA1c, weight and renal function should be recorded prior to initiating either dapagliflozin or canagliflozin. Routine Tests (if applicable) Monitor the patient’s response to the treatment by measuring HbA1c and weight at 3 months and 6 months and, once stable, 6 monthly thereafter. Daily blood glucose monitoring is not routinely required. However, blood glucose monitoring is necessary for patients who are also taking a sulfonylurea or basal insulin where a dose adjustment of the sulfonylurea or insulin may be necessary. Renal function should be monitored annually, or more frequently in patients whose renal function is approaching moderate impairment. Renal function should also be monitored prior to initiating concomitant medication that may affect renal function and periodically thereafter. Disease monitoring The patient will be reviewed by the Specialist if the need arises. Responsibilities of other prescribers Acceptance of Responsibility by the Primary Care Clinician It is optional for GPs to participate in taking on responsibility for shared care for the patient. GPs will take on shared care only if they are willing and able. Summary To reply to the request for shared care as soon as possible. To prescribe and adjust the dose as recommended by the specialist. To ensure there are no interactions with any other medications initiated in primary care. To monitor patient’s ongoing response to treatment, weight and HbA1c at 3 months, 6 months and 6 monthly thereafter. To review therapy or refer back to the specialist where appropriate. For example: o Patient or general practitioner is not comfortable to continue with the existing regime due to either change in condition or drug side effects o Blood glucose levels become unstable o Appropriate reduction (≥0.5%) in HbA1c and/or weight loss (eg ≥5% reduction at 6 months) are not achieved o The patient experiences any unmanageable side effects. Discontinue the drug as directed by the specialist if required. To identify adverse events if the patient presents with any signs 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). Page 3 of 6 Dapagliflozin/Canagliflozin Shared care Guideline Date Prepared: September 2014 Review Date: September 2016 Reduced Shared Care Protocol –remains open to review in light of any new evidence Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up prescribing by primary care. Once medical condition and drug dosage is stable, there is no specific requirement for ongoing monitoring. Adverse drug reactions, precautions, contraindications and interactions Please see the full Summary of Product Characteristics for more information. 6 http://www.medicines.org.uk/emc/ Dapagliflozin Canagliflozin Dosage and administration Adult over 18 years – 10mg od Over 75 years – not recommended Cautions Dose of concomitant insulin or drugs that stimulate insulin secretion may need to be reduced Hepatic impairment: Initiate dapagliflozin at 5mg daily in severe impairment and increase according to response. Canagliflozin is not recommended in severe hepatic impairment Dapagliflozin and canagliflozin can both cause increase diuresis associated with a modest decrease in blood pressure. This may be more pronounced in patients with very high blood glucose concentrations. Caution should be exercised in patients for whom a dapagliflozin/canagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension or elderly patients. Dapagliflozin is not recommended for use in patients receiving loop diuretics or who are volume depleted, e.g. due to acute illness such as GI illness. Elderly patients are at a greater risk for volume depletion Elderly patients are more likely to have impaired renal function, and/or to be treated with anti-hypertensive medicinal products that may cause changes in renal function such as angiotensin-converting enzyme inhibitors (ACE-I) and angiotensin II type 1 receptor blockers (ARB). Adult over 18 years of age – 100mg od. Increased to 300mg od if needed. Contraindications Known hypersensitivity to active substance or to any excipients. Type 1 diabetes mellitus, ketoacidosis, severe gastro-intestinal disease, pregnancy, breast-feeding, children under 18 years, end-stage renal disease or moderate to severe renal impairment (creatinine clearance <60 ml/min), severe hepatic dysfunction. Adverse drug reactions The most common adverse drug reactions are: Hypoglycaemia Urogenital infection (UTIs, candidal infection) is increased in patients taking dapagliflozin or canagliflozin, although this isn’t usually a reason to discontinue treatment Adverse drug reactions related to volume depletion (dehydration, hypovolaemia, hypotension) have been reported. Interactions Diuretics: Dapagliflozin or canagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension. Insulin and insulin secretagogues: Insulin and insulin secretagogues, such as sulfonylureas, cause hypoglycaemia. Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with dapagliflozin or canagliflozin. Page 4 of 6 Dapagliflozin/Canagliflozin Shared care Guideline Date Prepared: September 2014 Review Date: September 2016 Reduced Shared Care Protocol –remains open to review in light of any new evidence Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up prescribing by primary care. Once medical condition and drug dosage is stable, there is no specific requirement for ongoing monitoring. Communication Specialist to GP The specialist will inform the GP when they have initiated dapagliflozin or canagliflozin. When the patient is near completing the satisfactory initiation period, the specialist will write to the GP to request they take over prescribing and where possible give an indication as to the expected length of treatment. The Specialist will also send a Shared care request form to support the GP in undertaking reduced shared care. (Appendix A) GP to specialist If the GP has concerns over the prescribing of dapagliflozin or canagliflozin, they will contact the specialist as soon as possible. Contact Name Telephone number Email Dr K Sands Consultant Endocrinologist 01226 434050 [email protected] Dr E Uchegbu Consultant Diabetologist 01226 432598 [email protected] Dr Z Merza Consultant Endocrinologist and Diabetologist 01226 435366 [email protected] Prof TH Jones Consultant Endocrinologist and Diabetologist 01226 432147 [email protected] Natasha Kelly Diabetes Specialist Nurse Community Diabetes Specialist Nurse Team Apollo Court – Sue Jones Gillian Smith Medicines Information Pharmacist [email protected] 01226 209884 [email protected] 01226 432857 [email protected] References 1. NICE Technology Appraisal TA288: Dapagliflozin in combination therapy for treating type 2 diabetes. June 2013. Available at: http://publications.nice.org.uk/dapagliflozin-in-combination-therapy-for-treatingtype-2-diabetes-ta288 Accessed <15.7.13> 2. NICE Clinical Guideline 87. Type 2 diabetes: The management of Type 2 diabetes. May 2009. Available at: http://publications.nice.org.uk/type-2-diabetes-cg87/guidance#oral-glucose-controltherapies-2-other-oral-agents-and-exenatide Accessed <04.11.13> 3. NICE Technology Appraisal TA315: Canagliflozin in combination therapy for treating type 2 diabetes. June 2014. Available at: http://www.nice.org.uk/guidance/TA315 Accessed <16.07.14> 4. Diabetes (type 2) – Liraglutide. NICE technology appraisal TA203. October 2010. Available at: http://guidance.nice.org.uk/TA203 Accessed <6.11.13> 5. NICE Technology Appraisal TA 248. Exenatide prolonged release suspension for injection in combination with oral antidiabetic therapy for the treatment of type 2 diabetes. Available at: http://publications.nice.org.uk/exenatide-prolonged-release-suspension-for-injection-in-combinationwith-oral-antidiabetic-therapy-ta248 Accessed <6.11.13> 6. Summary of Product Characteristics Available at: www.medicines.org.uk Accessed <15.7.13> Development Process This guidance has been produced by Caron Applebee, Medicines Management Pharmacist, following an AMBER-G classification status of dapagliflozin and canagliflozin by the Barnsley Area Prescribing Committee. This guideline has been subject to consultation and endorsement by the Area Prescribing Committee on 8th October 2014 and the LMC on 14th October 2014. Page 5 of 6 Dapagliflozin/Canagliflozin Shared care Guideline Date Prepared: September 2014 Review Date: September 2016 Reduced Shared Care Protocol –remains open to review in light of any new evidence Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up prescribing by primary care. Once medical condition and drug dosage is stable, there is no specific requirement for ongoing monitoring. Appendix A – Reduced Shared Care (Amber-G) request form Specialist to complete when requesting GP to enter a shared care arrangement. GP to return signed copy of form. Both parties should retain a signed copy of the form in the patient’s record. From (Specialist): To (GP): Patient details Name: ID Number: Address: DOB: Diagnosed condition: Amber-G Drug details Drug name: Dose: Date of initiation: Length of treatment: The patient will be reviewed by the Consultant on: Telephone number(s) for contact: The patient should be reviewed by the GP by: Consultant: Date: Communication Consultant Telephone number: Fax number: Email address: Specialist Nurse Telephone number: Fax number: Email address: Confirmation of acceptance of shared care Specialist name: Specialist signature: Date: I, Dr can confirm I : □ □ accept the request to participate in shared care for the patient named above. reject the request to participate in shared care for the patient named above. The reason for this being ……………………………………………………………………………………….. GP signature: Date: Page 6 of 6 Dapagliflozin/Canagliflozin Shared care Guideline Date Prepared: September 2014 Review Date: September 2016