Mounjaro (Tirzepatide) 5mg/0.5mL Pre-Filled Pen Injection

– Administer SC in abdomen, thigh, or upper arm
– Rotate injection site with each dose
– Administer once weekly, at any time of day, with or without meals
– Change day of weekly administration: May be changed, if necessary, as long as time between the 2 doses is at least 3 days (72 hr)

– Inspect visually before use
– Solution should appear clear and colorless to slightly yellow; discard if particulate matter or discoloration observed

– Nausea

– Diarrhea

– Decreased appetite

– Vomiting

– Constipation

– Indigestion

– Stomach (abdominal) pain

– In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse

– It is important for you to drink fluids to help reduce your chance of dehydration

– Mounjaro has been associated with gastrointestinal adverse reactions, which include nausea, vomiting, and diarrhea. These events may lead to dehydration, which if severe could cause acute kidney injury. In patients treated with GLP-1 receptor agonists, there have been post-marketing reports of acute kidney injury and worsening of chronic renal failure, sometimes requiring hemodialysis. Some of these events have been reported in patients without known underlying renal disease. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Monitor renal function when initiating or escalating doses of Mounjaro in patients with renal impairment reporting severe adverse gastrointestinal reactions.

– Stomach problems, sometimes severe, have been reported in people who use MOUNJARO

– Tell your healthcare provider if you have stomach problems that are severe or will not go away

– Tell your healthcare provider if you have changes in vision during treatment with MOUNJARO.

– Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy.

– Mounjaro has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema

– Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.

– Gallbladder problems have happened in some people who use MOUNJARO

– In clinical trials, acute gallbladder disease was reported by 0.6% of Mounjaro-treated patients and 0% of placebo-treated patients. If cholelithiasis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated

– Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include:

• pain in your upper stomach (abdomen)
• fever
• yellowing of skin or eyes (jaundice)
• clay-colored stools

– 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

• dizziness or light-headedness
• sweating
• confusion or drowsiness
• headache
• blurred vision
• slurred speech
• shakiness
• fast heartbeat
• anxiety, irritability, or mood changes
• hunger
• weakness
• feeling jittery

– Concomitant use with an insulin secretagogue (e.g., sulfonylurea) or insulin may increase the risk of hypoglycemia, including severe hypoglycemia

– The risk of hypoglycemia may be lowered by reducing the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin.

– Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.

– Stop using MOUNJARO and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists. Pancreatitis has been reported in Mounjaro clinical trials. Mounjaro has not been studied in patients with a prior history of pancreatitis. It is unknown if patients with a history of pancreatitis are at higher risk for development of pancreatitis on Mounjaro. Observe patients for signs and symptoms, including persistent severe abdominal pain sometimes radiating to the back, which may or may not be accompanied by vomiting. If pancreatitis is suspected, discontinue Mounjaro and initiate appropriate management.

– Tell your healthcare provider if you are pregnant or plan to become pregnant

– Tell your healthcare provider if you become pregnant while using MOUNJARO

– Limited data on MOUNJARO use in pregnant women are available to inform on drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes

– Based on animal reproduction studies, there may be risks to the fetus from exposure to MOUNJARO

– Use only if potential benefit justifies the potential risk to the fetus

– Tirzepatide (Mounjaro)
Inactive Ingredients

– Sodium chloride

– Sodium phosphate dibasic heptahydrate

– Water for injection

– Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH