Mounjaro (tirzepatide)

Mounjaro (tirzepatide) is an injectable prescription medication used, along with diet and exercise, to treat the symptoms of type 2 diabetes mellitus and improve blood sugar (glucose) in adults with type 2 diabetes.

• Mounjaro may be used alone or with other medications.
• Mounjaro belongs to a class of drugs called antidiabetics, Glucagon-like Peptide-1 Agonists; Antidiabetics, Glucose-dependent Insulinotropic Polypeptides 
• Mounjaro is not for use in people with type 1 diabetes.
• It is not known if Mounjaro is safe and effective in children. 

RISK OF THYROID C-CELL TUMORS

Mounjaro is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) due to the potential risk for medullary thyroid carcinoma (MTC) with the use of Mounjaro. Symptoms of thyroid tumors include a mass in the neck, dysphagia, dyspnea, and persistent hoarseness.

In both male and female rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is not known whether Mounjaro causes thyroid C-cell tumors, including MTC, in humans as human relevance of tirzepatideinduced rodent thyroid C-cell tumors has not been determined.

Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Mounjaro.

Do not use Mounjaro if:

• you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• you have had a serious allergic reaction to tirzepatide or any of the ingredients in Mounjaro. See the end of this Medication Guide for a complete list of ingredients in Mounjaro.

Before using Mounjaro, tell your healthcare provider about all your medical conditions, including if you:

• have or have had problems with your pancreas or kidneys.
• have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
• have a history of diabetic retinopathy.
• are pregnant or plan to become pregnant. It is not known if Mounjaro will harm your unborn baby. Tell your healthcare provider if you become pregnant while using Mounjaro.
  • Birth control pills by mouth may not work as well while using Mounjaro. If you take birth control pills by mouth, your healthcare provider may recommend another type of birth control for 4 weeks after you start Mounjaro and for 4 weeks after each increase in your dose of Mounjaro. Talk to your healthcare provider about birth control methods that may be right for you while using Mounjaro.
• are breastfeeding or plan to breastfeed. It is not known if Mounjaro passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using Mounjaro.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Mounjaro may affect the way some medicines work, and some medicines may affect the way Mounjaro works.

Before using Mounjaro, tell your healthcare provider if you are taking other medicines to treat diabetes including insulin or sulfonylureas, which could increase your risk of low blood sugar.

Talk to your healthcare provider about low blood sugar and how to manage it.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Mounjaro may cause serious side effects including:

• hives, 
• difficulty breathing, 
• swelling of your face, lips, tongue, or throat, 
• dizziness, 
• fast heart rate, 
• shaking, 
• sweating, 
• nervousness, 
• anxiety, 
• irritability, 
• confusion, 
• hunger, 
• pain in the upper right side of your abdomen, 
• pain spreading to your back or below the shoulder blade, 
• nausea, 
• vomiting, 
• fever, 
• yellowing of the skin and eyes (jaundice), 
• clay-colored stools, and 
• bloating of the abdomen

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Mounjaro include:

• nausea, 
• diarrhea, 
• decreased appetite, 
• vomiting, 
• constipation, 
• indigestion, and
• stomach pain 

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Mounjaro. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• The recommended starting dosage of Mounjaro is 2.5 mg injected subcutaneously once weekly. The 2.5 mg dosage is for treatment initiation and is not intended for glycemic control.
• After 4 weeks, increase the dosage to 5 mg injected subcutaneously once weekly.
• If additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose.
• The maximum dosage of Mounjaro is 15 mg injected subcutaneously once weekly.
• If a dose is missed, instruct patients to administer Mounjaro as soon as possible within 4 days (96 hours) after the missed dose. If more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.
• The day of weekly administration can be changed, if necessary, as long as the time between the two doses is at least 3 days (72 hours).

Important Administration Instructions

• Administer Mounjaro once weekly, any time of day, with or without meals.
• Inject Mounjaro subcutaneously in the abdomen, thigh, or upper arm.
• Rotate injection sites with each dose.
• Inspect Mounjaro visually before use. It should appear clear and colorless to slightly yellow. Do not use Mounjaro if particulate matter or discoloration is seen.
• When using Mounjaro with insulin, administer as separate injections and never mix. It is acceptable to inject Mounjaro and insulin in the same body region, but the injections should not be adjacent to each other.

• In the event of an overdosage, contact Poison Control for latest recommendations.
• Appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
• A period of observation and treatment for these symptoms may be necessary, taking into account the half-life of tirzepatide of approximately 5 days.

Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) Or With Insulin

• When initiating Mounjaro, consider reducing the dose of concomitantly administered insulin secretagogues (e.g., sulfonylureas) or insulin to reduce the risk of hypoglycemia.

Oral Medications

• Mounjaro delays gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with Mounjaro.
• Monitor patients on oral medications dependent on threshold concentrations for efficacy and those with a narrow therapeutic index (e.g., warfarin) when concomitantly administered with Mounjaro.
• Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation with Mounjaro. Hormonal contraceptives that are not administered orally should not be affected.

• Available data with Mounjaro use in pregnant women are insufficient to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy. Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide during pregnancy. Mounjaro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity.
• There are no data on the presence of tirzepatide in animal or human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Mounjaro and any potential adverse effects on the breastfed infant from Mounjaro or from the underlying maternal condition.