MOUNJARO (Tirzepatide) | Drug Digest

MOUNJARO (tirzepatide injection) is indicated for once-weekly administration as an adjunct to diet and exercise to improve glycemic control for the treatment of adult patients with type 2 diabetes mellitus.

As monotherapy when metformin is inappropriate due to contraindication or intolerance.
In combination with metformin, or metformin and a sulfonylurea, or metformin and a sodium-glucose cotransporter 2 inhibitor (SGLT2i), or basal insulin with or without metformin.
As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial BMI of ≥30 kg/m (obesity) or ≥27 kg/m (overweight) in the presence of ≥1 weight-related comorbid condition (eg, cardiovascular disease, dyslipidemia, hypertension, obstructive sleep apnea, type 2 diabetes mellitus).

Limitations of Use

MOUNJARO has not been studied in combination with short-acting, medium-acting, or dual formulation insulins.
It is not a substitute for insulin.
Should not be used in patients with type 1 diabetes mellitus.
Should not be used for the treatment of diabetic ketoacidosis.
Has not been studied in patients with a history of pancreatitis.

MOUNJARO is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors.

Dosing Considerations

An increased risk of hypoglycemia was seen with concomitant use of a sulfonylurea or basal insulin with MOUNJARO. To reduce the risk of hypoglycemia, a reduction in the dose of insulin secretagogue or insulin should be considered when MOUNJARO is added to either of these existing therapies.
Recommended Dose and Dosage Adjustment
The recommended starting dose of MOUNJARO is 2.5 mg injected subcutaneously once weekly. The 2.5 mg dosage is for treatment initiation and is not intended for glycemic control. After 4 weeks, increase the dose to 5 mg once weekly.
If additional control is needed, increase the dosage in 2.5 mg increments after no less than 4 weeks on thecurrent dose.
The maximum dose is 15 mg once weekly.
Renal Insufficiency: No dose adjustment is required in patients with renal impairment.
Hepatic Insufficiency: No dose adjustment is recommended in patients with hepatic insufficiency.
Geriatrics (≥65 years): No dose adjustment is required in patients over 65 years of age.
Pediatrics (<18 years): The safety and effectiveness of MOUNJARO have not been studied in patients under 18 years of age. MOUNJARO is not indicated for pediatric use.