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Kayshild is a brand name for Semaglutide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Kayshild is indicated in conjunction with diet and exercise for the treatment of adults with non- cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3).
Verbatim from this product's EMA label. Tap a section to expand.
25 mg. 4 mg once weekly (see Table 1). In case of significant gastrointestinal symptoms, consider delaying dose escalation or lowering to the previous dose until symptoms have improved. When symptoms have improved, attempt to re-escalate the dose.
4 mg are not recommended. Patients with type 2 diabetes When initiating semaglutide in patients with type 2 diabetes, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycaemia, see section
5%), and fatigue (see section ‘Description of selected adverse reactions’). Tabulated list of adverse reactions Table 2 lists adverse reactions identified with semaglutide. 1), weight management phase 3a trials (STEP 1-4) and post-marketing reports.
8 Adverse reactions are listed by MedDRA 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); not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 2 Adverse reactions MedDRA system organ class Very common Common Uncommon Rare Very rare Not known Immune system disorders Anaphylactic reaction Metabolism and nutrition disorders Hypoglycaemia in patients with type 2 diabetesa Nervous system disorders Headachea,b Dizzinessb Dysaesthesiaa,c Dysgeusiab,c Eye disorders Diabetic retinopathy in patients with type 2 diabetesa Non- arteritic anterior ischemic optic neuropathy (NAION)a, d Cardiac disorders Hypotension Orthostatic hypotension Increased heart ratea,c Gastrointestinal disorders Vomitinga,b Diarrhoeaa,b Constipationa,b Nauseaa,b Abdominal painb,c Gastritisb,c Gastroesophageal reflux diseaseb Dyspepsiab Eructationb Flatulenceb Abdominal distensionb Delayed gastric emptying Gastroenteritis Increased lipasec Acute pancreatitisa Increased amylasec Intestinal obstructionc,d ,e Hepatobiliary disorders Cholelithiasisa Skin and subcutaneous disorders Hair lossa Angioedema General disorders and administration site conditions Fatigueb,c Injection site reactionsc a) See description of selected adverse reactions below b) Mainly seen in the dose-escalation period c) Grouped preferred terms d) From post-marketing reports with other marketed semaglutide products e) Grouped term covering PTs Intestinal obstruction, ileus, small intestinal obstruction 9 Description of selected adverse reactions Gastrointestinal adverse reactions The events were most frequently reported during dose escalation.
4. Missed dose If a dose is missed, it should be administered as soon as possible and within 5 days after the missed dose. If more than 5 days have passed, the missed dose should be skipped, and the next dose should be administered on the regularly scheduled day.
In each case, patients can then resume their regular once- weekly dosing schedule. If more doses are missed, reducing the starting dose for re-initiation should be considered. Special populations Elderly No dose adjustment is required based on age.
Therapeutic experience in patients ≥75 years of age is limited. Renal impairment No dose adjustment is required for patients with mild or moderate renal impairment. Experience with the use of semaglutide in patients with severe renal impairment is limited.
2). Hepatic impairment No dose adjustment is required for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. Experience with the use of semaglutide in patients with severe (Child-Pugh C) hepatic impairment is limited.
2). 8). There is limited experience in patients with MASH and F4c (Child- Pugh A), however with similar safety results as in studies in patients with preserved hepatic function. There is no experience in patients with MASH and moderate or severe hepatic impairment.
Paediatric population The safety and efficacy of Kayshild in children and adolescents below 18 years of age have not yet been established. No data are available. Method of administration Subcutaneous use. Kayshild is administered once weekly at any time of the day, with or without meals.
It is to be injected subcutaneously in the abdomen, in the thigh or in the upper arm. The injection site can be changed. It should not be administered intravenously or intramuscularly. The day of weekly administration can be changed if necessary, as long as the time between two doses is at least 3 days (> 72 hours).
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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6% for placebo). Most events were mild to moderate in severity and of short duration. 8% for placebo) and was mild to moderate in severity and of longer duration. 6% of patients treated with semaglutide. 3% for placebo). Most events were mild to moderate in severity and of short duration.
1% for placebo) and was mild to moderate in severity and of longer duration. In patients treated with semaglutide, median duration of nausea was 8 days, vomiting 2 days, diarrhoea 3 days, and constipation 47 days. 73m2) may experience more gastrointestinal effects when treated with semaglutide.
Patients with gastroparesis may experience more serious or severe gastrointestinal effects when treated with semaglutide. 5% for placebo. 1% for placebo, respectively. 3% for placebo. 8% of patients treated with placebo. 6% of patients treated with semaglutide.
3%, respectively, of patients treated with placebo. 3% of patients treated with placebo. 7% of patients treated with placebo. 5% of patients treated with placebo. 5% of patients treated with semaglutide and in 1% of patients treated with placebo.
The events were mainly of mild severity and most patients recovered while on continued treatment. Hair loss was reported more frequently in patients with a greater weight loss (≥ 20%). 10 Increased heart rate In ESSENCE, a mean increase of 2 beats per minute (bpm) at week 72 from a baseline mean of 75 bpm was observed in patients treated with semaglutide.
The proportions of […]
After selecting a new dosing day, once-weekly dosing should be continued. Patients should be advised to read carefully the instructions for use included in the package leaflet before administering the medicinal product. 6. 1. 4 Special warnings and precautions for use 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.
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.
Gastrointestinal effects and Dehydration Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. 8). Patients treated with semaglutide should be advised of the potential risk of dehydration in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion.
8). Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, semaglutide should be discontinued; if confirmed, semaglutide should not be restarted. Caution should be exercised in patients with a history of pancreatitis.
In the absence of other signs and symptoms of acute pancreatitis, elevations in pancreatic enzymes alone are not predictive of acute pancreatitis. Patients with type 2 diabetes Semaglutide should not be used as a substitute for insulin in patients with type 2 diabetes.
Semaglutide should not be used in combination with other GLP-1 receptor agonist products, as it has not been evaluated and an increased risk of adverse reactions related to overdose is considered likely. Hypoglycaemia in patients with type 2 diabetes Insulin and sulfonylurea are known to cause hypoglycaemia.
Patients treated with semaglutide in combination with a sulfonylurea or insulin may have an increased risk of hypoglycaemia. The risk of hypoglycaemia can be lowered by reducing the dose of sulfonylurea or insulin when initiating treatment with a GLP-1 receptor agonist.
The addition of Kayshild in patients treated with insulin has not been evaluated. 8). Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy, but other mechanisms cannot be excluded.
Patients with diabetic retinopathy using semaglutide should be monitored closely and treated according to clinical guidelines. There is no experience with Kayshild in patients with type 2 diabetes with uncontrolled or potentially unstable diabetic retinopathy.
In these patients, treatment with Kayshild is not recommended. Non-arteritic anterior ischemic […]