Select therapeutic use:

CHF and arrhythmias:

Indications for: XIGDUO XR

Dapagliflozin: to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction.

Limitations of Use:

Due to the metformin component, the use of Xigduo XR is limited to adults with type 2 diabetes mellitus for all indications.

Adult Dosage:

Swallow whole. Take in the AM with food. Individualize. Give dapagliflozin 10mg once daily. May adjust dose as tolerated; max 10mg/2000mg daily. Renal impairment (eGFR 30–<45mL/min/1.73m2): initiation is not recommended. Assess benefit/risk of continuing therapy if eGFR falls persistently <45mL/min/1.73m2.

Children Dosage:

<18yrs: not established.

XIGDUO XR Contraindications:

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

Boxed Warning:

Lactic acidosis.

XIGDUO XR 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. Assess volume status and renal function prior to initiation. Correct volume depletion before initiating, if needed. Monitor for hypotension and renal function (esp. elderly, patients with renal impairment, or on loop diuretics) during therapy. 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). 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. Hepatic impairment: not recommended. Pregnancy (2nd & 3rd trimesters), nursing mothers: not recommended.

XIGDUO XR Classification:

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

XIGDUO XR 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. May need 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, urosepsis, pyelonephritis, acute kidney injury; rare: lactic acidosis.

Generic Drug 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 $545
GoodRx

Diabetes:

Indications for: XIGDUO XR

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use:

Not recommended in patients with type 1 diabetes; may increase risk of diabetic ketoacidosis. Due to the metformin component, the use of Xigduo XR is limited to adults with type 2 diabetes mellitus for all indications.

Adult Dosage:

Swallow whole. Take in the AM with food. Individualize. Glycemic control (not already on dapagliflozin): initiate with dapagliflozin 5mg once daily. May adjust dose as tolerated; max 10mg/2000mg daily. Renal impairment (eGFR 30–<45mL/min/1.73m2): initiation is not recommended. Assess benefit/risk of continuing therapy if eGFR falls persistently <45mL/min/1.73m2.

Children Dosage:

<18yrs: not established.

XIGDUO XR Contraindications:

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

Boxed Warning:

Lactic acidosis.

XIGDUO XR 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. Assess volume status and renal function prior to initiation. Correct volume depletion before initiating, if needed. Monitor for hypotension and renal function (esp. elderly, patients with renal impairment, or on loop diuretics) during therapy. 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). 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. Hepatic impairment: not recommended. Pregnancy (2nd & 3rd trimesters), nursing mothers: not recommended.

XIGDUO XR Classification:

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

XIGDUO XR 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. May need 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, urosepsis, pyelonephritis, acute kidney injury; rare: lactic acidosis.

Generic Drug 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 $545
GoodRx

Miscellaneous urogenital disorders:

Indications for: XIGDUO XR

Dapagliflozin: to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.

Limitations of Use:

Due to the metformin component, the use of Xigduo XR is limited to adults with type 2 diabetes mellitus for all indications. Not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease; not expected to be effective in these populations.

Adult Dosage:

Swallow whole. Take in the AM with food. Individualize. Give dapagliflozin 10mg once daily. May adjust dose as tolerated; max 10mg/2000mg daily. Renal impairment (eGFR 30–<45mL/min/1.73m2): initiation is not recommended. Assess benefit/risk of continuing therapy if eGFR falls persistently <45mL/min/1.73m2.

Children Dosage:

<18yrs: not established.

XIGDUO XR Contraindications:

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

Boxed Warning:

Lactic acidosis.

XIGDUO XR 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. Assess volume status and renal function prior to initiation. Correct volume depletion before initiating, if needed. Monitor for hypotension and renal function (esp. elderly, patients with renal impairment, or on loop diuretics) during therapy. 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). 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. Hepatic impairment: not recommended. Pregnancy (2nd & 3rd trimesters), nursing mothers: not recommended.

XIGDUO XR Classification:

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

XIGDUO XR 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. May need 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, urosepsis, pyelonephritis, acute kidney injury; rare: lactic acidosis.

Generic Drug 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 $545
GoodRx