Farxiga

Uses

What is Farxiga® (dapagliflozin) used for?

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 treat type 2 diabetes.

Farxiga® is not for treating type 1 diabetes.

How should I take Farxiga® (dapagliflozin)?

Farxiga® is usually taken once per day in the morning. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Farxiga® with or without food, but take it the same way each time.

Your blood sugar will need to be checked often, and you may need other medical tests at your doctor’s office.

You may have very low blood pressure while taking Farxiga®. Call your doctor if you are sick with vomiting or diarrhea, if you consume less food or fluid than usual, or if you are sweating more than usual.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

This medicine can cause positive results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Farxiga®.

Farxiga® is only part of a treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

How do I store Farxiga® (dapagliflozin)?

Farxiga® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Farxiga® in the bathroom or the freezer. There may be different brands of Farxiga® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Farxiga® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Farxiga® (dapagliflozin)?

Before using this drug, tell your doctor if:

• You are pregnant or breastfeeding. This is because, while you are expecting or feeding a baby, you should only take medicines on the recommendation of a doctor.
• You are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
• You have allergy with any of active or inactive ingredients of Farxiga® or other medications.
• You have any other illnesses, disorders, or medical conditions.

You should not use Farxiga® if you are allergic to dapagliflozin, or if you have:

• Severe kidney disease (or if you are on dialysis)
• Diabetic ketoacidosis (call your doctor for treatment with insulin)

To make sure Farxiga® is safe for you, tell your doctor if you have:

• Kidney disease
• A history of bladder cancer
• Liver disease
• Congestive heart failure
• Low blood pressure
• High cholesterol levels
• If you use insulin or take other oral diabetes medications
• If you are on a low salt diet
• If you take blood pressure medicine

It is not known whether Farxiga® will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether dapagliflozin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Farxiga®.

Do not give Farxiga® to anyone under 18 years old without medical advice.

Is it safe during pregnancy or breastfeeding?

There are no adequate studies in women for determining risk when using Farxiga® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Farxiga®. Farxiga® is pregnancy risk category C, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

• A=No risk
• B=No risk in some studies
• C=There may be some risk
• D=Positive evidence of risk
• X=Contraindicated
• N=Unknown

Side effects

What side effects can occur from Farxiga® (dapagliflozin)?

Get emergency medical help if you have signs of an allergic reaction to Farxiga®: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• A light-headed feeling, like you might pass out
• Blood in your urine, bright red urine, painful or difficult urination, urinating more than usual
• Ketoacidosis (too much acid in the blood) – nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing
• Dehydration symptoms – feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin
• Kidney problems – little or no urinating; swelling in your feet or ankles; feeling tired or short of breath
• Signs of a bladder infection – pain or burning when you urinate, urine that looks cloudy, pain in pelvis or back
• Signs of a genital infection (penis or vagina) – pain, burning, itching, rash, redness, odor, or discharge

Side effects may be more likely to occur in older adults.

Common side effects may include:

• Sore throat, stuffy nose, flu symptoms
• Nausea
• Back pain

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Farxiga® (dapagliflozin)?

Farxiga® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Products that may interact with this drug are:

• A diuretic or “water pill’
• Heart or blood pressure medication
• An NSAID (nonsteroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, indomethacin, meloxicam, and others

Does food or alcohol interact with Farxiga® (dapagliflozin)?

Farxiga® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Farxiga® (dapagliflozin)?

Farxiga® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Farxiga® (dapagliflozin).

What is the dose of Farxiga® (dapagliflozin) for an adult?

Usual Adult Dose for Diabetes Type 2:

Initial dose: 5 mg orally once a day

Maximum dose: May increase to 10 mg orally once a day in patients tolerating therapy with 5 mg/day and requiring additional glycemic control

What is the dose of Farxiga® (dapagliflozin) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Farxiga® (dapagliflozin) available?

Farxiga® is available in the following dosage forms and strengths:

• Tablet, film coated: dapagliflozin propanediol 5mg

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Farxiga®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.