Navigating T2D Together
[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.
[Healthcare Professional]
Hi, I'm Stacy Brown. I'm a nurse practitioner and I specialize in endocrinology. And today I'm here with Bob and Nancy just to kind of share their experience and their journey with type 2 diabetes.
Bob, Nancy, thank you so much for joining me today. I truly appreciate it. And wow, what a journey you have been on with your type 2 diabetes. Just amazing to see the results that you've had.
And–but let's go back, let's go back to 18 months ago. I know, Bob, your journey with type 2 has been longer than that, but let's kind of go from when I first saw you 18 months ago. What brought you to me in the first place?
[Patient: Nancy]
Oh, well, I was seeing my primary care physician. I had just been diagnosed with type 2 diabetes a year before that. So we had been on some medications, but then he referred me to you.
[Healthcare Professional]
Bob, I saw you shortly after, but you had been diagnosed before.
What brought you in?
[Patient: Bob]
I was diagnosed with type 2 diabetes 13 years ago.
So after our primary care physician referred Nancy to you, I started seeing a change in her. And shortly thereafter, I had an appointment to go back to my primary physician.
I asked him, I said, “What are the chances that I can maybe come to see you too, see if you might be able to help me?” And he referred me to you.
[Healthcare Professional]
So, 2 people living in the same house with diabetes, I’m sure that affected so many things.
What was a day in the life of Bob and Nancy prior to 18 months ago?
[Patient: Nancy]
18 months ago, we–well, I work from home, so I did not really leave the house hardly any of the daytime at all. And so we had that part of a different life. But eating was hard for both of us to plan our meals and know to eat healthy too, because a lot of times he would be out on the road and eat fast foods, and then it was just hard to do, but now we are planning every day.
[Healthcare Professional]
That's amazing. That's so great. You know, when I first heard about Mounjaro, we had seen it in the medical world in kind of the preliminary phases. And when I think of people like you guys, I thought this is something that can help them.
You know, talk to me a little bit about Mounjaro and kind of that initiation. Was it scary when I said, “Okay, it's an injection, it's once a week, but it's an injection”? Was that “No, that's a hard ‘no’ for me” or were you open to that when we first talked about it?
Tell me a little bit about that.
[Patient: Nancy]
I didn’t have issues with the shots, but he was not really a shot person.
[Patient: Bob]
In the beginning, I mean, again, the things that we had tried, it didn't seem anything worked to our satisfaction, but I first thought it might be a pill. Then when I heard it was an injection, I thought, Well, you know, I'm at the point I want to try whatever it's going to take to be able to get my A1C in check.
[Healthcare Professional]
Bob, can you describe the very first time that you used Mounjaro?
[Patient: Bob]
Well, we had gotten the prescription picked up at our local pharmacy, and we kept it in the refrigerator. In the morning, we were supposed to give ourselves the injections.
[Healthcare Professional]
That's great. And y’all started these at the same time.
I think you have a unique experience because you're doing this both together. How does Mounjaro–how does giving this injection fit into your weekly routine?
[Patient: Bob]
Well, it's become a Thursday morning, is when we do it. We make sure that we don't skip it or miss it. And there was 1 week that we forgot Thursday morning to take it and we ended up taking it Thursday afternoon, which that was fine, but I told Nancy, I said, “We're not going to forget anymore.”
So every Wednesday, I make sure we have a little note, says “shot,” and we tape it on our bathroom mirror, so when we get up first thing that morning, if we don't go in there to take it out of the refrigerator, we go in there and we see that note. One of us will go in there and get it out and get, you know, so we don't forget, we take it every Thursday morning.
[Healthcare Professional]
That's perfect.
And I really do think you have a unique experience because you got to do that together.
[Patient: Bob]
It's been like a team effort and I'm just thankful for the opportunity because, you know, for the 10 years that I was diagnosed with type 2 diabetes, I–you know, I tried several things and it just didn't seem to work.
But now, there's something that works and it's got us on the right track. And again, we're doing it together.
[Healthcare Professional]
This question goes to both of you. Now that your A1C is under control, what has changed? What is different in your lives?
[Patient: Nancy]
Now that our A1C is under control, I think we are more motivated to live a fuller life and do more things to be more active. We just–we don't stop.
[Patient: Bob]
I mean, the A1C is–it's getting it in check has really been our priority. And now with Mounjaro, we've been able to accomplish that. And the motivation is there to do more things, whether it's take the dog for a walk or spending our time with our granddaughter and doing things with her.
[Healthcare Professional]
Well, thank you both for being here. And from my perspective, it has been a joy to watch both of you in this journey.
Thank you for trusting me when we talked about a new medication 18 months ago and kind of jumping in and doing this together. It has been amazing to watch. And I am so proud. I'm so proud of both of you. And I'm glad to be just a small part in your journey.
[Patient: Bob]
We appreciate it. Thank you very much.
[Patient: Nancy]
Thank you, Stacy.
[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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