Mounjaro for weight loss

Is Mounjaro FDA-approved for weight loss?

Not yet. The Food and Drug Administration (FDA) is expected to approve Mounjaro for weight loss in the near future.

In fact, the FDA has agreed to fast-track Mounjaro for possible approval as a weight loss treatment.

With fast-track approval, the FDA reviews the drug’s clinical trial results more quickly than they would for the traditional approval process. The FDA allows certain drugs to have fast-track approval if used for a serious condition with few treatment options, such as obesity. After more clinical trials are finished, the FDA will decide whether to approve Mounjaro for weight loss.

If you have questions about Mounjaro for weight loss, talk with your doctor.

Frequently asked questions

Below are answers to frequently asked questions about using Mounjaro for weight loss.

Is there a certain amount of weight I will lose each week by using Mounjaro?

Not necessarily. A specific amount of weight loss isn’t guaranteed each week that you use Mounjaro. Weight loss results with this drug can be different from person to person.

Your doctor can tell you more about what to expect when using Mounjaro for weight loss.

How does Mounjaro compare with Ozempic for weight loss?

Clinical trials have not directly compared Mounjaro with Ozempic when the drugs are used for weight loss. Both drugs can be used off-label for weight loss but are only approved to treat type 2 diabetes. (Off-label drug use means prescribing a drug for a purpose other than what the FDA approved it for.)

One clinical trial compared Mounjaro with Ozempic for treating type 2 diabetes. While this study wasn’t done specifically to look at weight loss, researchers did look at the effect of both drugs on body weight. They found that people who used Mounjaro to treat type 2 diabetes lost more weight than people who used Ozempic for this purpose.

However, more research is needed to understand how Mounjaro compares with Ozempic when the drugs are used for weight loss.

Do I have to use Mounjaro long term?

Possibly, but it isn’t known for certain.

Researchers are currently studying the long-term effects of Mounjaro on weight loss. An ongoing clinical trial is looking at how well Mounjaro helps maintain weight loss for up to 2 years. The trial is also studying whether weight loss is maintained after the drug is stopped. The results of this trial may help doctors decide whether Mounjaro should be used long term.

A past clinical trial looked at changes in body weight after semaglutide treatment. (Semaglutide is the active drug in Ozempic, a medication that’s similar to Mounjaro.) One year after the drug was stopped, the participants had regained some of the weight they had lost during treatment. Based on these results, your doctor may recommend long-term use of Mounjaro to maintain weight loss.

To learn more about how long you’ll use Mounjaro for weight loss, talk with your doctor.

* Mounjaro is a glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist.

Cost of Mounjaro

How much Mounjaro costs is based on several factors. These can include your prescribed treatment regimen, the insurance plan you have, the pharmacy you use, and your location.

The cost may also differ when Mounjaro is used off-label* for weight loss than when it’s prescribed for uses the Food and Drug Administration (FDA) approved. For example, insurance may cover Mounjaro when prescribed for FDA-approved uses but not when prescribed for off-label uses.

To learn more, talk with your doctor, pharmacist, or insurance provider. You can also refer to this article for details about the cost of Mounjaro.

* Off-label drug use is when a drug the FDA has approved is prescribed for a purpose other than what it’s approved for.

How to buy Mounjaro for weight loss

If you’re interested in taking Mounjaro for weight loss, which is an off-label use, talk with your doctor. They can help determine whether Mounjaro might be a good choice for you and provide a prescription.

Another way to obtain Mounjaro is by using a reputable telehealth service, such as Ro Body. A licensed telehealth professional will evaluate your health. If they determine that Mounjaro may be right for you, they’ll provide an electronic prescription. You can then order the medication through the service. The services also include coaching and other support to help you lose and manage your weight.

If you do get a Mounjaro prescription through a telemedicine provider such as Ro Body, we encourage you to tell your doctor. It’s important that they know about all medications you take.

Using Mounjaro

Below is information about dosages of Mounjaro when used off-label for weight loss. However, it’s important to follow the dosage and instructions your doctor has given you.

