Mounjaro (Tirzepatide) - Subcutaneous

What Is Mounjaro?

Mounjaro (tirzepatide) is an injectable prescription medication used along with diet and exercise to treat adults with type 2 diabetes. Tirzepatide is not insulin—people with type 1 diabetes should not use it.

Mounjaro is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. GIP receptor agonists help your body produce insulin and increase your body's sensitivity (responsiveness) to insulin. GLP-1 stimulates insulin secretion.

It works with diet and exercise to treat adults with type 2 diabetes. Mounjaro lowers fasting (not having anything to eat or drink except water for at least eight hours) and postprandial (after-meal) blood sugar levels, decreases food intake, and reduces body weight.

What Is Mounjaro Used For?

Mounjaro is used along with diet and exercise to treat adults with type 2 diabetes.

In the United States, type 2 diabetes is more common in people who are Black, Latinx/Hispanic, American Indian, Asian American, or Pacific Islander. According to the World Health Organization (WHO), in 2014, 422 million people had diabetes (types 1 and 2 combined) worldwide. In 2017, the financial cost of diabetes in the United States was $327 billion.

How to Take Mounjaro 

Mounjaro can be administered any time of day, with or without meals, as prescribed by your healthcare provider.

The recommended starting dosage of Mounjaro is to inject 2.5 milligrams (mg) under the skin for the first four weeks, then increase your dose to 5 milligrams once weekly. Some individuals may need additional blood sugar control for their type 2 diabetes. In this case, a healthcare provider will continue to increase the dose in 2.5 mg increments every four weeks until you find the correct dosage. The maximum dosage of Mounjaro is 15 milligrams once weekly.

A few things to keep in mind while taking Mounjaro include but aren't limited to:

• Mounjaro is injected under the skin (subcutaneous) into the abdomen, thigh, or upper arm.
• Rotate your injection sites with each dose.
• Inspect and check the liquid in the pen before administering your dose. It should be clear and colorless. Do not use it if it's discolored or has particles in it.
• Use a new needle and syringe each time you inject your medicine.
• Never share medicine pens or needles with others under any circumstances. Sharing needles or pens can result in infection transmission (passing on infections).
• You can change the day of weekly administration, if necessary, as long as the time between the two doses is at least three days (72 hours).
• If you use Mounjaro with insulin, administer it as separate injections and never mix the two medicines.
• It is OK to inject Mounjaro and insulin in the same body region, but the injections should not be right next to each other.

Storage

Store your Mounjaro medicine pen in its original carton in the refrigerator. Please protect it from light and do not place it in the freezer. If needed, you may store a single pen at room temperature (between 68 and 77 degrees F) for up to 21 days.

Off-Label Uses

Healthcare providers may prescribe medicines for conditions not approved by the FDA. This is called "off-label" use. Robust data supporting the off-label use of Mounjaro are currently lacking.

What Are the Side Effects of Mounjaro?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or healthcare provider. You may report side effects to the Food and Drug Administration (FDA) at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

Common side effects of Mounjaro may include but not be limited to:

• Stomach (abdominal) pain
• Nausea
• Vomiting
• Diarrhea
• Constipation
• Decreased appetite
• Indigestion
  

Severe Side Effects

Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you have a medical emergency.

Serious side effects of Mounjaro and their symptoms can include the following:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness or trouble breathing
• Angioedema: Swelling of the lower layer of skin tissue or mucous membranes due to fluid build-up and widening vessels
• Changes in thyroid gland or cells (C-cell hyperplasia of the thyroid): Pain in the front of the neck, difficulty swallowing or breathing, persistent cough, and hoarseness
• Hypoglycemia (low blood sugar): Shaking, trembling, sweating, fast or pounding heartbeat, lightheadedness, hunger, and confusion
• Gallbladder disorder or pancreatitis: Sudden and severe stomach pain, nausea, vomiting, fever, passing gas, stomach upset or bloating, and yellow eyes or skin
• Diabetic retinopathy (damage to blood vessels in the retina, the light-sensitive layer of tissue at the back of the eye): Blurred vision or any other change in vision
• Acute kidney injury: Change in how much or how often you urinate, lower back or side pain, or blood in your urine

Long-Term Side Effects

Data on the long-term side effects of Mounjaro is lacking.

Dosage: How Much Mounjaro Should I Take?

