Dapagliflozin

Brands

DEA Class; Rx

Common Brand Names; Farxiga

  • Antidiabetics, SGLT2 Inhibitors

Oral sodium-glucose co-transporter 2 (SGLT2) inhibitor
Used for improving glycemic control in adults with type 2 diabetes mellitus (DM); reducing hospitalization for heart failure (HF) in adults with type 2 DM and established cardiovascular (CV) disease or multiple CV risk factors; reducing CV death and HF hospitalization in adults with HF and reduced ejection fraction; and reducing sustained eGFR decline, end-stage kidney disease, CV death, and hospitalization for HF in adults with chronic kidney disease (CKD) at risk of disease progression
Not recommended for improving glycemic control in patients with type 2 DM and eGFR less than 45 mL/minute/1.73 m2 or for treating CKD in patients with polycystic kidney disease or requiring or with recent history of immunosuppressive therapy for the treatment of kidney disease

Indicated for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise.

For the reduction of heart failure hospitalizations in adults with type 2 diabetes mellitus and established cardiovascular (CV) disease or multiple CV risk factors.
For the treatment of reduced ejection fraction heart failure (NYHA class II to IV) and preserved ejection fraction heart failure for reduction of cardiovascular mortality and hospitalization for heart failure.
For the treatment of chronic kidney disease to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in those at risk of disease progression.

Serious hypersensitivity to dapagliflozin (eg, anaphylaxis, angioedema)

Patients on dialysis

Renal impairment

  • Overall (1.8-6.7%)
  • Age ≥65 yr (3.1-14%)
  • eGFR 30-60 mL/min (8-28.3%)
  • Age ≥65 yr and eGFR 30-60 mL/min (7-35.1%)

Female genital mycotic infections (6.9-8.4%)

Nasopharyngitis (6.3-6.6%)

Urinary tract infection (4.3-5.7%)

Back pain (3.1-4.2%)

Increased urination (2.9-3.8%)

Male genital mycotic infections (2.7-2.8%)

Nausea (2.5-2.8%)

Influenza (2.3-2.7%)

Dyslipidemia (2.1-2.5%)

Constipation (1.9-2.2%)

Discomfort with urination (2.1-2.6%)

Extremity pain (1.7-2%)

Volume depletion

  • Overall (0.6-1.1%)
  • Patients on loop diuretics (0-9.7%; 1.8-2.5%)
  • Patients with moderate renal impairment, GFR 30-60 mL/min (0.9-1.9%)
  • Age ≥65 yr (0.5-1.7%)

Hypersensitivity (0.3%)

Rash

Ketoacidosis

Acute kidney injury and renal impairment

Urosepsis and pyelonephritis

Necrotizing fasciitis of the perineum

Hypoglycemia

Genital mycotic infections may occur; patients with history of genital mycotic infections and uncircumcised males are more susceptible

Serious urinary tract infections, including urosepsis and pyelonephritis, requiring hospitalization reported in patients receiving SGLT2 inhibitors

Necrotizing fasciitis of the perineum (Fournier gangrene) reported with SGLT2 inhibitors; signs and symptoms include tenderness, redness or swelling of the genitals, or area from the genitals to the rectum, and have a fever >100.4ºF or generally feeling unwell; if suspected, discontinue SGLT2 inhibitor and start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary

Based on animal data showing adverse renal effects drug is not recommended during second and third trimesters of pregnancy

Limited data in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage

There is no information regarding presence of dapagliflozin in human milk, effects on breastfed infant, or on milk production

Adults

10 mg/day PO.

Geriatric

10 mg/day PO.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Infants

Not indicated.

Dapagliflozin

tablet (Farxiga, generic)

  • 5mg
  • 10mg
Drugs Generic
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