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.
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.
Most common adverse reactions (incidence >5%) are nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation.
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.
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 effectiveness of RYBELSUS® have not been established in pediatric patients.
For more information about RYBELSUS®, contact your local sales rep today.