Empacoza 25 mg 30 Film Coated Tablets

*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