Dapagliflozin

Farxiga reduces sustained eGFR decline, end-stage kidney disease, cardiovascular death and heart-failure hospitalization in adults with CKD at risk of progression. In adults with heart failure, it reduces cardiovascular death, heart-failure hospitalization and urgent heart-failure visits. The HF indication is not restricted to reduced ejection fraction in the current label.

With diet/exercise, it improves glycemic control in adults and children age 10 years or older with type 2 diabetes. It also reduces heart-failure hospitalization in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. That latter adult indication is not equivalent to an unrestricted claim of prevention of all cardiovascular events.

It is not recommended to improve glucose control in type 1 diabetes or in type 2 diabetes when eGFR <45 mL/min/1.73 m². For CKD it is not recommended with polycystic kidney disease or kidney disease requiring/recently treated with immunosuppression. This monotherapy profile does not supply fixed-combination dapagliflozin/metformin or saxagliptin regimens.

Start 5 mg orally once daily; increase to 10 mg once daily if additional glucose control is needed. This adult/pediatric type 2 diabetes regimen applies at eGFR ≥45 mL/min/1.73 m². Below 45, glucose-lowering use is not recommended because it is likely ineffective; do not infer a cardiorenal pediatric indication.

For the adult CKD, HF and type 2 diabetes/HF-hospitalization indications, the dose is 10 mg once daily. The table separates initiation from continuation; all eGFR values are mL/min/1.73 m².

Check renal function and volume status before starting; correct volume depletion first. Take orally once daily with or without food. If a dose is missed, take it as soon as possible and do not double the next dose.

Withhold at least 3 days, if possible, before surgery or a procedure involving prolonged fasting. Temporary clinical states predisposing to ketoacidosis may also require withholding under the care plan. Resume when clinically stable and eating again; after ketoacidosis, monitor for resolution before restart. Do not stop or markedly reduce prescribed insulin on your own.

No dose change is recommended solely for older age or mild/moderate/severe hepatic impairment. Severe hepatic impairment nevertheless needs an individualized benefit-risk assessment because specific efficacy/safety studies are lacking. This is not a claim of equal risk in all liver conditions.

A history of serious hypersensitivity to dapagliflozin or any Farxiga excipient is contraindicated. The current label does not list a separate dialysis contraindication; initiation evidence/renal limits must still be respected rather than treating absence of a contraindication as approval to start on dialysis.

The reviewed current Farxiga label contains no FDA boxed warning. Its potentially fatal ketoacidosis and serious infection warnings still apply to all eligible indications.

Commonly reported effects include genital mycotic infections, urinary tract infections, increased urination and nasopharyngitis. Volume depletion, ketoacidosis, severe GU infection, hypersensitivity and acute kidney injury are important serious events. Small early creatinine rises/eGFR falls may stabilize within about 2 weeks; changes outside that pattern merit evaluation rather than automatic attribution to an expected effect.

Insulin or sulfonylurea doses may need clinician-directed reduction to limit hypoglycemia. Do not make an indiscriminate insulin reduction: under-insulinization is a ketoacidosis trigger. Increase glucose surveillance with treatment changes.

SGLT2 inhibitors may lower serum lithium concentrations; monitor lithium more often during initiation and dose changes. Loop diuretics increase susceptibility to volume depletion/hypotension; reassess volume, pressure and renal function rather than inferring a universal diuretic reduction.

Glucosuria is expected from the mechanism and can produce a positive urine glucose test; use other measures for glucose control. The 1,5-anhydroglucitol assay is also unreliable during SGLT2 therapy. These findings do not exclude ketoacidosis, which needs its own assessment.

Glycemic-control safety/effectiveness are established from age 10; under 10 is not established. Pediatric CKD/HF/cardiovascular risk-reduction indications are not established. Older adults need no age-only dose change but are more susceptible to hypotension and require volume/renal surveillance.

Use the indication-specific 45 and 25 thresholds. Trials did not enroll people with eGFR <25 or already on dialysis; some enrolled patients continued after eGFR decline or dialysis initiation. That continuation evidence does not create a universal recommendation to initiate dialysis treatment. Reassess response, volume and kidney function individually.

Not recommended in the second/third trimesters because animal findings raise developing-kidney concerns; limited human pregnancy data cannot establish safety. Not recommended while breastfeeding because infant renal-development risk is possible. Severe hepatic impairment requires individualized benefit-risk assessment despite no specified dose adjustment.

Dapagliflozin increases urinary glucose excretion and sodium delivery distally, with associated effects on volume and intraglomerular pressure. Glucosuria typically approaches baseline about 3 days after stopping, but longer persistence is reported; half-life alone should not determine perioperative safety.

Fasting peak concentration is usually reached within about 2 hours and oral bioavailability is about 78% at 10 mg. It is about 91% protein-bound, metabolized mainly by UGT1A9 to an inactive glucuronide and eliminated predominantly as metabolites via urine. Mean terminal half-life is about 12.9 hours. Food does not meaningfully alter total exposure.

Renal impairment raises systemic exposure but reduces urinary glucose excretion, explaining the glycemic limitation. Approved adult HF/CKD outcomes and their dosing are based on separate trials and thresholds. Do not infer greater glucose lowering from a higher plasma concentration.

Assess renal function before initiation and as clinically indicated; evaluate volume and pressure, particularly with diuretics, older age or impaired kidney function. Track glucose for diabetes goals and adult HF/CKD outcomes through the clinical plan. Consider ketone monitoring when risk or symptoms warrant; do not use urine glucose or 1,5-AG to judge glycemic control.

Explain the 3-day preoperative hold and clinically stable/oral-intake restart criteria. Avoid unplanned insulin reduction and discuss poor intake, dehydration, illness, ketogenic diets and alcohol use. Get immediate help for ketosis symptoms or painful swollen/red perineal tissue with fever/malaise; report urinary/genital infection symptoms promptly. Fluid intake should follow the individualized HF/CKD plan.

Seek poison-service or medical advice after excess ingestion; treatment is supportive according to clinical status. Removal by hemodialysis has not been studied, so do not claim dialysis is an established antidote.

AstraZeneca Farxiga 10 mg is yellow, biconvex and diamond-shaped with 10 and 1428 on opposite sides; 30-count NDC 0310-6210-30. The 5 mg tablet is yellow and round with 5 and 1427; 30-count NDC 0310-6205-30. Verify the actual product label.

Reviewed film-coated tablets supply 5 or 10 mg dapagliflozin. These strengths are not interchangeable with fixed combinations based on their total tablet weight; no injectable or pediatric liquid regimen is supplied.

Store at 20–25°C, with permitted excursions of 15–30°C. Dispense with the Medication Guide and keep safely away from children.