Dapagliflozin / metformin ER

Class
Hypoglycemic agents
Subclass
Sodium-glucose cotransporter-2 inhibitor / biguanide combination
Substance name
Dapagliflozin / metFORMIN ER
Brand names
Xigduo XR®
Contains
Dapagliflozin
Metformin
Common formulations
Film-coated tablet
See also
Metformin (Riomet®)
Dosage and administration
Adults patients
CKD • Reduction of decline in renal function, progression to end-stage kidney disease, cardiovascular mortality, and HF hospitalization
•
Maintenance: 10/500-2,000 mg PO qAM
•
Maximum: 10/2,000 mg per day
Taken with food.
Diabetes mellitus type 2 • Glycemic control
•
Start at: 5/500 mg PO qAM
•
Maintenance: 5-10/500-2,000 mg PO qAM
•
Maximum: 10/2,000 mg per day
Taken with food.
Diabetes mellitus type 2 in patients with CVD • Reduction of HF hospitalization
•
Maintenance: 10/500-2,000 mg PO qAM
•
Maximum: 10/2,000 mg per day
Taken with food.
HF • Reduction of cardiovascular mortality and HF hospitalization
•
Maintenance: 10/500-2,000 mg PO qAM
•
Maximum: 10/2,000 mg per day
Taken with food.
Indications for use
Labeled indications
Adults
•
Treatment of CKD (reduction of decline in renal function, progression to end-stage kidney disease, cardiovascular mortality, and HF hospitalization)
•
Treatment of diabetes mellitus type 2 (glycemic control)
•
Treatment of diabetes mellitus type 2 in patients with CVD (reduction of HF hospitalization)
•
Treatment of HF (reduction of cardiovascular mortality and HF hospitalization)
Safety risks
Boxed warnings
Lactic acidosis
•
Use extreme caution in patients with renal impairment, concomitant use of certain drugs (carbonic anhydrase inhibitors, such as topiramate), age ≥ 65 years, undergoing a radiological evaluation with contrast, surgery, and other procedures, hypoxic states (such as acute congestive HF), excessive alcohol intake, and hepatic impairment. Assess eGFR before initiating metformin and monitor annually or more frequent in patients at risk of renal impairment.
Contraindications
Hypersensitivity to dapagliflozin/metformin or its components
Metabolic acidosis
Surgery
•
Discontinue dapagliflozin/metformin for at least 3 days before major surgery or procedures associated with prolonged fasting, and resume once clinically stable with oral intake resumed.
Use of iodine-containing contrast medium
•
Discontinue metformin before iodinated contrast imaging in patients with an eGFR 30-60 mL/min/1.73 m², history of liver disease, alcohol use disorder, or HF, or in patients who will be administered intra-arterial iodinated contrast. Reassess eGFR 48 hours after the imaging and restart metformin if renal function is stable.
Warnings and precautions
Decreased blood glucose
•
Use caution in patients taking insulin or insulin secretagogues. Consider reducing the insulin or insulin secretagogue dose.
Diabetic ketoacidosis
•
Maintain a high level of suspicion, as SGLT-2 inhibors have been associated with an increased risk of diabetic ketoacidosis, especially in patients with pancreatic disorders, acute febrile illness, reduced caloric intake, ketogenic diet, recent surgery, reduced insulin dose, volume depletion, or excessive alcohol use. Consider obtaining ketone monitoring in patients at risk for ketoacidosis as indicated. Assess for ketoacidosis in patients presenting with signs and symptoms consistent with severe metabolic acidosis, regardless of blood glucose levels. Withhold dapagliflozin at least 3 days, if possible, before major surgery or procedures associated with prolonged fasting. Resume once clinically stable and after oral intake has resumed.
Fournier's gangrene
•
Maintain a high level of suspicion, as SGLT-2 inhibors have been associated with an increased risk of Fournier's gangrene.
Reactivation of genital mycotic infections
•
Use caution in patients with a history of chronic or recurrent genital mycotic infections.
Vitamin B12 deficiency
•
Maintain a high level of suspicion, as metformin has been associated with an increased risk of vitamin B12 deficiency. Assess hematologic parameters annually and vitamin B12 every 2-3 years.
Volume depletion
•
Maintain a high level of suspicion, as SGLT-2 inhibitors have been associated with an increased risk of volume depletion, especially in patients with renal impairment, taking loop diuretics, or advanced age. Assess and correct volume status before initiating dapagliflozin. Monitor for volume depletion throughout treatment.
Specific populations
Renal impairment
eGFR > 60 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
eGFR 45-60 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required. Monitor renal function. Monitor for hypotension. Discontinue before iodinated contrast imaging.
eGFR 30-45 mL/min/1.73 m²
•
Do not initiate. Monitor renal function. Monitor for hypotension and lactic acidosis. Assess the benefit/risk of continuing therapy in patients initiated on dapagliflozin/metformin at higher eGFR rates. Discontinue before iodinated contrast imaging.
eGFR < 30 mL/min/1.73 m²
•
Do not use.
Renal replacement therapy
Any modality
•
Do not use.
Hepatic impairment
Any severity
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
First trimester • Australia Category: D
•
Avoid use.
Second and third trimesters • Australia Category: D
•
Do not use.
Breastfeeding
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Common 1-10%
•
↓ serum vitamin B12, genital infection, ↑ hematocrit, influenza virus infection, nasopharyngitis, pharyngitis, dyslipidemia, back pain, constipation, cough, diarrhea, dizziness, dysuria, headache, nausea, urinary frequency, urinary tract infections, volume depletion, vulvovaginal candidiasis
Uncommon < 1%
•
Angioedema, diabetic ketoacidosis
Unknown frequency
•
Renal failure, Fournier's gangrene, acute pyelonephritis, urosepsis, acute kidney injury, cholestasis, drug-induced liver injury, urticaria, ↑ serum creatinine, skin rash
Interactions
Drug(s)
Check Interactions
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