Classes
DEA Class; Rx
Common Brand Names; Xigduo XR
- Antidiabetics, Biguanides;
- Antidiabetics, SGLT2 Inhibitors
Description
Oral combination of metformin with a sodium-glucose co-transporter 2 (SGLT2) inhibitor
Used in adults with type 2 diabetes mellitus; to reduce the risk of hospitalization for heart failure in adults with T2DM and established CV disease or multiple CV risk factors; to reduce the risk of CV death and hospitalization for HF in adults with HF with reduced ejection fraction (NYHA class II-IV); and to reduce sustained eGFR decline, end-stage kidney disease, CV death, and hospitalization for HF in adults with chronic kidney disease (CKD) at risk of disease progression
Not recommended for improving glycemic control in patients with T2DM and eGFR less than 45 mL/minute/1.73 m2 or for treating CKD in patients with polycystic kidney disease or those requiring/recent history of immunosuppressive therapy for CKD
Indications
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) when treatment with both dapagliflozin and metformin is appropriate
Contraindications
Severe renal impairment (eg, eGFR <30 ml/min/1.73 m2), end stage renal disease or patients on dialysis, which may also result from conditions such as shock, acute MI, and septicemia
Acute or chronic metabolic acidosis, including diabetic ketoacidosis
Hypersensitivity
Adverse Effects
Female genital mycotic infections (9.3-9.4%)
Nasopharyngitis (5.2-6.3%)
Urinary tract infections (5.5-6.1%)
Diarrhea (4.2-5.9%)
Headache (3.3-5.4%)
Male genital mycotic infections (3.6-4.3%)
Influenza (2.6-4.1%)
Nausea (2.6-3.9%)
Back pain (2.5-3.4%)
Dizziness (1.8-3.2%)
Constipation (1.9-2.9%)
Dyslipidemia (1.5-2.7%)
Pharyngitis (1.5-2.7%)
Increased urination (2.4-2.6%)
Discomfort with urination (1.6-2.2%)
Lactic acidosis
Acute kidney injury and impairment in renal function
Dapagliflozin
- Ketoacidosis
- Acute kidney injury
- Impairment in renal function
- Urosepsis
- Pyelonephritis rash
Metformin hydrochloride
- Cholestatic, hepatocellular, and mixed hepatocellular liver injury
Warnings
Dapagliflozin increases risk of urinary tract infections (UTIs), including life-threatening urosepsis and pyelonephritis that started as UTIs; evaluate for signs and symptoms of urinary tract infections and treat promptly, if indicated
Dapagliflozin increases risk for genital mycotic infections
Metformin associated with a decrease to subnormal levels of previously normal serum vitamin B-12 levels, without clinical manifestations; measure hematological parameters annually and vitamin B12 at 2- to 3-year intervals and manage any abnormalities
Pregnancy and Lactation
Based on animal data showing adverse renal effects, not recommended during the second and third trimesters of pregnancy
Limited data in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage
There is no information regarding the presence in human milk, the effects on the breastfed infant, or the effects on milk production
Limited published studies report that metformin is present in human milk
Maximum Dosage
Dapagliflozin 10 mg/day PO and metformin 2000 mg/day PO.
Dapagliflozin 10 mg/day PO and metformin 2000 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Not indicated.
Not indicated.
How supplied
dapagliflozin/metformin extended-release
tablet, extended-release
- 2.5mg/1000mg
- 5mg/500mg
- 5mg/1000mg
- 10mg/500mg
- 10mg/1000mg
