FDA Approval:
FDA First approved on
January 8, 2014
Brand name: Farxiga
Generic name: Dapagliflozin
Dosage form: Tablets Oral
Company: AstraZeneca
Treatment for: Diabetes, Type 2, Renal Failure, Heart Failure
Farxiga (Dapagliflozin) is a sodium -glucose cotransporter 2 (SGLT2) inhibitor indicated for the treatment of Type II diabetes mellitus, heart failure, and chronic kidney disease.
Developmental timeline for Farxia(Dapaglidflozin):-
•April 30, 2021 Approval: Farxiga approved in the US for the Treatment of Chronic Kidney Disease in patients at risk of progression with and without ithout Type-2 Diabetes.
•May 6, 2020 Approval Farxiga Approved in the US for the treatment of Heart Failure in patients with Heart Failure with reduced ejection fraction.
•April 23, 2020 AstraZeneca and Saint Luke’s Mid America Heart Institute initiated Phase III DARE-19 Trial with Farxiga in COVID-19 Patients.
•Oct 21, 2019 Approval:
FDA Approved Farxiga (Dapagliflozin) to reduce the risk of hospitalization for Heart Failure in Patients with Type 2 Diabetes.
•January 8, 2014 Approval :
FDA Approved Farxiga to treat Type 2 Diabetes.
•December 12, 2013 FDA Advisory Committee recommended the Investigational SGLT2 Inhibitor Dapagliflozin for treatment of Type 2 Diabetes in adults
•July 25, 2013 AstraZeneca and Bristol-Myers Squibb resubmitted Dapagliflozin New Drug application for the treatment of type 2 diabetes in the U.S.
•January 19, 2012 Bristol-Myers Squibb and AstraZeneca Received Complete response letter from U.S. Food and Drug Administration for Dapagliflozin.
•October 27, 2011 U.S. Food and Drug Administration(FDA) extends action date for Dapagliflozin by 3 months.
•July 20, 2011 FDA Advisory Committee made recommendation on investigational compound Dapagliflozin.
•March 8, 2011 FDA Accepted New Drug application for investigational compound Dapagliflozin for the Treatment of Type 2 Diabetes.
Introduction :-
It is useful in the treatment of following conditions:
-Type 2 Diabetes mellitus
as an adjunct to diet and exercise to improve glycemic control in adults.
-To reduce the risk of hospitalization for heart failure in adults with Type II diabetes mellitus and
-Established cardiovascular disease or multiple cardiovascular risk factors.
-Heart Failure
to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction (NYHA class II-IV).
-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.
Dapaglidflozin is used along with diet and exercise, and sometimes with other medications, to lower blood sugar levels in adults with Type II diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally).
One can take Dapagliflozin any time of day, just try to take it at the same time every day. Swallow the tablets whole with a drink of water. Do not chew them. One can take them with or without food.
How long does it take to work? Dapagliflozin starts to work after about 2 hours to reduce your blood glucose levels, but it may take up to a week for it to take full effect. You may not have had any symptoms of diabetes, so you will not necessarily feel any different when you take Dapagliflozin.
You should not usee Dapagliflozin during the second or third trimester of pregnancy. Do not breastfeed. Not approved for use by anyone younger than 18 years old.
Dapaglidflozin 10 mg is available as combinational drug with 100 mg Vildagliptilin.
Dapaglidflozin 10 mg is also available as combinational drug with Tenigliptilin 20 mg .
Benifits of Dapagliflozin:
•Dapagliflozin is a medicine used to treat Type II diabetes - NHS.Dapagliflozin works in the kidneys to prevent absorption of glucose (blood sugar). This helps lower the blood sugar level. Metformin reduces the absorption of sugar from the stomach, reduces the release of stored sugar from the liver, and helps your body use sugar better.
•Effect on blood pressure:
Dapagliflozin also lowers blood pressure due to its natriuresis effect. Natriuresis is the process of sodium excretion in the urine through the action of the kidneys. It is promoted by ventricular and atrial natriuretic peptides as well as calcitonin, and inhibited by chemicals such as aldosterone.
