Mounjaro is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Mounjaro has not been studied in patients with a history of pancreatitis. Mounjaro is not indicated for use in patients with type 1 diabetes mellitus.
Select Important Safety Information for Mounjaro (tirzepatide)
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 determined.
Mounjaro is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2. Counsel patients regarding the potential risk for MTC with the use of Mounjaro and inform them of symptoms of thyroid tumors (for example, 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.
Hello, my name is Dr. Eduardo Dusty Luna. I'm an endocrinologist and partner at the Valley Diabetes and Endocrinology Comprehensive Center in Edinburg and Weslaco, Texas. I'm excited to talk to you about getting your patients started on Mounjaro, a treatment option for adults with type 2 diabetes.
As you are aware, Mounjaro has been approved by the U.S. Food and Drug Administration as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Mounjaro is the first and only approved single molecule that activates the GIP and GLP-1 receptors in the body to treat type 2 diabetes.
As you consider Mounjaro, you may have questions about treatment initiation and continuation based on the individual glycemic goals of your patients. You may also be concerned about adverse reactions related to this medication. In this video, we'll begin by answering some common questions about starting your patients on Mounjaro for the treatment of type 2 diabetes. That'll be followed by common questions you may have about the safety profile of Mounjaro.
What are the available doses for Mounjaro? What dose should be used to initiate patients on treatment?
Mounjaro, or tirzepatide, is available in 6 different doses— 2.5, 5, 7.5, 10, 12.5, and 15 milligrams, each provided in a single-dose injection pen.1 Patients should be initiated on the 2.5-milligram dose once weekly. It is important to note that the 2.5- milligram dosage is for the treatment initiation and is not intended for glycemic control.
Can you share how we can escalate to patient's individual treatment goals? This is a very important question as we think about getting patients started on this treatment.
After 4 weeks on the initiation dose of 2.5 milligrams, patients should increase their dose to 5 milligrams of Mounjaro once weekly. If additional glycemic control is needed, patients can continue to increase their dose by 2.5- milligram increments after at least 4 weeks on their current dose, up to a maximum dose of 15 milligrams once weekly.
As mentioned earlier, Mounjaro has multiple doses available to help your patients with type 2 diabetes. These dosing options allow you to individualize your patient's experience based on their specific needs. Of course, patients should be assessed for tolerability and adverse events before increasing a dose of Mounjaro.
Should I maintain my patient's dose of Mounjaro if they reach a glycated hemoglobin, or A1C, level below 7%?
For this scenario, I would say please use your clinical judgment when adjusting the dose of Mounjaro based on your patient's individual clinical characteristics or needs. You can tailor the multiple available doses of Mounjaro to your patient's particular glycemic needs. Please remember that patients should be initiated on the 2.5- milligram dose, which may be increased in 2.5- milligram increments after at least 4 weeks on their current dose.
Do patients have to take Mounjaro on the same day each week? What if they miss a dose?
Not necessarily. The day of weekly Mounjaro administration can be changed; however, it is important to note that the time between 2 doses must be at least 3 days, or 72 hours. If patients miss a dose, instruct them to administer Mounjaro as soon as possible within 4 days, or 96 hours, after the missed dose. If more than 4 days have passed, patients can 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.
Can Mounjaro be taken on an empty stomach?
Absolutely. Mounjaro can be administered once weekly, at any time of day, with or without meals.
Do you have to increase patient's doses in 2.5-milligram increments, or can you escalate in higher increments (for example, 5 milligrams to 10 milligrams, or 10 milligrams to 15 milligrams)?
It is important to note that Mounjaro dose escalation should not exceed increments of 2.5 milligrams. If your patients require additional glycemic control, you may increase the dosage in 2.5- milligram increments after at least 4 weeks on the current dose. It is also essential to assess how your patients tolerate the current dose or if they have any adverse events before prescribing a higher available dose.
How do I start a patient on Mounjaro who is currently on a GLP-1 receptor agonist?
