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.
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 […]