Farxiga (Dapagliflozin)

Farxiga is not recommended:

• If you are allergic or have had an allergic reaction to Farxiga or ingredients in Farxiga
• If you are pregnant or breastfeeding
• If you are under 18 years of age
• If you have type 1 diabetes

What are the Indications for Farxiga?

Farxiga is approved to treat type 2 diabetes and control your blood sugar levels along with diet and exercise.

How is Farxiga used?

Storage

Farxiga should be stored in its original package between 68°F and 77°F (20°C and 25°C) away from heat and moisture.

Keep out of reach from children.

Instruction

Take Farxiga by mouth, as directed by your doctor, with or without food at the same time every day.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, only take one dose. Do not catch up by taking two doses at once.

Do not change your dosage, take more than what is prescribed, or stop using Farxiga without consulting with your doctor. If you took more than prescribed, contact your doctor immediately or seek emergency medical care.

Your blood sugar must be checked often and your urine for ketones. Even if your blood sugar is normal, contact your doctor if your urine shows high levels of ketones.

Dosage

Farxiga is available in a film-coated tablet form in the following strength: 5 mg and 10 mg

The recommended starting dose is 5 mg once daily in the morning. It may be increased to 10 mg if you tolerate the lower dose.

Side Effects

It’s important to understand that although Farxiga is FDA-approved, it comes with side effects that may or may not affect you.

Before starting Farxiga, you should discuss possible side effects with your doctor or pharmacist.

Common Side Effects

Not all side effects require medical attention. As your body adjusts to Farxiga, side effects may go away. Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own.

• Genital yeast infection
• Urinary tract infection
• Infections like a cold or flu
• Increased urination
• Constipation
• Back pain
• Nausea
• Increased cholesterol levels
• Constipation

Serious Side Effects

Severe adverse reactions while taking Farxiga may occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:

• Ketoacidosis(too much acid in your blood): nausea, tiredness, vomiting, trouble breathing, and abdominal pain.
• Dehydration(the loss of body water and salt): dizziness, feeling faint, lightheaded or weak, fatigue, thirst, vomiting or diarrhea.
• Serious urinary tract infections (UTI): burning feeling when passing urine, a need to urinate often or right away, pain in the lower part of your stomach (pelvis), blood in the urine, fever, back pain, nausea, or vomiting.
• Low blood sugar (hypoglycaemia): dizziness or light-headedness, headache, shakiness, irritability, sweating, blurred vision, rapid heartbeat, mood change, confusion, slurred speech, anxiety, and hunger.
• Fournier’s gangrene (serious infection of the tissue between the anus and genitals): fever, weakness, tired or uncomfortable, pain, tenderness, swelling or redness of the skin in the genitals and areas around them.

The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.

Warnings & Precautions

Before using Farxiga, tell your doctor or pharmacist:

• If you are allergic to Farxiga or any ingredients in Farxiga
• If you have had, or have risk factors for ketoacidosis
• If you have or have had liver, bladder or pancreas problems
• If you are pregnant or plan to become pregnant
• If you are breastfeeding or plan to breastfeed

Hypotension

Farxiga may cause your blood pressure to drop. If you feel dizzy or faint, speak to your doctor.

Ketoacidosis

Ketoacidosis is a serious condition that occurs when the body does not have enough insulin to use the glucose in the blood, and the body starts to break down fat for energy. This can cause ketones to build up in the blood, making it more acidic. Contact your doctor if you experience high blood glucose levels, thirst, very dry mouth or frequent urination.

Acute Kidney Injury and Impairment in Renal Function

You should contact your doctor or emergency room immediately if you experience signs and symptoms of acute kidney injury. This is a serious condition where the kidneys suddenly stop working and cause dangerous levels of waste to build up in the body. Signs and symptoms include decreased urine or swelling in the legs or feet.

Urinary tract infections

Farxiga increases the risk of urinary tract infections and can lead to hospitalization or even death. Two of these infections are called urosepsis and pyelonephritis. Urosepsis happens when bacteria from a UTI infects the bloodstream. Pyelonephritis occurs when bacteria from a UTI invade essential kidney tissue.

Hypoglycemia

You could develop low blood sugar if you take Farxiga with another medicine that can cause low blood sugar. Symptoms include shaking, sweating, fast heartbeat, dizziness, hunger, headache, and irritability.

Infections in the penis or vagina

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.

Bladder Cancer

Some people taking this medicine have had bladder cancer, but it is not clear if Farxiga was the actual cause. Do not use Farxiga if you have bladder cancer or a history of bladder cancer.

Pregnant or Planning to Become Pregnant

Taking Farxiga while pregnant can impact the unborn baby and cause harm, especially during the second and third trimesters. If you are a female patient and pregnant or planning to become pregnant, please speak to your doctor first before taking Farxiga.

Breastfeeding or Planning to Breastfeed

Studies have not been conducted to determine if Farxiga will pass through to human milk. Farxiga is not recommended when breastfeeding.

Interactions & Contraindications

Before using Farxiga, tell your doctor or pharmacist if you take any medications, herbal supplements, or vitamins.

Farxiga should not be used if you have:

• Type 1 diabetes can increase your risk of diabetic ketoacidosis.
• Moderate to severe kidney problems, because it may not work.
• Certain genetic forms of polycystic kidney disease.
• Recently received immunosuppressive therapy to treat kidney disease.
• Severe renal impairment, end-stage renal disease or on dialysis.

Frequently Asked Questions