Segluromet for treating type 2 diabetes

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.
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Ademlog for treating diabetes

FDA Approves Admelog (insulin lispro) Short-Acting "follow-on" insulin product to treat diabetes, it is a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Diabetes increases the risk of serious health complications, including heart disease, blindness, and nerve and kidney damage. Improvement in blood sugar control through treatment with insulin, a common treatment, can reduce the risk of some of these long-term complications.

Admelog is a short-acting insulin product, which can be used to help patients with diabetes control their blood sugar. Short-acting insulin products are generally, but not always, administered just before meals to help control blood sugar levels after eating. These types of insulin products can also be used in insulin pumps to meet both background insulin needs as well as mealtime insulin needs. This is in contrast to long-acting insulin products, like insulin glargine, insulin degludec and insulin detemir, which are generally used to provide a background level of insulin to control blood sugars between meals, and are administered once or twice a day.

While both types of insulin products can play important roles in the treatment of types 1 and 2 diabetes mellitus, patients with type 1 diabetes require both types of insulin while patients with type 2 diabetes may never need a short-acting insulin product. Admelog can be administered by injection under the skin (subcutaneous), subcutaneous infusion (i.e., via insulin pump), or intravenous infusion. Dosing of Admelog should be individualized based on the route of administration and the patient’s metabolic needs, blood glucose monitoring results and glycemic control goal.

The most common adverse reactions associated with Admelog in clinical trials was hypoglycemia, itching, and rash. Other adverse reactions that can occur with Admelog include allergic reactions, injection site reactions, and thickening or thinning of the fatty tissue at the injection site (lipodystrophy). Admelog should not be used during episodes of hypoglycemia (low blood sugar) or in patients with hypersensitivity to insulin lispro or one of its ingredients. Admelog SoloStar prefilled pens or syringes must never be shared between patients, even if the needle is changed.

Admelog may cause low blood sugar (hypoglycemia), which can be life-threatening. Patients should be monitored more closely with changes to insulin dosage, co-administration of other glucose-lowering medications, meal pattern, physical activity and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness. Accidental mix-ups between insulin products can occur, patients should check insulin labels before injecting the insulin product. Severe life-threatening, generalized allergic reactions, including anaphylaxis, may occur.
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