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MOUNJARO

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Manufactured by Eli Lilly & Company

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MOUNJARO Uses, Side Effects, Interactions, Warnings & Dosing

What is MOUNJARO?

What is MOUNJARO?

MOUNJARO is the brand name for tirzepatide and is available as a subcutaneous injection.

What dosages is MOUNJARO available in?

What dosages is MOUNJARO available in?

MOUNJARO is available as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL in single-dose pen or single-dose vial.

What is MOUNJARO used for?

What is MOUNJARO used for?

MOUNJARO is a GIP and GLP-1 agonist and is used to treat type 2 diabetes, in addition to diet and exercise.

How does MOUNJARO work?

How does MOUNJARO work?

MOUNJARO is a glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist. It works by acting like GLP-1 and GIP, two hormones released by your gut after you eat to help you control blood sugar. These hormones tell your body to release more insulin, release less sugar, and slow down digestion. All of these actions help lower blood sugar levels. In people who have Type 2 diabetes, GLP-1 and GIP don’t work as well they should. So MOUNJARO helps by acting just like GLP-1 and GIP to help control blood sugar.

How do I take MOUNJARO?

How do I take MOUNJARO?

MOUNJARO is typically started at 2.5 mg injected under the skin of the stomach, thigh, or upper arm once weekly. After 4 weeks, your provider will raise your dose to 5 mg injected once weekly. Depending on your response, your provider might continue to raise your dose every 4 weeks or so until you’re at a dose that works for you. The maximum recommended dose is 15 mg once weekly.

Is it safe for me to take MOUNJARO?

Is it safe for me to take MOUNJARO?

MOUNJARO is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication if you have any of the following. Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. Known serious hypersensitivity to tirzepatide or any of the excipients in MOUNJARO.

MOUNJARO Common Side Effects

MOUNJARO Common Side Effects

Common side effects of MOUNJARO:

  • Nausea
  • Diarrhea
  • Low appetite
  • Vomiting
  • Stomach upset
  • Constipation
  • Stomach pain
MOUNJARO Serious Side Effects

MOUNJARO Serious Side Effects

Serious side effects are rare with MOUNJARO. Contact your healthcare provider immediately if you experience any of the following.

  • Serious allergic reaction: hives; trouble breathing; swelling of your lips, tongue, throat, or face
  • Dangerously low blood sugar: feeling hungry, fast heartbeat, shakiness, anxiety, sweating, tingling, dizziness, weakness, drowsiness, confusion
  • Kidney damage: nausea, vomiting, trouble urinating, muscle cramps, feeling confused, swelling in the ankles or feet, trouble breathing
Effects of other drugs, drug classes and over-the-counter products on MOUNJARO

Effects of other drugs, drug classes and over-the-counter products on MOUNJARO

The following medications may interact with MOUNJARO:

  • MOUNJARO delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications
Who makes MOUNJARO?

Who makes MOUNJARO?

Eli Lilly & Company

Is MOUNJARO safe in pregnancy?

Is MOUNJARO safe in pregnancy?

It is not known if MOUNJARO can harm your unborn baby. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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What to do if you missed your MOUNJARO dose

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US brand name of MOUNJARO and manufacturer

Mounjaro is the brand name of tirzepatide and is available in the US under the brand name Mounjaro. It is manufactured by Eli Lilly

A tube with a MOUNJARO label on it.

Source: Eli Lilly

 

UK brand name of MOUNJARO and manufacturer

Mounjaro is the brand name of tirzepatide and is available in the UK under the brand name Mounjaro. It is manufactured by Eli Lilly.

Is MOUNJARO available in the UK on the NHS?

Mounjaro is available on the NHS in the UK. It can be prescribed by healthcare providers for eligible patients.

Prescription requirement for MOUNJARO

Mounjaro (tirzepatide) is available as Pen 0.5ml of 2.5mg/0.5ml, Pen 0.5ml of 5mg/0.5ml, Pen 0.5ml of 7.5mg/0.5ml, Pen 0.5ml of 10mg/0.5ml, Pen 0.5ml of 12.5mg/0.5ml and Pen 0.5ml of 15mg/0.5ml injection pen.  It is a prescription medicine and requires a valid prescription.

FDA approval of MOUNJARO

Mounjaro has received FDA approval for:

  • Treatment of adults with type 2 diabetes as an adjunct to diet and exercise

It is not known if MOUNJARO is safe and effective for use in children under 18 years of age.

It is not known if MOUNJARO can be used in people who have had pancreatitis.

When not to use MOUNJARO?

