Mounjaro 2.5 MG/0.5 ML 4 Vial or pen

Description

Mounjaro 2.5 MG/0.5 ML 4 Vial or pen

What is Mounjaro?
Mounjaro (tirzepatide) injection is used to lower blood sugar (blood glucose) and A1C levels in adults with type 2 diabetes. Mounjaro is a once-weekly injection that should be used along with diet and exercise. Clinical studies of 15 mg of Munjaro (tirzepatide) for weight loss showed that patients lost an average of 20.9% of their body weight over 72 weeks, compared to 3.1% for placebo. Zepbound is the brand name for the weight loss version of Mounjaro. They both contain the same active ingredient (tirzepatide). Mounjaro is FDA-approved for type 2 diabetes and Zepbound is FDA-approved to help with weight loss.

Mounjaro is the first GIP and GLP-1 receptor agonist that works on glucose-dependent insulinotropic polypeptide (GIP) receptors and glucagon-like peptide-1 (GLP-1) receptors.

Mounjaro works to lower blood sugar by helping the pancreas produce more insulin, reducing the amount of sugar the liver makes, and slowing the rate at which food passes through the body, making you feel full. It does this by activating two receptors, GIP and GLP-1, which are natural incretin hormones that help regulate blood sugar levels.

Mounjaro injection became an FDA-approved drug on May 13, 2022, to improve blood sugar (glucose) levels in adults with type 2 diabetes when used together with diet and exercise. Mounjaro is not for people with type 1 diabetes. It is not known whether this drug can be used in people with pancreatitis.

Is Mounjaro FDA-approved for weight loss?
Yes, the active ingredient in Mounjaro, tirzepatide, is approved for weight loss, but it is under the brand name Zepbound. Zepbound has the same active ingredient as Mounjaro, and both are made by Eli Lilly and Company.

The brand name Mounjaro is not FDA-approved for weight loss. Mounjaro is an FDA-approved medication used to improve blood sugar (glucose) levels in adults with type 2 diabetes mellitus when used together with diet and exercise.

The active ingredient in Mounjaro, tirzepatide, was used in the Phase 3 SURMOUNT-1 72-week weight loss clinical trial. The mean weight loss for tirzepatide was 15% for the 5 mg dose, 19.5% for the 10 mg dose, 20.9% for the 15 mg dose, and 3.1% for placebo. The study included patients who were overweight, obese, and had weight-related health problems, but excluded patients with diabetes.

How much does Mounjaro cost?
Ask your pharmacist, or visit the website

What are the side effects of Mounjaro?

Common side effects of Mounjaro
The most common side effects of Mounjaro include nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain, affecting 5% or more of patients.

Serious side effects of Mounjaro
Stop using this medicine and get emergency medical help if you have:

Signs of an allergic reaction: hives; difficulty breathing; feeling light-headed; swelling of your face, lips, tongue, or throat; or
Pancreatitis with symptoms of severe pain in your upper abdomen that spreads to your back, nausea, and vomiting.
Call your doctor if you have:

Severe stomach problems;

Eye side effects or vision changes, including blurred or dim vision;
Symptoms of a thyroid tumor may include swelling or a lump in the neck, difficulty swallowing, a hoarse voice, or if you feel short of breath;
Gallbladder problems with symptoms including chalky stools, stomach pain after eating, nausea, heartburn, bloating, and severe pain in the upper abdomen that may spread to your back;
Symptoms of low blood sugar may include headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heartbeat, or feeling anxious; or
Kidney problems with little or no urination, swelling in the feet or ankles, feeling tired, or shortness of breath.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Warning
Seek immediate medical attention if you have symptoms of a thyroid tumor, such as a lump or swelling in the neck, hoarseness, difficulty swallowing, or shortness of breath.

In studies in rats, tirzepatide and drugs that work similarly have caused thyroid tumors, including thyroid cancer. It is not known whether Munjaro will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC).

You should not use this medicine if you have or have a family history of thyroid cancer such as a type called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called multiple endocrine neoplasia syndrome type 2 (MEN 2).

