Forxiga

Forxiga

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Product dosage: 10mg
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Synonyms

Forxiga: Advanced SGLT2 Inhibitor for Glycemic Control and Cardiovascular Protection

Forxiga (dapagliflozin) is a once-daily, oral medication belonging to the sodium-glucose cotransporter 2 (SGLT2) inhibitor class, approved for the management of type 2 diabetes mellitus in adults. It functions by inhibiting SGLT2 proteins in the proximal tubule of the kidney, reducing renal glucose reabsorption and promoting urinary glucose excretion. This mechanism offers a insulin-independent approach to lowering blood glucose levels. Beyond glycemic control, Forxiga demonstrates significant cardiovascular and renal protective benefits, reducing the risk of hospitalization for heart failure and delaying the progression of renal disease in appropriate patient populations. It is suitable for use as monotherapy or in combination with other antidiabetic agents, including metformin, insulin, and sulfonylureas, providing flexibility in treatment regimens.

Features

  • Contains dapagliflozin propanediol monohydrate equivalent to 5 mg or 10 mg dapagliflozin
  • Oral tablet formulation for once-daily administration
  • Works independently of insulin secretion or sensitivity
  • Promotes weight loss and modest blood pressure reduction
  • Demonstrated cardiovascular risk reduction in outcomes trials
  • Renal protective effects shown in dedicated clinical studies
  • Compatible with multiple antidiabetic combination therapies

Benefits

  • Significant reduction in HbA1c levels by promoting urinary glucose excretion
  • Lowers risk of major adverse cardiovascular events, particularly heart failure hospitalization
  • Slows progression of renal disease and reduces albuminuria
  • Promotes modest weight loss through caloric excretion
  • Provides blood pressure lowering effects through osmotic diuresis
  • Low intrinsic risk of hypoglycemia when used without insulin or sulfonylureas
  • Once-daily dosing supports medication adherence

Common use

Forxiga is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is also approved to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. Additionally, Forxiga is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.

Dosage and direction

The recommended starting dose is 5 mg or 10 mg orally once daily, taken in the morning with or without food. For glycemic control, the dose may be increased to 10 mg daily for additional efficacy. For cardiovascular and renal risk reduction, the 10 mg dose is recommended. Dose adjustment is not required based on age, gender, race, or body mass index. For patients with hepatic impairment, no dose adjustment is necessary. In patients with moderate renal impairment (eGFR 30 to less than 60 mL/min/1.73 m²), the 10 mg dose is recommended for indicated uses. Not recommended when eGFR is persistently below 25 mL/min/1.73 m² for glycemic control, or below 20 mL/min/1.73 m² for heart failure and chronic kidney disease indications.

Precautions

Monitor renal function before initiation and periodically during treatment. Assess volume status and correct volume depletion before starting therapy. Consider temporary interruption in situations of reduced oral intake or fluid losses. Monitor for signs and symptoms of urinary tract infections and genital mycotic infections. Evaluate patients for history of pancreatitis. Monitor for ketoacidosis, even in the presence of normal or mildly elevated blood glucose levels. Assess for lower limb amputations, particularly in patients with previous amputation, peripheral vascular disease, neuropathy, or diabetic foot ulcers. Regular monitoring of blood glucose, HbA1c, blood pressure, and weight is recommended.

Contraindications

Hypersensitivity to dapagliflozin or any excipients in Forxiga. Severe renal impairment (eGFR less than 25 mL/min/1.73 m²) for glycemic control indication, or eGFR less than 20 mL/min/1.73 m² for heart failure and chronic kidney disease indications. End-stage renal disease patients requiring dialysis. History of serious hypersensitivity reactions to SGLT2 inhibitors. Patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Possible side effects

Common adverse reactions (≥2%) include genital mycotic infections, urinary tract infections, increased urination, back pain, nausea, constipation, and elevated low-density lipoprotein cholesterol. Serious but less common side effects include ketoacidosis, volume depletion, acute kidney injury, urosepsis and pyelonephritis, hypersensitivity reactions, Fournier’s gangrene, and lower limb amputations. Laboratory abnormalities may include increases in hematocrit, serum phosphate, and serum creatinine.

Drug interaction

No clinically significant interactions with metformin, glimepiride, pioglitazone, sitagliptin, digoxin, warfarin, or oral contraceptives containing ethinylestradiol and levonorgestrel. Concomitant use with diuretics may increase the risk of volume depletion. Insulin and insulin secretagogues may increase the risk of hypoglycemia, requiring dose adjustment of these agents. Monitor for increased risk of ketoacidosis when used with antipsychotics, corticosteroids, or other medications that can cause volume depletion.

Missed dose

If a dose is missed, it should be taken as soon as remembered on the same day. If remembered the next day, skip the missed dose and take the next scheduled dose at the regular time. Do not take a double dose to make up for a missed dose. Maintain regular dosing schedule to ensure consistent therapeutic effect.

Overdose

In case of overdose, contact poison control or seek emergency medical attention immediately. Symptoms may include severe dehydration, hypotension, and hypoglycemia if taken with other antidiabetic medications. Treatment should involve supportive measures including correction of dehydration and electrolyte imbalances. Hemodialysis is unlikely to be effective due to high protein binding of dapagliflozin.

Storage

Store at room temperature between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). Keep in the original container to protect from moisture. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging. Properly dispose of unused or expired medication according to local regulations.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Forxiga should be used only under the supervision of a qualified healthcare professional. Individual patient responses may vary. Always follow the prescribing information provided by the manufacturer and the instructions of your healthcare provider. Report any adverse reactions to your healthcare professional promptly.

Reviews

Clinical trials demonstrate Forxiga’s efficacy in reducing HbA1c by 0.5-0.8% when used as monotherapy and 0.5-1.0% when used in combination with other antidiabetic agents. The DECLARE-TIMI 58 trial showed a 17% reduction in cardiovascular death or hospitalization for heart failure in patients with type 2 diabetes. The DAPA-CKD trial demonstrated a 39% reduction in risk of worsening renal function or cardiovascular or renal death in patients with chronic kidney disease. Real-world evidence supports the trial findings, showing sustained glycemic control and cardiovascular benefits in diverse patient populations. Healthcare providers report good patient tolerance and adherence due to once-daily dosing and low hypoglycemia risk.