PLOSBRIO

). If cholelithiasis or cholecystitis are suspected, gallbladder studies and appropriate clinical follow-up are indicated. Immune Hypersensitivity Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with any GLP-1 receptor agonist, including PLOSBRIO™.

If a hypersensitivity reaction occurs, the patient should discontinue PLOSBRIO™ and promptly seek medical advice. Monitoring and Laboratory Tests Regular self-monitoring of blood glucose is not needed in order to adjust the dose of PLOSBRIO™.

However, when initiating treatment with PLOSBRIO™ in combination with a sulfonylurea or insulin, blood glucose self-monitoring may become necessary to reduce the dose of the sulfonylurea or insulin in order to reduce the risk of hypoglycemia.

However, patients should be informed that response to all diabetic therapies should be monitored by periodic measurement of A1C levels, with a goal of decreasing these levels towards the normal range. A1C is especially useful for evaluating long-term glycemic control.

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.

Long-term glycemic control may decrease the risk of diabetic retinopathy. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy. Perioperative Considerations Aspiration in association with general anaesthesia or sedation.

PLOSBRIO™ 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. Renal 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. Monitor renal function in patients with renal insufficiency reporting severe adverse gastrointestinal reactions (see 8 Adverse Reactions).

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. Some of these events were reported in patients without known underlying renal disease.

A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Because these reactions may worsen renal function, use caution when initiating or escalating doses of PLOSBRIO™ in patients with renal impairment.