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Xultophy is a brand name for Insulin Degludec. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Xultophy is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to other oral medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic…
Verbatim from this product's EMA label. Tap a section to expand.
Posology Xultophy is given once daily by subcutaneous administration. 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 is administered as dose steps. 036 mg of liraglutide. The pre-filled pen can provide from 1 up to 50 dose steps in one injection in increments of one dose step. 8 mg liraglutide). The dose counter on the pen shows the number of dose steps.
36 mg liraglutide). Xultophy can be added to existing oral antidiabetic treatment. 4). Transfer from GLP-1 receptor agonist Therapy with GLP-1 receptor agonists should be discontinued prior to initiation of Xultophy. 1). The recommended starting dose should not be exceeded.
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. Close glucose monitoring is recommended during the transfer and in the following weeks.
Transfer from any insulin regimen that includes a basal insulin component Therapy with other insulin regimens should be discontinued prior to initiation of Xultophy. 1). The recommended starting dose should not be exceeded, but may be reduced to avoid hypoglycaemia in selected cases.
Close glucose monitoring is recommended during the transfer and in the following weeks. Special populations Elderly patients (≥ 65 years old) Xultophy can be used in elderly patients. Glucose monitoring is to be intensified and the dose adjusted on an individual basis.
Renal impairment When Xultophy is used in patients with mild, moderate or severe renal impairment, glucose monitoring is to be intensified and the dose adjusted on an individual basis. 2). Hepatic impairment Xultophy can be used in patients with mild or moderate hepatic impairment.
Summary of the safety profile The Xultophy clinical development programme included approximately 1 900 patients treated with Xultophy. The most frequently reported adverse reactions during treatment with Xultophy were hypoglycaemia and gastrointestinal adverse reactions (see section ‘Description of selected adverse reactions’ below).
Tabulated list of adverse reactions Adverse reactions associated with Xultophy are given below, listed by system organ class and frequency.
Frequency categories are defined as:
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000) and not known (cannot be estimated from the available data). Table 1 Adverse reactions reported in phase 3 controlled studies MedDRA System organ class Frequency Adverse reaction Immune system disorders Uncommon Urticaria Uncommon Hypersensitivity Unknown Anaphylactic reaction Metabolism and nutrition disorders Very common Hypoglycaemia Common Decreased appetite Uncommon Dehydration Nervous system disorders Common Dizziness Uncommon Dysgeusia Gastrointestinal disorders Common Nausea, diarrhoea, vomiting, constipation, dyspepsia, gastritis, abdominal pain, gastroesophageal reflux disease, abdominal distension Uncommon Eructation, flatulence Unknown Pancreatitis (including necrotising pancreatitis) Delayed gastric emptying† Intestinal obstruction† Hepatobiliary disorders Uncommon Cholelithiasis Uncommon Cholecystitis Skin and subcutaneous tissue disorders Uncommon Rash Uncommon Pruritus Uncommon Lipodystrophy acquired 9 MedDRA System organ class Frequency Adverse reaction Not known Cutaneous amyloidosis† General disorders and administration site condition Common Injection site reaction Unknown Peripheral oedema Investigation Common Increased lipase Common Increased amylase Uncommon Increased heart rate † ADR from postmarketing sources.
Xultophy should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Hypoglycaemia Hypoglycaemia may occur if the dose of Xultophy is higher than required. Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia.
In combination with sulfonylurea, the risk of hypoglycaemia may be lowered by a reduction in the dose of sulfonylurea. Concomitant diseases in the kidney, liver or diseases affecting the adrenal, pituitary or thyroid gland may require changes of the Xultophy dose.
g. by intensified therapy) may experience a change in their usual warning symptoms of hypoglycaemia and must be advised accordingly. 8) of hypoglycaemia may disappear in patients with long-standing diabetes. The prolonged effect of Xultophy may delay recovery from hypoglycaemia.
Hyperglycaemia Inadequate dosing and/or discontinuation of antidiabetic treatment may lead to hyperglycaemia and potentially to hyperosmolar coma. In case of discontinuation of Xultophy, ensure that instruction for initiation of alternative antidiabetic treatment is followed.
