Mounjaro® (mown-JAHR-OH) is an injectable medicine for adults with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose).

• It is not known if Mounjaro is safe and effective for use in children.
  

Mounjaro is the first and only approved treatment in a different class of medication for type 2 diabetes.*

*It works differently than other type 2 diabetes medications by directly activating GIP and GLP-1 pathways to help regulate blood sugar.

Select Safety Information

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Mounjaro with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness, and feeling jittery.

WARNING: RISK OF THYROID C-CELL TUMORS

• In both male and female rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether MOUNJARO causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determine.
  

MOUNJARO® is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Mounjaro Single-Dose Pen Instructions for Use

INSTRUCTIONS FOR USE MOUNJARO® (mown-JAHR-OH) (tirzepatide) injection, for subcutaneous use 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 use 1 time each week

Important information you need to know before injecting MOUNJARO

Read this Instructions for Use and the Medication Guide before using your MOUNJARO Pen and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Talk to your healthcare provider about how to inject MOUNJARO the right way.

• MOUNJARO is a single-dose prefilled pen.
• MOUNJARO is used 1 time each week.
• Inject under the skin (subcutaneously) only.
• You or another person can inject into your stomach (abdomen) or thigh.
• Another person can inject into the back of your upper arm.

Guide to parts.

 

Preparing to inject MOUNJARO

Remove the Pen from the refrigerator. Leave the gray base cap on until you are ready to inject.
Check the Pen label to make sure you have the right medicine and dose, and that it has not expired. Inspect the Pen to make sure that it is not damaged.

 

Make sure the medicine:
is not frozen is not cloudy	is colorless to slightly yellow does not have particles

 

Wash your hands.

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 (abdomen) or thigh.

Another person should give you the injection in the back of your upper arm. Change (rotate) your injection site each week. You may use the same area of your body but be sure to choose a different injection site in that area.

Step 2	Pull off the gray base cap
		Make sure the Pen is locked. Do not unlock the Pen until you place the clear base on your skin and are ready to inject.

Step 3	Place clear base on skin, then unlock
		Place the clear base flat against your skin at the injection site.

Unlock by turning the lock ring.

Step 4	Press and hold up to 10 seconds
		Press and hold the purple injection button for up to 10 seconds. Listen for: • First click = injection started • Second click = injection completed
		You will know your injection is complete when the gray plunger is visible.

After your injection, place the used Pen in a container.

Disposing of your used Pen Put your used Pen in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) Pens in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal. Do not recycle your used sharps disposal container.

Storage and handling

• Store your Pen in the refrigerator between 36°F to 46°F (2°C to 8°C).
  
  
• You may store your Pen at room temperature up to 86°F (30°C) for up to 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 reach of children.

Commonly asked questions

What if I see air bubbles in my Pen?

Air bubbles are normal.

What if my Pen is not at room temperature?

It is not necessary to warm the Pen to room temperature.

What if I unlock the Pen and press the purple injection button before pulling off the gray base cap?

Do not remove the gray base cap. Throw away the Pen and get a new Pen.

What if there is a drop of liquid on the tip of the needle when I remove the gray base cap?

A drop of liquid on the tip of the needle is normal. Do not touch the needle.

Do I need to hold the injection button down until the injection is complete?

This is not necessary, but it may help you keep the Pen steady against your skin.

I heard more than 2 clicks during my injection—2 loud clicks and 1 soft one. Did I get my complete injection?

Some people may hear a soft click right before the second loud click. That is the normal operation of the Pen. Do not remove the Pen from your skin until you hear the second loud click.

I am not sure if my Pen worked the right way.

Check to see if you have received your dose. Your dose was delivered the right way if the gray plunger is visible,Until then, store your Pen safely to avoid an accidental needle stick.

What if there is a drop of liquid or blood on my skin after my injection?

This is normal. Press a cotton ball or gauze over the injection site. Do not rub the injection site.

Other information

• If you have vision problems, do not use your Pen without help from a person trained to use the MOUNJARO Pen.

Disclaimer:Prescription only. Use as directed by your healthcare provider. Not for type 1 diabetes or children