Licensed Indication Shared Care Agreement Insulin Degludec (Tresiba ) Insulin Degludec is licensed for the treatment of diabetes mellitus in adults. Countess of Chester prescribing guidelines Restricting the use of insulin degludec to patients who have: 1. Type 1 diabetes with recurrent severe hypoglycaemia, who have trialled available long acting analogues but are unable to achieve target HbA1c and/or nocturnal hypoglycaemia remains a problem before starting insulin pump therapy. 2. Type 1 diabetes with recurrent severe hypoglycaemia, who have trialled available long acting analogues but are unable to achieve target HbA1c and/or nocturnal hypoglycaemia remains a problem and are unsuitable for insulin pump therapy (i.e., visually impaired, not motivated to dose adjust based on carbohydrate counting). 3. Type 2 diabetes, who are insulin resistant, with poor control on greater than 200units of insulin per day. These patients will use 200units/ml pen as this will allow large doses to be given in a smaller volume resulting in better absorption and therefore better control of blood glucose. Dose and administration Insulin degludec should be administered once daily at any time of the day, with a minimum interval of 8 hours between doses, but preferably at the same time each day. Insulin degludec is to be dosed in accordance with the individual patient s needs. Dose adjustment should be based on fasting plasma glucose to optimise glycaemic control. In type 1 diabetes it must be combined with short/rapid-acting insulin to cover meal-time requirements. In type 2 diabetes the starting dose is 10 units per day. When adding insulin degludec to GLP-1 receptor agonists, the recommended daily starting dose is 10 units followed by individual dosage adjustments. When adding GLP-1 receptor agonists to insulin degludec, it is recommended to reduce the dose of insulin degludec by 20% to minimise the risk of hypoglycaemia. Subsequently, dosage should be adjusted individually. Note: One unit of insulin degludec corresponds to one unit of human insulin, one unit of insulin glargine or one unit of insulin detemir. Insulin Degludec (Tresiba ) shared care FINAL v1.0 Uploaded by Liz Kowlessar, December 2014
Adverse effects The most frequently reported adverse reaction during treatment is hypoglycaemia. Immune system disorders With insulin preparations, allergic reactions may occur. Immediate-type allergic reactions to either insulin itself or the excipients may potentially be life-threatening. Hypersensitivity (manifested with swelling of tongue and lips, diarrhoea, nausea, tiredness and itching) and urticaria reactions were reported rarely in clinical trial data. Hypoglycaemia Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. Severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death. The symptoms of hypoglycaemia usually occur suddenly. They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation. Lipodystrophy Lipodystrophy (including lipohypertrophy, lipoatrophy) may occur at the injection site. Continuous rotation of the injection site within the particular injection area may help to reduce the risk of developing these reactions. Injection site reactions Injection site reactions (including injection site haematoma, pain, haemorrhage, erythema, nodules, swelling, discolouration, pruritus, warmth and injection site mass) occurred in patients treated with Tresiba. These reactions are usually mild and transitory and they normally disappear during continued treatment. As insulin degludec is a new drug all adverse reactions should be reported to MHRA. Contraindications and warnings Hypersensitivity to the active substance or to any of the excipients listed. Tresiba should not be used during pregnancy, breast-feeding and for children under the age of eighteen as there is no experience of use in this group. Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac failure. This should be kept in mind if treatment with the combination of pioglitazone and Tresiba is considered. Tresiba must not be administered intravenously as it may result in severe hypoglycaemia. Tresiba must not be administered intramuscularly as it may change the absorption. Tresiba must not be used in insulin infusion pumps. Insulin Degludec (Tresiba ) shared care FINAL v1.0 Uploaded by Liz Kowlessar, December 2014
Drug Interactions The following substances may reduce the insulin requirement Oral anti diabetic medicinal products, GLP-1 receptor agonists, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulphonamides. The following substances may increase the insulin requirement Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol. Beta-blockers may mask the symptoms of hypoglycaemia. Octreotide/lanreotide may either increase or decrease the insulin requirement. Alcohol may intensify or reduce the hypoglycaemic effect of insulin Monitoring requirements In accordance with NICE guidance, patients must be monitored to ensure metabolic response of reduction in HbA1c. Refer back or discuss with secondary care if not achieved. Routine capillary blood glucose monitoring must be undertaken as with any other basal insulin therapy. Preparations available FlexTouch 100 units/ml 3ml prefilled pen provides accurate dosing up to 80 units of insulin (from 1-80 units in 1 unit increments) FlexTouch 200 units/ml 3ml prefilled pen which provides accurate dosing up to 160 units of insulin (from 2-160 units in 2 unit increments) The dose counter shows the number of units regardless of strength and no dose conversion should be done when transferring a patient to a new strength. Penfill 100 units/ml cartridges 3ml compatible with Novo Nordisk durable delivery devices (such as NovoPen 4). Insulin Degludec (Tresiba ) shared care FINAL v1.0 Uploaded by Liz Kowlessar, December 2014
Before first use: Store in a refrigerator (2 8 C). Keep away from the freezing element. Do not freeze. After first opening or carried as a spare: After first opening, the product may be stored for a maximum of 8 weeks. Do not refrigerate. Do not store above 30 C. Keep cartridges in the outer carton in order to protect from light. Cost For one year treatment (excluding VAT) based on 52 units daily 911 per patient per year. RESPONSIBILITIES Specialist responsibilities (consultant only) 1. Identify patients who may benefit from insulin degludec treatment as per COCH guidelines. 2. Discuss the benefits and side effects of treatment with the patient to enable them to make informed choices about how to manage their diabetes. 3. Initiate treatment and assess response for at least three months. Treatment should only be continued beyond this time period, and in the longer term, if there is a demonstrable improvement in the frequency and severity of hypoglycaemia whilst maintaining HbA1c that is judged to be clinically relevant to the individual patient s overall risk of developing long term complications of diabetes and hospitalisation due to hypoglycaemia. 4. Stabilise patient on insulin degludec before asking the GP to commence prescribing. 5. Report all adverse events to the MHRA. GP responsibilities 1. To prescribe insulin degludec as recommended by the specialist at COCH. 2. If unwilling to continue prescribing insulin degludec, please complete the attached form (Appendix 1), stating reasons and return to the consultant as soon as possible. 3. If patient develops worsening blood glucose control then to inform the specialist. 4. To report all adverse events to the specialist and the MHRA. Additional information This document should be read in conjunction with the Summary of Product Characteristics (SPC). The doctor who prescribes the medication assumes legal responsibility for the drug. Contacts Dr David Ewins Consultant Endocrinologist, COCH 01244 366451 Dr Frank Joseph Consultant Endocrinologist, COCH 01244 363708 Dr Sunil Nair Consultant Endocrinologist, COCH 01244 363708 Sister Karen Perkins, Diabetes Specialist Nurse, COCH 01244 363061 Haley Toop, Endocrinology Pharmacist, COCH 01244 362065 References: 1. Summary of Product Characteristics. Insulin Degludec (Tresiba ) Novo nordisk. Accessed June 2014. Insulin Degludec (Tresiba ) shared care FINAL v1.0 Uploaded by Liz Kowlessar, December 2014
Appendix 1: Shared Care Agreement Insulin degludec To be completed by GP if not in agreement with continued prescribing Name of patient Date of Birth Address Patient NHS No I do not agree to prescribe insulin degludec for the above patient in accordance with the enclosed shared care protocol. Reason for not wanting to continue prescription GP Date Insulin Degludec (Tresiba ) shared care FINAL v1.0 Uploaded by Liz Kowlessar, December 2014