MOUNJARO

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).

, urticaria, eczema, dermatitis and rash). 5 % of placebo-treated patients, respectively. Cases of anaphylactic reaction and angioedema have been rarely reported with tirzepatide during post-marketing surveillance. 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. 7 events per 100 patient years of exposure). The risk of hypoglycaemia was increased when tirzepatide was used with a sulfonylurea.

No cases of severe hypoglycaemia were reported. Gastrointestinal adverse reactions Type 2 diabetes mellitus In pooled adult placebo-controlled type 2 diabetes mellitus phase 3 studies, gastrointestinal […]

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.

8) should be considered prior to performing procedures with general anaesthesia or deep sedation. 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.

Benzyl alcohol may cause allergic reactions. Patients with hepatic or renal impairment should be informed of the potential risk of metabolic acidosis due to accumulation of benzyl alcohol over time.

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