Mounjaro and the FDA: What It Is Approved For
The FDA approved Mounjaro in 2022 for 2 uses: It helps lower blood sugar in children 10 and older and adults who have type 2 diabetes, when used with diet and exercise; Taking this medicine lowers the risk of Heart attack, stroke and heart-related death in high-risk adults with type 2 diabetes.
- FDA approval
- 2022
- Approved uses
- 2
- Boxed warning
- Yes
Mounjaro in brief
Its half-life is about 5 days: after 5 d, half is gone, while about 3% remains after five half-lives (25 d).
In the 40-week SURPASS-1 trial of type 2 diabetes, people lost 7.8 kg, compared with 1 kg on placebo.
Monthly prices in US dollars include the list price and self-pay offers, all taken from the maker's price page.
Sources: FDA label (DailyMed), healthsystemtracker.org, pricinginfo.lilly.com.
What the FDA approved Mounjaro to do
It helps lower blood sugar in children 10 and older and adults who have type 2 diabetes, when used with diet and exercise.
Label Words
“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: the DailyMed FDA label.
Taking this medicine lowers the risk of Heart attack, stroke and heart-related death in high-risk adults with type 2 diabetes.
Label Words
“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: the DailyMed FDA label.
One drug, two labels: Mounjaro and Zepbound
| Brand | Main approved use |
|---|---|
| Mounjaro | It helps lower blood sugar in children 10 and older and adults who have type 2 diabetes, when used with diet and exercise. |
 Zepbound | With diet and activity, the medicine helps adults with obesity, or overweight adults with a weight-related condition, lose weight and maintain that loss long term. |
Source: the DailyMed FDA label.
FDA warnings listed on the product label
- Thyroid C-cell tumors: boxed warning. In rodents, it led to thyroid C-cell tumors; whether it does the same in people is not known. Do not use it if you have MEN 2, or if you or a family member has a history of medullary thyroid cancer (MTC).
- Pancreatitis. Pancreatitis risk. It may cause inflammation in the pancreas. Severe stomach pain that does not go away can sometimes reach your back.
- Low blood sugar. Low blood sugar concern. Using it alongside insulin or a sulfonylurea makes this side effect more likely, so the doses may need lowering.
- Serious allergic reactions. Reports include serious allergic reactions with swelling of the face, lips or throat. If these reactions happen, stop the medicine and get help right away.
- Kidney injury from fluid loss. Losing fluid from vomiting or diarrhea can harm your kidneys. Report heavy fluid loss, and drink fluids.
- Severe stomach and gut reactions. Side effects in the stomach and gut are common, and some can be severe. This medicine is not recommended for people who have severe gastroparesis.
Source: the DailyMed FDA label.
Source: the DailyMed FDA label.