Contraindications  

In patients with hypersensitivity to active substance or to any auxiliary substances in the product components;

Also, it is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC), also in patients with Multiple Endocrine Neoplasia type 2 (MEN 2) syndrome. 

 Special warnings and precautions for use

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. In the absence of other signs and symptoms of acute pancreatitis, elevations in pancreatic enzymes alone are not predictive of acute pancreatitis.

Hypoglycaemia in patients with Type 2 diabetes

Patients receiving Tirzepatide in combination with an insulin secretagogue (for example, a sulphonylurea) or insulin may have an increased risk of hypoglycaemia. The risk of hypoglycaemia may be lowered by a reduction in the dose of the insulin secretagogue or insulin.

Gastrointestinal effects

Tirzepatide has been associated with gastrointestinal adverse reactions, which include nausea, vomiting, and diarrhoea. 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. 

Sensitivity reactions

Sensitivity (allergic) reactions have been reported at the time of use of Tirzepatide. If such reaction is suspected, use of medicine should be discontinued.

Acute renal injury

In patients with severe gastrointestinal side effects and injured renal function, the renal function should be kept under control.

Severe gastrointestinal diseases

Tirzepatide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis (delayed gastric emptying), 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 (swelling in the eyes). Therefore, it should be used with caution in these patients and should be kept under proper control.

Thyroid C-cell tumours risk

Thyroid C-cell tumours risk may be studied with use of Tirzepatide.

Elderly patients

Very limited data are available from patients aged 85 and elderly.

Aspiration risk at the time of general anaesthesia or deep sedation

Cases of pulmonary aspiration (passage of food or liquid into the lungs) have been reported in patients receiving GLP-1 receptor agonists undergoing general anaesthesia or deep sedation. Due to delayed gastric emptying, there may be residual food in the abdomen, it causes to risk.

Sodium content 

This medicinal product contains less than 1 mmol sodium (23 mg) per dose. That is to say practically ‘sodium-free’.