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Kyinsu is a brand name for Insulin Icodec. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Kyinsu is indicated for the treatment of adults with type 2 diabetes mellitus insufficiently controlled on basal insulin or glucagon-like peptide 1 (GLP-1) receptor agonists as an adjunct to diet and exercise in addition to oral antidiabetic medicinal products. For study results with respect to combinations, effects…
Verbatim from this product's EMA label. Tap a section to expand.
Posology Kyinsu is given once weekly by subcutaneous administration. Kyinsu is intended to be administered on the same day of the week. Kyinsu can be administered at any time of the day. Kyinsu is administered as dose steps. 029 mg of semaglutide.
The dose counter on the pen shows the number of dose steps. e. 350 units insulin icodec and 1 mg semaglutide. 3 Kyinsu should be dosed according to individual patient´s needs. It is recommended to optimise glycaemic control by adjusting the dose based on self-monitored fasting plasma glucose.
Due to the long half-life of Kyinsu, adjustment of dose is not advised during acute illness nor if patients make short-term changes in their physical activity level or usual diet. g. glucose intake or changes to other glucose lowering medicinal product(s).
Initiation of Kyinsu Treatment with basal insulin or GLP-1 receptor agonist should be discontinued prior to initiation of Kyinsu. 114 mg of semaglutide), followed by individual once-weekly dose adjustments. Frequent glucose monitoring is recommended during the switch and in the subsequent weeks.
When Kyinsu is added to sulfonylurea treatment, discontinuation or a reduction in the dose of sulfonylurea should be considered. 4). When switching from a daily basal insulin to Kyinsu, adjustments of other antidiabetic medicinal products may be considered.
4). Switch from once weekly basal insulin There is no experience from switching from a weekly basal insulin to Kyinsu. When switching from a weekly basal insulin, the time of treatment initiation with Kyinsu should be based on the individual patient’s fasting plasma glucose one week after the last administered dose of weekly basal insulin.
Switch from once weekly GLP-1 receptor agonist When switching from a weekly GLP-1 receptor agonist, treatment with Kyinsu should be initiated one week after the last administered dose of the previous weekly GLP-1 receptor agonist treatment.
Dose titration Kyinsu should be dosed according to individual patient’s needs. 1). Adjustment of the dose should be made based on the self-monitored fasting plasma glucose on the day of titration and the two prior days. Missed dose If a dose is missed, it should be administered as soon as possible.
If it is still within 3 days of the missed dose, the patient can then resume their original once weekly dosing schedule. If more than 3 days have passed, the missed dose should still be administered as soon as possible. The once weekly dosing schedule will then be changed to the day of the week where the missed dose was administered.
8. Hypersensitivity reactions Immediate-type allergic reactions to either insulin icodec or semaglutide may potentially be life- threatening. 8). 8). There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these adverse 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 7 injection site from an affected to an unaffected area, and dose adjustment of antidiabetic medicinal products 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, especially in patients with risk factors for development of congestive heart failure.
This should be kept in mind if treatment with the combination of pioglitazone and Kyinsu is considered. If the combination is used, patients should be observed for signs and symptoms of congestive heart failure, weight gain and oedema.
Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs. Avoidance of medication errors Patients must be instructed to always check the label on the pre-filled pen before each injection to avoid accidental mix-ups between Kyinsu and other injectable diabetes medicinal products.
Patients must visually verify the dialled dose steps on the dose counter of the pre-filled 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 pre-filled pen.
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 at the end of the package leaflet.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General Kyinsu should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
There is no therapeutic experience in patients with congestive heart failure New York Heart Association (NYHA) class IV. 9). Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. 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.
g. by intensified treatment) 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. Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring.
g. by removal of stress factors or weight change), change in the injection area, and certain uncompensated endocrine disorders. The prolonged effect of basal insulins may delay recovery from hypoglycaemia. Upon onset of a hypoglycaemic episode, patient is recommended to closely measure blood glucose until recovery.
8). This should be considered when treating patients with impaired renal function, as nausea, vomiting, and diarrhoea may cause dehydration which could cause a deterioration of renal function. Patients should be advised of the potential risk of dehydration in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion.
1. 5
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If the original day of once-weekly administration is to be maintained, the time between subsequent doses can be successively extended to finally obtain the same administration day. 2). 2). In patients with renal impairment, more frequent glucose monitoring is recommended.
2). 2). In patients with hepatic impairment, more frequent glucose monitoring is recommended. Experience with the use of Kyinsu in patients with severe hepatic impairment is limited. Caution should be exercised when treating these patients with Kyinsu.
Paediatric population The safety and efficacy of Kyinsu in children and adolescents below 18 years have not been established. No data are available. Method of administration Subcutaneous use only. Kyinsu must not be administered intravenously as it may result in severe hypoglycaemia.
Kyinsu must not be administered intramuscularly as it may change the absorption. Kyinsu must not be used in insulin infusion pumps. 4). Kyinsu is administered subcutaneously by injection in the thigh, the upper arm, or the abdominal wall.
