dapagliflozin + saxagliptin hydrochloride: clinical use

Prescribing considerations

• Confirm that the patient meets the fixed combination's type 2 diabetes indication.
• Assess renal and hepatic function, volume status, hypotension risk, previous pancreatitis, heart-failure risk, recurrent urogenital infection and ketoacidosis risk factors.
• Counsel about ketoacidosis, dehydration, infections, Fournier's gangrene, pancreatitis, hypersensitivity and perioperative communication.

Contraindications and cautions

• Hypersensitivity to an active substance, excipient, or previous serious hypersensitivity reaction to a DPP-4 or SGLT2 inhibitor.
• Type 1 diabetes, pregnancy or breastfeeding.
• Product-specific renal-function restrictions apply; do not use in end-stage renal disease.
• Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption; severe hepatic impairment is not recommended.

Monitoring

• Renal function before treatment, periodically and when adding treatments that may impair it.
• Glycaemic control; urinary glucose is expected and the 1,5-anhydroglucitol assay is unreliable.
• Volume status and blood pressure when dehydration or hypotension is a risk.
• Blood ketones when ketoacidosis is suspected and during interruption for hospitalised major surgery or acute serious illness.
• Symptoms of pancreatitis, heart failure, severe infection, blistering skin disease and serious hypersensitivity.

Clinical pharmacology

Saxagliptin inhibits DPP-4, increasing active incretin hormones and glucose-dependent insulin secretion while reducing glucagon. Dapagliflozin inhibits renal SGLT2, promoting insulin-independent urinary glucose excretion and osmotic diuresis.

Formulation and product differences

• Fixed-dose film-coated tablet intended to be swallowed whole.
• Contains lactose and is essentially sodium-free.
• No special storage conditions are required.

Tablet

Route: Oral

Strengths: 5 mg + 10 mg