Dosage

Your doctor will typically start with a low dosage of Mounjaro, adjusting it over time to reach the right amount for you. The exact dosage you’ll be prescribed depends on how well Mounjaro is working for weight loss.

The usual starting dosage of Mounjaro for weight loss is 2.5 milligrams (mg) once per week for 4 weeks. After that, your doctor may increase your dose by 2.5 mg of Mounjaro every 4 weeks. The maximum dosage they’ll prescribe is 15 mg of Mounjaro once per week.

Note: In addition to being prescribed off-label for weight loss, Mounjaro is approved by the Food and Drug Administration (FDA) for certain uses. Keep in mind that the drug’s dosage may differ with these approved uses. To learn more, talk with your doctor.

How to use

Mounjaro comes as a liquid solution in a single-use injection pen. It’s given as a subcutaneous injection. You’ll inject Mounjaro under the skin of your abdomen or thigh. If needed, a caregiver can give you an injection under the skin of your upper arm.

To learn more about how to use Mounjaro, talk with your doctor or pharmacist.

How often to use

Mounjaro is injected once per week. You can inject the drug any time of day. If possible, try to inject it on the same day each week.

You should not take Mounjaro for weight loss unless your doctor has prescribed the drug for this purpose. The use of Mounjaro for weight loss is considered an off-label use. Off-label drug use is when a medication the Food and Drug Administration (FDA) has approved is prescribed for a purpose other than what it’s approved for.

Who Mounjaro is prescribed for

Mounjaro may be prescribed off-label for weight loss in adults with or without type 2 diabetes. (Off-label drug use means prescribing a drug for a purpose other than what it’s been approved for by the FDA.)

In addition, it may be used off-label in adults who have one of the following:

• obesity (body mass index [BMI] of 30 or greater)
• overweight (BMI of 27 or greater) and at least one health condition related to weight, such as high cholesterol, high blood pressure, or sleep apnea

Your doctor will determine whether using Mounjaro off-label for weight loss is safe for you.

How Mounjaro works

Mounjaro is approved to treat type 2 diabetes and may also be used off-label for weight loss.

Below are details about how Mounjaro works for its approved and off-label uses.

The way Mounjaro works

Mounjaro is a type of drug called a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. It works by mimicking the activity of the hormones GIP and GLP-1.

Mounjaro works to treat type 2 diabetes in several ways:

• increases the amount of insulin your body makes after eating
• reduces the amount of glucose (sugar) released into your blood
• slows the movement of food through your stomach, which helps prevent your blood sugar from spiking after eating

Mounjaro also reduces your appetite, which can help you consume fewer calories. As a result, you may have weight loss.

How well Mounjaro works

Mounjaro has been found effective for weight loss.

Clinical trials of Mounjaro for treating type 2 diabetes looked at the drug’s effect on body weight. Many people who used the drug for type 2 diabetes did lose weight. However, these trials did not specifically look at Mounjaro as a weight loss medication.

A separate clinical trial looked at the use of Mounjaro for weight loss in people without diabetes. The trial included adults with either:

• obesity (body mass index [BMI] of 30 or greater), or
• overweight (BMI of 27 or greater) and at least one health condition related to weight, such as high cholesterol, high blood pressure, or sleep apnea

Most adults in this trial lost at least 10% of their body weight after using Mounjaro for 72 weeks (about 18 months). As an example, for a person weighing 90 kg (about 200 lb), 10% of their body weight is 9 kg (about 20 lb). One kilogram (kg) is about 2.2 pounds (lb).

To learn more about how well Mounjaro works for weight loss, talk with your doctor.

Mounjaro side effects

The off-label use of Mounjaro for weight loss may cause side effects that are mild or serious. Off-label drug use is when a medication the Food and Drug Administration (FDA) has approved is prescribed for a purpose other than what it’s approved for.

The lists below include some of the main side effects reported in clinical trials of Mounjaro for its FDA-approved use. The side effects of Mounjaro when used off-label for weight loss are expected to be similar.

