In this edition of our Guidelines Monographs Series, we will be taking a look at AstraZeneca’s medication dapagliflozin, brand name Farxiga. Initially approved in 2014, Farxiga is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, provided to individuals with diabetes, heart disease, or kidney disease to improve their outcomes.
This Guidelines+ Monograph will take a deeper dive into dapagliflozin, as well as outline the current clinical practice guidelines featuring the medication. Please note that this Guidelines+ Monograph for dapagliflozin is current as of August 2024. Consult our clinical guidelines library and/or or medication information look up tool to ensure you are always accessing the most current information.
Without further delay, let’s jump in!
Medication Overview:
- Brand name: Farxiga
- Generic name: Dapagliflozin
- Manufacturer(s): AstraZeneca
- Initial FDA Approval: 2014
- Available Dosages: Tablets: 5 mg and 10 mg
Indications and FDA Approval Details
| Indicated Condition | Indicated For | Age | Date Approved |
|---|---|---|---|
Chronic Kidney Disease | 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. | Adult | April 2021 |
Heart Failure | To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure. | Adult | May 2023 |
| Type 2 Diabetes | To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors | Adult | October 2019 |
Glycemic Control in Individuals with Type 2 Diabetes Mellitus | As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. | Adults and Children 10 years and older | June 2024 |
Dosage Forms and Strengths
| Dosage Form | Strength |
|---|---|
| Yellow, round, film-coated tablets with “5” engraved on one side and “1427” engraved on the other side. | 5 mg |
| Yellow, diamond-shaped, film-coated tablets with “10” engraved on one side and “1428” engraved on the other side. | 10 mg |
Warnings and Precautions
- Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue FARXIGA if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting.
- Volume depletion: Before initiating FARXIGA, assess volume status and renal function in the elderly, patients with renal impairment or low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms during therapy.
- Urosepsis and Pyelonephritis: Evaluate for signs and symptoms of urinary tract infections and treat promptly, if indicated.
- Hypoglycemia: Consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia when used in combination with FARXIGA.
- Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, life threatening cases have occurred in patients with diabetes, both females and males. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment.
- Genital Mycotic Infections: Monitor and treat if indicated.
Adverse Reactions
- Most common adverse reactions (5% or greater incidence) were female genital mycotic infections, nasopharyngitis, and urinary tract infections.
Now that we’ve covered the basic monograph information for dapagliflozin, let’s take a closer look at how Farxiga is currently recommended in various clinical practice guidelines. We will categorize the list based on year, and then provide a general summary table at the end.
Specific Inclusions of SGLT2 Inhibitors (Including Dapagliflozin) in Clinical Guidelines
- Management of Patients With Lower Extremity Peripheral Artery Disease
- Authoring Societies: American College of Cardiology/American Heart Association (ACC/AHA)
- Publication: May 14, 2024
- Glucagon-like peptide-1 agonists such as liraglutide and semaglutide, as well as SGLT-2 inhibitors like canagliflozin, dapagliflozin, and empagliflozin, can effectively reduce major adverse cardiovascular events (MACE) in patients with type 2 diabetes and cardiovascular disease, including those with underlying peripheral artery disease (PAD).
- Newer Pharmacologic Treatments in Adults With Type 2 Diabetes
- Authoring Society: American College of Physicians (ACP)
- Publication: April 19, 2024
- ACP strongly recommends incorporating a sodium-glucose cotransporter-2 (SGLT-2) inhibitor or glucagon-like peptide-1 (GLP-1) agonist alongside metformin and lifestyle adjustments for adults with type 2 diabetes who are experiencing inadequate glycemic control. This recommendation is supported by high-certainty evidence.
- Utilizing an SGLT-2 inhibitor can help lower the risk of all-cause mortality, major adverse cardiovascular events, progression of chronic kidney disease, and hospitalization due to congestive heart failure. It is crucial for healthcare providers to consider these options when developing treatment plans for patients with type 2 diabetes.
- ACP strongly recommends incorporating a sodium-glucose cotransporter-2 (SGLT-2) inhibitor or glucagon-like peptide-1 (GLP-1) agonist alongside metformin and lifestyle adjustments for adults with type 2 diabetes who are experiencing inadequate glycemic control. This recommendation is supported by high-certainty evidence.
- Evaluation and Management of Chronic Kidney Disease
- Authoring Society: Kidney Disease Improving Global Outcomes (KDIGO)
- Publication: March 13, 2024
- KDIGO recommends treating patients with type 2 diabetes (T2D), CKD, and an eGFR ‡20 ml/min per 1.73 m2 with an SGLT2i.