For providers looking to transition patients to Mounjaro, have patients discontinue their current GLP-1 receptor agonist, and at the time of their next weekly dose start Mounjaro at 2.5 milligrams. Their dose can be escalated in 2.5 milligram increments every 4 weeks according to their glycemic needs.
I hope we were able to address some common questions and concerns about the initiation of patients on this treatment. I'll answer some common questions you may have about the safety profile of Mounjaro for the treatment of adults with type 2 diabetes.
What adverse reactions should my patients expect with Mounjaro?
The possibility of adverse reactions with any new treatment is a natural concern. In the pool of placebo-controlled studies, adverse reactions reported in at least 5% of Mounjaro-treated adult patients with type 2 diabetes were nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain. Please note that this is not a comprehensive list of all possible adverse reactions that patients may experience with Mounjaro.
I want to emphasize that because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug. Also, adverse event rates observed in clinical trials may not reflect the rates observed in practice.
Are there any concerns about hypoglycemia and/or worse tolerability?
Hypoglycemia was more frequent when Mounjaro was used in combination with a sulfonylurea or insulin.1 In clinical studies of Mounjaro, reductions in glycated hemoglobin, or A1C, and the frequency of adverse events were generally dose dependent; however, there was no relationship between dose and the incidence of hypoglycemia.
The most commonly reported adverse events with Mounjaro were gastrointestinal related. Nausea, vomiting, and diarrhea were most frequent during the dose-escalation period and tended to decrease over time.
Are there any recommendation s for mitigating gastrointestinal side effects?
Yes, in clinical studies investigators were to provide dietary advice to patients, including eating smaller meals, and/or prescribe anti-emetic or anti-diarrheal agents as needed to mitigate gastrointestinal adverse events.
Has the cardiovascular safety of Mounjaro been assessed? Are there any cardiovascular safety concerns with the use of Mounjaro?
Mounjaro is approved for the treatment of adults with type 2 diabetes and meets the requirements for cardiovascular safety from the U.S. Food and Drug Administration.1 In the SURPASS-4 study, the efficacy and safety of Mounjaro were compared against insulin glargine, which has been demonstrated to be safe from a cardiovascular perspective.
Participants with type 2 diabetes and increased cardiovascular risk whose diabetes was inadequately controlled on 1 to 3 oral glucose- lowering medications were followed for up to 104 weeks. The study was powered to assess glycemic efficacy, but there was also a safety objective to compare Mounjaro and insulin glargine for adjudicated deaths and nonfatal major adverse cardiovascular events. There was no increased risk of major adverse cardiovascular events with Mounjaro compared with insulin glargine.
Do I need to adjust any concomitant oral medications when I prescribe Mounjaro?
It is important to note that 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.
It is necessary to monitor patients on oral medications that depend on threshold concentrations for efficacy and those with a narrow therapeutic index, such as warfarin, when these medications are administered concomitantly with Mounjaro.
Please advise patients using oral hormonal contraceptives to switch to a non- oral contraceptive method or to add a barrier method of contraception. This should be done for 4 weeks after initiation of Mounjaro and for 4 weeks after each dose escalation with Mounjaro. Hormonal contraceptives that are not administered orally should not be affected.
I mentioned earlier that hypoglycemia was more frequent when Mounjaro was used in combination with a sulfonylurea. When initiating Mounjaro, consider reducing the dose of sulfonylurea to reduce the risk of hypoglycemia.
Are any dose adjustments recommended for specific patient populations, such as those with renal or hepatic impairment?
No dosage adjustment of Mounjaro is recommended for patients with renal impairment. In subjects with renal impairment including end- stage renal disease, no change in tirzepatide pharmacokinetics was observed. Please monitor renal function when initiating or escalating doses of Mounjaro in patients with renal impairment reporting severe adverse gastrointestinal reactions. No dosage adjustment of Mounjaro is recommended for patients with hepatic impairment either. In a clinical pharmacology study in subjects with varying degrees of hepatic impairment, no change in tirzepatide pharmacokinetics was observed.
