Usual Adult Dose for Diabetes Type 2

Initial dose: 2.5 mg subcutaneously once a week
After 4 weeks: The dosage should be increased to 5 mg subcutaneously once a week.
If additional glycemic control is needed: The dosage should be increased in 2.5 mg increments after at least 4 weeks on the current dose.
Maximum dose: 15 mg subcutaneously once a week

Comments:

• The 2.5 mg dosage is for treatment initiation and is not intended for glycemic control.
• The day of weekly administration can be changed, if necessary, as long as the time between the 2 doses is at least 3 days (72 hours).
• Missed dose: Administer as soon as possible within 4 days (96 hours); if more than 4 days have passed, skip dose, and administer next dose on scheduled day. In each case, patients can resume their regular once weekly dosing schedule.

Renal Dose Adjustments

Renal dysfunction: No adjustment recommended.

Comments:

• Renal function should be monitored when starting or escalating doses in patients with renal dysfunction reporting severe adverse GI reactions.

Liver Dose Adjustments

Liver dysfunction: No adjustment recommended.

Precautions

US BOXED WARNING:

• RISK OF THYROID C-CELL TUMORS: In both male and female rats, this drug causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures; it is unknown if this drug causes thyroid C-cell tumors (including medullary thyroid carcinoma [MTC]) in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been established. This drug is contraindicated in patients with personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2); patients should be counseled about the potential risk for MTC with use of this drug and should be informed of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with this drug.

• Personal or family history of medullary thyroid carcinoma
• Patients with multiple endocrine neoplasia syndrome type 2
• Known serious hypersensitivity to the active component or any of the ingredients

Dialysis

Data not available

Other Comments

Administration advice:

• Administer once a week, any time of day, with or without meals.
• Inject subcutaneously in the abdomen, thigh, or upper arm; rotate injection sites with each dose.
• When using with insulin, administer as separate injections and never mix; it is acceptable to inject this drug and insulin in the same body region, but the injections should not be adjacent to each other.
• Do not use if frozen.
• Do not shake.

• Store in a refrigerator at 2C to 8C (36F to 46F); do not freeze.
• If needed, each single-dose pen can be stored unrefrigerated (up to 30C [86F]) for up to 21 days.
• Store in original carton to protect from light.

• Limitations of Use:
• This drug has not been studied in patients with history of pancreatitis.
• This drug is not indicated for use in patients with type 1 diabetes mellitus.

• Metabolic: Monitor for signs/symptoms of hypoglycemia
• GI: Monitor for signs/symptoms of pancreatitis (after starting therapy)
• Renal: Monitor renal function in patients with renal dysfunction reporting severe adverse GI reactions (when starting or escalating doses)

• Read the US FDA-approved patient labeling (Medication Guide and Instructions for Use).
• Report symptoms of thyroid tumors (e.g., a lump in the neck, persistent hoarseness, dysphagia, dyspnea) to health care provider.
• Stop this drug without delay and contact health care provider if pancreatitis is suspected (severe abdominal pain that may radiate to the back, with or without vomiting).
• Stop this drug and seek medical advice right away if symptoms of hypersensitivity reaction occur.
• Take precautions to avoid fluid depletion.
• Contact health care provider if severe/persistent GI symptoms develop or if changes in vision occur during therapy.
• Consult health care provider for appropriate clinical follow-up if gallbladder disease is suspected.
• Inform health care provider if you are pregnant or intend to become pregnant.
• If using oral hormonal contraceptives, switch to a nonoral contraceptive method or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation with this drug.
• If a dose is missed, administer as soon as possible within 4 days (96 hours) 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, you can resume your once weekly dosing schedule.

Frequently asked questions

• Does Mounjaro have a $25 coupon available?
• Does Mounjaro work for weight loss?