canagliflozin hemihydrate: clinical use

Prescribing considerations

• Confirm type 2 diabetes; do not use to treat type 1 diabetes.
• Assess renal function, fluid status, blood pressure and ketoacidosis risk factors before initiation.
• Glycaemic efficacy declines as renal function worsens, while volume-depletion reactions become more likely.
• Review amputation risk, preventive foot care and active lower-limb complications.
• Use in severe hepatic impairment is not recommended; experience in advanced symptomatic heart failure is limited.

Contraindications and cautions

• Hypersensitivity to canagliflozin or an excipient.
• The selected tablet contains lactose and should not be used in specified rare hereditary disorders of galactose metabolism or absorption.

Monitoring

• Renal function before treatment, periodically thereafter and when adding treatments that may impair renal function.
• Glycaemic response and hypoglycaemia risk with insulin or an insulin secretagogue.
• Hydration, blood pressure and symptoms of volume depletion.
• Blood ketones when ketoacidosis is suspected.
• Feet for ulcers, infection, osteomyelitis, gangrene or other complications.
• Haematocrit when already elevated; lithium or digoxin levels when clinically indicated.

Clinical pharmacology

Canagliflozin is an orally active SGLT2 inhibitor with insulin-independent glucose lowering. It is highly protein bound and cleared mainly through UGT1A9- and UGT2B4-mediated O-glucuronidation; CYP3A4 metabolism is minor. Haemodialysis removes negligible amounts.

Formulation and product differences

• The selected product is an immediate-release, white, capsule-shaped film-coated tablet intended to be swallowed whole.
• It contains lactose and is essentially sodium-free.

Tablet

Route: Oral

Strengths: 100 mg, 300 mg