- KDIGO recommends treating adults with CKD with an SGLT2i for the following (1A): eGFR ‡20 ml/min per 1.73 m2 with urine ACR ‡200 mg/g (‡20 mg/mmol), or heart failure, irrespective of level of albuminuria.
- KDIGO suggests treating adults with eGFR 20 to 45 ml/min per 1.73 m2 with urine ACR<200 mg/g (<20 mg/mmol) with an SGLT2i.
- Diabetes Standards of Care 2024
- Authoring Society: American Diabetes Association (ADA)
- Publication: December 11, 2023
- In adults with type 2 diabetes and established or high risk of atherosclerotic cardiovascular disease, heart failure (HF), and/or chronic kidney disease (CKD), the treatment plan should include agent(s) that reduce cardiovascular and kidney disease risk (e.g., SGLT2 and/or GLP-1 RA) for glycemic management and comprehensive cardiovascular risk reduction, independent of A1C and in consideration of person-specific factors
- In adults with type 2 diabetes who have HF, an SGLT2 inhibitor is recommended, for glycemic management and prevention of HF hospitalizations
- In adults with type 2 diabetes who have CKD, an SGLT2 inhibitor should be used for minimizing progression of CKD, reduction in cardiovascular events, and reduction in hospitalizations for HF
- Among people with type 2 diabetes who have established ASCVD or established kidney disease, an SGLT2 inhibitor or GLP-1 receptor agonist with demonstrated cardiovascular disease benefit is recommended as part of the comprehensive cardiovascular risk reduction and/or glucose-lowering treatment plans.
- In people with type 2 diabetes and established ASCVD, multiple ASCVD risk factors, or diabetic kidney disease, an SGLT2 inhibitor with demonstrated cardiovascular benefit is recommended to reduce the risk of major adverse cardiovascular events and/or heart failure hospitalization
- In people with type 2 diabetes and established ASCVD or multiple risk factors for ASCVD, combined therapy with an SGLT2 inhibitor with demonstrated cardiovascular benefit and a GLP-1 receptor agonist with demonstrated cardiovascular benefit may be considered for additive reduction of the risk of adverse cardiovascular and kidney events.
- In people with type 2 diabetes and established heart failure with either preserved or reduced ejection fraction, an SGLT2 inhibitor (including SGLT1/2 inhibitor) with proven benefit in this patient population is recommended to reduce the risk of worsening heart failure and cardiovascular death.
- In people with type 2 diabetes and established heart failure with either preserved or reduced ejection fraction, an SGLT2 inhibitor with proven benefit in this patient population is recommended to improve symptoms, physical limitations, and quality of life
- In individuals with type 2 diabetes and asymptomatic stage B heart failure or with high risk of or established cardiovascular disease, treatment with an SGLT inhibitor (including SGLT2 or SGLT1/2 inhibitors) is recommended to reduce the risk of hospitalization for heart failure.
- In individuals with diabetes, guideline-directed medical therapy for myocardial infarction and symptomatic stage C heart failure is recommended with ACE inhibitors/ARBs, MRAs, angiotensin receptor/neprilysin inhibitor, b-blockers, and SGLT2 inhibitors, similar to guideline-directed medical therapy for people without diabetes.
- Management of Heart Failure
- ACC/AHA/Heart Failure Society of America (HFSA)
- Publication: April 01, 2022
- For patients suffering from symptomatic chronic heart failure with reduced ejection fraction (HFrEF), SGLT2 inhibitors are recommended to decrease hospitalizations for heart failure and cardiovascular mortality, regardless of whether they have type 2 diabetes.
- Furthermore, in patients with symptomatic chronic HFrEF, SGLT2 inhibitor therapy offers moderate economic benefits.
- Diabetes Management in Chronic Kidney Disease
- KDIGO/National Kidney Foundation (NKF)
- Publication: October 01, 2020
- KDIGO/NKF recommends treating patients with type 2 diabetes (T2D), CKD, and an eGFR ‡20 ml/min per 1.73 m2 with an SGLT2i
- KDIGO/NKF recommends treating patients with type 2 diabetes (T2D), CKD, and an eGFR ‡20 ml/min per 1.73 m2 with an SGLT2i
This concludes our Guidelines+ Monographs for Dapagliflozin (Farxiga). This list is current as of August 2024 and may be updated over time as new indications are approved and/or new guidelines published or updated. Sign up for alerts and stay informed on the latest published guidelines and articles.
Copyright © 2024 Guideline Central, All Rights Reserved.