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Once-daily Xultophy® insulin degludec/liraglutide


Taking progress a step further with:


Superiority confi rmed vs glargine U100 Greater HbA1c


reduction


With secondary benefi ts of: Weight loss vs weight gain*


Lower rate of hypoglycaemia


demonstrated in type 2 diabetes patients uncontrolled on glargine1,2


is indicated for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with a GLP-1 receptor agonist or basal insulin do not provide adequate glycaemic control.


Xultophy®


The fi rst–ever basal insulin and GLP-1 receptor agonist in one pen *Xultophy®


is not licensed for weight loss. Change in bodyweight from baseline was a secondary endpoint in DUAL V, a 26 week study.2 Prescribing Information Xultophy® Insulin degludec and Liraglutide. Xultophy®


is a pre-fi lled dial-a-dose pen. 1 mL solution contains 100 units insulin degludec and 3.6 mg liraglutide. One pre-fi lled pen contains 3 mL equivalent to 300 units insulin degludec and 10.8 mg liraglutide. One dose step contains 1 unit of insulin degludec and 0.036 mg of liraglutide. Indication: Xultophy®


is indicated for the treatment of adults


with type 2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with a GLP-1 receptor agonist or basal insulin do not provide adequate glycaemic control. Posology and administration: Xultophy® Xultophy®


can be administered at any time of the day, preferably at the same time of the day. Xultophy®


is to be dosed in accordance with the individual patient’s needs. It is recommended to optimise glycaemic control via dose adjustment based on fasting plasma glucose. Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness. Patients who forget a dose are advised to take it upon discovery and then resume their usual once- daily dosing schedule. A minimum of 8 hours between injections should always be ensured. This also applies when administration at the same time of the day is not possible. Xultophy®


The dose counter on the pen shows the number of dose steps. The recommended starting dose of Xultophy®


liraglutide) when added to existing oral anti-diabetic treatment. When Xultophy® is


added to sulphonylurea therapy, a reduction in the dose of sulphonylurea should be considered. Therapy with GLP-1 receptor agonists should be discontinued prior to initiation of Xultophy®


recommended starting dose of Xultophy®


. When transferring from a GLP-1 receptor agonist, the is 16 dose steps (16 units insulin degludec


and 0.6 mg liraglutide). The recommended starting dose should not be exceeded. If transferring from a long-acting GLP-1 receptor agonist (e.g. once-weekly dosing), the prolonged action should be considered. Treatment with Xultophy®


should be initiated


at the moment the next dose of the long-acting GLP-1 receptor agonist would have been taken. Therapy with basal insulin should be discontinued prior to initiation of Xultophy®


dose of Xultophy®


The recommended starting dose should not be exceeded. Close glucose monitoring is recommended during the transfer and in the following weeks. Xultophy®


can be used


in elderly patients. Glucose monitoring is to be intensifi ed and the dose adjusted on an individual basis. The therapeutic experience in patients ≥75 years of age is limited. When Xultophy®


to be intensifi ed and the dose adjusted on an individual basis. Xultophy®


is used in patients with mild renal impairment, glucose monitoring is cannot be


recommended for use in patients with moderate or severe renal impairment including patients with end-stage renal disease. The therapeutic experience with Xultophy®


in


patients with hepatic impairment is currently too limited to recommend the use in these patients. There is no relevant use of Xultophy® Xultophy®


is for subcutaneous use only. Xultophy® intravenously or intramuscularly. Xultophy®


Summary of Product Characteristics. Novo Nordisk A/S. Bagsværd, Denmark. 25 June 2015. 2. Buse JB., Perez Manghi FC., Garcia-Hernandez PA et al., Insulin degludec/liraglutide (IDegLira) is superior to insulin glargine (IG) in A1c reduction, risk of hypoglycaemia and weight change: DUAL V study. Diabetes, 2015;64(Suppl. 1):A43-44 (166-OR). 3. Scottish Medicines Consortium. Insulin degludec/liraglutide 100 units/ml / 3.6mg/mL solution for injection pre-fi lled pen (Xultophy® (1088/15). 2015. Available at: www.scottishmedicines.org.uk/SMC_Advice/Advice/1088_15_insulin_degludec_liraglutide_Xultophy/insulin_degludec_liraglutide_Xultophy (Accessed October 2015).


REFERENCES 1. Xultophy®


) SMC No.


Learn more at NovoNordiskPro.co.uk Xultophy®


is a registered trademark of Novo Nordisk A/S. ©Novo Nordisk Ltd, 3 City Place, Beehive Ring Road, Gatwick, RH6 0PA UK Zinc#UK/XT/1015/0350; Approval date: November 2015. is administered subcutaneously by


in the paediatric population. must not be administered


. When transferring from basal insulin therapy, the recommended starting is 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide).


is given once daily by subcutaneous administration.


