Dapagliflozin

Dapagliflozin (Farxiga) is a selective sodium-glucose cotransporter 2 inhibitor that promotes glycosuria. It is labeled for the treatment of type 2 diabetes mellitus in adults as an adjunct to diet and exercise to improve glycemic control. Recently the labeling has been revised to include use in reducing the risk of hospitalization for heart failure in patients with type 2 diabetes and established cardiovascular disease (CVD) or multiple cardiovascular risk factors, and to reduce the risk of cardiovascular death and hospitalization of adults with New York Heart Association (NYHA) class II to IV heart failure with reduced ejection fraction (HFrEF), with or without type 2 diabetes. In postmarketing reports of dapagliflozin, adverse effects include hypotension, hypoglycemia, ketoacidosis, acute kidney injury, urosepsis, pyelonephritis, and necrotizing fasciitis of the perineum. 2. It should not be prescribed to patients with an eGFR of less than 30 mL per minute per 1.73 m 2, those with end-stage renal disease, pregnant women in the second and third trimesters, or lactating women. Dapagliflozin has been shown to reduce the risk of hospitalization for heart failure in patients with type 2 diabetes who have or are at high risk of CVD (men older than 55 years or women older than 60 years with hypertension, hyperlipidemia, smoking, or statin use). There were fewer hospitalizations for heart failure in patients taking dapagliflozin compared with patients taking placebo over the me...

Farxiga Generic name: DAP-a-gli-FLOE-zin] Drug class: Medically reviewed by • • • • • • • What is Farxiga? Farxiga is an oral diabetes medicine that helps control blood sugar levels. Dapagliflozin works by helping the kidneys get rid of glucose from your bloodstream. Farxiga is used together with diet and exercise to improve blood sugar control in adults with type 2 Farxiga is also used to lower the risk of death from Farxiga is also used in adults to lower the risk needing to be in the hospital for Farxiga is also used to lower the risk of further worsening of kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalization for heart failure in adults with Warnings You should not use Farxiga if you have Tell your doctor if you are sick with Taking Farxiga can make you dehydrated, which could cause you to feel weak or dizzy (especially when you stand up). Farxiga can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don't feel well. Some people taking this medicine have had bladder cancer, but it is not clear if dapagliflozin was the actual cause. Before taking this medicine You should not use Farxiga if you are allergic to dapagliflozin, or if you have: • severe kidney disease (or if you are on dialysis); or • To make sure Farxiga is safe for you, tell your doctor if you hav...

Description and Brand Names Drug information provided by: US Brand Name • Farxiga Descriptions Dapagliflozin is used together with proper diet and exercise to treat type 2 diabetes. It works in the kidneys to prevent absorption of glucose (blood sugar). This helps lower the blood sugar level. Dapagliflozin does not help patients who have insulin-dependent or type 1 diabetes. Type 1 diabetic patients must use insulin injections. Dapagliflozin is also used to lower the risk of hospitalization for heart failure in patients with type 2 diabetes and cardiovascular (heart or blood vessel) disease or multiple cardiovascular risk factors. This medicine is also used to lower the risk of cardiovascular death, hospitalization, and urgent heart failure visit in patients with heart failure with reduced ejection fraction (the heart is weak and cannot pump enough blood to the rest of the body). Dapagliflozin is also used to lower the risk of worsening of kidney disease, end stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease. This medicine is available only with your doctor's prescription. This product is available in the following dosage forms: • Tablet • Portions of this document last updated: June 01, 2023 Copyright: © Merative US L.P. 1973, 2023. All rights reserved. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. • •

Farxiga is a brand-name prescription medication. It’s approved for different uses in adults with In people with type 2 diabetes, it’s approved to: • improve • reduce the risk of hospitalization for heart failure in people with heart disease or risk factors for heart disease In people with heart failure with or without type 2 diabetes, it’s approved to: • reduce the risk of either hospitalization for heart failure or cardiovascular death* in people with reduced ejection fraction (EF)† For people with • lowered • • cardiovascular death • hospitalization for heart failure It’s important to note that Farxiga isn’t approved to treat * Cardiovascular death is death that’s related to a heart or blood vessel problem. † With reduced EF, your heart isn’t able to pump out as much blood to the rest of your body as usual. Drug details Farxiga can be used by itself or along with other diabetes and heart failure medications. Farxiga comes as a tablet you take by mouth once daily. It contains the active drug dapagliflozin. And it belongs to a class of medications called Effectiveness In About 44% to 51% of people in the studies who took Farxiga for 24 weeks reached their goal A1C of less than 7%. To learn about Farxiga’s effectiveness for its other approved uses, see the “ * Fasting blood sugar is measured after you’ve fasted for a certain period of time. The † A1C is a measurement that shows your average blood sugar levels over the past 2 to 3 months. The ADA recommends an A1C goal of le...

To reduce the risk of dizziness and Remember that this Tell your doctor right away if you have any serious side effects, including: signs of a Get medical help right away if you have any very serious side effects, including: unusual tiredness, Dapagliflozin can sometimes cause This medication may cause a new This medication may cause you to become dehydrated. This can lead to serious kidney damage. Drink plenty of fluids to prevent If you are taking dapagliflozin for Symptoms of high blood sugar ( A very serious This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Before taking dapagliflozin, tell your doctor or Before using this If you have If you have diabetes, it may be harder to control your Before having surgery, tell your doctor or Older adults may be more sensitive to the side effects of this drug, especially dizziness/ During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your It is unknown if this dru...

