Mounjaro

The active ingredient in Mounjaro is tirzepatide. Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) and a GLP-1 receptor agonist.

GLP-1( glucagon-like peptide-1) and GIP are hormones naturally produced in our bodies. When we eat, they increase insulin release from the pancreas to help decrease our blood sugar levels. In addition to increasing insulin release, they also send signals to the brain which helps you eat less and feel fuller for longer. As a GIP and GLP-1 receptor agonist, tirzepatide mimics the effects of these natural hormones. Clinical studies have explored its use both as a monotherapy and an adjunct to other diabetes medications such as metformin, sulfonylureas, insulin glargine, and SGLT2 inhibitors.

In addition to Mounjaro, tirzepatide is also available under another brand name called Zepbound. Although both brand names contain the same medication, they have FDA approval for different uses. Unlike Mounjaro, Zepound has approval for weight management in adults with a BMI or body mass index of 30 or more (obesity). It can also be used in overweight patients for weight loss if they have additional comorbidities such as high blood pressure or cardiovascular disease.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Mounjaro. However, the following is a synopsis of the general guidelines for the use of Mounjaro:

• Your nurse, pharmacist, or another healthcare provider will demonstrate how to use Mounjaro before you administer it for the first time.
• Mounjaro is a once-a-week subcutaneous injection that is injected right under the skin of the stomach (abdomen), thigh, or upper arm. The starting dose is typically 2.5 mg a week. Your dose may be increased depending on your body’s response. Mounjaro can be used with or without meals. For each weekly injection, a new site should used. Do not use the same injection site each time. Doing so could increase your risk for injection site reactions such as redness, swelling, itching, soreness, or a burning sensation.
• Mounjaro is typically used on the same day each week. If you need to change your injection day, make sure there is at least a 3-day window between your last dose and the new day of your injection.
• If you miss a dose, inject as soon as you remember as long as it has not been more than 4 days since your last dose. If more than 4 days have passed, skip the missed dose and continue injecting on your regular scheduled day.

The most common side effects of Mounjaro seen in clinical trials as compared to placebo include:

• Nausea
• Vomiting
• Constipation
• Diarrhea
• Decreased appetite
• Indigestion
• Stomach pain

Some individuals may experience serious side effects while using Mounjaro. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Changes in vision
• Symptoms of a serious allergic reaction such as swelling of the face/lips/tongue, difficulty breathing, severe and widespread rash, fainting, or heart palpitations.
• Symptoms of hypoglycemia or low blood sugar such as dizziness or lightheadedness, sweating, confusion, drowsiness, headache, blurred vision, slurred speech, shakiness, heart palpitation, irritability or mood changes, hunger, and weakness.
• Symptoms of gallbladder problems including upper abdominal pain, fever, yellowing of the skin or eyes, and clay-colored stools.
• Symptoms of pancreatitis or inflammation of the pancreas such as severe abdominal pain that radiates to the back with or without vomiting.
• Symptoms of kidney failure such as feeling dehydrated, decreased urination, swelling of the hands or ankles, and confusion.
• Symptoms of a thyroid tumor such as a lump in the neck, hoarse voice, difficulty breathing, and difficulty swallowing.

These are not all of the possible side effects of Mounjaro. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Mounjaro, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Kidney problems
• Problems with your pancreas
• Diabetic retinopathy
• Severe gastrointestinal problems such as slowed emptying (gastroparesis) or difficulty digesting food
• A scheduled surgery or other procedure that uses anesthesia or deep sleepiness

Boxed Warning

• Tirzepatide has caused thyroid C-cell tumors in rats. It is unknown how this risk translates to humans. Do not use it if you have a personal or family history of medullary thyroid carcinoma (MTC). If you develop symptoms of thyroid tumors, discontinue use and follow up with your healthcare provider as soon as possible.
• Mounjaro should not be used in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Do not use Mounjaro if you have:

• A personal history or a family history of thyroid cancer
• Multiple endocrine neoplasia syndrome type 2
• Known hypersensitivity or allergy to tirzepatide or other ingredients in Mounjaro such as sodium chloride, sodium phosphate dibasic heptahydrate, hydrochloric acid, and sodium hydroxide.

Mounjaro begins working within hours after your first injection. You should see some effects on your blood sugar within the first 4 weeks of treatment. However, it can take 4 to 6 months after starting it to see its full effects.

When Mounjaro is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking, including:

• Any oral medications. Mounjaro can delay gastric emptying which can affect how well your other medications may work.
• Other diabetes medications, especially insulin secretagogues (e.g. sulfonylureas) or insulin
• Hormonal contraceptives

Mounjaro is available as a single-dose pre-filled pen or vial in the following strengths:

• 2.5mg/0.5mL
• 5mg/0.5mL
• 7.5mg/0.5mL
• 10mg/0.5mL
• 12.5mg/0.5mL
• 15mg/0.5mL

Mounjaro should be kept in its original packaging to protect it from light. It can be stored in the fridge between 36⁰F to 46⁰F (2⁰C to 8⁰C) until its expiry date or at room temperature for up to 21 days. Do not freeze Mounjaro or use it if it has been frozen.

Mounjaro is manufactured by the pharmaceutical company Eli Lilly and Company.

No, Mounjaro does not have a generic version available yet.

Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Mounjaro.

Mounjaro may cause harm to the unborn child. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is not known if Mounjaro passes into your breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.