Jardiance Empagliflozin

Get an overview of JARDIANCE (empagliflozin tablet, film coated), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Jardiance can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Jardiance.

Drug Basics

Brand Name: Jardiance

Generic Name: EMPAGLIFLOZIN

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET, FILM COATED

Data Current As Of: 2020-02-10

Warnings and Precautions, Ketoacidosis (5.2) 1/2020

indications & usage

JARDIANCE is indicated:

  • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus,
  • to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.

JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated:

  • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus,
  • to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease. (1)

Limitations of Use: Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis (1)

Limitations of Use

JARDIANCE is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

drug interactions

diuretics

Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion [see Warnings and Precautions (5.1)].

insulin or insulin secretagogues

Coadministration of empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia [see Warnings and Precautions (5.5)].

positive urine glucose test

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.

interference with 1,5-anhydroglucitol (1,5-ag) assay

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.

patient counseling information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Instructions

Instruct patients to read the Medication Guide before starting JARDIANCE therapy and to reread it each time the prescription is renewed. Instruct patients to inform their doctor or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens.

Inform patients of the potential risks and benefits of JARDIANCE and of alternative modes of therapy. Also inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. Advise patients to seek medical advice promptly during periods of stress such as fever, trauma, infection, or surgery, as medication requirements may change.

Instruct patients to take JARDIANCE only as prescribed. If a dose is missed, it should be taken as soon as the patient remembers. Advise patients not to double their next dose.

Inform patients that the most common adverse reactions associated with the use of JARDIANCE are urinary tract infections and mycotic genital infections.

Advise pregnant women, and females of reproductive potential of the potential risk to a fetus with treatment with JARDIANCE [see Use in Specific Populations (8.1)]. Instruct females of reproductive potential to report pregnancies to their physicians as soon as possible.

Advise women that breastfeeding is not recommended during treatment with JARDIANCE [see Use in Specific Populations (8.2)].

Hypotension

Inform patients that hypotension may occur with JARDIANCE and advise them to contact their healthcare provider if they experience such symptoms [see Warnings and Precautions (5.1)]. Inform patients that dehydration may increase the risk for hypotension, and to have adequate fluid intake.

Ketoacidosis

Inform patients that ketoacidosis is a serious life-threatening condition and that cases of ketoacidosis have been reported during use of JARDIANCE, sometimes associated with illness or surgery among other risk factors. Instruct patients to check ketones (when possible) if symptoms consistent with ketoacidosis occur even if blood glucose is not elevated. If symptoms of ketoacidosis (including nausea, vomiting, abdominal pain, tiredness, and labored breathing) occur, instruct patients to discontinue JARDIANCE and seek medical attention immediately [see Warnings and Precautions (5.2)].

Acute Kidney Injury

Inform patients that acute kidney injury has been reported during use of JARDIANCE. Advise patients to seek medical advice immediately if they have reduced oral intake (such as due to acute illness or fasting) or increased fluid losses (such as due to vomiting, diarrhea, or excessive heat exposure), as it may be appropriate to temporarily discontinue JARDIANCE use in those settings [see Warnings and Precautions (5.3)].

Serious Urinary Tract Infections

Inform patients of the potential for urinary tract infections, which may be serious. Provide them with information on the symptoms of urinary tract infections. Advise them to seek medical advice if such symptoms occur [see Warnings and Precautions (5.4)].

Necrotizing Fasciitis of the Perineum (Fournier's Gangrene)

Inform patients that necrotizing infections of the perineum (Fournier's gangrene) have occurred with JARDIANCE. Counsel patients to promptly seek medical attention if they develop pain or tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, along with a fever above 100.4°F or malaise [see Warnings and Precautions (5.6)].

Genital Mycotic Infections in Females (e.g., Vulvovaginitis)

Inform female patients that vaginal yeast infections may occur and provide them with information on the signs and symptoms of vaginal yeast infections. Advise them of treatment options and when to seek medical advice [see Warnings and Precautions (5.7)].

