FDA Approves Segluromet (ertugliflozin and metformin hydrochloride) for Type 2 Diabetes. Segluromet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing ertugliflozin or metformin, or in patients who are already treated with both ertugliflozin and metformin.
Segluromet is not recommended in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. The labeling for Segluromet contains a boxed warning for lactic acidosis. Segluromet is contraindicated in patients with severe renal impairment, end-stage renal disease or on dialysis, acute or chronic metabolic acidosis, including diabetic ketoacidosis, or a history of a serious hypersensitivity reaction to Segluromet, ertugliflozin or metformin hydrochloride.
Segluromet combines 2.5 mg or 7.5 mg of ertugliflozin with 500 mg or 1,000 mg of metformin hydrochloride. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.
If metformin-associated lactic acidosis is suspected, immediately discontinue Segluromet (ertugliflozin and metformin hydrochloride) and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. Ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, has been reported in patients with type 1 and type 2 diabetes receiving SGLT2 inhibitors, including ertugliflozin. Some cases were fatal. Assess patients with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If ketoacidosis is suspected, Segluromet should be discontinued, patient should be evaluated, and prompt treatment should be instituted.
Before initiating Segluromet, consider risk factors for ketoacidosis, including pancreatic insulin deficiency from any cause, caloric restriction, and alcohol abuse. In patients treated with Segluromet, consider monitoring for ketoacidosis and temporarily discontinuing Segluromet in clinical situations known to predispose to ketoacidosis (e.g., prolonged fasting due to acute illness or surgery).
Segluromet causes intravascular volume contraction and can cause renal impairment.
There have been reports of acute kidney injury, some requiring hospitalization and dialysis, in patients receiving SGLT2 inhibitors. Before initiating Segluromet, consider factors that may predispose patients to acute kidney injury. Consider temporarily discontinuing Segluromet in any setting of reduced oral intake or fluid losses; monitor patients for signs and symptoms of acute kidney injury. If acute kidney injury occurs, discontinue Segluromet promptly and institute treatment.
haleplushearty.blogspot.com
No comments:
Post a Comment