Empagliflozin

Empagliflozin is a prescription medication used to treat the symptoms of Type 2 Diabetes Mellitus and Heart Failure. 

• Empagliflozin is available under the following different brand names: Jardiance

Adult dosage

Tablet

• 10mg
• 25mg

Type 2 Diabetes Mellitus

• 10 mg orally once daily, may increase to 25 mg per day if needed and tolerated

Heart Failure

• 10 mg orally once daily 

Pediatric Dosage

• Safety and efficacy not established in children in younger than 18 years of age

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Empagliflozin include:

• bladder infection, and
• vaginal yeast infection

Serious side effects of Empagliflozin include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, 
• fever, 
• feeling unwell, 
• little or no urination, 
• dizziness, 
• weakness, 
• lightheadedness, 
• nausea, 
• vomiting, 
• stomach pain, 
• confusion, 
• unusual drowsiness, 
• pain or burning during urination, 
• increased urination, 
• blood in the urine, and
• pain in the pelvis or back

Rare side effects of Empagliflozin include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first

• Empagliflozin has severe interactions with no other drugs.
• Empagliflozin has serious interactions with no other drugs.
• Empagliflozin has moderate interactions with at least 38 other drugs.
• Empagliflozin has minor interactions with no other drugs.  

This information does not contain all possible interactions or adverse effects.  Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use.  Keep a list of all your medications with you, and share this information with your doctor and pharmacist.  Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Serious hypersensitivity to empagliflozin (eg, anaphylaxis, angioedema)
• Patients on dialysis

Effects of drug abuse

• None

Short-Term Effects

• See “What are Side Effects Associated with Using Empagliflozin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Empagliflozin?”

Cautions

• Increases serum creatinine and decreases eGFR; risk increased in elderly or those with moderate renal impairment
• Increased incidence of bone fractures reported; American Diabetes Association recommends avoiding sodium glucose cotransporter-2 inhibitors in patients with fracture risk factors
• Genital mycotic infections may occur; patients with history of genital mycotic infections and uncircumcised males are more susceptible
• Increases risk of urinary tract infections (UTIs), including life-threatening urosepsis and pyelonephritis that started as UTIs
• Dose-related increases in LDL-C reported
• No conclusive evidence of macrovascular risk reduction with antidiabetic agent
• Serious hypersensitivity reactions (eg, angioedema) reported; if a hypersensitivity reaction occurs, discontinue treatment; treat promptly per standard of care, and monitor until signs and symptoms resolve
• Volume depletion
  • Intravascular volume depletion, which may manifest as symptomatic hypotension or acute changes in creatinine, occurred
  • Acute kidney injury, some requiring hospitalization and dialysis, in patients with T2DM receiving SGLT2 inhibitors reported
  • Patients with impaired renal function (eGFR <60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension
  • Before initiating therapy in patients with one or more of these characteristics, assess volume status and renal function; in patients with volume depletion, correct this condition before initiating treatment; monitor for signs and symptoms of volume depletion, and renal function after initiating therapy
• Renal function
  • Acute kidney injury reported
  • Consider risk factors, including hypovolemia, heart failure, and chronic renal insufficiency or use of medications, including diuretics, ACE inhibitors, NSAIDs, or angiotensin receptor blockers
  • Correct volume status before initiating if needed and monitor renal function periodically thereafter
• Necrotizing fasciitis
  • Necrotizing fasciitis of the perineum (Fournier gangrene) reported with SGLT2 inhibitors
  • Signs and symptoms include pain or tenderness, erythema, or swelling in genital or perineal area, along with fever or malaise
  • If suspected, discontinue SGLT2 inhibitor and start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary
• Ketoacidosis
  • Ketoacidosis, including fatal cases, reported in patients treated with SGLT2 inhibitors
  • Not indicated for treatment of type 1 diabetes mellitus
  • Before initiating therapy, consider factors in patient history that may predispose to ketoacidosis, including pancreatic insulin deficiency from any cause, caloric restriction, and alcohol abuse
  • Consider temporarily discontinuing therapy for at least 3 days for patients who undergo scheduled surgery
  • Consider monitoring for ketoacidosis and temporarily discontinuing therapy in other clinical situations known to predispose to ketoacidosis (eg, prolonged fasting due to acute illness or post-surgery); ensure risk factors for ketoacidosis are resolved prior to restarting therapy
  • Restart once the patient’s oral intake is back to baseline and any other risk factors for ketoacidosis (blood acid buildup) are resolved
• Drug interactions overview
  • Hypoglycemia risk increased with insulin and insulin secretagogues (eg, sulfonylureas); a lower dose of insulin or insulin secretagogue may be required
  • Laboratory testing
    • Urine glucose tests is not recommended in patients taking SGLT2 inhibitors, as SGLT2 inhibitors, increase urinary glucose excretion and lead to positive urine glucose tests; use alternative methods to monitor glycemic control
    • 1,5-AG assay is not recommended, as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors; use alternative methods to monitor glycemic control

Pregnancy and Lactation

• Based on animal data showing adverse renal effects, use not recommended during the second and third trimesters of pregnancy
• Limited data available in pregnant women are insufficient to determine a drug-associated risk for major birth defects and miscarriage
• There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy
• Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications; poorly controlled diabetes increases fetal risk for major birth defects, still birth, and macrosomia related morbidity
• There is no information regarding presence in human milk, the side effects on breastfed infant or on milk production. 
• Empagliflozin is present in the milk of lactating rats.
• Because of potential for serious adverse reactions in a breastfed infant, advise women that it is not recommended while breastfeeding.