Dosage Forms & Strengths tablet (Farxiga, generic) • 5mg • 10mg Type 2 Diabetes Mellitus Improve glycemic control • Indicated as an adjunct to diet and exercise to improve glycemic control with type 2 diabetes mellitus (T2DM) • Initial: 5 mg PO qDay in AM • May increase to 10 mg qDay in patients tolerating 5 mg/day who require additional glycemic control Reduce risk of hospitalization for heart failure • Indicated to reduce hospitalization risk for heart failure in adults with T2DM and established cardiovascular disease (CVD) or multiple CV risk factors • 10 mg PO qDay in AM Heart Failure Indicated to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), and urgent heart failure visit in adults with HF; this indication includes HF with either reduced or preserved ejection fraction 10 mg PO qDay 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 chronic kidney disease (CKD) who are at risk of progression 10 mg PO qDay Dosage Modifications Renal impairment eGFR ≥45mL/min/1.73 m 2: No dosage adjustment required • eGFR 25 to <45 mL/min/1.73 m2 • T2DM: Not recommended • HF or CKD: No dosage adjustment required • eGFR <25 mL/min/1.73 m2 • Initiation not recommended • Patients with HF or CKD may continue 10 mg/day to reduce risk of eGFR decline, ESKD, CV death, and HF hospitalization ​ESRD/dialysis: Contraindicated Hepatic impairment ...

Farxiga Generic name: DAP-a-gli-FLOE-zin] Drug class: Medically reviewed by • • • • • • • What is Farxiga? Farxiga is an oral diabetes medicine that helps control blood sugar levels. Dapagliflozin works by helping the kidneys get rid of glucose from your bloodstream. Farxiga is used together with diet and exercise to improve blood sugar control in adults with type 2 Farxiga is also used to lower the risk of death from Farxiga is also used in adults to lower the risk needing to be in the hospital for Farxiga is also used to lower the risk of further worsening of kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalization for heart failure in adults with Warnings You should not use Farxiga if you have Tell your doctor if you are sick with Taking Farxiga can make you dehydrated, which could cause you to feel weak or dizzy (especially when you stand up). Farxiga can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don't feel well. Some people taking this medicine have had bladder cancer, but it is not clear if dapagliflozin was the actual cause. Before taking this medicine You should not use Farxiga if you are allergic to dapagliflozin, or if you have: • severe kidney disease (or if you are on dialysis); or • To make sure Farxiga is safe for you, tell your doctor if you hav...

Farxiga is a brand-name prescription medication. It’s approved for different uses in adults with In people with type 2 diabetes, it’s approved to: • improve • reduce the risk of hospitalization for heart failure in people with heart disease or risk factors for heart disease In people with heart failure with or without type 2 diabetes, it’s approved to: • reduce the risk of either hospitalization for heart failure or cardiovascular death* in people with reduced ejection fraction (EF)† For people with • lowered • • cardiovascular death • hospitalization for heart failure It’s important to note that Farxiga isn’t approved to treat * Cardiovascular death is death that’s related to a heart or blood vessel problem. † With reduced EF, your heart isn’t able to pump out as much blood to the rest of your body as usual. Drug details Farxiga can be used by itself or along with other diabetes and heart failure medications. Farxiga comes as a tablet you take by mouth once daily. It contains the active drug dapagliflozin. And it belongs to a class of medications called Effectiveness In About 44% to 51% of people in the studies who took Farxiga for 24 weeks reached their goal A1C of less than 7%. To learn about Farxiga’s effectiveness for its other approved uses, see the “ * Fasting blood sugar is measured after you’ve fasted for a certain period of time. The † A1C is a measurement that shows your average blood sugar levels over the past 2 to 3 months. The ADA recommends an A1C goal of le...

To reduce the risk of dizziness and Remember that this Tell your doctor right away if you have any serious side effects, including: signs of a Get medical help right away if you have any very serious side effects, including: unusual tiredness, Dapagliflozin can sometimes cause This medication may cause a new This medication may cause you to become dehydrated. This can lead to serious kidney damage. Drink plenty of fluids to prevent If you are taking dapagliflozin for Symptoms of high blood sugar ( A very serious This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Before taking dapagliflozin, tell your doctor or Before using this If you have If you have diabetes, it may be harder to control your Before having surgery, tell your doctor or Older adults may be more sensitive to the side effects of this drug, especially dizziness/ During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your It is unknown if this dru...

Dosage Forms & Strengths tablet (Farxiga, generic) • 5mg • 10mg Type 2 Diabetes Mellitus Improve glycemic control • Indicated as an adjunct to diet and exercise to improve glycemic control with type 2 diabetes mellitus (T2DM) • Initial: 5 mg PO qDay in AM • May increase to 10 mg qDay in patients tolerating 5 mg/day who require additional glycemic control Reduce risk of hospitalization for heart failure • Indicated to reduce hospitalization risk for heart failure in adults with T2DM and established cardiovascular disease (CVD) or multiple CV risk factors • 10 mg PO qDay in AM Heart Failure Indicated to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), and urgent heart failure visit in adults with HF; this indication includes HF with either reduced or preserved ejection fraction 10 mg PO qDay 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 chronic kidney disease (CKD) who are at risk of progression 10 mg PO qDay Dosage Modifications Renal impairment eGFR ≥45mL/min/1.73 m 2: No dosage adjustment required • eGFR 25 to <45 mL/min/1.73 m2 • T2DM: Not recommended • HF or CKD: No dosage adjustment required • eGFR <25 mL/min/1.73 m2 • Initiation not recommended • Patients with HF or CKD may continue 10 mg/day to reduce risk of eGFR decline, ESKD, CV death, and HF hospitalization ​ESRD/dialysis: Contraindicated Hepatic impairment ...