Diabetes:

Indications for XIGDUO XR:

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). To reduce the risk of hospitalization for heart failure in adults with T2DM and established cardiovascular (CV) disease or multiple CV risk factors.

Limitations of Use:

Not for treating type 1 diabetes or diabetic ketoacidosis.

Adult:

Swallow whole. Take once daily in the AM with food. Individualize. Glycemic control (not already on dapagliflozin): initiate with dapagliflozin 5mg. Reduce hospitalization risk: dapagliflozin 10mg. Both: may adjust dose as tolerated; max 10mg/2000mg daily. Hepatic or renal impairment (eGFR <45mL/min/1.73m2): not recommended.

Children:

<18yrs: not established.

Contraindications:

Severe renal impairment (eGFR <30mL/min/1.73m2), ESRD, or on dialysis. Metabolic acidosis, diabetic ketoacidosis.

Boxed Warning:

Lactic acidosis.

Warnings/Precautions:

Increased risk of metformin-associated lactic acidosis in renal or hepatic impairment, concomitant use of certain drugs (eg, cationic drugs), ≥65yrs of age, undergoing radiological contrast study, surgery and other procedures, hypoxic states, and excessive alcohol intake; discontinue if lactic acidosis occurs. Discontinue at time of, or prior to intravascular iodinated contrast imaging in patients with a history of hepatic impairment, alcoholism, heart failure, or will be given intra-arterial contrast; reevaluate eGFR 48hrs after procedure and restart therapy if renally stable. Correct volume depletion before initiating. Monitor for symptomatic hypotension in renal impairment (eGFR <60mL/min/1.73m2), elderly, or on loop diuretics. Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected, evaluate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). Consider temporarily discontinuing prior to scheduled surgery (for ≥3 days) or other clinical situations (eg, prolonged fasting due to illness or post-surgery). Assess renal function prior to starting and periodically thereafter; more frequently in elderly. Risk of acute kidney injury in hypovolemia, chronic renal insufficiency, CHF, and concomitant drugs (eg, diuretics, ACEIs, ARBs, NSAIDs). Consider temporarily discontinuing in reduced oral intake or fluid losses; monitor for acute kidney injury; discontinue and treat if occurs. Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Monitor for genital mycotic infections, UTIs, hematology (esp. serum Vit. B12); treat if needed. Pregnancy (2nd & 3rd trimesters), nursing mothers: not recommended.

Pharmacologic Class:

Sodium-glucose co-transporter 2 (SGLT2) inhibitor + biguanide.

Interactions:

Increased risk of lactic acidosis with topiramate, other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide); monitor. Concomitant cationic drugs that interfere with renal tubular transport systems (eg, ranolazine, vandetanib, dolutegravir, cimetidine) may increase metformin levels. Diuretics, steroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, CCBs, and isoniazid may cause hyperglycemia; monitor. Avoid excessive alcohol. Consider a lower dose of concomitant insulin/insulin secretagogue to reduce risk of hypoglycemia. β-blockers may mask hypoglycemia. May cause false (+) urine glucose tests or unreliable measurements of 1, 5-AG assay; use alternative methods to monitor glycemic control.

Adverse Reactions:

Female genital mycotic infections, nasopharyngitis, UTIs, diarrhea, headache, nausea, vomiting; ketoacidosis, acute kidney injury, urosepsis, pyelonephritis; rare: lactic acidosis.

Generic Availability:

NO

How Supplied:

XR tabs 2.5mg/1000mg—60; 5mg/ 500mg, 10mg/500mg—30, 500; 5mg/1000mg—30, 60, 90, 400; 10mg/1000mg—30, 90, 400

Pricing for XIGDUO XR

5mg/1000mg tablet (Qty: 60)
Appx. price $537
GoodRx