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ArticleFDA Updates

FDA approves Dapagliflozin for Chronic Kidney Disease

The US Food and Drug Administration (FDA) has approved dapagliflozin (Farxiga, AstraZeneca) to reduce the risk for kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) at risk for disease progression.

Dapagliflozin  (5mg, 10mg OD) is a selective sodium-glucose transporter-2 (SGLT2) inhibitor.

Uses:

  1. Type 2 Diabetes Mellitus: Initial 5 mg PO qDay in AM
  2. Reduce the risk of hospitalization for heart failure: 10 mg PO qDay in AM. Used in Heart Failure with a reduced ejection fraction
  3. Chronic Kidney Disease: Indicated to reduce risk of sustained eGFR decline, end-stage kidney disease (ESKD), cardiovascular death, and hospitalization for HF in adults with CKD who are at risk of progression

Dosage Modifications:
1. Renal impairment
eGFR ≥45mL/min/1.73 m2: No dosage adjustment required

2. eGFR 25 to <45 mL/min/1.73 m2
T2DM: Not recommended
3. HF or CKD: No dosage adjustment required
4. eGFR <25 mL/min/1.73 m2
Initiation not recommended
5. Patients with HF or CKD may continue 10 mg/day to reduce risk of eGFR decline, ESKD, CV death, and HF hospitalization
​6. ESRD/dialysis: Contraindicated

7.  Hepatic impairment
Mild or moderate: No dosage adjustment required
Severe: Not studied
Dosing Considerations

Source: FDA

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