There are certain precautions where Mounjaro may not be suitable if:

  • You are allergic to tirzepatide or ingredients found in Mounjaro pen
  • You have problems with your pancreas or kidney
  • You have a history of diabetic retinopathy
  • You are pregnant or breastfeeding or plan to become pregnant or breastfeed
  • You or you family have had medullary thyroid carcinoma – MTC
  • You have Multiple Endocrine Neoplasia syndrome type 2 -MEN 2
  • You have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food
  • You are taking insulin or sulfonylureas
  • You take birth control pills by mouth? These may not work as well while using Mounjaro. Your healthcare provider may recommend another type of birth control when you start Mounjaro or when you increase your dose
  • You have type 1 diabetes

Active ingredient of MOUNJARO and mechanism of action

Mounjaro is the first and only approved treatment in a different class of medication for type 2 diabetes. The active ingredient in Mounjaro is tirzepatide. Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. It is the first and only unimolecular dual GIP/GLP-1 receptor agonist. 

Both GIP and GLP-1 increase the production of insulin in your body. 

It has proven to result in significant reductions in A1c levels and body weight. Mounjaro works in several ways:

  • It increases insulin production, but only when your blood sugar is rising—which makes the risk of low blood sugar minimal
  • It decreases your liver’s production of sugar
  • It slows down the speed at which your stomach empties food into your intestine. This helps manage your blood sugars after eating while also leaving you feeling full longer

Is MOUNJARO as effective as Ozempic? 

Mounjaro is more effective than Ozempic (semaglutide) for blood sugar control and weight loss. For people taking Mounjaro, 82% reached an A1C under 7% on the 5-mg dose, 86% reached an A1C under 7% on the 10-mg dose, and 86% reached an A1C under 7% on the 15-mg dose. For people taking Ozempic 1-mg, 79% reached an A1C under 7%.

The American Diabetes Association (ADA) recommends that a reasonable goal for most adults with type 2 diabetes is an HbA1C less than 7%. 

Does MOUNJARO reduce cardiovascular risks?

It is not yet proven, however there may be a follow-through assumption of the Novo Nordisk Phase III SELECT trial of Wegovy (semaglutide) which showed a statistically significant reduction in major adverse cardiovascular events (MACE) of 20%. Eli Lilly is sponsoring the CVOT in obese patients, SURMOUNT-MMO, which is expected to yield data in 2027.  

Can MOUNJARO be used for weight loss?

Mounjaro is not currently FDA approved for weight loss or chronic weight management, despite data that shows that there is significant weight loss associated with using Mounjaro.  

In June 2023 Eli Lilly presented data from the Phase III SURMOUNT-2 study at the American Diabetes Association meeting, which showed a mean weight loss of 13.4% among patients receiving the 10mg dose and 15.7% for the 15mg dose after 72 weeks in overweight and obese patients with type 2 diabetes.

In August 2023, Eli Lilly confirmed that it had applied to the US Food and Drug Administration for the approval of Mounjaro for chronic weight management.

Some physicians and doctors are currently prescribing Mounjaro for weight loss, off-licence. 

 

People climbing Mounjaro lost up to 25 pounds.

 

‡Individual results may vary. In studies with or without other diabetes medications, weight loss in adults ranged from 12 lb (5 mg) to 25 lb (15 mg).

Can MOUNJARO Pen be shared?

No. You should not share your Mounjaro pen with others, even if the needle is changed. You may give other people a serious infection or get a serious infection from them through cross-contamination.

Is it safe to use compounded MOUNJARO?

The manufacturer has said that they do not sell Mounjaro or the active ingredient tirzepatide for compounding. Eli Lilly is the sole company that has FDA approval to market Mounjaro and it is supplied in a branded box that includes a proprietary pen along with FDA-approved prescribing information. Eli Lilly  cannot validate safety or effectiveness of products claiming to contain tirzepatide. Therefore, compounded Mounjaro should be avoided. While doctors can prescribe these medications “off-label” for obesity, insurance companies may deny these claims.

Is there a shortage of MOUNJARO?

Mounjaro, in all strengths, is available to community pharmacies nationwide for treatment in patients with type 2 diabetes. There may be normal delays given the time required to order the product from their local distribution center, and geographical variabilities. However, there are concerns about supply effects, in anticipation of the manufacturer confirming it will be looking to licence the product for chronic weight management.

Forms of MOUNJARO

Mounjaro comes as a solution in a prefilled, single-dose injection pen with the following dosage strengths:

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

Storage requirements for MOUNJARO

Mounjaro is temperature sensitive and should be handled as follows: 

  • Store your Pen in the refrigerator between 2C to 8C
  • You may store your Pen at room temperature below 30C for up to a total of 21 days
  • Do not freeze your Pen. If the Pen has been frozen, throw the Pen away and use a new Pen
  • Store your Pen in the original carton to protect your Pen from light
  • The Pen has glass parts. Handle it carefully. If you drop the Pen on a hard surface, do not use it. Use a new Pen for your injection
  • Keep your MOUNJARO Pen and all medicines out of the sight and reach of children

Dosage of MOUNJARO

Mounjaro is given as a weekly injection under the skin (subcutaneous). It should be administered at the same time each week, at any time of the day. The 2.5-mg dose is for treatment initiation and is not intended for glycemic (blood sugar) control. 

