"Good. You too. How are you?"
The first time I prescribed RYEBLSUS® was in a patient who was a 58-year-old Caucasian male on metformin therapy with an A1C 8%, so he was exercising already.
"It looks like you've been losing some weight. Have you been getting some exercise in as well?"
So I followed up with him and his A1C was down to 6.6%.
"I cannot believe how awesome your A1C came back. You take care and I'll see you soon, OK?"
I'm not sure who was more excited, him or myself. We knew that this was going to be a good option for many more patients to come. If I have one therapy that I can start a patient on after metformin, I would start RYBELSUS® based on the strength of the A1C reduction.
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% of 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.
One of the best things both patients and providers can do is to be proactive in managing patients’ diabetes. "We're going to get to learn a lot about you today."
With RYBELSUS® being an oral GLP-1 option, it definitely opens the doors for primary care providers to prescribe early on and regularly after somebody, for example, fails metformin therapy.
With having a diagnosis of diabetes myself, I feel that I'm able to connect at a different level with my patients. Going back to the struggles that I walked away with after my diagnosis, I would tell myself, you're going to do a greater amount of good for a higher number of people.
This is only going to make you stronger.
Important Safety Information.
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.
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.
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.
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.
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.
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.
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.
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.
Safety and efficacy of RYBELSUS® have not been established in pediatric patients (younger than 18 years).
For more information about RYBELSUS®, contact your local sales rep today.