Modifications

The following modifications (changes) should be kept in mind when using Mounjaro:

• Pregnancy: In animal studies, Mounjaro negatively affected the fetus (fetal growth abnormalities). Not enough data is available to determine the exact risk of significant congenital (present at birth) disabilities, miscarriage, or other adverse outcomes during pregnancy for pregnant people taking Mounjaro. If you are or plan to become pregnant, speak with your healthcare provider to weigh the benefits and risks of taking Mounjaro during your pregnancy.
• Breastfeeding: There's not enough scientific evidence available to tell whether there would be a risk to your breastfeeding child. Talk with your healthcare provider if you plan to breastfeed, to weigh the benefits and risks of taking Mounjaro while nursing, and the different ways to feed your baby.
• Adults over 65: Based on clinical studies of Mounjaro, no overall differences in safety or effectiveness were found between adults over 65 years and adults less than 65. However, some adults over 65 may be more sensitive to Mounjaro than others.
• Children: The safety and effectiveness of Mounjaro have not been established in people younger than 18 years of age. Therefore, children under 18 should not take Mounjaro.

Missed Dose

If you forget to administer your Mounjaro dose, administer it as soon as you remember, within four days (96 hours) of your missed dose. If more than four days have passed, skip the missed dose, administer the next dose on a regularly scheduled day, and resume the regular once-weekly dosing schedule. Do not use extra medicine to make up for a missed dose.

Overdose: What Happens If I Take Too Much Mounjaro?

There is limited information available about Mounjaro overdose.

Precautions

What Are Reasons I Shouldn’t Take Mounjaro?

You should not take Mounjaro if you have one of the following:

• An allergy to Mounjaro or any of its ingredients. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you're unsure.
• Personal or family history of medullary thyroid carcinoma (MTC)
• Multiple endocrine neoplasia syndrome type 2 (MEN 2) 

Please let your healthcare provider know if you have the following:

• Kidney disease
• Pancreas issues
• Type 1 diabetes
• Digestion issues (including gastroparesis, a delay in stomach emptying)
• Gallbladder disease
• History of diabetic retinopathy

Taking Mounjaro with any of the above conditions may make them worse.

What Other Medications Interact With Mounjaro?

Use caution when taking Mounjaro with the following medications:

• Insulin or drugs that stimulate insulin release in your body (insulin secretagogues) such as a sulfonylurea: When starting Mounjaro, your healthcare provider may consider reducing the dose of your insulin or insulin secretagogues to reduce your risk of hypoglycemia (low blood sugar).
• Hormonal birth control pills: Mounjaro may affect how well your hormonal birth control pills work. When starting Mounjaro, you should switch to a non-oral birth control method or add a barrier method of birth control, like condoms, for four weeks after the initial dose and four weeks after any dosage increase. Non-oral hormonal contraceptives should not be affected.

Mounjaro delays stomach (gastric) emptying, so some oral medications may be affected while taking Mounjaro, especially those with a narrow therapeutic window, like warfarin. A narrow therapeutic window means a minimal difference in the dose or concentration of this medicine in the body can lead to severe adverse reactions or toxicities that can be life-threatening or disabling.

This is not a complete list of medicines that interact with Mounjaro. Talk with your pharmacist or healthcare provider for more detailed information about medication interactions with Mounjaro.

Be sure to talk with your healthcare provider about any other medicines you take or plan to take, including over-the-counter (OTC), nonprescription products, vitamins, herbs, or plant-based medicines.

What Medications Are Similar?

There are no medications that are similar to Mounjaro. Mounjaro is the only drug approved by the FDA to work as a glucose-dependent insulinotropic polypeptide (GIP) receptor agonist and a glucagon-like peptide-1 (GLP-1) receptor agonist.

How Can I Stay Healthy While Taking Mounjaro?

If you're taking Mounjaro, chances are you have been navigating type 2 diabetes. While living with type 2 diabetes has its challenges, there are ways to help improve your quality of life. Below are some general tips to support your health:

• Take all type 2 diabetes-related medications as recommended by your healthcare provider.
• Exercise regularly.
• Follow a balanced healthy diet. Consider working with a registered dietitian nutritionist (RD or RDN) to cultivate and meet your diet and movement goals.
• Test your blood sugar levels regularly as directed by your healthcare provider.
• Drink plenty of water; avoid dehydration.