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GLP-1 RA Expert Insights from Dr Richard Pratley Part 2

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Novo Nordisk HCP Video Library

Please click here to see the Prescribing Information—https://bit.ly/2OiAhVt.

Please click here to see the Important Safety Information—https://bit.ly/2PnElzx.

Hear from GLP1 expert, Dr Richard Pratley, as he explains the SUSTAIN 7 Trial results and how Ozempic® (semaglutide) injection 0.5 mg or 1 mg compared to Trulicity® in reducing and controlling A1C.

Learn more about the SUSTAIN 7 Trial—https://bit.ly/3PsegiJ.

Important Safety Information

BOXED WARNING: RISK OF THYROID CCELL TUMORS
• In rodents, semaglutide causes dosedependent and treatmentdurationdependent thyroid Ccell tumors at clinically relevant exposures. It is unknown whether Ozempic® causes thyroid Ccell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutideinduced rodent thyroid Ccell tumors has not been determined.
• Ozempic® 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 Ozempic® and inform them of symptoms of thyroid tumors (eg, 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 Ozempic®.

Indications and Limitations of Use

Ozempic® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes mellitus and established CV disease.
• Ozempic® has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
• Ozempic® is not indicated for use in patients with type 1 diabetes mellitus.

Important Safety Information (cont’d)

Contraindications
• Ozempic® is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a hypersensitivity reaction to semaglutide or to any of the excipients in Ozempic®. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with Ozempic®.

Warnings and Precautions
• Risk of Thyroid CCell Tumors: Patients should be referred to an endocrinologist for further evaluation if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging.
• Pancreatitis: Acute and chronic pancreatitis have been reported in clinical studies. Observe patients carefully for signs and symptoms of pancreatitis (persistent severe abdominal pain, sometimes radiating to the back with or without vomiting). If pancreatitis is suspected, discontinue Ozempic® promptly, and if pancreatitis is confirmed, do not restart.
• Diabetic Retinopathy Complications: In a 2year trial involving patients with type 2 diabetes and high cardiovascular risk, more events of diabetic retinopathy complications occurred in patients treated with Ozempic® (3.0%) compared with 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. The effect of longterm glycemic control with semaglutide on diabetic retinopathy complications has not been studied. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.
• Never Share an Ozempic® Pen Between Patients: Ozempic® pens must never be shared between patients, even if the needle is changed. Pensharing poses a risk for transmission of bloodborne pathogens.
• Hypoglycemia: Patients receiving Ozempic® in combination with an insulin secretagogue (eg, 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 GLP1 receptor agonists. Some of these events have been reported in patients without 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 Ozempic® in patients reporting severe adverse gastrointestinal reactions.

Click here: https://bit.ly/2PnElzx, or see video above for additional Important Safety information.

posted by florin6r