Genital Mycotic Infections in Males (e.g., Balanitis or Balanoposthitis)

Inform male patients that yeast infection of penis (e.g., balanitis or balanoposthitis) may occur, especially in uncircumcised males and patients with chronic and recurrent infections. Provide them with information on the signs and symptoms of balanitis and balanoposthitis (rash or redness of the glans or foreskin of the penis). Advise them of treatment options and when to seek medical advice [see Warnings and Precautions (5.7)].

Hypersensitivity Reactions

Inform patients that serious hypersensitivity reactions, such as urticaria and angioedema, have been reported with JARDIANCE. Advise patients to report immediately any skin reaction or angioedema, and to discontinue drug until they have consulted prescribing physician [see Warnings and Precautions (5.8)].

Laboratory Tests

Inform patients that renal function should be assessed prior to initiation of JARDIANCE and monitored periodically thereafter.

Inform patients that elevated glucose in urinalysis is expected when taking JARDIANCE.

Inform patients that response to all diabetic therapies should be monitored by periodic measurements of blood glucose and HbA1c levels, with a goal of decreasing these levels toward the normal range. Hemoglobin A1c monitoring is especially useful for evaluating long-term glycemic control.

Distributed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA

Marketed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA
and
Eli Lilly and Company
Indianapolis, IN 46285 USA

Licensed from:
Boehringer Ingelheim International GmbH, Ingelheim, Germany

Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the Jardiance® and EMPA-REG OUTCOME® trademarks under license.

The other brands listed are trademarks of their respective owners and are not trademarks of Boehringer Ingelheim Pharmaceuticals, Inc.

Copyright © 2020 Boehringer Ingelheim International GmbH
ALL RIGHTS RESERVED

IT5728VA152020

This MEDICATION GUIDE has been approved by the U.S. Food and Drug Administration. Revised: January 2020    
MEDICATION GUIDE
JARDIANCE® (jar DEE ans)
(empagliflozin)
Tablets
What is the most important information I should know 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 pills)
    • are on low sodium (salt) diet
    • have kidney problems
    • are 65 years of age or older
  • Vaginal yeast infection. Women who take JARDIANCE may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
  • Yeast infection of the penis (balanitis or balanoposthitis). Men who take JARDIANCE 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.
    • to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.
  • JARDIANCE is not for people with type 1 diabetes.
  • JARDIANCE is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).
  • It is not known if JARDIANCE 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 ingredients in JARDIANCE. See the end of this Medication Guide for a list of ingredients in JARDIANCE.
  • have severe kidney problems or are on dialysis
What should I tell my doctor before using JARDIANCE?
Before you take JARDIANCE, tell your doctor if you:
  • have kidney problems
  • have liver problems
  • have a history of urinary tract infections or problems with urination
  • are going to have surgery. Your doctor may stop your JARDIANCE before you have surgery. Talk to your doctor if you are having surgery about when to stop taking JARDIANCE and when to start it again.
  • are eating less, or there is a change in your diet
  • have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas
  • drink alcohol very often, or drink a lot of alcohol in the short term ("binge" drinking)
  • have any other medical conditions
  • are pregnant or plan to become pregnant. JARDIANCE may harm your unborn baby. If you become pregnant while taking JARDIANCE, tell your doctor as soon as possible. Talk with your doctor about the best way to control your blood sugar while you are pregnant.
  • are breastfeeding or plan to breastfeed. JARDIANCE may pass into your breast milk and may harm your baby. Talk with your doctor about the best way to feed your baby if you are taking JARDIANCE. Do not breastfeed while taking JARDIANCE.
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 other medicines may affect how JARDIANCE works.
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 JARDIANCE exactly as your doctor tells you to take it.
  • Take JARDIANCE by mouth 1 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 of JARDIANCE at the same time. Talk with your doctor if you have questions about a missed dose.
  • Your doctor may tell you to take JARDIANCE along with other diabetes medicines. Low blood sugar can happen more often when JARDIANCE is taken with certain other diabetes medicines. See "What are the possible side effects of JARDIANCE?"
  • If you take too much JARDIANCE, 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 while taking JARDIANCE.
  • 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 JARDIANCE, you may have sugar in your urine, which will show up on a urine test.
What are the possible side effects of JARDIANCE?
JARDIANCE may cause serious side effects, including:
  • See " What is the most important information I should know about JARDIANCE? "
  • Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes, during treatment with JARDIANCE. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with JARDIANCE. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with JARDIANCE even if your blood sugar is less than 250 mg/dL. Stop taking JARDIANCE and call your doctor right away if you get any of the following symptoms:
  • nausea
  • vomiting
  • stomach-area (abdominal) pain
  • tiredness
  • trouble breathing
  •  If you get any of these symptoms during treatment with JARDIANCE, if possible, check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.
  • Kidney problems. Sudden kidney injury has happened to people taking JARDIANCE. Talk to your doctor right away if you:
    • reduce the amount of food or liquid you drink for example, if you are sick or cannot eat or
    • start to lose liquids from your body for example, from vomiting, diarrhea or being in the sun too long
  • Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking JARDIANCE. Tell your doctor if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.
  • 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 while you take JARDIANCE. Signs and symptoms of low blood sugar may include:
  • 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). Necrotizing fasciitis of the perineum has happened in women and men who take JARDIANCE. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death. Seek medical attention immediately if you have a fever or you are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals:
  • pain or tenderness
  • swelling
  • redness of skin (erythema)
  • Allergic (hypersensitivity) reactions. Serious allergic reactions have happened in people who are taking JARDIANCE. Symptoms may include
    • swelling of your face, lips, throat and other areas of your skin
    • difficulty with swallowing or breathing.
    • raised, red areas on your skin (hives)

