Generic Name: empagliflozin
Date of Approval: August 1, 2014
Company: Boehringer Ingelheim Pharmaceuticals, Inc.

Treatment for: Type 2 Diabetes

FDA Approves Jardiance

The U.S. Food and Drug Administration (FDA) approved Jardiance (empagliflozin), a sodium glucose co-transporter-2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise in adults with type 2 diabetes.

Jardiance is taken once daily, and works by blocking the reabsorption of glucose in the kidney, increasing glucose excretion and lowering blood glucose levels. It is the third SGLT2 inhibitor to be approved, after canagliflozin (Invokana) and dapagliflozin (Farxiga).

The most common side effects include urinary tract infections and vaginal yeast infections. Hypoglycemia was more commonly reported in patients who were treated in combination with a sulfonylurea or insulin.

Jardiance Patient Information

Read this Patient Information before you start taking this medicine and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

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Important information about Jardiance

Jardiance can cause serious side effects, including:

  • Dehydration. Jardiance can cause some people to have dehydration (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up (orthostatic hypotension).

    You may be at higher risk of dehydration if you:

    • have low blood pressure
    • take medicines to lower your blood pressure, including diuretics (water pill)
    • are on low sodium (salt) diet
    • have kidney problems
    • are 65 years of age or older
  • Vaginal yeast infection. Women who take this medicine may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
    • vaginal odor
    • white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
    • vaginal itching
  • Yeast infection of the penis (balanitis or balanoposthitis). Men who take this medicine may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:
    • redness, itching, or swelling of the penis
    • rash of the penis
    • foul smelling discharge from the penis
    • pain in the skin around penis

Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis. Your doctor may suggest you use an over-the-counter antifungal medicine. Talk to your doctor right away if you use an over-the-counter antifungal medication and your symptoms do not go away.

What is Jardiance?

Jardiance is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

It is not for people with type 1 diabetes.

It is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).

It is not known if it is safe and effective in children under 18 years of age.

Who should not take Jardiance?

Do not take Jardiance if you:

  • are allergic to empagliflozin or any of the other ingredients. See the end of this leaflet for a list of ingredients.
  • have severe kidney problems or are on dialysis

Before using Jardiance

Before you take this medicine, tell your doctor if you:

  • have kidney problems
  • have liver problems
  • have a history of urinary tract infections or problems with urination
  • have any other medical conditions
  • are pregnant or planning to become pregnant. It is not known if this medicine will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. Talk with your doctor about the best way to feed your baby during treatment.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Jardiance may affect the way other medicines work, and vice versa.

Especially tell your doctor if you take:

  • diuretics (water pills)
  • insulin or other medicines that can lower your blood sugar

Ask your doctor or pharmacist for a list of these medicines if you are not sure if your medicine is listed above.

How should I take Jardiance?

Take exactly as your doctor tells you to take it.

Take it by mouth one time in the morning each day, with or without food.

Your doctor may change your dose if needed.

If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses at the same time. Talk with your doctor if you have questions about a missed dose.

Your doctor may tell you to take this medicine along with other diabetes medicines. Low blood sugar can happen more often when Jardiance is taken with certain other diabetes medicines.

If you take too much, call your doctor or go to the nearest hospital emergency room right away.

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 that you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor’s instructions.

Check your blood sugar as your doctor tells you to.

Stay on your prescribed diet and exercise program.

Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and complications of diabetes.

Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin HbA1c.

When taking this medicine, you may have sugar in your urine, which will show up on a urine test.

Jardiance side effects

Jardiance may cause serious side effects, including:

  • See Important information about Jardiance
  • low blood sugar (hypoglycemia). If you take Jardiance with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered. Signs and symptoms of low blood sugar may include:
    • headache
    • irritability
    • drowsiness
    • hunger
    • weakness
    • fast heart beat
    • dizziness
    • sweating
    • confusion
    • shaking or feeling jittery
  • kidney problems, especially in people 75 years of age or older and people who already have kidney problems
  • increased fats in your blood (cholesterol)

See also: Side effects (in more detail)

Jardiance side effects

The most common of Jardiance include:

  • urinary tract infection. Signs and symptoms of a urinary tract infection may include burning feeling when passing urine, urine that looks cloudy, pain in the pelvis, or back pain.

These are not all the possible side effects. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Jardiance?

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

General information

This Patient Information summarizes the most important information. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information that is written for health professionals.

What are the ingredients?

Active Ingredient: empagliflozin

Inactive Ingredients: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, talc, polyethylene glycol, and yellow ferric oxide.