empagliflozin

em-pa-gli-FLOE-zin

Therapeutic Classification: antidiabetics

Pharmacologic Classification: sodium-glucose co-transporter 2 (SGLT2) inhibitors

BEERS REMS

Type 2 diabetes (as adjunct to diet and exercise).
To reduce risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease.
To reduce the risk of cardiovascular death and hospitalization for HF in patients with HF.
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.

Inhibits proximal renal tubular sodium-glucose cotransporter 2 (SGLT2), which determines reabsorption of glucose from the tubular lumen. Inhibits reabsorption of glucose, lowers renal threshold for glucose, and increases excretion of glucose in urine.

Therapeutic effects:

Improved glycemic control.
Reduced death due to cardiovascular causes in patients with type 2 diabetes and cardiovascular disease.
Reduced death due to cardiovascular causes and hospitalizations due to HF in patients with HF.
Reduced risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression.

Absorption: Well absorbed following oral administration.

Distribution: Enters red blood cells; remainder of distribution unknown.

Metabolism/Excretion: Minimally metabolized; excreted in feces (41.2% mostly as unchanged drug) and urine (54.4% half as unchanged drug, half as metabolites).

Half-Life: 12.4 hr.

(↓ in A1c)

ROUTE	ONSET	PEAK	DURATION
PO	within 6 wk	12 wk	unknown

Contraindicated in:

Hypersensitivity;
Severe renal impairment (eGFR <30 mL/min/1.73 m² [patients with type 2 diabetes] or eGFR <20 mL/min/1.73 m² [patients with heart failure]) or receiving dialysis;
Type 1 diabetes;
Diabetic ketoacidosis;
Lactation: Lactation.

Use Cautiously in:

eGFR <60 mL/min/1.73 m² or concurrent use of loop diuretics (↑ risk of volume depletion or hypotension);
History of pancreatitis, pancreatic surgery, reduced caloric intake due to illness or surgery, surgical procedures, or alcohol abuse (↑ risk of ketoacidosis);
Peripheral arterial disease, diabetic foot infection, or osteomyelitis (↑ risk of lower limb amputation);
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Pedi: Children 10 yr (safety and effectiveness not established);
Geri: Appears on Beers list. Older adults may have risk of urogenital infections (especially women in the 1st mo of treatment) and euglycemic diabetic ketoacidosis. Use with caution in older adults.

CV: hypotension, volume depletion

Endo: hypoglycemia (↑ with other medications)

F and E: hyperphosphatemia, KETOACIDOSIS

GU: ↑urination, acute kidney injury, genital mycotic infections, NECROTIZING FASCIITIS OF PERINEUM (FOURNIER'S GANGRENE), renal impairment, urinary tract infection(including pyelonephritis), UROSEPSIS

Metab: hyperlipidemia

MS: lower limb amputation

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANGIOEDEMA)

Drug-drug:

↑risk of hypotension with antihypertensives or diuretics.
↑risk of hypoglycemia with other antidiabetics (dose adjustments may be required).
↑risk of acute kidney injury with diuretics, ACE inhibitors, angiotensin II receptor blockers, or NSAIDs.
May ↓ lithium levels and effectiveness.

Type 2 Diabetes

PO (Adults and Children ≥10 yr): 10 mg once daily in the morning;, may ↑ to 25 mg once daily for additional glycemic control.

Type 2 Diabetes in Patients with Established Cardiovascular Disease, Heart Failure, and Chronic Kidney Disease

PO (Adults ): 10 mg once daily in the morning.

(Generic available)

Tablets: 10 mg; 25 mg
In combination with: linagliptin (Glyxambi); linagliptin and metformin XR (Trijardy XR); metformin (Synjardy); metformin XR (Synjardy XR). See Appendix [not included in this PDA edition].

Observe patient for signs and symptoms of hypoglycemic reactions (sweating, hunger, weakness, dizziness, confusion, headache, tremor, tachycardia, irritability, drowsiness).
Monitor for signs and symptoms of volume depletion (dizziness, feeling faint, weakness, orthostatic hypotension) after initiating therapy, especially in elderly patients and patients with renal impairment, low systolic BP, or on diuretics.
Monitor for signs and symptoms of urinary tract infection during therapy. Treat promptly.
Monitor for infection (pain or burning on urination, frequency), new pain, tenderness, erythema, swelling, sores, ulcers involving genital or perianal area, with fever or malaise, or ulcers involving lower limbs; assess for necrotizing fasciitis. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement. Discontinue empagliflozin if these occur.
Assess for ketoacidosis in patients presenting with signs and symptoms of dehydration and metabolic acidosis (nausea, vomiting, abdominal pain, malaise, shortness of breath), regardless of blood glucose level. Discontinue empagliflozin and treat promptly (insulin, fluid and caloric replacement) if suspected. Consider risk factors for ketoacidosis (pancreatic insulin deficiency, caloric restriction, alcohol abuse) before starting empagliflozin.

