Mounjaro

Extracted Attributes

• Field

  Pharmacology / Endocrinology

• Drug Class

  GIP analog and GLP-1 receptor agonist

• Limitations

  Gastrointestinal side effects, potential muscle loss, thyroid tumor risk in rodents

• Applications

  Type 2 diabetes, weight management, obstructive sleep apnea

• Manufacturer

  Eli Lilly and Company

• Administration

  Subcutaneous injection (weekly)

• Active Ingredient

  Tirzepatide

• Prescription Count (2023)

  6 million (United States)

Timeline

• U.S. FDA approval for the treatment of type 2 diabetes. (Source: Wikipedia)

  2022-05-01

• European Union approval for the treatment of diabetes. (Source: Wikipedia)

  2022-09-01

• Canadian approval for the treatment of diabetes. (Source: Wikipedia)

  2022-11-01

• Australian approval for the treatment of diabetes. (Source: Wikipedia)

  2022-12-01

• U.S. FDA approval for weight loss and U.K. MHRA approval for weight management. (Source: Wikipedia)

  2023-11-01

• U.S. FDA approval for the treatment of obstructive sleep apnea (as Zepbound). (Source: Wikipedia)

  2024-12-01

Tirzepatide

Tirzepatide is a gastric inhibitory polypeptide (GIP) analog and a GLP-1 receptor agonist. It is used as an antidiabetic medication to treat type 2 diabetes and for weight loss. Tirzepatide is administered via subcutaneous injections (under the skin). It is sold in several countries under the brand name Mounjaro for diabetes treatment. In the United States it is sold with the trade name Zepbound for weight loss and treatment of obstructive sleep apnea. The most frequent side-effects of tirzepatide include nausea, vomiting, diarrhea, decreased appetite, constipation, upper abdominal discomfort, and abdominal pain. Developed by Eli Lilly and Company, tirzepatide was approved for treatment of diabetes in the U.S. in May 2022, in the European Union in September 2022, in Canada in November 2022, and in Australia in December 2022. The U.S. Food and Drug Administration (FDA) considers it a first-in-class medication. The FDA approved it for weight loss in November 2023. Also in November 2023, the U.K. Medicines and Healthcare products Regulatory Agency revised the indication for tirzepatide (as Mounjaro) to include the treatment for weight management and weight loss. In December 2024, the FDA revised the indication for tirzepatide (as Zepbound) to include the treatment of moderate to severe obstructive sleep apnea. In 2023, tirzepatide was the 110th-most commonly prescribed medication in the U.S., with more than six million prescriptions.

Web Search Results

• Mounjaro | European Medicines Agency (EMA)

  Mounjaro is also used together with diet and physical activity to help people to lose weight and keep their weight under control. It is used in people who have obesity (BMI of 30 kg/m2 or more) or who are overweight (BMI between 27 and 30 kg/m2) and have weight-related health problems such as diabetes, abnormally high levels of fat in the blood, high blood pressure or obstructive sleep apnoea (frequent interruption of breathing during sleep). BMI (body mass index) is a measure of your weight in relation to your height. Mounjaro contains the active substance tirzepatide. ## [...] Mounjaro contains the active substance tirzepatide. ## Mounjaro is available as a solution for injection in prefilled pens and can only be obtained with a prescription. It is injected once a week, under the skin of the abdomen (belly), upper arm or thigh. Mounjaro should be injected on the same day each week. For more information about using Mounjaro, see the package leaflet or contact your doctor or pharmacist. ## [...] ## Mounjaro was effective at controlling blood glucose in five main studies involving more than 6,000 adults with type 2 diabetes. In these studies, the main measure of effectiveness was the reduction in the proportion of haemoglobin in the blood that has glucose attached (HbA1c). This indicates how well blood glucose is controlled. In two studies, Mounjaro lowered HbA1c by up to 2.1 and 2.6 percentage points after 40 weeks when added to existing treatment consisting of lifestyle changes only or insulin glargine with or without metformin, respectively. These results compared with no decrease or a decrease of 0.9 percentage points, respectively, in patients who received placebo (a dummy treatment).

• Understanding Mounjaro: A Guide for Type 2 Diabetes Patients

  More than 30 million Americans have type 2 diabetes, the most common form of diabetes. Type 2 diabetes is a chronic and progressive condition in which the body does not make or use insulin properly, leading to high levels of glucose (sugar) in the blood. (Insulin is a naturally occurring hormone made by your pancreas that helps your body use sugar for energy.) In the spring of 2022, the US Food and Drug Administration (FDA) approved the medication Mounjaro (generic name: tirzepatide) to improve blood sugar control in adults with type 2 diabetes, in addition to diet and exercise. Please note that people with type 1 diabetes should not take Mounjaro. [...] At a past Phelps Health diabetes support group meeting, Phelps Health Clinical Pharmacy Coordinator Tyler Craft, PharmD, BCPS, answered frequently asked questions about Mounjaro. ## What is Mounjaro? And how does it work? Mounjaro belongs to a class of medications that mimic two hormones involved in digestion, which are glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). A delicate balance: Glucagon is a hormone that your pancreas makes to help regulate your blood sugar levels. Glucagon increases your blood sugar level and prevents it from dropping too low, whereas insulin, another hormone, decreases blood sugar levels. For people without diabetes, insulin and glucagon work as a team, to keep blood sugar in balance. [...] Most type 2 diabetic patients produce some insulin, but their cells often don’t respond well. A deficiency in the pancreas also can be a contributing factor in type 2 diabetes. ## How is Mounjaro administered? Mounjaro is administered once a week via subcutaneous injection (injected into the fatty layer of tissue just under the skin). Keep the following guidelines in mind when injecting the prescription: Administer the injection the same day each week. Mounjaro can be given any time of day. Rotate injection sites: ideal sites include the abdomen, thigh or upper arm. Do NOT mix with other injectable medications or products. Mounjaro does NOT require priming. For those with a fear of needles, the needle retracts into the plastic after use, remaining unseen.

