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Mounjaro is a brand name for Tirzepatide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Type 2 diabetes mellitus Mounjaro is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications •…
Verbatim from this product's EMA label. Tap a section to expand.
5 mg once weekly. After 4 weeks, the dose should be increased to 5 mg once weekly. 5 mg increments after a minimum of 4 weeks on the current dose. Adults The recommended maintenance doses are 5 mg, 10 mg and 15 mg. The maximum dose is 15 mg once weekly.
Paediatric population aged 10 years and above (treatment of type 2 diabetes mellitus) The recommended maintenance doses are 5 mg and 10 mg. The maximum dose is 10 mg once weekly. Combination therapy When tirzepatide is added to existing metformin and/or sodium-glucose co-transporter 2 inhibitor (SGLT2i) therapy, the current dose of metformin and/or SGLT2i can be continued.
When tirzepatide is added to existing therapy of a sulphonylurea and/or insulin, a reduction in the dose of sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia. Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea and insulin.
8). 5 Missed doses If a dose is missed, it should be administered as soon as possible within 4 days after the missed dose. If more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day.
In each case, patients can then resume their regular once weekly dosing schedule. Changing the dosing schedule The day of weekly administration can be changed, if necessary, as long as the time between two doses is at least 3 days. 2).
Only very limited data are available from patients aged ≥ 85 years. Renal impairment No dose adjustment is required for patients with renal impairment including end stage renal disease (ESRD). Experience with the use of tirzepatide in patients with severe renal impairment and ESRD is limited.
2). Hepatic impairment No dose adjustment is required for patients with hepatic impairment. Experience with the use of tirzepatide in patients with severe hepatic impairment is limited. 2). Paediatric population No dose adjustment is needed based on age, gender, race, ethnicity or body weight in children and adolescents aged 10 to less than 18 years treated for type 2 diabetes mellitus.
No data are available for children and adolescents with type 2 diabetes mellitus with a body weight < 50 kg or BMI below the 85th percentile at treatment initiation. In children weighing < 60 kg, caution is advised when escalating to the 10 mg dose, since safety data are limited.
Summary of safety profile In 13 completed phase 3 studies, 8 522 adult patients were exposed to tirzepatide alone or in combination with other glucose lowering medicinal products. The most frequently reported adverse reactions were gastrointestinal disorders and these were mostly mild or moderate in severity.
4). Tabulated list of adverse reactions The following related adverse reactions from clinical studies are listed below by system organ class and in order of decreasing incidence (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).
Within each incidence grouping, adverse reactions are presented in order of decreasing frequency. Table 1. Adverse reactions System organ class Very common Common Uncommon Rare Immune system disorders Hypersensitivity reactions Anaphylactic reaction#, Angioedema# Metabolism and nutrition disorders Hypoglycaemia1* when used with sulphonylurea or insulin Hypoglycaemia1* when used with metformin and SGLT2i, Decreased appetite1 Hypoglycaemia1* when used with metformin6, Weight decreased1 Nervous system disorders Dizziness2 Dysgeusia, Dysaesthesia 9 #From post-marketing reports *Hypoglycaemia defined below.
†Fatigue includes the terms fatigue, asthenia, malaise, and lethargy. 1 Adverse reaction that only applies to patients with type 2 diabetes mellitus (T2DM). 2 Adverse reaction that mainly applies to patients with overweight or obesity, with or without T2DM.
3 Frequency was very common in weight management, OSA, HFpEF and paediatric T2DM trials, and common in adult T2DM trials. 4 Frequency was very common in weight management, OSA and HFpEF trials, and common in adult and paediatric T2DM trials.
5 Frequency was common in weight management and HFpEF trials, uncommon in adult T2DM and OSA trials, and very rare in the paediatric T2DM trial. 6 Frequency was common in the paediatric T2DM trial. , urticaria, eczema, rash, dermatitis).
Acute pancreatitis Tirzepatide has not been studied in patients with a history of pancreatitis, and should be used with caution in these patients. Acute pancreatitis has been reported in patients treated with tirzepatide. Patients should be informed of the symptoms of acute pancreatitis.
If pancreatitis is suspected, tirzepatide should be discontinued. If the diagnosis of pancreatitis is confirmed, tirzepatide should not be restarted. 8). Hypoglycaemia Patients receiving tirzepatide in combination with an insulin secretagogue (for example, a sulphonylurea) or insulin may have an increased risk of hypoglycaemia.
8). 8). These adverse reactions may lead to dehydration, which could lead to a deterioration in renal function including acute renal failure. Patients treated with tirzepatide should be advised of the potential risk of dehydration, due to the gastrointestinal adverse reactions and take precautions to avoid fluid depletion and electrolyte disturbances.
This should particularly be considered in the elderly, who may be more susceptible to such complications. Severe gastrointestinal disease Tirzepatide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and should be used with caution in these patients.
Diabetic retinopathy Tirzepatide has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy or diabetic macular oedema, and should be used with caution in these patients with appropriate monitoring.
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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The safety and efficacy of tirzepatide have not been established in children aged less than 10 years for treatment of type 2 diabetes mellitus and in children and adolescents aged less than 18 years for weight management. Method of administration Mounjaro is to be injected subcutaneously in the abdomen, thigh or another person should inject in the back of the upper arm.
The dose can be administered at any time of day, with or without meals. Injection sites should be rotated with each dose. If a patient also injects insulin, they should inject Mounjaro into a different injection site. Patients and caregivers should be advised to carefully read the instructions for use included with the package leaflet before administering the medicinal product.
In paediatric patients, a caregiver may give injections or a patient may self-inject if a healthcare provider determines that it is appropriate. Before using Mounjaro KwikPen, the instructions for use must be read carefully. Vial 6 Patients and their caregivers should be trained in subcutaneous injection technique before administering Mounjaro.
6.
5 % of placebo- treated patients, respectively. Cases of anaphylactic reaction and angioedema have been rarely reported with marketed use of tirzepatide. 64 events/patient year) of patients when tirzepatide was added to basal insulin.
1). 2 %) patients reported 12 episodes of severe hypoglycaemia. 1 %) were on a background of insulin glargine or sulphonylurea who reported 1 episode each. 3 % of placebo-treated patients. 1 %). No severe hypoglycaemia episodes were reported.
4 %). 9 % for tirzepatide 5 mg, 10 mg and 15 mg versus placebo. 3 %) in severity. The incidence of nausea, vomiting, and diarrhoea was higher during the dose escalation period and decreased over time. 4 %) discontinued permanently due to the gastrointestinal event.
3 %). 3 % for tirzepatide 5 mg, 10 mg and 15 mg respectively versus placebo. Gastrointestinal adverse […]
7 Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. 6 ml dose of Mounjaro KwikPen.