Keep all appointments with your doctor and lab. Your doctor may order certain tests to check your body’s response to this medicine.

Before using this medicine
You should not use this medicine if:

you are allergic to tirzepatide or any of the ingredients in this medicine; see ingredients at the bottom of this page.
have a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer); or
multiple endocrine neoplasia type 2 (tumors in your glands).
Tell your doctor if you have ever had:

pancreatic problems;
Kidney disease;
Severe stomach problems, such as indigestion or slow stomach emptying (gastroparesis); or
Diabetic retinopathy (a complication of diabetes that affects the eyes).

Pregnancy
Tell your healthcare provider if you are pregnant, become pregnant, or plan to become pregnant while taking this medication. It is not known whether this medication will harm your unborn baby.

This medication can make birth control pills less effective. Ask your doctor about other birth control options, such as an injection, implant, skin patch, vaginal ring, condom, diaphragm, cervical cap, or sponge. If you are taking birth control pills, you may need to use an additional method of birth control for 4 weeks after starting this medication and for 4 weeks after each dose increase.

Breastfeeding
Tell your healthcare provider if you are breast-feeding or plan to breast-feed while using this medication. It is not known whether tirzepate passes into breast milk. Talk to your healthcare provider about the best way to feed your baby while using this medication.

How should I use Mounjaro?
You should follow the directions on your prescription label carefully and ask your pharmacist or doctor to explain any part you do not understand. It is important to use this medication exactly as directed. Do not take more or less of it or more often than your doctor tells you to.

Mounjaro is a pre-filled pen that is injected subcutaneously (under the skin).

Mounjaro is usually given:

Once a week.

It may be given with or without food at any time of day.

It may be given in the thigh, abdomen, or upper arm.

You should change the injection site with each dose.

Your doctor will usually start you on a low dose that will be gradually increased, but not more than once every 4 weeks.

You can change the day of the week you use this medicine as long as there is at least three days between doses.

You can inject your insulin into the same place as this medicine, but they should not be given next to each other. Do not mix insulin and Mounjaro in the same injection.

Mounjaro controls type 2 diabetes, but does not cure it. It may take four weeks or longer before you see the full benefit of this medicine. Continue to take this medicine even if you feel well. Do not stop taking this medicine without talking to your doctor.

Mounjaro dosing information
Usual adult dose for type 2 diabetes:
Starting dose: 2.5 mg injected under the skin (subcutaneously) once a week.

After 4 weeks: The dose should be increased to 5 mg injected under the skin once a week.

If additional glycemic control is required: The dose should be increased in 2.5 mg increments after at least 4 weeks of the current dose.

Maximum dose: 15 mg subcutaneously once a week.

Comments: The 2.5 mg dose is intended for initiation of treatment and is not intended for glycemic control. The weekly dosing day can be changed if necessary, provided that the time between 2 doses is at least 3 days (72 hours).

What doses are Mounjaro pens available in?

2.5 mg/0.5 ml single-dose pen

5 mg/0.5 ml single-dose pen

7.5 mg/0.5 ml single-dose pen

10 mg/0.5 ml single-dose pen

12.5 mg/0.5 ml single-dose pen

15 mg/0.5 ml single-dose pen.

What should I do if I miss a dose?

Take the missed dose as soon as you remember, within 4 days of the missed dose. However, if more than 4 days have passed, skip the missed dose and continue your regular dosing schedule. Do not inject two doses within 3 days of each other.

Storage
Store in the refrigerator at 36⁰F to 46⁰F (2⁰C to 8⁰C).
Keep single-dose pens in the original carton until use to protect from light.
If necessary, each single-dose pen may be stored at room temperature at 86⁰F (30⁰C) for up to 21 days.

Ingredients
Active ingredient: tirzepatide

Inactive ingredients: sodium chloride, sodium phosphate dibasic heptahydrate, and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may be added to adjust pH.

Company
Eli Lilly and Company.

Marketing: Lilly USA, LLC Indianapolis, IN 46285, USA.