Lab Test Considerations:

Monitor A1c prior to and periodically during therapy.
- May ↑ serum creatinine and ↓ eGFR. Monitor renal function prior to starting and periodically during therapy. Do not begin therapy if eGFR <30 mL/min/1.73 m². Discontinue therapy if eGFR is persistently <30 mL/min/1.73 m².
- May cause ↑ serum phosphate levels. Monitor electrolytes periodically during therapy.
- May cause ↑ LDL-cholesterol. Monitor serum lipid levels periodically during therapy.
- May cause ↑ hematocrit.
- Monitor for ketoacidosis, especially during prolonged fasting for illness or surgery. May require temporary discontinuation of therapy.

Patients stabilized on a diabetic regimen who are exposed to stress, fever, trauma, infection, or surgery may require administration of insulin. Discontinue empagliflozin for at least 3 days before surgery; therapy can be resumed once patient is clinically stable following surgery and has resumed oral intake.
Correct volume depletion before starting therapy with empagliflozin.
PO: Administer once daily in the morning with or without food.

Instruct patient to take empagliflozin as directed. Take missed doses as soon as remembered, unless it is almost time for next dose; do not double doses. Advise patient to read the Medication Guide before starting and with each Rx refill in case of changes.
Explain to patient that empagliflozin helps control hyperglycemia but does not cure diabetes. Therapy is usually long term.
Instruct patient not to share this medication with others, even if they have the same symptoms; it may harm them.
Encourage patient to follow prescribed diet, medication, and exercise regimen to prevent hyperglycemic or hypoglycemic episodes.
Review signs of hypoglycemia and hyperglycemia with patient. If hypoglycemia occurs, advise patient to take a glass of orange juice or 2–3 teaspoons of sugar, honey, or corn syrup dissolved in water, and notify health care professional.
Instruct patient in proper testing of serum glucose and ketones, especially during periods of stress or illness. Inform patient that empagliflozin will cause a positive test result when testing for urine glucose. Notify health care professional if significant changes occur.
Advise patient to inform health care professional of therapy before surgery. Empagliflozin should be discontinued for at least 3 days before surgery. Monitor for ketoacidosis during and after surgery. Advise patient to discontinue empagliflozin and to notify health care professional immediately if signs and symptoms of ketoacidosis occur.
Advise patient to notify health care professional immediately if new pain or tenderness, sores or ulcers, or infections involving the leg or foot occur and to immediately seek care if pain or tenderness, redness, or swelling of the genitals or area from the genitals back to the rectum, along with a fever above 100.4°F or malaise, occur.
Advise patient to notify health care professional if signs and symptoms of hypotension occur and to maintain adequate hydration as dehydration may increase risk of hypotension.
Inform patient that empagliflozin may cause mycotic (yeast) infections. Women may have signs and symptoms of a vaginal yeast infection (vaginal odor, white or yellow vaginal discharge [may be lumpy or look like cottage cheese], vaginal itching). Men may have signs and symptoms of a yeast infection of the penis (redness, itching, or swelling of penis; rash on penis; foul-smelling discharge from penis; pain in skin around penis). Advise patient to notify health care professional if yeast infection occurs.
Advise patient to notify health care professional if signs and symptoms of urinary tract infection (burning feeling when passing urine, cloudy urine, pain in pelvis or back) occur.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially other oral hypoglycemic medications.
Advise patient to notify health care professional promptly if signs and symptoms of hypersensitivity reactions (rash; raised red patches on skin; swelling of face, lips, tongue, throat; difficulty breathing or swallowing) occur.
Rep: Insulin is the recommended method of controlling blood sugar during pregnancy. Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy.
Emphasize importance of routine follow up with routine lab tests for blood glucose and renal function.

Improved A1c and glycemic control in adults and children >10 yr with type 2 diabetes.
Reduced risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease.
Reduced death due to cardiovascular causes and hospitalizations due to HF in patients with HF.
Reduced risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression.

Jardiance

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US Brand Names ⬆