Cardiovascular: Heart Rate Increase and PR Interval Prolongation
OZEMPIC® causes an increase in heart rate. Caution should be observed in patients who have cardiac conditions that might be worsened by an increase in heart rate, such as tachyarrhythmias. OZEMPIC® also causes a prolongation of the PR interval of the electrocardiogram. Caution should be observed in patients with pre-existing conduction system abnormalities (e.g., marked first-degree AV block or second- or third-degree AV block) or a history of rhythm disturbances. There is no therapeutic experience in patients with congestive heart failure NYHA class IV.[4]Section 7, page 9
Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
Patients receiving OZEMPIC® in conjunction with sulfonylurea or basal insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin when initiating treatment with OZEMPIC®.[4]Section 7, page 9
Gastrointestinal
Use of GLP-1 receptor agonists may be associated with severe gastrointestinal disease (ileus). Events of delayed gastric emptying, dysgeusia, intestinal obstruction, and ileus have been reported in the post-marketing database with an unknown frequency. Semaglutide-treated patients with gastroparesis may experience more serious or severe gastrointestinal adverse events. Semaglutide should be used with caution in these patients.[5]Section 7, page 10
Hepatic/Biliary/Pancreatic: Pancreatitis and Acute Gall Bladder Disease
Acute pancreatitis has been observed with the use of GLP-1 receptor agonists. In glycemic control trials, acute pancreatitis was confirmed by adjudication in 7 OZEMPIC®-treated patients (0.3 cases per 100 patient years) versus 3 in patients treated with another GLP-1 receptor agonist. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, OZEMPIC® should be discontinued; if confirmed, OZEMPIC® should not be restarted. Consider anti-diabetic therapies other than OZEMPIC® in patients with a history of pancreatitis. Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and post-market. If cholelithiasis or cholecystitis are suspected, gallbladder studies and appropriate clinical follow-up are indicated.[5]Section 7, page 10
Hypersensitivity
Serious hypersensitivity reactions, including anaphylaxis, may occur with any GLP-1 receptor agonist, including OZEMPIC®. If a hypersensitivity reaction occurs, the patient should discontinue OZEMPIC® and promptly seek medical advice. Do not use in patients with a previous hypersensitivity to OZEMPIC®. Caution should be exercised with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to anaphylaxis with OZEMPIC®.[5]Section 7, page 10
Diabetic Retinopathy Complications and NAION
In a 2-year 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 to placebo (1.8%). 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. Data from epidemiological studies may indicate an increased risk of non-arteritic anterior ischaemic optic neuropathy (NAION) with a very rare frequency during treatment with semaglutide. Patients reporting a sudden loss of vision should be urgently referred for ophthalmological examination and treatment with semaglutide should be discontinued if NAION is confirmed.[6]Section 7, page 11
Perioperative Considerations: Aspiration Risk
OZEMPIC® delays gastric emptying. Pulmonary aspiration has been reported in patients receiving GLP-1 receptor agonists undergoing general anaesthesia or sedation. This should be considered prior to such procedures.[6]Section 7, page 11
Renal Insufficiency
Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. This should be considered when treating patients with impaired renal function as nausea, vomiting, and diarrhea may cause dehydration which could cause a deterioration of renal function. In patients treated with GLP-1 receptor agonists, there have been post-marketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.[6]Section 7, page 11