Jardiance Vs. Synjardy: Drug Comparison

Jardiance^® (empagliflozin) is an oral medication used to improve blood sugar control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus, as an adjunct to diet and exercise. It is also indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. Additionally, Jardiance helps reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. It is also used to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression. This medication works as a sodium-glucose co-transporter 2 (SGLT2) inhibitor, promoting the excretion of glucose through the urine​.

Synjardy^® is a combination medication containing empagliflozin and metformin, used to improve blood sugar control in adults with type 2 diabetes. Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that reduces glucose reabsorption in the kidneys, promoting glucose excretion through urine, while metformin decreases glucose production by the liver and improves insulin sensitivity. Its FDA-approved indication is for the treatment of type 2 diabetes, in conjunction with diet and exercise, to help manage blood sugar levels. Synjardy is available in tablet form, typically taken twice daily. Common side effects include urinary tract infections, diarrhea, headache, and nausea, and it carries a boxed warning for the risk of lactic acidosis, a rare but serious complication associated with metformin use.

Sodium-glucose co-transporter 2 (SGLT2) inhibitor

Empagliflozin: sodium-glucose co-transporter 2 (SGLT2) inhibitor

Metformin hydrochloride: biguanide

Jardiance (empagliflozin) is indicated:

• To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure

• To reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression

• To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease

• 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 (empagliflozin and metformin hydrochloride) is 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

Empagliflozin, when used as a component of Synjardy, is indicated in adults with type 2 diabetes mellitus 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

• Typically taken orally once daily

• Comes in 10 mg and 25 mg tablets

• Typically taken orally twice daily

• Comes in 5 mg/500 mg, 5 mg/1,000 mg, 12.5 mg/500 mg, and 12.5 mg/1,000 mg tablets

Most common adverse reactions (5% or greater incidence) were:

• Urinary tract infections

• Female genital fungal infections

Most common adverse reactions associated with empagliflozin (5% or greater incidence) were:

• Urinary tract infections

• Female genital fungal infections

Most common adverse reactions associated with metformin (>5%) are:

• Diarrhea

• Nausea/Vomiting

• Flatulence

• Abdominal discomfort

• Indigestion

• Weakness

• Headache

• Hypersensitivity to empagliflozin or any of the excipients in Jardiance

• See the Full Prescribing Information for information on drug interactions and interference of Jardiance with laboratory tests

• Severe renal impairment (eGFR below 30 mL/min/1.73 m²), end stage renal disease, or on dialysis

• Metabolic acidosis, including diabetic ketoacidosis

• Hypersensitivity to empagliflozin, metformin or any of the excipients in Synjardy

• Drug interactions: carbonic anhydrase inhibitors, drugs that reduce metformin clearance

• See the Full Prescribing Information for additional drug interactions and information on interference of Synjardy with laboratory tests

• Diabetic ketoacidosis in patients with type 1 diabetes mellitus and other ketoacidosis

• Volume depletion

• Urosepsis and pyelonephritis

• Low blood sugar

• Necrotizing fasciitis of the perineum (Fournier's gangrene)

• Genital fungal infections

• Lower limb amputation

• Hypersensitivity reactions

• Pregnancy: Potential risk to a fetus especially during the second and third trimesters

• Breastfeeding: Not recommended when breastfeeding

• Diabetic ketoacidosis in patients with type 1 diabetes mellitus and other ketoacidosis

• Volume depletion

• Urosepsis and pyelonephritis: Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.

• Low blood sugar: Adult patients taking an insulin secretagogue or insulin may have an increased risk of hypoglycemia

• Necrotizing fasciitis of the perineum (Fournier's gangrene)

• Genital fungal infections

• Lower limb amputation

• Hypersensitivity reactions

• Vitamin B12 deficiency

• Pregnancy: Advise females of the potential risk to a fetus especially during the second and third trimesters

• Breastfeeding: Not recommended when breastfeeding

• Females and males of reproductive potential: Advise premenopausal females of the potential for an unintended pregnancy

WARNING: LACTIC ACIDOSIS

Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL.

Risk factors include renal impairment, concomitant use of certain drugs, age ≥65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information.

If lactic acidosis is suspected, discontinue Synjardy or Synjardy XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

*This information is from the label for brand name Jardiance^®. See the Full Prescribing Information for more complete information.

*This information is from the label for brand name Synjardy^®. See the Full Prescribing Information for more complete information. Empagliflozin and metformin, the active ingredients in Synjardy, may also be the active ingredients in other medications, and this information may not be accurate for all medications that include the active ingredients empagliflozin and metformin.