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FDA approved Synjardy XR (empagliflozin/metformin HCl ER) for Type 2 DiabetesFDA approved new once-daily pill for adults with type 2 diabetes.

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Key Takeaway
Consider Synjardy XR for adults with type 2 diabetes needing combination therapy, but avoid in type 1 diabetes and eGFR <45.

The FDA has approved Synjardy XR (empagliflozin and metformin HCl extended-release) for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. This fixed-dose combination tablet pairs the SGLT2 inhibitor empagliflozin with extended-release metformin, offering a once-daily option for patients who may benefit from both mechanisms. The approval expands the available formulations of this combination, which was previously available as an immediate-release product (Synjardy).

Clinically, the approval provides a convenient once-daily dosing regimen that may improve adherence. The label also includes indications for empagliflozin, when used as a component of Synjardy XR, to reduce the risk of cardiovascular death in adults with established cardiovascular disease, and to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. Additionally, it is indicated to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression.

However, the label notes that Synjardy XR is not recommended for glycemic control in patients with type 1 diabetes due to increased risk of diabetic ketoacidosis. Because of the metformin component, its use is limited to type 2 diabetes for all indications. Clinicians should assess renal function and volume status before initiating therapy.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Synjardy XR combines empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and metformin HCl, a biguanide. Empagliflozin reduces renal glucose reabsorption, increasing urinary glucose excretion. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity.

Indication & Patient Population

Synjardy XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin, when used as a component of Synjardy XR, is also indicated in adults with type 2 diabetes to reduce the risk of: cardiovascular death in adults with established cardiovascular disease; cardiovascular death and hospitalization for heart failure in adults with heart failure; and sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression. Limitations of use: Not recommended for glycemic control in type 1 diabetes; use limited to type 2 diabetes due to metformin component; not recommended for chronic kidney disease in patients with polycystic kidney disease or those requiring or with recent history of intravenous immunosuppressive therapy or >45 mg prednisone equivalent for kidney disease.

Dosing & Administration

Assess renal function before initiating and as clinically indicated. Assess volume status and correct volume depletion before initiating. Individualize starting dosage based on current regimen and renal function. Maximum recommended dosage is 25 mg/day empagliflozin and 2,000 mg/day metformin HCl. Initiation is not recommended if eGFR <45 mL/min/1.73 m². Take orally once daily with a meal in the morning; swallow whole, do not split, crush, dissolve, or chew. Gradual dosage escalation is recommended to reduce gastrointestinal adverse reactions. May need to discontinue at time of iodinated contrast imaging; withhold at least 3 days prior to surgery or procedures associated with prolonged fasting.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Warnings include risk of diabetic ketoacidosis in type 1 diabetes, lactic acidosis due to metformin, and volume depletion. Not recommended in patients with type 1 diabetes. Contraindications not explicitly listed in the provided label text.

Place in Therapy

Synjardy XR provides a once-daily fixed-dose combination of empagliflozin and extended-release metformin for adults with type 2 diabetes. It may be considered for patients needing both an SGLT2 inhibitor and metformin, particularly those with cardiovascular or kidney disease where empagliflozin has shown benefit. However, it is not recommended for type 1 diabetes or for glycemic control in patients with type 1 diabetes.

The U.S. Food and Drug Administration has approved a new medication called Synjardy XR for adults with type 2 diabetes. This pill combines two diabetes drugs: empagliflozin and extended-release metformin. It is taken once a day and is meant to be used along with diet and exercise to improve blood sugar control. The approval provides a new option for patients who may benefit from both medicines in a single daily dose, which could make it easier to stick to a treatment plan.

Synjardy XR is for adults with type 2 diabetes. It is not for people with type 1 diabetes, because it may increase the risk of a serious condition called diabetic ketoacidosis. The medication also has additional approved uses for certain people with heart or kidney disease. Specifically, it can help reduce the risk of death from heart problems in adults with established heart disease, and it can lower the risk of heart failure hospitalizations and kidney disease progression in some patients.

This approval is important because it gives doctors and patients another tool to manage diabetes and related health risks. However, it is not a cure for diabetes, and it does not replace the need for a healthy lifestyle. Before starting this medicine, doctors should check kidney function and fluid levels to make sure it is safe for each patient.

If you have type 2 diabetes and are interested in this new option, talk to your doctor. They can help you decide if Synjardy XR is right for you based on your medical history and current health. Always follow your doctor's advice about your diabetes care.

What this means for you:
Synjardy XR is a new once-daily pill for type 2 diabetes that also helps some people with heart or kidney issues. Talk to your doctor to see if it's right for you.

Study Details

Study typeFda approval
PublishedDec 2016
View Original Abstract ↓
1 INDICATIONS AND USAGE SYNJARDY SYNJARDY is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin hydrochloride (HCl) immediate-release, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. SYNJARDY XR SYNJARDY XR is a combination of empagliflozin, a SGLT2 inhibitor and metformin HCl extended-release, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . Empagliflozin Empagliflozin, when used as a component of SYNJARDY or SYNJARDY XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: Cardiovascular (CV) death in adults with established CV disease. ( 1 ) CV death and hospitalization for heart failure in adults with heart failure. ( 1 ) Sustained decline in eGFR, end-stage kidney disease, CV death, and hospitalization in adults with chronic kidney disease at risk of progression. ( 1 ) Limitations of Use : Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. ( 1 ) Because of the metformin HCl component, the use of SYNJARDY or SYNJARDY XR is limited to patients with type 2 diabetes mellitus for all indications. ( 1 ) Empagliflozin, when used as a component of SYNJARDY or SYNJARDY XR, is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of intravenous immunosuppressive therapy or greater than 45 mg of prednisone or equivalent for kidney disease. Empagliflozin is not expected to be effective in these populations. ( 1 ) SYNJARDY SYNJARDY is a combination of empagliflozin and metformin hydrochloride (HCl) immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus . SYNJARDY XR SYNJARDY XR is a combination of empagliflozin and metformin HCl extended-release indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . Empagliflozin Empagliflozin, when used as a component of SYNJARDY or SYNJARDY XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: • Cardiovascular (CV) death in adults with established CV disease. • CV death and hospitalization for heart failure in adults with heart failure. • Sustained decline in eGFR, end-stage kidney disease, CV death, and hospitalization in adults with chronic kidney disease at risk of progression. Limitations of Use • SYNJARDY and SYNJARDY XR are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.2) ] . • Because of the metformin HCl component, the use of SYNJARDY or SYNJARDY XR is limited to patients with type 2 diabetes mellitus for all indications. • Empagliflozin, when used as a component of SYNJARDY or SYNJARDY XR, is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of intravenous immunosuppressive therapy or greater than 45 mg of prednisone or equivalent for kidney disease [see Clinical Studies (14.5) ] . Empagliflozin is not expected to be effective in these populations.
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