injection in the thigh, the upper arm or the abdomen. Injection sites are always to be rotated. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Special warnings and precautions for use: Xultophy®


used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Hypoglycaemia may occur if the dose of Xultophy®


should not be is higher than


required. Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia. In combination with sulphonylurea, the risk of hypoglycaemia may be lowered by a reduction in the dose of sulphonylurea. Concomitant diseases in the kidney, liver or diseases affecting the adrenal, pituitary or thyroid gland may require changes of the Xultophy®


dose. Patients whose blood-glucose control is greatly


improved (e.g. by intensifi ed therapy) may experience a change in their usual warning symptoms of hypoglycaemia, and must be advised accordingly. Usual warning symptoms of hypoglycaemia may disappear in patients with long-standing diabetes. The prolonged effect of Xultophy®


dosing and/or discontinuation of anti-diabetic treatment may lead to hyperglycaemia. In case of discontinuation of Xultophy®


may delay recovery from hypoglycaemia. Inadequate , ensure that instruction for initiation of


is administered as dose steps. One dose step contains 1 unit of


insulin degludec and 0.036 mg of liraglutide. The pre-fi lled pen can provide from 1 up to 50 dose steps in one injection in increments of one dose step. The maximum daily dose of Xultophy®


is 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). is 10 dose steps (10 units insulin degludec and 0.36 mg


alternative anti-diabetic medication is followed. Furthermore, concomitant illness, especially infections, may lead to hyperglycaemia and thereby cause an increased requirement for anti-diabetic treatment. Administration of rapid-acting insulin should be considered in situations of severe hyperglycaemia. Untreated hyperglycaemic events eventually lead to hyperosmolar coma/diabetic ketoacidosis, which is potentially lethal. Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin medicinal products, especially in patients with risk factors for development of cardiac failure. If the combination of pioglitazone and Xultophy®


is used, patients


should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs. Intensifi cation of therapy with insulin, a component of Xultophy®


, with abrupt


improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy. Administration of Xultophy®


of antibodies against insulin degludec and/or liraglutide. In rare cases, the presence of such antibodies may necessitate adjustment of the Xultophy®


may cause formation dose in order to correct


a tendency to hyper- or hypoglycaemia. Very few patients developed insulin degludec specifi c antibodies, antibodies cross-reacting to human insulin or anti-liraglutide antibodies following treatment with Xultophy® associated with reduced effi cacy of Xultophy® including liraglutide, a component of Xultophy®


. Antibody formation has not been . Use of GLP-1 receptor agonists , has been associated with a risk of


developing acute pancreatitis. There have been few reported events of acute pancreatitis. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, Xultophy® pancreatitis is confi rmed, Xultophy®


should be discontinued; if acute should not be restarted. Caution should be


exercised in patients with a history of pancreatitis. Thyroid adverse events, including increased blood calcitonin, goitre and thyroid neoplasm have been reported in clinical trials with GLP-1 receptor agonists including liraglutide, a component of Xultophy® particular in patients with pre-existing thyroid disease, and Xultophy®


, in


be used with caution in these patients. There is no experience with Xultophy® patients with infl ammatory bowel disease and diabetic gastroparesis. Xultophy®


should therefore in is


therefore not recommended in these patients. Signs and symptoms of dehydration, including renal impairment and acute renal failure have been reported in clinical trials with GLP-1 receptor agonists including liraglutide, a component of Xultophy® treated with Xultophy®


. Patients should be advised of the potential risk of dehydration in


relation to gastrointestinal side effects and take precautions to avoid fl uid depletion. Patients must be instructed to always check the pen label before each injection to avoid accidental mix-ups between Xultophy® products. Transfer to Xultophy® been studied. Xultophy®


and other injectable diabetes medicinal


from doses of basal insulin < 20 and > 40 units has not has not been studied in combination with dipeptidyl peptidase


should therefore be used with caution. There is no experience in patients with congestive heart failure NYHA class III-IV and Xultophy®


4 (DPP-4) inhibitors, glinides or prandial insulin. There is limited experience in patients with congestive heart failure New York Heart Association (NYHA) class I-II and Xultophy®


is therefore not


recommended in these patients. Fertility, pregnancy and lactation: If a patient wishes to become pregnant, pregnancy occurs or is breast feeding; treatment with Xultophy®


should be discontinued. There is no clinical experience with Xultophy® in


relation to fertility. Animal reproduction studies with insulin degludec or liraglutide have not revealed any adverse effects on fertility. Undesirable effects: Adverse reactions associated with Xultophy®


are given below, listed by system organ class and


frequency. Very common (≥1/10): Hypoglycaemia. Common (≥1/100 to <1/10): Decreased appetite, nausea, diarrhoea, vomiting, constipation, dyspepsia, gastritis, abdominal pain, fl atulence, gastroesophageal refl ux disease, abdominal distension and injection site reactions. Uncommon (≥1/1,000 to <1/100): Urticaria, anaphylactic reactions, dehydration, rash, pruritus and increased heart rate. Rare (≥1/10,000 to <1/1,000):


Hypersensitivity, lipodystrophy acquired. The Summary of Product


Characteristics should be consulted for a full list of side effects. MA numbers and Basic NHS Price: 3 x 3 ml 100 U/mL, EU/1/14/947/002, £95.53. 5 x 3 ml 100 U/mL, EU/1/14/947/003, £159.22. Xultophy®


pre-fi lled dial-a-dose pen. Legal category:


POM. Full prescribing information can be obtained from: Novo Nordisk Limited, 3 City Place, Beehive Ring Road, Gatwick, West Sussex, RH6 0PA. Marketing Authorisation Holder: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark. Date last revised: September 2015.


Adverse events should be reported. Reporting forms and information can be found at


www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novo Nordisk Limited (Telephone Novo Nordisk Customer Care Centre 0845 6005055). Calls may be monitored for training purposes.


Xultophy® , NovoTwist® and NovoFine® are trademarks owned by Novo Nordisk A/S, Denmark.


At Novo Nordisk, we are changing diabetes. In our approach to developing treatments, in our commitment to operate profi tably and ethically, and in our search for a cure.


Xultophy®


approved by the SMC has been


Approved for restricted use in patients who are uncontrolled on basal insulin analogues (HbA1c


a GLP-1 receptor agonist is appropriate as an add-on intensifi cation therapy to basal insulin to obtain glucose control.3


>7.5% [59 mmol/mol]) and for whom


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