Canagliflozin

2
Canagliflozin
Brands

DEA Class; Rx

Common Brand Names; Invokana

  • Antidiabetics, SGLT2 Inhibitors

Oral sodium-glucose co-transporter 2 (SGLT2) inhibitor
Used in adults with type 2 diabetes mellitus; also provides cardiovascular (CV) risk reduction if CV disease also present; if diabetic nephropathy with albuminuria is present, the drug reduces the risk of end-stage kidney disease, doubling of serum creatinine, CV death, and hospitalization for heart failure (HF)
Contraindicated in patients with severe renal impairment who are treated for glycemic control and any patient on dialysis

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

For the reduction of cardiovascular mortality and major cardiovascular events (MACE) in T2DM patients with established cardiac disease; also to reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, and reduction of heart failure hospitalizations and CV death in adults with T2DM and diabetic nephropathy with albuminuria more than 300 mg/day.

Serious hypersensitivity reaction (eg, anaphylaxis, angioedema)

Patients on dialysis

Female genital mycotic infections (10.4-11.4%)

Urinary tract infections (4.4-5.9%)

Increased urination (4.6-5.1%)

Male genital mycotic infections (3.8-4.2%)

Thirst (2.4-2.8%)

Constipation (1.8-2.4%)

Nausea (2.1-2.3%)

Volume depletion

  • Overall population (2.3-3.4%)
  • Age >75 yr (4.9-8.7%)
  • eGFR <60/mL/min/1.73 m³ (4.7-8.1%)
  • Use of loop diuretic (3.2-8.8%)

Ketoacidosis

Acute kidney injury

Anaphylaxis

Angioedema

Urosepsis

Pyelonephritis

Necrotizing fasciitis of the perineum (Fournier’s gangrene)

Causes intravascular volume contraction and symptomatic hypotension and/or acute kidney injury can occur, particularly if eGFR <60 mL/min/1.73 m2, advance age, existing low systolic BP, or taking either diuretics or drugs that interfere with renin-angiotensin-aldosterone system (RAS) (eg, ACE inhibitors, ARBs); monitor for signs and symptoms during therapy

Increases in serum creatinine and decreases in estimated GFR also observed with initiation

Increases risk of urinary tract infections (UTIs), including life-threatening urosepsis and pyelonephritis that started as UTIs; evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated

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

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

Increased risk of bone fracture, occurring as early as 12 weeks after treatment initiation, reported; consider factors that contribute to fracture risk before initiating therapy

Hypersensitivity reactions, including angioedema and anaphylaxis reported; reactions generally occurred within hours to days after initiation; if hypersensitivity reactions occur, discontinue therapy; treat and monitor until signs and symptoms resolve

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

Data are limited in pregnant women and are not sufficient to determine a drug associated risk for major birth defects or miscarriage

No information regarding distribution in human milk or effects on the breastfed infant or milk production

Adults

300 mg/day PO.

Geriatric

300 mg/day PO.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Infants

Not indicated.

Canagliflozin

tablet

  • 100mg
  • 300mg
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