Mounjaro Prescribing Information, Explained Section by Section
The Mounjaro label carries a boxed warning for thyroid c-cell tumors, 9 other warnings and 4 drug interaction lines. It is approved for 2 uses.
- Boxed warning
- About thyroid C-cell tumors
- Approved uses
- 2
- Warnings
- 9
- First approved
- 2022
Mounjaro in brief
Its half-life is about 5 days. After 5 d, half is gone, and about 3% remains after five half-lives (25 d).
In SURPASS-1, people with type 2 diabetes lost 7.8 kg over 40 weeks, compared with 1 kg on placebo.
In US dollars, monthly prices include the list price and self-pay offers. Each comes from the maker's price page.
Sources: FDA label (DailyMed), healthsystemtracker.org, pricinginfo.lilly.com.
Boxed warning for Mounjaro
The boxed warning says it caused thyroid C-cell tumors in rodents. Whether it causes them in people is not known. Do not use it if you or a family member has had medullary thyroid cancer (MTC), or if you have MEN 2.
Words from the label
“In both male and female rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether MOUNJARO causes thyroid”
Source: FDA label (DailyMed).
Indications
It lowers blood sugar for adults and children 10 and older who have type 2 diabetes, when used along with diet and exercise.
Words from the label
“as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2”
Source: FDA label (DailyMed).
For adults with type 2 diabetes who are at high risk, it helps reduce the chance of a heart attack, a stroke or heart-related death.
Words from the label
“to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction (MI), or non-fatal stroke) in adults with type 2 diabetes”
Source: FDA label (DailyMed).
Contraindications
Either MEN 2, or medullary thyroid cancer (MTC) in your personal or family history.
Words from the label
“personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)”
Source: FDA label (DailyMed).
A serious allergic reaction in the past to tirzepatide or any product ingredient.
Words from the label
“serious hypersensitivity to tirzepatide or any of the excipients in MOUNJARO. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with MOUNJARO”
Source: FDA label (DailyMed).
Warnings plus precautions
About thyroid C-cell tumors It caused thyroid C-cell tumors in rodents, and whether it does so in people is not known. Do not use it if your personal or family history includes medullary thyroid cancer (MTC), or if you have MEN 2.
Words from the label
“In both sexes of rats, tirzepatide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) in a 2-year”
Source: FDA label (DailyMed).
About pancreatitis It can cause pancreas inflammation. If severe stomach pain does not go away, stop taking it and get care. The pain may spread to the back.
Words from the label
“Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, or MOUNJARO [see Adverse Reactions”
Source: FDA label (DailyMed).
Blood sugar that is too low. Taking it with insulin or a sulfonylurea raises the chance of low blood sugar. Those doses may need to be lower.
Words from the label
“Patients receiving MOUNJARO in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia [see Adverse”
Source: FDA label (DailyMed).
Allergic reactions that are serious. Reports describe serious allergic reactions, such as swelling of your face, lips or throat. If they occur, stop taking it and get help right away.
Words from the label
“Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported in patients treated with MOUNJARO. If hypersensitivity reactions occur, discontinue use of MOUNJARO; treat promptly per”
Source: FDA label (DailyMed).
Fluid loss can cause kidney injury. Kidney injury can develop when vomiting or diarrhea causes fluid loss. Take in fluids and report heavy fluid loss.
Words from the label
“There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists, or MOUNJARO. The majority”
Source: FDA label (DailyMed).
Severe reactions affecting the stomach and gut. Side effects in the stomach and gut often occur, and they can be serious. It is not recommended for people with severe gastroparesis.
Words from the label
“Use of MOUNJARO has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions (6)]. In the pool of placebo-controlled trials in adults, severe”
Source: FDA label (DailyMed).
Worsening diabetic eye disease. Diabetic eye disease can worsen in people with type 2 diabetes, particularly when blood sugar drops fast. If you already have the condition, eye checks are important.
Words from the label
“Temporary worsening of diabetic retinopathy has been reported with rapid improvement in glucose control. Patients with a history of diabetic retinopathy should be monitored for”
Source: FDA label (DailyMed).
Disease of the gallbladder. You may develop gallstones or inflammation of the gallbladder. Report belly pain in the upper right area, a fever, or yellow skin or eyes.
Words from the label
“Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing.”
Source: FDA label (DailyMed).
Food reaching the lungs while under anesthesia or sedation. During anesthesia or deep sedation, it matters that food can remain in your stomach longer. Let the care team know before any procedure.