Patients are initiated with the 2.5-mg dose once weekly.

After 4 weeks on the 2.5-mg dose, the physician may increase to the 5-mg dose once weekly. If additional glycemic control is needed, the physician can continue to increase the dose by 2.5-mg increments after at least 4 weeks on the current dose. The maximum dose is 15 mg once weekly.

 

A poster displaying the various MOUNJARO glucometers available.

Source: Eli Lilly

 

Even though doses change, the administration frequency will always be weekly. It is important to follow the dosage instructions provided by your healthcare provider.

How long does it take for MOUNJARO to start working?

Mounjaro starts working immediately. It achieves glycaemic control faster than other treatment. SURPASS-2 and SURPASS-3 studies have shown that those taking any dose of Mounjaro reached A1C targets about 4 weeks sooner than those using injected semaglutide (Ozempic) 1 mg. When compared to titrated insulin degludec (Tresiba), participants using Mounjaro achieved the A1C goals between 4 and 12 weeks sooner.

 

How do I use the MOUNJARO Pen?

Follow these 4 steps to use your Mounjaro pen:

Step 1: Choose your injection site. Your healthcare provider can help you choose the injection site that is best for you. You or another person can inject the medicine in your stomach, thighs, or the back of your upper arms. Another person should give you the injection in the back of your upper arm.

Step 1 of taking Mounjaro

Step 2: Pull off the base cap.

Step 2 of taking Mounjaro

Step 3: Place the base flat on your skin, then unlock.

Step 3 of taking Mounjaro

Step 4: Press and hold the button for up to 10 seconds. Listen for the first click. It means the injection has started. The second click means that the injection is complete.

Step 4 of taking Mounjaro

How long can I continue using MOUNJARO?

Mounjaro is designed to be a long-term maintenance treatment. Mounjaro is safe and effective when used as indicated for the treatment of adults with type 2 diabetes to lower blood sugar, along with diet and exercise.

What are the common side effects of MOUNJARO?

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

What are the serious side effects of MOUNJARO?

  • Sudden inflammation of your pancreas (pancreatitis)
  • Severe diarrhea, nausea, or vomitin
  • Low blood sugar (hyproglycemia)
  • Serious allergic reactions
  • Possible risk of thyroid cancer

Contact your healthcare provider if you experience any serious side effects.

What can I do if I experience nausea when using MOUNJARO?

  • Consume bland, low-fat foods, like crackers, toast, rice
  • Eat smaller meals–try splitting your 3 daily meals into 4 or more smaller ones
  • Stop eating when you feel full
  • Avoid laying down after eating
  • Avoid fat or fatty foods
  • Drink ice-cold drinks

What support resources are there for MOUNJARO?

You can contact the Mounjaro patient services support center at 1-833-807-MJRO (833-807-6576).

What prescription assistance is available for MOUNJARO?

Prescription drug prices can be confusing. Two people may pay different prices for the same drug, depending on their insurance situation. The list price of Mounjaro is $1,023.04 per fill, but the amount you pay will largely depend on your prescription drug insurance plan.

Commercially insured patients may be eligible for the Mounjaro Savings Card program.

If you are not eligible for the Mounjaro Savings Program, then you may have to pay close to the list price shown above, plus any additional pharmacy charges depending on where you purchase your medicine.

If you are interested in obtaining insurance, there are resources available to help you:

  • To find out if you qualify for Medicaid and for information about copayments in your state, please visit: https://www.medicaid.gov/state-overviews/index.html
  • To learn more about private individual policies via the Insurance Marketplace, please visit: https://mat.org/Health-Insurance-Resources

For the most accurate information, talk to your insurance provider who knows the details of your plan.

Interactions with other drugs

Ozempic may interact with certain medications, including:

  • Insulin (Humalog, Tresiba, Lantus, Basaglar, Fiasp)
  • Sulfonylureas (Amayrl, glyburide, glipizide)
  • Meglitinides (repaglinide, nateglinide)
  • Birth control pills (drospirenone/estetrol, ethinyl estradiol/norethindrone, ethinyl estradiol/norgestimate) 
  • Ibuprofen
  • Simvastatin
  • Atorvastatin (Lipitor)

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NowPatient has taken all reasonable steps to ensure that all material is factually accurate, complete, and current. However, the knowledge and experience of a qualified healthcare professional should always be sought after instead of using the information on this page. Before taking any drug, you should always speak to your doctor or another qualified healthcare provider.

The information provided here about medications is subject to change and is not meant to include all uses, precautions, warnings, directions, drug interactions, allergic reactions, or negative effects. The absence of warnings or other information for a particular medication does not imply that the medication or medication combination is appropriate for all patients or for all possible purposes.

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