Farxiga

What is Farxiga?

Farxiga is an oral medication used to treat certain conditions, such as diabetes, kidney disease, and heart disease. Farxiga can be used to treat:

• Exercise and diet can help control blood sugar levels in adults with type 2 diabetes.

• Reduce hospitalization risk among adults with type 2 diabetes who also have cardiovascular disease or multiple risk factors for heart failure hospitalizations.

• Adults with heart failure can reduce their risk of death from cardiovascular causes, hospitalizations for heart failure, and urgent heart failure visits.

• Reduce the risk of worsening kidney disease and end-stage kidney diseases (ESKD), cardiovascular disease death, and hospitalization due to heart failure among adults with chronic renal disease who are at risk for progression.

Farxiga increases urine output by decreasing glucose reabsorption into our kidneys.It inhibits sodium-glucose transporter 2 (SGLT2), which is found in the proximal tubules of the kidneys and is responsible for reabsorption. This inhibits this enzyme, which promotes glucose excretion in the urine. Farxiga works by increasing the amount of sodium that reaches the distal tubeule and reducing how much is reabsorbed. It is believed that this drug affects several physiological functions, including lowering the preload and postload of the heart and downregulating sympathetic activation. Farxiga received FDA approval for the first time on January 8, 2014. Farxiga belongs to a class of drugs known as selective sodium glucose-cotransporter-2 inhibitors.

Warnings

Farxiga should not be used if you are hypersensitive to dapagliflozin or any other ingredient in Farxiga. Farxiga shouldn't be used by patients with type 1 diabetes because it can increase the risk of diabetic ketaacidosis. It is not recommended for type 2 diabetics with an eGFR less than 45 mL/min/1.73 m2 in order to improve blood glucose control. This treatment will likely be ineffective. In other indications, initiation of treatment in patients with an eGFR lower than 25 mL/min/1.73 m2 is not recommended. However, patients can continue to take 10mg once daily orally to reduce the risk of further worsening kidney disease, ESKD, death from cardiovascular disease, and hospitalization due to heart failure. Patients with polycystic renal disease, or those who have received immunosuppressive treatment for kidney disease recently or are currently receiving it (likely ineffective), should not be treated with this drug for chronic kidney disease.

Patients at higher risk of ketoacidosis may not be able to take this medication. Farxiga should be avoided by patients who have ketoacidosis or are in situations that may predispose them to it. Farxiga may cause dehydration, which can lead to feeling weak or dizzy. Before starting the treatment, patients should drink enough water. They should also be closely monitored for any signs or symptoms of dehydration, particularly in elderly patients, patients with kidney impairment, patients taking diuretics, and those with low blood pressure. If you have diarrhea or vomiting, or if your appetite or drinking are less than normal, tell your doctor. To avoid hypoglycemia, you may need to reduce the dose of insulin or insulin-secretagogues.Farxiga has been prescribed to diabetic patients who have experienced serious, life-threatening cases of necrotizing fasciitis (Fournier’s Gangrene). Consult your doctor if you experience pain, tenderness, swelling, redness, or swelling around your genital area or perineum, or if you have a fever or malaise.

Can increase the risk of genital fungal infection. Prior genital infections are more likely to cause a heightened risk. If you experience burning, itching, or odors, seek medical attention immediately. Urinary tract infections should be treated immediately and monitored.

Before you take this drug

Farxiga should not be used if:

• If you have severe kidney disease or are currently on dialysis,

• Diabetic ketoacidosis: Call your doctor to get treated.

Tell your doctor about any of the following to ensure that Farxiga will be safe for you:

• Polycystic kidney disease

• Liver disease

• Other urination or bladder problems

• Pancreatic problems, including surgery

• Are You Drinking Too Much or Have Alcoholism? If you're an alcohol abuser or addicted individual, treatment might help.

• If you're on a diet low in salt,

Farxiga should not be used during the second and third trimesters. If you are pregnant, or if you become pregnant, follow your doctor's advice about Farxiga. During pregnancy, it is important to control diabetes. Farxiga should not be used during breastfeeding due to the possibility of severe adverse reactions occurring in the breastfed baby.

How to take Farxiga?

Follow your doctor's instructions and take Farxiga only as directed. Read and follow all instructions that accompany your prescription, since sometimes your physician can alter its dose.

• Farxiga can be taken with or without food.

• Diet, exercise, weight management, and other medical treatments may be part of your treatment.

You will have to check your blood sugar often and may need to test for ketones in your urine. Dapagliflozin may cause life-threatening ketoacidosis. Contact your doctor even if you have normal blood sugar if a urine sample shows high levels of ketones. Stress, illness, surgery, or alcohol consumption can affect blood sugar levels. Hypoglycemia (low blood sugar) can cause you to feel irritable or shaky, as well as very hungry. Eat or drink hard candies, crackers, or raisins. Fruit juice or regular soda will also help. In the case of severe hypoglycemia, your doctor may prescribe glucagon shots. You can become dehydrated if you have a prolonged illness. If you have diarrhea or vomiting or are eating or drinking less than normal, call your doctor.

Details on dosage

Before starting therapy, patients should be properly hydrated.

Adult dose for diabetes type 2 to improve blood glucose control

• Initial dose: 5mg once daily.

• If a lower dose is tolerated, the dosage can be increased to 10 mg once daily for additional glycemic management.

• Maximum dose: 10 mg/day

Adult dosage for other indications

• Initial and maintenance dosage: 10 mg once daily orally

• Maximum dose: 10 mg/day

What happens if I miss the dose?

If you are almost due for your next dose, skip the missed one. Never take two doses of the same medicine at once.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

Avoid alcohol consumption. You could feel dizzy if you rise quickly from sitting or lying position.

Side effects of Farxiga

If you experience symptoms of an allergic reaction such as hives, difficulty breathing, swelling of the face, lips, or throat, and difficulty breathing, seek emergency medical attention.

If any of the symptoms listed above arise, seek medical help immediately.These symptoms can get worse very quickly.

If you experience:

• Dehydration symptoms include dizziness, confusion, and feeling thirsty.

• Kidney problems: little or no urine, swelling of the feet or ankles, and feeling tired or short of breath

• Ketoacidosis is a condition where there is too much acid in your blood. This can cause nausea, vomiting, and stomach pain. It may also lead to confusion, unusual sleepiness, or difficulty breathing.

• Signs and symptoms of a urinary tract infection include: pain or burning while urinating; increased urination or blood in the urine; fever; or pain in the pelvis or lower back.

Some side effects are more common in older adults.

Farxiga is associated with the following side effects:

• Female genital fungi

• Urinary tract infection

• Nasopharyngitis is a runny or stuffy nasal condition.

There may be other side effects.Call your physician if experiencing side effects; for medical advice. Report side effects to the FDA by calling 1-800-FDA-1088.

Interaction with other drug

Other drugs can increase or decrease Farxiga's ability to lower your blood sugar. Tell your doctor if you are taking any new or old medications and if you will stop using them.

• Insulin or oral diabetes medications

• Diuretics or "water pills"

Farxiga increases urinary glucose excretion, and this will result in positive urine glucose tests. Monitor glycemic levels using alternative methods. This also interferes with the 1,5-anhydroglucitol (AG) assay. This list is incomplete. Dapagliflozin may interact with other drugs, including prescription, over-the-counter, herbal, and vitamin products. This list does not include all drug interactions.