Dapagliflozin

What is Dapagliflozin?

Dapagliflozin (Farxiga) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used to treat type 2 diabetes and, with certain restrictions, type 1 diabetes. It is also used to treat adults with certain kinds of heart failure.

What are the uses of this medicine?

This medicine is used:

• along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes
• to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes who also have known cardiovascular disease or multiple cardiovascular risk factors
• to reduce the risk of cardiovascular death, hospitalization for heart failure in adult patients with heart failure, when the heart is weak and cannot pump enough blood to the rest of your body
• to reduce the risk of further worsening of your kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalization for heart failure in adults with chronic kidney disease.

Limitations of use:

• Farxiga is not for people with type 1 diabetes. Farxiga may increase the risk of diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes.
• Farxiga is not for use to improve blood sugar (glucose) control in adults with type 2 diabetes who have moderate to severe kidney problems, because it may not work.
• Farxiga is not for people with certain genetic forms of polycystic kidney disease, or who are taking or have recently received immunosuppressive therapy to treat kidney disease. Farxiga is not expected to work if you have these conditions.
• It is not known if Farxiga is safe and effective in children younger than 18 years of age.

How does this medicine work?

• Sodium-glucose cotransporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen.
• Dapagliflozin is an inhibitor of SGLT2.
• By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and thereby promotes urinary glucose excretion.
• Dapagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule.
• This may influence several physiological functions including, but not restricted to, lowering both pre- and afterload of the heart and downregulation of sympathetic activity, and decreased intraglomerular pressure which is believed to be mediated by increased tubuloglomerular feedback.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• serious hypersensitivity reaction to Farxiga, such as anaphylactic reactions or angioedema
• on dialysis

What drug interactions can this medicine cause?

• Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.
• Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

Is this medicine FDA approved?

• It was approved for use in the United States in 2014.

How should this medicine be used?

• Assess renal function prior to initiation of Farxiga therapy and then as clinically indicated.

Recommended Dosage:

• Assess volume status and correct volume depletion before initiating.

The dosage recommendations based on estimated glomerular filtration rate (eGFR) is shown below:

eGFR 45 or greaterː

• To improve glycemic control, the recommended starting dose is 5 mg orally once daily. Dose can be increased to 10 mg orally once daily for additional glycemic control*.
• For all other indications, the recommended starting dose is 10 mg orally once daily.

eGFR 25 to less than 45ː

• 10 mg orally once daily

eGFR less than 25ː

• Initiation is not recommended, however patients may continue 10 mg orally once daily to reduce the risk of eGFR decline, ESKD, CV death and hHF.

On dialysis

• Contraindicated.

Administration

• Take Farxiga exactly as your healthcare provider tells you to take it.
• Do not change your dose of Farxiga without talking to your healthcare provider.
• Take Farxiga by mouth 1 time each day, with or without food.
• Stay on your prescribed diet and exercise program while taking Farxiga.
• Farxiga will cause your urine to test positive for glucose.
• Your healthcare provider may do certain blood tests before you start Farxiga and during your treatment.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take 2 doses of Farxiga at the same time.
• If you take too much Farxiga, call your healthcare provider or go to the nearest emergency room right away.
• If you have diabetes
• When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine you need may change. Tell your healthcare provider right away if you have any of these conditions and follow your healthcare provider’s instructions.
• Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your HbA1c.
• Follow your healthcare provider’s instructions for treating low blood sugar (hypoglycemia). Talk to your healthcare provider if low blood sugar is a problem for you.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 5 mg and 10 mg

This medicine is available in fallowing brand namesː

• Farxiga

What side effects can this medication cause?

The most common side effects of this medicine include:

• 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

Farxiga may cause serious side effects, including:

• Dehydration
• Vaginal yeast infection
• Yeast infection of the penis (balanitis)
• Ketoacidosis in people with diabetes mellitus (increased ketones in your blood or urine)
• Serious urinary tract infections
• Low blood sugar (hypoglycemia) in patients with diabetes mellitus
• A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum)

What special precautions should I follow?

• Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in patients with type 1 and type 2 diabetes mellitus receiving sodium-glucose cotransporter 2 (SGLT2) inhibitors, including Farxiga. Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis regardless of blood glucose level. If suspected, discontinue Farxiga, evaluate and treat promptly. Before initiating Farxiga, consider risk factors for ketoacidosis. Patients on Farxiga may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.
• 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.
• Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been reported in patients receiving SGLT2 inhibitors, including Farxiga. Evaluate for signs and symptoms of urinary tract infections and treat promptly, if indicated.
• Farxiga may increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue. Consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia when used in combination with Farxiga.
• Reports of necrotizing fasciitis of the perineum (Fournier’s Gangrene), a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in postmarketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors, including Farxiga. 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.
• Farxiga increases the risk of genital mycotic infections. Monitor and treat if indicated.

What to do in case of emergency/overdose?

• There were no reports of overdose during the clinical development program for Farxiga.

Management of overdosage:

• In the event of an overdose, contact the Poison Control Center.
• It is also reasonable to employ supportive measures as dictated by the patient’s clinical status.
• The removal of dapagliflozin by hemodialysis has not been studied.

Can this medicine be used in pregnancy?

• Based on animal data showing adverse renal effects, Farxiga is not recommended during the second and third trimesters of pregnancy.
• Limited data with Farxiga in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage.

Can this medicine be used in children?

• Safety and effectiveness of Farxiga in pediatric patients under 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: dapagliflozin.
• Inactive ingredients: microcrystalline cellulose, anhydrous lactose, crospovidone, silicon dioxide, and magnesium stearate. The film coating contains: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and yellow iron oxide.

Who manufactures and distributes this medicine?

• Distributed by: AstraZeneca Pharmaceuticals LP Wilmington

What should I know about storage and disposal of this medication?

• Store Farxiga at room temperature between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Dapagliflozin
• FDA Dapagliflozin

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