Nancy’s experience with Mounjaro
[Indication]
Mounjaro is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
[Boxed Warning]
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 (MEN 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.
[Patient]
Hi I'm Nancy from Tennessee, and I was diagnosed with type 2 diabetes 3 years ago.
When I was first diagnosed with type 2 diabetes and working from home, I didn't have any exercise really at all. I mean, it's like walking from the kitchen to my office, and that was pretty much it.
And then I’d usually just have dinner and sit at home. That was my lifestyle.
My type 2 diabetes was keeping me from doing anything outside of the house, really.
I see my regular primary care doctor, and he had diagnosed me with type 2 diabetes.
He put me on some medications, and he recommended a better diet and exercise program for me to follow, to try to lower my A1C.
When I started diet and exercise and medications, I was frustrated when I didn't have my A1C where it needed to be.
[Healthcare Professional]
I'm Stacy Brown. I'm a nurse practitioner in Tennessee, and I've been practicing for 27 years with an emphasis on endocrinology.
I have been treating Nancy for her type 2 diabetes for 18 months.
When she came to me, she had had diabetes for over a year. She was frustrated and a little defeated because she had been trying other modalities, and she was not where she wanted to be in her A1C goals. So she came to me looking for guidance, looking for help, looking for some answers on how to get there, and that's when we started Nancy on Mounjaro.
[Patient]
It was a year and a half after I had been diagnosed with type 2 diabetes that I started Mounjaro, July of 2022.
Now that I'm on Mounjaro, and my A1C is where it needs to be and my weight is also down…my eating habits now, I have made better choices. I'm now planning out my meals in the mornings when I get up to have breakfast. My lunch and dinner, everything, is pretty much planned out for the day.
My routine now is, the minute I clock out, I'm usually leaving the house to go out of the house, to go do something, to even walk somewhere, to get some exercise in. And so I do not just sit home all night.
[Healthcare Professional]
When Nancy comes in to see me now, it's a different countenance. She has seen success with her A1C goals and has even lost some weight, so when she comes in, I think that she looks forward to seeing where she is on her A1C goals and where her numbers are exactly.
[Patient]
Now that my A1C is under control, I'm proud of the lifestyle changes I've been able to make.
[Voiceover Narrator]
The effectiveness of Mounjaro as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes was established in five phase 3 clinical studies.
In SURPASS-1 through -5, patients were randomized to receive Mounjaro 5, 10, or 15 milligrams, placebo, or active comparator.
Background glucose-lowering therapy in the SURPASS studies included various combinations of metformin, SGLT2 inhibitors, sulfonylurea, titrated insulin glargine, or no background glucose-lowering therapy at all.
Comparator treatments in the SURPASS studies included placebo, Ozempic 1 milligram, titrated Tresiba, and titrated insulin glargine.
The primary endpoint across the SURPASS studies was the mean change in A1C from baseline at 40 or 52 weeks.
Mounjaro demonstrated superior A1C reductions across the SURPASS clinical studies. In the SURPASS-1 and -5 placebo-controlled studies, mean reductions in A1C from baseline to week 40 for the Mounjaro 5-, 10-, and 15-milligram groups ranged from 1.7% to 2.4% compared with 0.1% to 0.9% for the placebo groups.
Adverse reactions in the pool of placebo-controlled studies reported in at least 5% of patients taking Mounjaro included nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.
Treatment discontinuation due to gastrointestinal-related adverse events ranged from 3.0% to 6.6% for the Mounjaro 5-, 10-, and 15-milligram groups, compared to 0.4% for the placebo groups.
[Select Important Safety Information]
Contraindications
Mounjaro is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with known serious hypersensitivity to tirzepatide or any of the excipients in Mounjaro. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with Mounjaro.
Risk of Thyroid C-cell Tumors
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. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values greater than 50 nanograms per liter. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.
Acute Pancreatitis
Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, or 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.
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 the signs and symptoms of hypoglycemia.
Hypersensitivity Reactions
Serious hypersensitivity reactions (for example, anaphylaxis and angioedema) have been reported in patients treated with Mounjaro. If hypersensitivity reactions occur, discontinue use of Mounjaro; treat promptly per standard of care, and monitor until signs and symptoms resolve. Do not use in patients with a previous serious hypersensitivity to tirzepatide or any of the excipients in Mounjaro. Use caution in patients with a history of angioedema or anaphylaxis with a GLP-1 receptor agonist because it is unknown if such patients will be predisposed to these reactions with Mounjaro.
Acute Kidney Injury Due to Volume Depletion
There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists, or Mounjaro. The majority of reported events occurred in patients who experienced gastrointestinal adverse reactions leading to dehydration such as nausea, vomiting, or diarrhea. Monitor renal function in patients reporting adverse reactions to Mounjaro that could lead to volume depletion, especially during dosage initiation and escalation of Mounjaro.
Severe Gastrointestinal Adverse Reactions
Use of Mounjaro has been associated with gastrointestinal adverse reactions, sometimes severe. In the pool of placebo-controlled trials, severe gastrointestinal adverse reactions occurred more frequently among patients receiving Mounjaro (5 milligrams 1.3%, 10 milligrams 0.4%, 15 milligrams 1.2%) than placebo (0.9%). Mounjaro is not recommended in patients with severe gastroparesis.
Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy
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.
Acute Gallbladder Disease
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.
Pulmonary Aspiration During General Anesthesia or Deep Sedation
Mounjaro delays gastric emptying. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking Mounjaro.
Adverse Reactions
The most common adverse reactions reported in greater than or equal to 5% of Mounjaro-treated patients in placebo-controlled trials were nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.
Drug Interactions
When initiating Mounjaro, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia. Mounjaro delays gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications, so caution should be exercised.
Pregnancy
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 tirzepatide. Use only if potential benefit justifies the potential risk to the fetus.
Lactation
There are no data on the presence of tirzepatide in 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.
Females of Reproductive Potential
Advise females 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.
Pediatric Use
Safety and effectiveness of Mounjaro have not been established and use is not recommended in pediatric patients.
Please see the Full Prescribing Information, including Boxed Warning about possible thyroid tumors, including thyroid cancer, and Medication Guide by clicking the links within www.mounjaro.lilly.com/hcp.
Please see Instructions for Use included with the pen.
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