The FDA has approved Synjardy (empagliflozin/metformin hydrochloride) to help control blood glucose in adults with type 2 diabetes, the drug’s manufacturers announced Aug. 27.
Synjardy, which contains the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin, is indicated as an adjunct to diet and exercise in patients unable to achieve sufficient glycemic control on empagliflozin or metformin, or in patients already being treated with both drugs.
When combined, empagliflozin and metformin offer “complementary mechanisms of action” to help control blood glucose, according to a statement by the manufacturers, Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Co.
“Empagliflozin ... removes excess glucose through the urine by blocking glucose reabsorption in the kidney,” the statement said. Metformin, frequently prescribed as a first-line treatment, lowers glucose production by the liver and its absorption in the intestine.
Synjardy contains a boxed warning for lactic acidosis and should not be used by adults with severe kidney problems or allergies to empagliflozin, metformin, or any other ingredients in the medication. It also should not be used to treat type 1 diabetes or diabetic ketoacidosis.
Common side effects from Synjardy include runny nose, sore throat, urinary tract infections, female genital infections, diarrhea, headache, nausea, and vomiting.
Visit the Boehringer Ingelheim website for full prescribing information. Adverse effects may be reported to the FDA at http://www.fda.gov/medwatch.com.