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What are the Indications for Mounjaro?

Mounjaro is approved for the treatment of type 2 diabetes in adults. Type 2 diabetes is a long-term or chronic condition where the body is unable to regulate sugar in  the bloodstream. Uncontrolled blood sugar can lead to complications such as heart disease, nerve damage, kidney diseases, eye damage, hearing impairment, sleep apnea, and dementia.

Mounjaro is not recommended for patients who:

• Are allergic to Mounjaro or any ingredients in Mounjaro
• Have type 1 diabetes
• Have a family history or have had medullary thyroid carcinoma (MTC)
• Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

How is Mounjaro used?

Storage

Mounjaro injectable pens should be stored in the refrigerator between 36°F and 46°F (2°C – 8°C) and may be stored at room temperature up to 86°F(30°C) for 21 days. Mounjaro injectable pens should never be frozen. If frozen, discard the frozen injectable pen and use a new injectable pen.

Keep out of reach of children.

Instruction

Follow the patient information pamphlet that comes with the medication. Mounjaro needs to be injected under the skin of the stomach, thigh, or upper arm. Mounjaro should never be injected into a vein or muscle.

Mounjaro should only be prepared when ready to use. Mounjaro should be injected once a week with or without a meal. Mounjaro can be injected anytime of the day.

1. Select the injection site and clean with an alcohol swab. The injection site should be rotated so as not to be in the exact same location as the last injection.

• Do not inject in areas with scars, stretch marks, bruises, or where the skin is tender, hard, or red.
• Do not use the medication if it appears to be broken, cloudy, has clumps or debris in it, or if it has expired.

1. Inject the medication as directed in the patient information pamphlet or as directed by a doctor.
2. After the injection, dispose of the injection pen in an FDA-cleared sharps disposal container immediately. Do not reuse or share needles with other people. A sharps disposable container can be created by using any heavy-duty plastic household container that:

• Is leak-resistant
• Has a tight-fitting, puncture-proof lid so sharps such as needles cannot escape
• Has a label warning there are hazardous materials inside the container

Dosage

Mounjaro is available as a single-dose injectable pen in the following strengths: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL.

The recommended starting dose for Mounjaro is 2.5 mg once weekly. Increase the dose to 5 mg after 4 weeks. A doctor will monitor blood sugar levels and adjust  dosage as needed (up to 15 mg) after a patient has been on 5 mg for at least 4 weeks.

Do not change the dosage and take more than what is prescribed without consulting with a doctor. If you took more than prescribed, contact your doctor or seek emergency medical care right away.

Side Effects

It’s important to understand that although Mounjaro is FDA approved, it comes with side effects that may or may not affect you.

Before starting Mounjaro, patients should discuss possible side effects a doctor or pharmacist.

Common Side Effects

Not all side effects require medical attention. As the body adjusts to Mounjaro, side effects may go away.

Speak to a doctor if experiencing the following symptoms, and they become severe or do not go away on their own:

• Nausea
• Vomiting
• Diarrhea
• Upset stomach
• Stomach pain
• Loss of appetite

Serious Side Effects

Severe adverse reactions while taking Mounjaro can occur. Seek emergency medical care or call 911 if experiencing any of the following symptoms:

• Severe allergic reaction: severe rash or itching, swelling in the face, lips, tongue, or throat, rapid heartbeat, fainting or dizziness, or problems breathing or swallowing.
• Low blood sugar (hypoglycemia)
• Kidney problems: nausea, vomiting, unable to urinate, swelling in the ankle or feet, feeling confused, or muscle cramps

The information above does not list all possible side effects. Contact a doctor or pharmacist if experiencing any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.

Warnings & Precautions

Before taking Mounjaro, speak to a doctor or pharmacist:

• If you are allergic to any medications such as Mounjaro
• If you have or have had a family history of a certain type of thyroid cancer known as medullary thyroid carcinoma (MTC)
• If you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• If you are pregnant or expect to become pregnant or conceive
• If you are breastfeeding or plan to breastfeed

Inflammation of the pancreas (pancreatitis)

Taking Mounjaro can cause your pancreas to become inflamed. Symptoms include severe back pain, vomiting, and severe stomach pain. If you experience any of these symptoms, stop use of this medication and contact your provider immediately.

Low blood sugar (hypoglycemia)

Taking Mounjaro with other medications to treat diabetes can significantly lower your blood sugar resulting in hypoglycemia. Symptoms include feeling weak or shaky, irritated, confused, and nervous. Your doctor will monitor your treatment plan and adjust medications as needed however if you notice any of these symptoms, contact your doctor right away.

Thyroid cancer

Taking Mounjaro can increase your risk for certain types of thyroid cancer. Mounjaro is not recommended if you’ve had thyroid cancer or have a family history of thyroid cancer. Signs of thyroid cancer include a lump on your neck, hoarseness, trouble breathing or swallowing. Contact your doctor right away if you notice any of these symptoms.

Hypersensitivity

Taking Mounjaro may create lung problems with similar symptoms as lung cancer that may result in death. Symptoms include shortness of breath or trouble breathing, fever, and cough. Contact your doctor right away if you experience any of these symptoms or these symptoms have increased.

Kidney problems

Taking Mounjaro can cause or make current kidney problems worse due to its common side effects of nausea, vomiting, and diarrhea. These common side effects can result in dehydration. It’s important to stay hydrated by drinking enough fluid. Contact your doctor if these symptoms become worse or if you’re unable to urinate.

Diabetic retinopathy

Taking Mounjaro can worsen your eye condition if you have diabetic retinopathy. The risk for symptoms appears when you first start Mounjaro and every time the dose is increased. Contact your doctor right away if you experience any new eye symptoms.

Gallbladder disease

Taking Mounjaro can increase your risk for gallbladder problems including gallstones. Symptoms of gallstones include nausea, vomiting, fever, and severe pain in the upper part of your stomach. If you experience any of these symptoms, contact your doctor right away.

Pregnant or planning to become pregnant

Taking Mounjaro while pregnant is not recommended. Mounjaro can impact the unborn baby and cause harm according to studies conducted on animals. If you become pregnant while on Mounjaro, tell your doctor immediately. Consult with your doctor for the best treatment to control diabetes while pregnant or planning to become pregnant.

Breastfeeding or Planning to Breastfeed

Studies have not been conducted to determine if Mounjaro will pass through to human milk. Taking Mounjaro while breastfeeding is not recommended. Consult with your doctor for the best treatment to control diabetes while breastfeeding.

Interactions & Contraindications

Before taking Mounjaro, tell your doctor or pharmacist if you take any medications, herbal supplements, or vitamins.

Contraception

Taking Mounjaro can reduce the effectiveness of oral hormonal contraceptives. Consult with your doctor to determine the best contraceptive to use while taking Mounjaro.

Gatifloxacin

Taking Mounjaro with gatifloxacin can cause your blood sugar levels to fluctuate. Consult with your doctor to determine the best alternative treatment for your eyes or diabetes.

Quinolones

Taking Mounjaro with quinolone antibiotics can cause your blood sugar level to drop. Consult with your doctor to determine the best alternative antibiotic treatment.

Chloroquine/Hydroxychloroquine

Taking Mounjaro with quinolone antibiotics can cause your blood sugar level to drop. Consult with your doctor to determine the best alternative malaria treatment.

Sulfonylureas

Taking Mounjaro with sulfonylureas medication such as glimepiride, glipizide, and glyburide, can significantly lower your blood sugar. Consult with your doctor to determine if your treatment plan needs to be adjusted.