Dapagliflozin reduces systolic blood pressure and modulates vasoactive factors.
•It improves levels of visceral fat and reduces body weight, and thus ameliorates metabolic syndrome.
•Dapagliflozin reduces oxidative stress and may delay atherosclerosis.
•Dapagliflozin reduced the risk of kidney failure, death from cardiovascular causes or hospitalization for heart failure, and prolonged survival in people with chronic kidney disease, with or without Type II diabetes, independently of the presence of concomitant cardiovascular disease.
•Adding Dapagliflozin to current standard care has been shown to significantly reduce the risk of having declining kidney function, end-stage kidney disease, or dying from causes related to the kidneys or cardiovascular system.
•Dapagliflozin is good for heart:-
Dapagliflozin reduced the risk of worsening HF, cardiovascular death, and all-cause death and improved symptoms, physical function, and health-related quality of life similarly in men and women with heart failure and reduced ejection fraction.
Side effects of dapagliflozin:-
•Thrush. Ask your pharmacist to recommend an antifungal treatment for thrush.
•Back pain:If you get sudden unexpected back pain, do not try to treat it yourself.
•Feeling dizzy.
•Mild skin rash.
•Liver damage:
A theoretical pathologic link of Dapagliflozin as possibly causing direct liver damage may be supported by the presence of SGLT1 in biliary duct cells and intestines.
•Long-term study of patients with Type II diabetes and moderate renal impairment shows that Dapagliflozin reduces weight and blood pressure but does not improve glycemic control.
•There may be symptoms of a serious kidney problem. This medicine may increase risk of having urinary tract infections, including Pyelonephritis or urosepsis.
Pyelonephritis is the
inflammation of the kidney as a result of bacterial infection. Check with your doctor right away if you have bladder pain, bloody or cloudy urine, difficult, burning, or painful urination, or lower back or side pain.These are the symptoms of Urinary tract infection.
•Dapagliflozin makes you pee more:-Peeing more than normal. This is a sign that you're peeing out more sugar in your urine. There may be foaming in urine.
Vaginal yeast infections and yeast infections of the penis. Stuffy or runny nose and sore throat. Changes in urination, including urgent need to urinate more often, in larger amounts, or at night.
•Dapagliflozin diminishes memory and cognition impairment in Streptozotocin induced diabetes through its effect on Wnt/ β-Catenin and CREB pathway.
When one should not take Dapagliflozin apagliflozin:-
Dapagliflozin is not used to treat Type I diabetes (condition in which the body does not produce insulin and,e therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated).
•The Safest drug for Type II Diabetes:-
Most experts consider Metformin to be the safest medicine for Type II diabetes because it has been used for many decades, is effective, affordable, and safe. Metformin is recommended as a first-line treatment for Type II diabetes by the American Diabetes Association (ADA). Metformin is the most common oral medication for Type II diabetes. It's been around a long time and is very well studied. Because of this, healthcare providers often recommend trying metformin first. Providers also prescribe metformin as the first choice for gestational diabetes if medication is necessary.
•The latest medication for the treatment for Type II diabetes.The new medicine for Type II diabetes:-
Tirzepatide:
Tirzepatide is the first drug in a new class of diabetes medications. It is a dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist. GLP-1 and GIP are gut hormones called incretins, and the intestines release them when we eat.
This new medication has been shown to dramatically lower A1C and weight in clinical trials. In May 2022, the FDA approved Lilly's new medication Mounjaro (also known as Tirzepatide) for Type II diabetes management, in addition to diet and exercise.
*Other alternatives to Farxiga
•Qtern (Dapagliflozin/saxagliptin)
•Invokamet (canagliflozin/empagliflozin/linagliptin)
•Trijardy XR (empagliflozin/linagliptin/metformin ER).
Information compiled by:
Dr. Bhairavsinh Raol