Furthermore, concomitant illness, especially infections, may lead to hyperglycaemia and thereby cause an increased requirement for antidiabetic treatment. Usually, the first symptoms of hyperglycaemia develop gradually over a period of hours or days.
They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, and loss of appetite as well as acetone odour of breath. 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. Skin and subcutaneous tissue disorders Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Glucose monitoring is to be intensified and the dose adjusted on an individual basis. 2). Paediatric population There is no relevant use of Xultophy in the paediatric population. Method of administration Xultophy is for subcutaneous use only.
Xultophy must not be administered intravenously or intramuscularly. Xultophy is administered subcutaneously by injection in the thigh, the upper arm or the abdomen. 8). 6. 4). Patients should be instructed to always use a new needle. The re-use of insulin pen needles increases 4 the risk of blocked needles, which may cause under- or overdosing.
6).
Description of selected adverse reactions Hypoglycaemia Hypoglycaemia may occur if the Xultophy dose is higher than required. 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.
1. 2%)) have been reported for Xultophy. Few cases of anaphylactic reactions with additional symptoms such as hypotension, palpitations, dyspnoea, and oedema have been reported during marketed use of liraglutide. Anaphylactic reactions may potentially be life threatening.
Gastrointestinal adverse reactions Gastrointestinal adverse reactions may occur more frequently at the beginning of Xultophy therapy and usually diminish within a few days or weeks on continued treatment. 8% of patients and was transient in nature for most patients.
The proportion of patients reporting nausea per week at any point during treatment was below 4%. 9% of patients, respectively. The frequency of nausea and diarrhoea was ‘Common’ for Xultophy and ‘Very common’ for liraglutide. 6% of patients treated with Xultophy.
6% of patients treated with Xultophy. These reactions were usually mild and transitory and they normally disappear during continued treatment. Skin and subcutaneous tissue disorders Lipodystrophy (including lipohypertrophy, lipoatrophy) and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption.
4). Increased heart rate Mean increase in heart rate from baseline of 2 to 3 beats per minute has been observed in clinical trials with Xultophy. 1). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system 10 listed in Appendix V.
There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia.
Blood glucose monitoring is recommended after the change in the injection site from an affected to an unaffected area, and dose adjustment of antidiabetic medications may be considered. Combination of pioglitazone and insulin medicinal products 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.
This should be kept in mind if treatment with the combination of pioglitazone and Xultophy is considered. If the combination 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.
5 Eye disorder Intensification 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.
Antibody formation Administration of Xultophy may cause formation of antibodies against insulin degludec and/or liraglutide. In rare cases, the presence of such antibodies may necessitate adjustment of the Xultophy dose in order to correct a tendency to hyper- or hypoglycaemia.
Very few patients developed insulin degludec specific antibodies, antibodies cross-reacting to human insulin or anti-liraglutide antibodies following treatment with Xultophy. Antibody formation has not been associated with reduced efficacy of Xultophy.
Acute pancreatitis Acute pancreatitis has been observed with the use of GLP-1 receptor agonists, including liraglutide. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, Xultophy should be discontinued; if acute pancreatitis is confirmed, Xultophy should not be restarted.
Thyroid adverse events Thyroid adverse events, such as goitre have been reported in clinical trials with GLP-1 receptor agonists including liraglutide, and in particular in patients with pre-existing thyroid disease. Xultophy should therefore be used with caution in these patients.
Inflammatory bowel disease and diabetic gastroparesis There is no experience with Xultophy in patients with inflammatory bowel disease and diabetic gastroparesis. Xultophy is therefore not recommended in these patients. Dehydration 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.
Patients treated with Xultophy should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion. Avoidance of medication errors Patients must be instructed to always check the pen label before each injection to avoid accidental mix-ups between Xultophy and other injectable diabetes medicinal products.
Patients must visually verify the dialled units on the dose counter of the pen. Therefore, the requirement for patients to self-inject is that they can read the dose counter on the pen. Patients who are blind or have poor vision must be instructed to always get help/assistance from another person who has good vision and is trained in using the insulin device.
To avoid dosing errors and potential overdose, patients and healthcare professionals should never use a syringe to draw the medicinal product from the cartridge in the pre-filled pen. In the event of blocked needles, patients must follow the instructions described in the instructions for use accompanying the package […]