For information about other potential side effects of the drug, talk with your doctor or pharmacist. You can also refer to Mounjaro’s prescribing information.

Note: After the FDA approves a medication, it tracks and reviews side effects of the drug. If you develop a side effect while taking Mounjaro and would like to inform the FDA, visit MedWatch.

Mild side effects

Mounjaro may cause certain mild side effects. Examples of these include:

• injection site reactions
• slight increase in heart rate
• mild problems with digestion, such as:
  • abdominal pain
  • constipation
  • diarrhea
  • indigestion
  • loss of appetite
  • nausea
  • vomiting

These Mounjaro side effects may be temporary, lasting a few days to weeks. But if they last for a longer time, or if they bother you or become severe, it’s important to talk with your doctor or pharmacist.

Serious side effects

The use of Mounjaro may lead to rare but serious side effects. These include:

• severe problems with digestion, such as severe diarrhea, nausea, or vomiting, which may lead to dehydration and kidney problems
• acute pancreatitis (sudden inflammation of the pancreas)
• hypoglycemia (low blood sugar)
• acute (sudden) gallbladder disease, which may include gallstones or cholecystitis (inflammation of the gallbladder)
• risk of thyroid cancer*
• allergic reaction

Call your doctor right away if you develop serious side effects while using Mounjaro. If the side effects seem life threatening or you think you’re having a medical emergency, call 911 or your local emergency number immediately.

* Mounjaro has a boxed warning for this side effect. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Before using Mounjaro” section below.

Before using Mounjaro

Before your doctor prescribes Mounjaro off-label for weight loss, there’s some important information to keep in mind. The drug may not be a safe option for you if you have certain medical conditions or other factors that affect your health. Some of these are mentioned below.

Off-label drug use is when a drug the Food and Drug Administration (FDA) has approved is prescribed for a purpose other than what it’s approved for.

Boxed warning: Risk of thyroid cancer

Mounjaro has a boxed warning for the risk of thyroid cancer. This is a serious warning from the Food and Drug Administration (FDA).

Animal trials have shown an increased risk of thyroid cancer with the use of tirzepatide (the active drug in Mounjaro). However, animal trials don’t always predict what will happen in humans. It’s not known for certain if the use of Mounjaro increases the human risk of thyroid cancer.

Due to this risk, doctors likely will not prescribe Mounjaro for people with a personal or family history of medullary thyroid carcinoma (MTC). MTC is a type of thyroid cancer.

In addition, doctors will likely not prescribe Mounjaro for people with multiple endocrine neoplasia syndrome type 2 (MEN2). MEN2 is a rare genetic (inherited) condition that may lead to thyroid cancer.

Tell your doctor right away if you have symptoms of thyroid cancer while using Mounjaro. These include a hoarse voice, a lump in your neck, and trouble swallowing. If you have these symptoms, your doctor may order tests to check for thyroid cancer.

Other warnings

In addition to boxed warnings, Mounjaro has other warnings.

If any of the following medical conditions or other health factors are relevant to you, talk with your doctor before using Mounjaro:

• if you have a problem with your digestive system, such as gastroparesis (stomach paralysis)
• if you have a kidney problem, such as kidney failure
• if you have a history of pancreatitis (inflammation of the pancreas)
• if you have diabetic retinopathy (eye damage related to diabetes)
• if you’re pregnant or thinking of becoming pregnant if you’re breastfeeding or thinking of breastfeeding
• if you’ve had an allergic reaction to Mounjaro or any of its ingredients

Next steps

Now that you’ve learned about the off-label use of Mounjaro for weight loss, you may still have some questions. Talk with your doctor or pharmacist, who can advise you on whether Mounjaro might be right for you.

Here are some other helpful references:

• More details. For details about Mounjaro and its FDA-approved uses, refer to this article.
• Information about weight loss. For more information about weight loss, see our exercise & fitness hub and nutrition hub.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.