4). Patients must be instructed to always use a new needle. The re-use of pen needles increases the risk of blocked needles, which may cause underdosing. 6). Kyinsu is available in a pre-filled pen. The dose counter shows the number of dose steps of Kyinsu to be injected.
No dose recalculation is required. 43 mL delivers 10–300 dose steps in one injection in increments of 10 dose steps. • The pre-filled pen of 1 mL delivers from 10–350 dose steps in one injection in increments of 10 dose steps. 5 mL delivers from 10–350 dose steps in one injection in increments of 10 dose steps.
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g. overdose or dosing errors. These errors could result in hypoglycaemia, hyperglycaemia or gastrointestinal adverse reactions. Patients switching from a daily or other once-weekly injectable diabetes treatment must be instructed to check that they inject the correct prescribed dose on a once- weekly basis.
Patients who are uncertain about the correct dose must be instructed to consult their healthcare professional for further guidance. Immunogenicity Administration of Kyinsu may cause formation of antibodies against insulin icodec and/or semaglutide.
2). Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. 5 Interaction with other medicinal products and other forms of interaction No clinical studies on potential drug, food or alcohol interactions have been performed for Kyinsu.
Interactions with other medicinal products identified with the use of the mono-components insulin icodec and semaglutide, are presented below. 8 Insulin icodec A number of medicinal products are known to interact with glucose metabolism.
Substances that may reduce the insulin requirement Antidiabetic medicinal products, GLP-1 receptor agonists, sulfonylurea, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides.
Substances that may increase the insulin requirement Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol. Octreotide/lanreotide may either increase or decrease the insulin requirement.
Alcohol may intensify or reduce the hypoglycaemic effect of insulin. Beta-blockers may mask the symptoms of hypoglycaemia. Semaglutide Semaglutide may delay gastric emptying and could potentially influence the absorption of concomitantly administered oral medicinal products.
The potential effect of semaglutide on the absorption of co-administered oral medicinal products was studied for semaglutide 1 mg at steady state exposure. No clinically relevant drug-drug interactions with semaglutide were observed based on the evaluated medicinal products (warfarin and other coumarin derivatives, paracetamol, oral contraceptives, atorvastatin, digoxin and metformin).
Therefore, no dose adjustment is required when these medicinal products are co-administered with semaglutide. • Warfarin and other coumarin derivates: Upon initiation of semaglutide treatment in patients on warfarin or other coumarin derivatives, frequent monitoring of international normalised ratio (INR) is recommended.
Semaglutide did not change the overall exposure or Cmax of R- and S- warfarin following a single dose of warfarin (25 mg), and the pharmacodynamic effects of warfarin as measured by the international normalised ratio (INR) were not affected in a clinically relevant manner.
However, cases of decreased INR have been reported during concomitant use of acenocoumarol and semaglutide. • Paracetamol: Semaglutide delays the rate of gastric emptying as assessed by paracetamol pharmacokinetics during a standardised meal test.
Paracetamol AUC0-60min and Cmax were decreased by 27% and 23%, respectively, following concomitant use of semaglutide 1 mg. The total paracetamol exposure (AUC0-5h) was […]
Aspiration in association with general anaesthesia or deep sedation Cases of pulmonary aspiration have been reported in patients receiving GLP-1 receptor agonists undergoing general anaesthesia or deep sedation. 8) should be considered prior to performing procedures with general anaesthesia or deep sedation.
1% vs. 2% vs. 6%), respectively. For Kyinsu, most of the hyperglycaemic events were reported during the first 12 weeks of treatment. 2 mmol/L) at week 14-17. During treatment initiation, patient’s blood glucose value should be closely monitored.
2). Inadequate dosing and/or discontinuation of antidiabetic medicinal products may lead to hyperglycaemia and potentially to diabetic ketoacidosis. 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, loss of appetite as well as acetone odour of breath.
Untreated hyperglycaemia may eventually lead to diabetic ketoacidosis, which is potentially lethal. Administration of rapid-acting insulin should be considered in situations of severe hyperglycaemia. 8). Patients should be informed of the characteristic symptoms of acute pancreatitis.
If pancreatitis is suspected, Kyinsu should be discontinued; if confirmed, Kyinsu should not be restarted. Caution should be exercised when treating patients with a history of pancreatitis. Diabetic retinopathy In patients with diabetic retinopathy treated with insulin and semaglutide, an increased risk of developing diabetic retinopathy complications has previously been observed.
Patients with medical history of diabetic retinopathy should therefore be monitored closely and treated according to clinical guidelines. 8), but other mechanisms cannot be excluded. There is no experience with Kyinsu in patients with uncontrolled and potentially unstable diabetic retinopathy or maculopathy and Kyinsu is therefore not recommended in these patients.
8. Hypersensitivity reactions Immediate-type allergic reactions to either insulin icodec or semaglutide may potentially be life- threatening. In Kyinsu clinical studies, hypersensitivity reactions have been reported in […]