The FDA has approved the expanded indication for Synjardy (empagliflozin and metformin hydrochloride) tablets (Eli Lilly and Boehringer Ingelheim), to include treatment-naïve adults with type 2 diabetes.

Indication: Synjardy is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate.

Dosage and administration: Individualize the starting dose based on the patient’s current regimen. The maximum recommended dose is 12.5 mg empagliflozin/1000 mg metformin twice daily. Take twice daily with meals, with gradual dose escalation to reduce the gastrointestinal side effects due to metformin. Assess renal function before initiating.

Adverse reactions: The most common adverse reactions associated with empagliflozin (≥5% incidence) are urinary tract infection and female genital mycotic infections. The most common adverse reactions associated with metformin (>5%) are diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache.

Citation: U.S. FDA expands indication for type 2 diabetes treatment Synjardy® (empagliflozin/metformin hydrochloride) to include treatment-naïve adults). [news release]. Ridgefield, CT: Eli Lilly; July 19, 2016: https://investor.lilly.com/releaseDetail.cfm?ReleaseID=980079. Accessed July 25, 2016.