Composition:
Each Empacoza 10mg tablet contains: empagliflozin………………………………………… 10 mg.
Each Empacoza 25mg tablet contains: empagliflozin………………………………………… 25 mg.
*Dosage Modifications
Hepatic impairment: No dosage adjustment required
Surgery:
- Withhold for at least 3 days, if possible, before major surgery or procedures associated with prolonged fasting
- Resume once patient is clinically stable and has resumed oral intake
Renal Impairment:
Type 2 diabetes mellitus
- eGFR 30-90 mL/min/1.73 m2: No dosage adjustment required
- eGFR <30 mL/min/1.73 m2 without cardiovascular (CV) risk factors: Not recommended
- Glucose lowering benefit of 25 mg/day decreased in patients with worsening renal function
- Risks of renal impairment, volume depletion adverse reactions and urinary tract infection-related adverse reactions increased with worsening renal function
T2DM and CV disease, HF, or CKD
- T2DM with CV disease GFR ≥30 mL/min/1.73 m2: No dosage adjustment required
- HF or CKD with eGFR ≥20 mL/min/1.73 m2: No dosage adjustment required
- eGFR <20 mL/min/1.73 m2 or on dialysis: Not studied
*Dosing Considerations
Limitations of use
- Not indicated for treatment of type 1 diabetes or diabetic ketoacidosis
- Not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR <30 mL/min/1.73 m2
Before initiating therapy
- Assess renal function beforehand and periodically thereafter
- Correct condition in patients with volume depletion
Drug Interaction
- Contraindicated (0)
- Serious – Use Alternative (0)
- Monitor Closely (42):
amiloride
bendroflumethiazide
bumetanide
chlorothiazide
chlorpropamide
chlorthalidone
dulaglutide
ethacrynic acid
furosemide
glimepiride
glipizide
glyburide
hydrochlorothiazide
indapamide
insulin aspart
insulin aspart protamine/insulin aspart
insulin degludec
insulin degludec/insulin aspart
insulin detemir
insulin glargine
insulin glulisine
insulin inhaled
insulin isophane human/insulin regular human
insulin lispro
insulin lispro protamine/insulin lispro
insulin NPH
insulin regular human
letermovir
lithium
lonapegsomatropin
methyclothiazide
metolazone
nateglinide
repaglinide
somapacitan
somatrogon
somatropin
spironolactone
tolazamide
tolbutamide
torsemide
triamterene
- Minor (1): patiromer
Adverse Effects
- 1-10%
Urinary tract infection (7.6-9.3%)
Female genital mycotic infections (5.4-6.4%)
Upper respiratory tract infection (3.1-4%)
Increased urination (3.2-3.4%)
Dyslipidemia (2.9-3.9%)
Male genital mycotic infections (1.6-3.1%)
Arthralgia (2.3-2.4%)
Nausea (1.1-2.3%)
Polydipsia (1.5-1.7%)
- <1%
Adverse reactions related to volume depletion (eg, blood pressure [ambulatory] decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolemia, orthostatic hypotension, and syncope)
Increased urination (eg, nocturia)
- Postmarketing reports
Ketoacidosis
Urosepsis and pyelonephritis
Necrotizing fasciitis of the perineum (Fournier’s gangrene)
Angioedema
Skin reactions
Acute kidney injury
Constipation
Diabetic ketoacidosis in patients with type 1 diabetes mellitus and other ketoacidosis
Warnings
Contraindications
Serious hypersensitivity to empagliflozin (eg, anaphylaxis, angioedema)
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