MOUNJARO

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, 10 and 15 mg. The maximum dose is 15 mg once weekly.

Children and adolescents aged 10 to less than 18 years for the 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). 1). 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).

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 The maximum dose is 10 mg once weekly for children and adolescents. 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 and 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.

In general, these reactions 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 #From post-marketing reports. *Hypoglycaemia defined below. †Fatigue includes the terms fatigue, asthenia, malaise, and lethargy.

** “hypotension-related” events include “blood pressure decreased,” “hypotension,” and “orthostatic hypotension”. In Weight Management placebo-controlled trials, hypotension- related events were observed, 94% of the events observed were mild to moderate.

1 Frequency reported in clinical trials supporting the type 2 diabetes indication. 2 Frequency reported in clinical trials supporting the weight management indication. 3 Frequency was common in the paediatric type 2 diabetes mellitus trial 4 Frequency was very common in the weight management and in the paediatric type 2 diabetes mellitus trials.

a sodium-glucose co-transporter 2 inhibitor. 1). The adverse drug reactions were consistent with those reported in the pooled, placebo-controlled clinical trials for weight management. The frequencies of adverse drug reactions in Table 1 reflect those observed in clinical trials in adults.

Adverse drug reactions in the placebo-controlled period of the clinical trial with paediatric patients aged 10 to less than 18 years with type 2 diabetes mellitus were similar with the exception of the frequencies of hypoglycaemia with metformin alone (common), vomiting (very common), abdominal pain (very common) and blood calcitonin (very rare).

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. This includes post- marketing reports of necrotising pancreatitis and reports with a fatal outcome.

Patients should be informed of the symptoms of acute pancreatitis, including persistent, severe abdominal pain. Patients should be advised to seek immediate medical attention if they occur. If pancreatitis is suspected, tirzepatide should be discontinued.

If the diagnosis of pancreatitis is confirmed, tirzepatide should not be restarted. 8). Hypoglycaemia in patients with type 2 diabetes mellitus 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.

Elderly Only very limited data are available from patients aged ≥ 85 years. 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.

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