FDA Approves Synjardy XR for Type 2 Diabetes

The U.S. Food and Drug Administration has approved Synjardy XR (empagliflozin and metformin hydrochloride extended-release) tablets for adults with type 2 diabetes.

When used along with diet and exercise, SYNJARDY XR is indicated to improve blood sugar in adults with type 2 diabetes when both empagliflozin and metformin can be taken. It is marketed by Boehringer Ingelheim and Eli Lilly and Company.
Synjardy Label - Synjardy for Type 2 Diabetes
Approximately 29 million Americans and an estimated 415 million people worldwide have diabetes, and nearly 28 percent of Americans with diabetes – totaling 8 million people – are undiagnosed. In the U.S., approximately 12 percent of those aged 20 and older have diabetes.

Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diagnosed adult diabetes cases in the U.S. Diabetes is a chronic condition that occurs when the body does not properly produce or use the hormone insulin.

SYNJARDY XR is a combination of empagliflozin and metformin – two medicines with complementary mechanisms of action – to help improve blood glucose in adults with type 2 diabetes. Empagliflozin, a sodium-glucose co-transporter 2 inhibitor, removes excess glucose through the urine by blocking glucose re-absorption in the kidney.

SYNJARDY XR is the fourth FDA-approved treatment that contains empagliflozin. Metformin, a commonly prescribed initial treatment for type 2 diabetes, lowers glucose production by the liver and its absorption in the intestine.

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“Adults with type 2 diabetes often take multiple medications, sometimes more than once a day, to manage their condition,” said Paul Fonteyne, president and CEO, Boehringer Ingelheim Pharmaceuticals, Inc. “With SYNJARDY XR, the eighth FDA-approved treatment to emerge from our partnership with Lilly, adults with type 2 diabetes now have another convenient daily option to help them reach their glycemic goals, whether they are already being treated or are just at the beginning of their treatment.”

The FDA approval of SYNJARDY XR is based on results from multiple clinical trials examining the co-administration of empagliflozin and metformin, alone or in combination with sulfonylurea, in the treatment of adults with type 2 diabetes. SYNJARDY XR is not for the treatment of type 1 diabetes or diabetic ketoacidosis.

SYNJARDY XR can cause serious side effects, including lactic acidosis (a buildup of lactic acid in the blood). Metformin, one of the medicines in SYNJARDY XR, can cause lactic acidosis, a rare, but serious condition that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. SYNJARDY XR can cause dehydration, low blood pressure and increased ketones in the blood (ketoacidosis).

What is SYNJARDY XR?

SYNJARDY XR is a prescription medicine that contains 2 diabetes medicines, empagliflozin and metformin. SYNJARDY XR can be used along with diet and exercise to improve blood sugar in adults with type 2 diabetes when both metformin and empagliflozin can be taken.

Who should not take SYNJARDY XR?

SYNJARDY XR is not for people with type 1 diabetes, or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

Do not take SYNJARDY XR if you:

  • have moderate to severe kidney problems or are on dialysis
  • have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine)
  • are allergic to empagliflozin, metformin, or any of the ingredients in SYNJARDY XR. Symptoms of serious allergic reactions to SYNJARDY XR may include skin rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing. If you have any of these symptoms, stop taking SYNJARDY XR and contact your doctor or go to the nearest emergency room right away

Source: Lilly / Synjardy

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