Words from the label
“MOUNJARO delays gastric emptying [see Clinical Pharmacology (12.2)]. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective”
Source: FDA label (DailyMed).
Source: FDA label (DailyMed).
Adverse reactions listed in the table
In the label trials, the most common side effects are shown by dose group, next to placebo.
| Side effect | Placebo | Mounjaro 5 mg | Mounjaro 10 mg | Mounjaro 15 mg | More than placebo, 15 mg |
|---|---|---|---|---|---|
| Nausea | 4% | 12% | 15% | 18% | +14 points |
| Diarrhea | 9% | 12% | 13% | 17% | +8 points |
| Decreased Appetite | 1% | 5% | 10% | 11% | +10 points |
| Vomiting | 2% | 5% | 5% | 9% | +7 points |
| Dyspepsia | 3% | 8% | 8% | 5% | +2 points |
| Constipation | 1% | 6% | 6% | 7% | +6 points |
| Abdominal Pain | 4% | 6% | 5% | 5% | +1 points |
Source: Mounjaro label (DailyMed).
Interactions with other drugs
When you take it with insulin or a sulfonylurea, including glipizide or glimepiride, it raises your risk of low blood sugar. Your doctor may lower those doses.
Words from the label
“When initiating MOUNJARO, consider reducing the dose of concomitantly administered insulin secretagogues (e.g., sulfonylureas) or insulin to reduce the risk of hypoglycemia [see Warnings and”
Source: FDA label (DailyMed).
Because it slows stomach emptying, other pills may be absorbed differently.
Words from the label
“MOUNJARO delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications”
Source: FDA label (DailyMed).
It can weaken the effect of birth control pills for a while. Once you start it, and after every dose increase, use a non-oral option or add a barrier method.
Words from the label
“Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method or add a barrier method of contraception for 4 weeks after initiation”
Source: FDA label (DailyMed).
For certain medicines, small changes in their levels matter, such as with warfarin. These medicines need closer monitoring.
Words from the label
“Monitor patients on oral medications dependent on threshold concentrations for efficacy and those with a narrow therapeutic index (e.g., warfarin) when concomitantly administered with MOUNJARO.”
Source: FDA label (DailyMed).
Use in pregnancy and breastfeeding
The pregnancy data are too limited to judge the risk, so talk to your doctor before you try to conceive.
Words from the label
“Available data with MOUNJARO use in pregnant women are insufficient to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal”
Source: FDA label (DailyMed).
One small study found levels in breast milk to be undetectable or low.
Words from the label
“In a single-dose clinical lactation study, the concentration of tirzepatide in breast milk was found to be either undetectable or low compared to the maternal”
Source: FDA label (DailyMed).
How to store it and counselling for patients
Store it in the fridge. You can keep a single-dose pen or vial unrefrigerated, at up to 86°F, for no more than 21 days. Never freeze it.
Words from the label
“pen or single-dose vial can be stored unrefrigerated at temperatures not to exceed 30°C (86°F) for up to a total of 21 days. Discard the”
Source: FDA label (DailyMed).
How this label compares with other GLP-1 labels
| Label | Boxed warning | Warnings | Interaction lines | Named beyond insulin and pills |
|---|---|---|---|---|
 Ozempic | Yes | 9 | 2 | Not listed |
 Wegovy | Yes | 10 | 3 | Levothyroxine |
 Rybelsus | Yes | 9 | 3 | Levothyroxine |
| Mounjaro | Yes | 9 | 4 | Birth control pills, Warfarin and narrow-range drugs |
 Zepbound | Yes | 9 | 4 | Birth control pills, Warfarin and narrow-range drugs |
 Foundayo | Yes | 9 | 6 | Strong CYP3A4 inhibitors, Strong CYP3A4 inducers, Simvastatin, Birth control pills |
 Trulicity | Yes | 9 | 3 | Warfarin and narrow-range drugs |
 Saxenda | Yes | 9 | 2 | Not listed |
 Victoza | Yes | 8 | 2 | Not listed |
| Byetta | No | 9 | 4 | Narrow-range drugs and Warfarin, Birth control pills and antibiotics |
Label sources: Ozempic label (DailyMed), Wegovy label (DailyMed), Rybelsus label (DailyMed), Mounjaro label (DailyMed), Zepbound label (DailyMed), Foundayo label (DailyMed), Trulicity label (DailyMed), Saxenda label (DailyMed), Victoza label (DailyMed), Byetta label (DailyMed).
Read the complete Mounjaro label
You can find the complete prescribing information on DailyMed, the National Library of Medicine label site.