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

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^® is not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans.

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^®.
 

Gangi

My day generally starts at 5 o’clock. I try to read, I look up journals, spend time to empower myself with more knowledge. When I read about studies and drugs that are in the pipeline, I get very excited. I will have one more option for my patients.

"Good Afternoon, I'm Doctor Gangi. I'm Doctor Gangi, nice to meet you."

I'm Doctor Sumana Gangi, I am a board-certified endocrinologist. I always wanted to be a doctor. I didn't think of anything else, actually.

"Tell me, what brought you here today."

In regards to my specialty, endocrinology. I lost my grandmother to diabetes and its complications. At that time there wasn’t much awareness about diabetes. She deteriorated very quickly and passed away. So that's been a driving force in terms of choosing the specialty.

"Tell me about your day. When is your first meal?"

Diabetes is an epidemic. People don't understand what it is doing to their body because they don't feel anything.

"Do you have any trouble with your feet?"

That's why it's very hard to explain to the patients that even though they feel fine, they are not fine.

"I see you are already on maximum doses of metformin."

Around 2014 is when I first heard about the oral GLP-1 receptor agonist therapy that was being studied. At that time, I was very skeptical about how the peptide in a pill form is going to work because until now we didn't have any peptides in a pill form because we know they get degraded by the stomach acid. What cleared my skepticism was the clinical studies that I looked at. "How are you?"

My first patient that I prescribed RYBELSUS^® was a 40-year-old female. Patient is on metformin maximum tolerated dose and diet and exercise. But her sugars were not controlled.

"I think it's time to talk about additional medication. Adding on to metformin."

Initially I thought about prescribing Jardiance^® for this patient, but by looking at the head-to-head study comparing RYBELSUS^® to Jardiance^® in PIONEER 2, because of the significant improvement in the A1C, I chose RYBELSUS^® over Jardiance^®.

In a head-to-head study, RYBELSUS^® delivered superior A1C reduction versus Jardiance^®. On average, patients on RYBELSUS^® 14 milligrams had reductions of 1.3%, compared to 0.9% with Jardiance^® 25 milligrams. In the same study, RYBELSUS^® delivered comparable weight loss versus Jardiance^®, with patients on average losing 8.4 pounds on RYBELSUS^® 14 milligrams, compared to 8.1 pounds with Jardiance^® 25 milligrams.
 

Gangi

When you see patients with the type 2 diabetes, it's a day-to-day struggle trying to keep their blood sugars under control. So I want to be more proactive and start RYBELSUS^® early on.

“Let's look at your results. Your A1C looks great, it's 6.8 now. Three months ago it was 8.1.”

My patient was very happy and more motivated to keep doing what she's doing in terms of her diet and exercise.

"And you did lose some weight. Excellent."

As we have seen in the clinical studies, as well as my experience using RYBELSUS^®, it is a great drug to add on to metformin.

"Excellent. It's time for celebration."

I would like to encourage my primary care colleagues to start RYBELSUS^® very early on, right after metformin with their diet and exercise when the patients A1C are not at goal. That way, we can be more proactive than reactive. 20 years ago, when my grandmother was suffering from diabetes, medication options were limited. We now know so many resources that can help our patients. I wish I had more options for my grandmother at that time.

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 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.
The most common adverse reactions, reported in greater than or equal to 5% of patients treated with RYBELSUS^® are nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation.

Drug interactions.
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 efficacy of RYBELSUS^® have not been established in pediatric patients (younger than 18 years).

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