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FDA Approves Synjardy XR for Adults with T2D

Eli Lilly news release; 2016 Dec 12

The FDA has approved Synjardy XR (empagliflozin/metformin hydrochloride extended-release) tablets for adults with type 2 diabetes. The combination drug is manufactured by Boehringer Ingelheim and Eli Lilly and Co.

Indication: Synjardy XR 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 of Synjardy XR based on the patient’s current regimen. The maximum recommended total daily dose is 25 mg empagliflozin and 2,000 mg metformin. Take once daily with a meal in the morning, with gradual dose escalation to reduce the gastrointestinal side effects due to metformin.

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

Citation:

US FDA approves Synjardy XR (empagliflozin/metformin hydrochloride extended-release) tablets for adults with type 2 diabetes. [news release]. Ridgefield, CN: Eli Lilly and Boehringer Ingelheim; December 12, 2016: https://investor.lilly.com/releasedetail.cfm?ReleaseID=1003818. Accessed December 16, 2016.