Giving my patients the possibilities of RYBELSUS^® with Dr Soboeiro.

Please see Important Safety Information throughout, and link above for Prescribing Information, including Boxed Warning.

Indication and usage.
RYBELSUS^® semaglutide tablets 7 mg or 14 mg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Limitations of use.
RYBELSUS^® has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.

RYBELSUS^® is not indicated for use in patients with type 1 diabetes.

Important safety information. Warning. Risk of thyroid C-cell tumors.
In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether RYBELSUS^® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.

RYBELSUS^® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of RYBELSUS^® 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 RYBELSUS^®.
 

Dr Soboeiro

Practicing medicine in Garner, North Carolina is a special joy because we have it all. We have farmers, we have business executives. When I started in medicine, in Pinehurst, there was not a lot of good diabetes care in the community and patients who are traveling an hour or more just for routine diabetes care. And I felt like I had the skills to do this. I can bring this care to Pinehurst and improve their care.

My name is Dr Michael Soboeiro. I am board certified in internal medicine. I've practiced internal medicine for 27 years with a focus on the primary care of type 2 diabetes. "Hey, Mr Wrightman, how are you? Good to see you. I'll be right in."

In the U.S., there are over 34 million adults with type 2 diabetes.

Those numbers are astounding. "Hey, Mr Martin." There aren't enough endocrinologists to take care of even a fraction of patients. So primary care providers need to become experts in diabetes.

“I'm Dr Soboeiro.”

When a patient is faced with a diagnosis of type 2 diabetes, fearful is probably the best way to describe them initially. They may well have had family members who had diabetes who had severe downstream effects of diabetes. This is what I do every day. My love in medicine is helping people with their type 2 diabetes.

I'm somebody who has paid very close attention to the GLP-1 receptor agonist portfolio for many years. I first saw the data in 2016 that you could use a GLP-1 receptor agonist in an oral form. My skepticism, even when I heard it was coming, was, are they really going to get this in a form that can be absorbed and be clinically effective?

But when you saw the studies, the light went on, this looks like it really is effective. "Let me examine you briefly."

My first thought when RYBELSUS^® came out was this is going to be great for primary care. And the first lady who walked in, a 54-year-old patient who was on metformin along with diet and exercise, she had an A1C of 7.9.

"RYBELSUS^® can add to metformin to start moving things in the right direction." I might have given that patient Januvia^®, but I added RYBELSUS^® to her regimen and she had an excellent improvement. Her A1C dropped from 7.9 to below seven and she had an 8-pound weight reduction with RYBELSUS^®. As I saw how effective this therapy was, I began to use it more.

The more I used it, the more comfortable I was and the better my results. "Mr Wrightman."

In a head-to-head study RYBELSUS^® delivered superior A1C reduction versus Januvia^®. On average, patients on RYBELSUS^® 14 milligrams had reductions of 1.3% and 1% on 7 milligrams, compared to 0.8% with Januvia^® 100 milligrams. In the same study, RYBELSUS^® delivered superior weight loss versus Januvia^®, with patients on average losing 6.8 pounds on RYBELSUS^® 14 milligrams and 4.8 pounds on 7 milligrams, compared with losing 1.3 pounds on Januvia^® 100 milligrams.

Whenever you present to your colleagues. Sometimes the lectures aren't that exciting, but when you talk about RYBELSUS^® the people who are listening come up to me afterward and they ask questions.

"We need more primary care providers to understand the armamentarium of diabetes." And it's exciting. The prospect that I'm doing good, not just with my own patients, but I'm doing good helping other practitioners with their patients.

It always gives you a very warm feeling in your heart to know that you've helped people achieve their best health.

Important Safety Information.
Contraindications.
RYBELSUS^® is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), and in patients with a prior serious hypersensitivity reaction to semaglutide or to any of the excipients in RYBELSUS^®. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with RYBELSUS^®.

Warnings and precautions.
Risk of thyroid C-cell tumors.
Patients should be further evaluated if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging.

Pancreatitis.
Has been reported in clinical trials. Observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, discontinue RYBELSUS^® and initiate appropriate management; if confirmed, do not restart RYBELSUS^®.

Diabetic retinopathy complications.
In a pooled analysis of glycemic control trials with RYBELSUS^®, patients reported diabetic retinopathy related adverse reactions during the trial (4.2% with RYBELSUS^® and 3.8% with comparator). In a 2-year trial with semaglutide injection involving patients with type 2 diabetes and high cardiovascular risk, more events of diabetic retinopathy complications occurred in patients treated with semaglutide injection (3.0%) compared to placebo (1.8%). The absolute risk increase for diabetic retinopathy complications was larger among patients with a history of diabetic retinopathy at baseline than among patients without a known history of diabetic retinopathy.
Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.

Warnings and precautions.
Hypoglycemia.
Patients receiving RYBELSUS^® in combination with an insulin secretagogue (for example, sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.

Acute kidney injury.
There have been postmarketing reports of acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis in patients treated with GLP-1 receptor agonists, including semaglutide. Some of these events have been reported in patients without a known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Monitor renal function when initiating or escalating doses of RYBELSUS^® in patients reporting severe adverse gastrointestinal reactions.

Hypersensitivity.
Serious hypersensitivity reactions (for example, anaphylaxis, angioedema) have been reported in patients treated with RYBELSUS^®. If hypersensitive reactions occur, discontinue use of RYBELSUS^®, treat promptly per standard of care, and monitor until signs and symptoms resolve. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist.

Acute Gallbladder Disease.
Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials cholelithiasis was reported in 1% of patients treated with RYBELSUS^® 7 mg. Cholelithiasis was not reported in RYBELSUS^® 14 mg or placebo-treated patients. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.

Adverse reactions.
Most common adverse reactions (incidence >5%) are nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation.

Drug interactions.
RYBELSUS^® stimulates insulin release in the presence of elevated blood glucose concentrations.

When initiating, RYBELSUS^®, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia.

RYBELSUS^® delays gastric emptying and has the potential to impact the absorption of other oral medications. Closely follow RYBELSUS^® administration instructions when coadministering with other oral medications and consider increased monitoring for medications with a narrow therapeutic index, such as levothyroxine.

Use in specific populations.
Pregnancy.
Available data with RYBELSUS^® are not sufficient to determine a 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 RYBELSUS^®. Use only if the potential benefit justifies the potential risk to the fetus.

Lactation.
There are no data on the presence of semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the unknown potential for serious adverse reactions in the breastfed infant due to the possible accumulation of salcaprozate sodium (SNAC), an absorption enhancer in RYBELSUS^®, from breastfeeding and because there are alternative formulations of semaglutide that can be used during lactation, advise patients that breastfeeding is not recommended during treatment with RYBELSUS^®.

Discontinue RYBELSUS^® in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide.

Pediatric use.
Safety and effectiveness of RYBELSUS^® have not been established in pediatric patients.

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