    If you have any of these symptoms, stop taking JARDIANCE and call your doctor right away or go to the nearest hospital emergency room.

  • Increased fats in your blood (cholesterol)
These are not all the possible side effects of JARDIANCE. 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 JARDIANCE at room temperature 68°F to 77°F (20°C to 25°C).
General information about the safe and effective use of JARDIANCE.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use JARDIANCE for a condition for which it is not prescribed. Do not give JARDIANCE to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about JARDIANCE. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about JARDIANCE that is written for health professionals.
For more information about JARDIANCE including current prescribing information and Medication Guide, go to www.jardiance.com, scan the code below, or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or (TTY) 1-800-459-9906.

What are the ingredients in JARDIANCE?
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.
Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield, CT 06877 USA
Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield, CT 06877 USA and Eli Lilly and Company, Indianapolis, IN 46285 USA
Licensed from: Boehringer Ingelheim International GmbH, Ingelheim, Germany
Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the Jardiance® and EMPA-REG OUTCOME® trademarks under license.
The other brands listed are trademarks of their respective owners and are not trademarks of Boehringer Ingelheim Pharmaceuticals, Inc.
Copyright © 2020 Boehringer Ingelheim International GmbH
ALL RIGHTS RESERVED
IT5728VA152020

package label.principal display panel

NDC 0597-0152-37
DISPENSE WITH ENCLOSED MEDICATION GUIDE
Jardiance®
(empagliflozin)

Tablets

10 mg

This unit does package is not child-resistant. If dispensed for outpatient use, a child-resistant container should be utilized.

Rx only

30 tablets
3 blister cards. Each card contains 10 tablets.

Boehringer Ingelheim

Lilly

NDC 0597-0153-37
DISPENSE WITH ENCLOSED MEDICATION GUIDE
Jardiance®
(empagliflozin)

Tablets

25 mg

This unit does package is not child-resistant. If dispensed for outpatient use, a child-resistant container should be utilized.

Rx only

30 tablets
3 blister cards. Each card contains 10 tablets.

Boehringer Ingelheim

Lilly

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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