• Mounjaro (tirzepatide): Uses, Side Effects, Dosage & More - GoodRx

  Image 37: Mounjaro and alcohol aren’t known to directly interact with each other. However, alcohol use can raise the risk of serious side effects of Mounjaro, including low blood sugar. Mounjaro and Alcohol: 6 Things to Know About This Interaction Mounjaro and alcohol aren’t known to directly interact with each other. However, alcohol use can raise the risk of serious side effects of Mounjaro, including low blood sugar. [...] _How to use Mounjaro (tirzepatide):_ [...] Research suggests that Mounjaro may result in greater weight loss compared to Ozempic. Mounjaro and Ozempic aren’t approved for weight loss, but people taking them tend to lose weight. And people taking Mounjaro have been shown to lose more weight than those taking Ozempic. How much weight do people use taking Mounjaro vs. Ozempic? During a head-to-head trial, people taking Mounjaro lost an average of 16 lbs to 25 lbs, depending on their dose. This is compared to people in the Ozempic group who lost an average of about 12 lbs. What’s more, more than 1 out of every 3 people receiving the highest Mounjaro dose (15 mg) lost at least 15% of their starting body weight. This is compared to less than 1 out of every 10 people in the Ozempic group achieving this amount of weight loss.Learn more

• [PDF] MOUNJAROTM (tirzepatide) Injection, for subcutaneous use

  Studies The effectiveness of MOUNJARO as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus was established in five trials. In these trials, MOUNJARO was studied as monotherapy (SURPASS-1); as an add-on to metformin, sulfonylureas, and/or sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors) (SURPASS-2, -3, and -4); and in combination with basal insulin with or without metformin (SURPASS-5). In these trials, MOUNJARO (5 mg, 10 mg, and 15 mg given subcutaneously once weekly) was compared with placebo, semaglutide 1 mg, insulin degludec, and/or insulin glargine. In adult patients with type 2 diabetes mellitus, treatment with MOUNJARO produced a statistically significant reduction from baseline in HbA1c compared to placebo. The [...] exactly as your healthcare provider tells you to. • MOUNJARO is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. • Use MOUNJARO 1 time each week, at any time of the day. • You may change the day of the week you use MOUNJARO as long as the time between the 2 doses is at least 3 days (72 hours). • If you miss a dose of MOUNJARO, take the missed dose 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 take your next dose on the regularly scheduled day. Do not take 2 doses of MOUNJARO within 3 days of each other. • MOUNJARO may be taken with or without food. • Do not mix insulin and MOUNJARO together in the same injection. • You may give an injection of MOUNJARO and insulin in the [...] 4 single-dose pens 0002-1457-80 16.2 Storage and Handling • Store MOUNJARO in a refrigerator at 2°C to 8°C (36°F to 46°F). • If needed, each single-dose pen can be stored unrefrigerated at temperatures not to exceed 30ºC (86ºF) for up to 21 days. • Do not freeze MOUNJARO. Do not use MOUNJARO if frozen. • Store MOUNJARO in the original carton to protect from light. 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Risk of Thyroid C-Cell Tumors Inform patients that MOUNJARO causes thyroid C-cell tumors in rats and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, persistent hoarseness, dysphagia, or

• [PDF] mounjaro-uspi.pdf - Eli Lilly

  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 determined. MOUNJARO is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of MOUNJARO and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with MOUNJARO. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of [...] 7.1% (3/42), 9.3% (4/43), and 23% (10/43) of patients treated with placebo, MOUNJARO 5 mg, 10 mg, and 15 mg, respectively. The clinical relevance of heart rate increases is uncertain. Hypersensitivity Reactions Hypersensitivity reactions have been reported with MOUNJARO in the pool of placebo-controlled trials in adults, sometimes severe (e.g., urticaria and eczema); hypersensitivity reactions were reported in 3.2% of MOUNJARO-treated patients compared to 1.7% of placebo-treated patients. In the pool of seven clinical trials in adults, hypersensitivity reactions occurred in 106/2,570 (4.1%) of MOUNJARO-treated adult patients with anti-tirzepatide antibodies and in 73/2,455 (3.0%) of MOUNJARO-treated patients who did not develop anti-tirzepatide antibodies. In the clinical trial in [...] older with type 2 diabetes in combination with metformin and/or basal insulin [see Clinical Studies (14.5)]. 14.2 Monotherapy Use of MOUNJARO in Adult Patients with Type 2 Diabetes Mellitus SURPASS-1 (NCT03954834) was a 40-week double-blind trial that randomized 478 adult patients with type 2 diabetes mellitus with inadequate glycemic control with diet and exercise to subcutaneous MOUNJARO 5 mg, MOUNJARO 10 mg, MOUNJARO 15 mg, or placebo once weekly. Patients had a mean age of 54 years, and 52% were men. The mean duration of type 2 diabetes mellitus was 4.7 years, and the mean BMI was 32 kg/m2. Overall, 36% were White, 35% were Asian, 25% were American Indians/Alaska Natives, and 5% were Black or African American; 43% identified as Hispanic or Latino ethnicity. Monotherapy with MOUNJARO 5