If my patient is taking Mounjaro with basal insulin or an insulin secretagogue and has a hypoglycemic event, what should I do?
Patients receiving Mounjaro in combination with insulin or an insulin secretagogue such as sulfonylurea may have an increased risk of hypoglycemia, including severe hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of insulin or sulfonylurea or other concomitantly administered insulin secretagogue.
Please inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
Are there any patients who should not take Mounjaro?
Mounjaro is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2. It is also contraindicated in patients with known serious hypersensitivity to tirzepatide or the excipients in Mounjaro, which are sodium chloride and sodium phosphate dibasic heptahydrate. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with Mounjaro.
What were the discontinuation rates with Mounjaro compared to Ozempic?
Discontinuation due to any adverse event occurred in 6%, 8.5%, and 8.5% of patients receiving 5, 10, and 15 milligrams of Mounjaro, respectively, compared with 4.1% of patients receiving 1 milligram of Ozempic. Discontinuation due to gastrointestinal- related adverse events occurred in 2.8%, 4.3%, and 4.3% of patients receiving 5, 10, and 15 milligrams of Mounjaro compared with 3.2% of patients receiving 1 milligram of Ozempic.10 Most reports of nausea, vomiting, and diarrhea occurred during the dose-escalation period, and decreased over time.
I hope we have helped address some of the safety concerns you might have about Mounjaro as you consider this treatment option for your patients with type 2 diabetes. When considering a treatment, I assess the benefits and safety profile, and discuss them with my patient. Keeping patients informed and engaged can help support a positive mindset to initiate treatment and to manage side effects that can help patients stay on treatment. Most importantly, we want patients to feel supported and empowered along their treatment journey, which is a comprehensive effort between healthcare professionals and patients.
If you have additional questions about getting your patients started, including the efficacy and safety profile of this treatment, please visit the Mounjaro website for detailed information. You may also review the US Prescribing Information or contact your local Mounjaro representative. Thank you for joining us to learn more about Mounjaro.
Mounjaro is a GIP and GLP-1 receptor agonist that is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Mounjaro has not been studied in patients with a history of pancreatitis and is not indicated for the treatment of type 1 diabetes mellitus.
WARNING: RISK OF THYROID C- CELL TUMORS: In 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 determined. Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors.
Mounjaro is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2, and in patients with a known serious hypersensitivity reaction to tirzepatide or any of the product components. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with Mounjaro.
Pancreatitis: Acute pancreatitis, sometimes fatal, has been observed in patients treated with GLP-1 receptor agonists. Pancreatitis has been reported in Mounjaro clinical trials. Discontinue promptly if pancreatitis is suspected.
Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: Concomitant use with an insulin secretagogue (for example, 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 signs and symptoms of hypoglycemia.
Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported in patients treated with Mounjaro. If hypersensitivity reactions occur, discontinue Mounjaro and treat promptly per standard of care. Use caution in patients with a history of anaphylaxis or angioedema with a GLP-1 receptor agonist. It is unknown if such patients will be predisposed to these reactions with Mounjaro.
Acute Kidney Injury: Monitor renal function when initiating or escalating doses of Mounjaro in patients with renal impairment reporting severe adverse gastrointestinal reactions. Severe Gastrointestinal Disease: Use may be associated with gastrointestinal adverse reactions, sometimes severe. Has not been studied in patients with severe gastrointestinal disease and is not recommended in these patients.
Diabetic Retinopathy Complications in Patients with a History 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. Monitor patients with a history of diabetic retinopathy for progression.
Acute Gallbladder Disease: In placebo-controlled clinical trials, acute gallbladder disease (cholelithiasis, biliary colic, and cholecystectomy) was reported by Mounjaro-treated patients. If cholelithiasis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.
The most common adverse reactions reported in ≥5% of patients treated with Mounjaro in placebo-controlled trials were nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.
Mounjaro slows gastric emptying and may impact absorption of concomitantly administered oral medications. Advise females using oral 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.