Forxiga

# Forxiga ## Overview - **Classification**: Sodium-Glucose Co-transporter 2 (SGLT2) Inhibitor - **Mechanism**: Blocks SGLT2 in renal proximal tubules, reducing glucose reabsorption and increasing urinary glucose excretion. Also promotes osmotic diuresis, impacting cardiovascular and renal hemodynamics. ## Primary Indications 1. **Type 2 Diabetes Mellitus (T2DM)** - To improve glycemic control in adults. 2. **Heart Failure with Reduced Ejection Fraction (HFrEF)** - To reduce the risk of CV death and hospitalization for heart failure in adults and pediatric patients ≥10 years. 3. **Chronic Kidney Disease (CKD)** - To reduce the risk of sustained eGFR decline, ESRD, CV death, and hospitalization for heart failure in adults and pediatric patients ≥10 years. 4. **Heart Failure with Preserved Ejection Fraction (HFpEF)** - To reduce the risk of CV death and hospitalization for heart failure in adults. ## Adult Dosing ### Standard Dosing **Type 2 Diabetes Mellitus (T2DM)** - **Dose**: Start with **5 mg** once daily. - **Frequency**: Once daily - **Route**: Oral - **Maximum Dose**: **10 mg** once daily **Heart Failure with Reduced Ejection Fraction (HFrEF)** - **Dose**: **10 mg** once daily - **Frequency**: Once daily - **Route**: Oral - **Special Considerations**: Initiate as soon as clinically stable. **Heart Failure with Preserved Ejection Fraction (HFpEF)** - **Dose**: **10 mg** once daily - **Frequency**: Once daily - **Route**: Oral - **Special Considerations**: Initiate as soon as clinically stable. **Chronic Kidney Disease (CKD)** - **Dose**: **10 mg** once daily - **Frequency**: Once daily - **Route**: Oral - **Special Considerations**: Initiate as soon as clinically stable. ### Dose Adjustments - **Renal Impairment**: - **T2DM**: Not recommended to initiate if eGFR < **45 mL/min/1.73 m²**. Discontinue if eGFR consistently < **30 mL/min/1.73 m²**. - **HFrEF, HFpEF, CKD**: Initiate at **10 mg** once daily if eGFR ≥ **25 mL/min/1.73 m²**. - **HFrEF, HFpEF, CKD**: Continue if eGFR falls below **25 mL/min/1.73 m²** (down to dialysis), but do not initiate if eGFR < **25 mL/min/1.73 m²**. - **Hemodialysis**: Not recommended (efficacy not established). - **Hepatic Impairment**: No dose adjustment for mild/moderate impairment. Use with caution in severe impairment. - **Elderly Patients**: No dose adjustment needed. Monitor for volume depletion. ## Pediatric Dosing Forxiga is indicated for HFrEF and CKD in pediatric patients aged ≥10 years. It is not indicated for T2DM in pediatric patients. ### Neonates (0-28 days) - **Not indicated.** ### Infants (1-12 months) - **Not indicated.** ### Children (1-9 years) - **Not indicated.** ### Children & Adolescents (10-18 years) **Heart Failure with Reduced Ejection Fraction (HFrEF)** **Chronic Kidney Disease (CKD)** - **Dose**: **10 mg** once daily - **Frequency**: Once daily - **Route**: Oral - **Maximum**: **10 mg** once daily - **Special Notes**: Dosing is similar to adults. Ensure patient can swallow tablets. ## Safety Information ### Contraindications - **Absolute**: Hypersensitivity to dapagliflozin or any component of the formulation. - **Relative**: Not recommended in Type 1 Diabetes Mellitus due to increased risk of diabetic ketoacidosis (DKA). - **Relative**: Not recommended for initiation in patients with T2DM and eGFR < **45 mL/min/1.73 m²**. ### Common Adverse Effects - **Very Common (>10%)**: Genital mycotic infections (e.g., vulvovaginal candidiasis, balanitis), urinary tract infections (UTIs). - **Common (1-10%)**: Increased urination, back pain, nausea, dyslipidemia, influenza-like illness, thirst, constipation, rash, volume depletion. - **Serious but Rare**: Diabetic ketoacidosis (e.g., euglycemic DKA), Fournier's gangrene, acute kidney injury, severe UTIs (urosepsis, pyelonephritis), severe hypersensitivity reactions. ### Key Drug Interactions - **Diuretics (loop, thiazide)**: Increased risk of dehydration and hypotension. Monitor volume status and blood pressure. - **Insulin/Insulin Secretagogues**: Increased risk of hypoglycemia when used for T2DM. May require dose reduction of these agents. - **Renin-Angiotensin System (RAS) Inhibitors, NSAIDs**: Increased risk of renal impairment, especially with volume depletion. Monitor renal function. ## Monitoring & Follow-up - **Before Treatment**: Assess renal function (eGFR), volume status, and blood pressure. - **During Treatment**: - **Renal Function**: Periodically (e.g., annually, or more frequently if eGFR <60 mL/min/1.73 m² or with concomitant nephrotoxic drugs). - **Volume Status**: Monitor for signs of dehydration, especially in elderly or patients on diuretics. - **Glucose**: If for T2DM, monitor HbA1c and blood glucose. - **Clinical Signs**: Watch for symptoms of DKA (nausea, vomiting, abdominal pain, rapid breathing), UTIs, genital infections, or Fournier's gangrene. ## Clinical Pearls - 💡 **Hydration**: Counsel patients to maintain adequate hydration, particularly during illness or in hot weather, to reduce the risk of volume depletion. - 💡 **DKA Awareness**: Educate patients on DKA symptoms (even if blood glucose is normal) and to seek immediate medical attention if symptoms occur. - 💡 **Genital Hygiene**: Advise on proper hygiene to minimize the risk of genital mycotic infections. - 💡 **Timing**: Can be taken with or without food, any time of day, but consistency in timing is recommended. > **⚠️ Important**: This information is for educational purposes only. Always consult current prescribing information, local guidelines, and clinical judgment before prescribing.