Mounjaro

/ Eli Lilly

The starting dose of tirzepatide is 2.5 mg once weekly. After 4 weeks, the dose should be increased to 5 mg once weekly. If needed, dose increases can be made in 2.5 mg increments after a minimum of 4 weeks on the current dose.
The recommended maintenance doses are 5 mg, 10 mg and 15 mg.
The maximum dose is 15 mg once weekly.

Type 2 diabetes mellitus
Treatment of adults 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
• In addition to other medicinal products for the treatment of diabetes.
Weight management
As an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI):
• ≥ 30 kg/m2 (obesity) or
• ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus).

Hypersensitivity to the active substance or to any of the excipients.

Acute pancreatitis
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
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 diarrhea. 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
Increased risk of residual gastric content due to delayed gastric emptying should be considered prior to performing procedures with general anaesthesia or deep sedation.

Very common: Hypoglycaemia when used with sulphonylurea or insulin, Nausea, Diarrhoea, Vomiting, Abdominal pain, Constipation.
Common: Hypersensitivity reactions, Hypoglycaemia when used with metformin and SGLT2i, Decreased appetite, Dizziness, Hypotension, Dyspepsia, Abdominal distention, Eructation, Flatulence, Gastroesophageal reflux disease, Hair loss, Fatigue, Injection site reactions, Heart rate increased, Lipase increased, Amylase increased, Blood calcitonin increased.

Tirzepatide delays gastric emptying and thereby has the potential to impact the rate of absorption of concomitantly administered oral medicinal products. This effect, resulting in decreased Cmax and a delayed tmax, is most pronounced at the time of tirzepatide treatment initiation.
Paracetamol
Following a 5 mg single dose of tirzepatide, the maximum plasma concentration (Cmax) of paracetamol was reduced by 50 %, and the median (tmax) was delayed by 1 hour. The effect of tirzepatide on the oral absorption of paracetamol is dose and time dependent. At low doses (0.5 and 1.5 mg), there was only a minor change in paracetamol exposure. After four consecutive weekly doses of tirzepatide (5/5/8/10 mg), no effect on the paracetamol Cmax and tmax was observed. The overall exposure (AUC) was not influenced. No dose adjustment of paracetamol is necessary when administered with tirzepatide.
Oral contraceptives
Administration of a combination oral contraceptive (0.035 mg ethinyl estradiol plus 0.25 mg norgestimate, a prodrug of norelgestromin) in the presence of a single dose of tirzepatide (5 mg) resulted in a reduction of oral contraceptive Cmax and area under the curve (AUC). Ethinyl estradiol Cmax was reduced by 59 % and AUC by 20 % with a delay in tmax of 4 hours. Norelgestromin Cmax was reduced by 55 % and AUC by 23 % with a delay in tmax of 4.5 hours. Norgestimate Cmax was reduced by 66 %, and AUC by 20 % with a delay in tmax of 2.5 hours. This reduction in exposure after a single dose of tirzepatide is not considered clinically relevant. No dose adjustment of oral contraceptives is required.

Pregnancy: There are no or a limited amount of data from the use of tirzepatide in pregnant women. Tirzepatide is not recommended during pregnancy and in women of childbearing potential not using contraception. If a patient is planning pregnancy, or pregnancy occurs, tirzepatide should be discontinued. Tirzepatide should be discontinued at least 1 month before a planned pregnancy due to the long half-life.
Lactation: It is unknown whether tirzepatide is excreted in human milk. A risk to the newborn/infant cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from tirzepatide therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. Patients may experience gastrointestinal adverse reactions including nausea. There is no specific antidote for overdose of tirzepatide. A prolonged period of observation and treatment of these symptoms may be necessary, taking into account the half-life of tirzepatide (approximately 5 days).