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Canagliflozin Dosage

Medically reviewed by Drugs.com. Last updated on Aug 30, 2018.

Applies to the following strengths: 100 mg; 300 mg

Usual Adult Dose for Diabetes Type 2

Initial dose: 100 mg orally once a day
-May increase to 300 mg orally once a day for additional glycemic control in patients who have tolerated therapy and who have an eGFR of 60 mL/min/1.73 m2 or greater
Maximum dose: 300 mg/day

Comments:
-Assess renal function before initiating therapy; consult renal dose adjustments for patients with an eGFR less than 60 mL/min/1.73 m2.
-Normalize volume status before initiating therapy.
-If used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue should be considered to reduce the risk of hypoglycemia.

Uses:
-As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
-To reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.
-To reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.

Usual Adult Dose for Cardiovascular Risk Reduction

Initial dose: 100 mg orally once a day
-May increase to 300 mg orally once a day for additional glycemic control in patients who have tolerated therapy and who have an eGFR of 60 mL/min/1.73 m2 or greater
Maximum dose: 300 mg/day

Comments:
-Assess renal function before initiating therapy; consult renal dose adjustments for patients with an eGFR less than 60 mL/min/1.73 m2.
-Normalize volume status before initiating therapy.
-If used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue should be considered to reduce the risk of hypoglycemia.

Uses:
-As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
-To reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.
-To reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.

Renal Dose Adjustments

eGFR of 60 mL/min/1.73 m2 or greater: No adjustment recommended
eGFR 45 to less than 60 mL/min/1.73 m2: Maximum dose: 100 mg orally once a day
eGFR 30 to less than 45 mL/min/1.73 m2 with albuminuria greater than 300 mg/day: Maximum dose: 100 mg orally once a day
eGFR less than 30 mL/min/1.73 m2 with albuminuria greater than 300 mg/day: Initiation of therapy is not recommended; however, may continue therapy at 100 mg orally once a day
eGFR less than 45 mL/min/1.73 m2 with albuminuria 300 mg/day or less: Initiation of therapy is not recommended
Severe renal dysfunction (eGFR less than 30 mL/min/1.73 m2): Use is contraindicated
ESRD on dialysis: Use is contraindicated

Concomitant use of Uridine 5-diphospho (UDP)-glucuronosyl transferase (UGT) Enzyme Inducers AND eGFR less than 60 mL/min/1.73 m2:
-Increase canagliflozin to 200 mg/day in patients tolerating 100 mg/day; consider adding an alternative antihyperglycemic agent in patients requiring additional glycemic control

Liver Dose Adjustments

Mild to moderate liver dysfunction: No adjustment recommended
Severe liver dysfunction: Not recommended

Dose Adjustments

Concomitant Use of Insulin and Insulin Secretagogues:
-A lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycemia.

Concomitant use of Uridine 5-diphospho (UDP)-glucuronosyl transferase (UGT) Enzyme Inducers, AND:
-eGFR 60 mL/min/1.73 m2 or greater: Increase canagliflozin to 200 mg/day in patients tolerating therapy at 100 mg/day; may further increase dose to 300 mg/day in patients tolerating therapy and requiring additional glycemic control
-eGFR less than 60 mL/min/1.73 m2: Increase canagliflozin to 200 mg/day in patients tolerating 100 mg/day; consider adding an alternative antihyperglycemic agent in patients requiring additional glycemic control

Precautions

US BOXED WARNING: LOWER LIMB AMPUTATION:
-An increased risk of lower limb amputations has been associated with canagliflozin versus placebo in the CANVAS (5.9 vs 2.8 events per 1000 patient-years) and CANVAS-R studies (7.5 vs 4.2 events per 1000 patient-years); these 2 large, randomized, placebo-controlled trials were conducted in patients with type 2 diabetes and established cardiovascular disease (CVD) or at risk for CVD.
-Amputations of the toe and midfoot were most frequent; however, amputations involving the leg were also observed. Some patients had multiple amputations, some involving both limbs.
-Consider factors that may increase the risk of amputation, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers before initiating therapy.
-Monitor for infection, new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue therapy if these complications occur.

CONTRAINDICATIONS:
-Serious hypersensitivity reaction to active substance such as anaphylaxis or angioedema
-Severe renal impairment (eGFR less than 30 mL/min/1.73 m2) who are being treated for glycemic control
-Dialysis

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Contraindicated

Other Comments

Administration advice:
-Take orally before the first meal of the day; swallow whole
-If a dose is missed, it should be taken as soon as it is remembered; however, double dosing to make up for a missed dose is not recommended

General:
-Correct volume depletion prior to initiating treatment.
-Not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Monitoring:
-Assess fluid status prior to initiation and monitor for signs and symptoms of volume depletion during therapy.
-Verify renal function at baseline, and monitor periodically during therapy.
-Evaluate for the presence of acidosis, including ketoacidosis in symptomatic patients even if their blood sugar is not elevated.
-Monitor legs and feet for any new pain, tenderness, sores, ulcers, or infections.

Patient advice:
-Read the US FDA-approved patient labeling (Medication Guide).
-Patients experiencing symptoms of ketoacidosis such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue, or sleepiness should be instructed to check for ketones even if their blood sugar is not elevated; patients should be instructed to stop taking this drug and seek immediate medical attention if symptoms of ketoacidosis occur.
-This drug will cause the urine to test positive for glucose.
-Ensure adequate fluid intake to avoid adverse reactions related to volume depletion such as orthostatic hypotension.
-Seek medical advice during periods of stress as medical management of glycemic control may change.
-Inform patients that genital mycotic infections, urinary tract infections, and hypersensitivity reactions may occur; patients should be instructed to contact their health care professional.
-Patients should be instructed to seek immediate medical attention for symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, especially if they have a fever and are feeling unwell.
-Inform patients that use of this drug may increase their risk of bone fractures.
-Patients should be advised that this drug may increase their risk of lower limb amputations and should be instructed to report any new pain, tenderness, sores, ulcers, or infections of legs or feet.
-Patients should be instructed to seek medical attention promptly for signs and symptoms of acute kidney injury such as decreased urine, swelling in the legs or feet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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