Jardiance

Jardiance comes as a tablet to take by mouth in either a 10 milligram (mg) dose or a 25 mg dose.

It's typically taken once a day in the morning.

Your doctor may start you on a low dose of Jardiance and then gradually increase it.

The medication can be taken with or without food.

You should try to take Jardiance around the same time every day.

Take this drug exactly as prescribed. Don't take more or less of the medicine than is recommended.

Jardiance Overdose

If you suspect an overdose, you should contact a poison control center or emergency room immediately.

You can get in touch with a poison control center at 800-222-1222.

Missed Dose of Jardiance

If you miss a dose of Jardiance, take it as soon as you remember.

However, if it's almost time for your next dose, skip the missed dose and continue on your regular dosing schedule.

Don't take extra medicine to make up for a missed dose.

The following important adverse reactions are described below and elsewhere in the labeling:

• Hypotension [see WARNINGS AND PRECAUTIONS]
• Ketoacidosis [see WARNINGS AND PRECAUTIONS]
• Acute Kidney Injury and Impairment in Renal Function [see WARNINGS AND PRECAUTIONS]
• Urosepsis and Pyelonephritis [see WARNINGS AND PRECAUTIONS]
• Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see WARNINGS AND PRECAUTIONS]
• Genital Mycotic Infections [see WARNINGS AND PRECAUTIONS]
• Increased Low-Density Lipoprotein Cholesterol (LDL-C) [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data in Table 1 are derived from a pool of four 24-week placebo-controlled trials and 18-week data from a placebo-controlled trial with insulin. JARDIANCE was used as monotherapy in one trial and as add-on therapy in four trials [see Clinical Studies].

These data reflect exposure of 1976 patients to JARDIANCE with a mean exposure duration of approximately 23 weeks. Patients received placebo (N=995), JARDIANCE 10 mg (N=999), or JARDIANCE 25 mg (N=977) once daily. The mean age of the population was 56 years and 3% were older than 75 years of age. More than half (55%) of the population was male; 46% were White, 50% were Asian, and 3% were Black or African American. At baseline, 57% of the population had diabetes more than 5 years and had a mean hemoglobin A1c (HbA1c) of 8%. Established microvascular complications of diabetes at baseline included diabetic nephropathy (7%), retinopathy (8%), or neuropathy (16%). Baseline renal function was normal or mildly impaired in 91% of patients and moderately impaired in 9% of patients (mean eGFR 86.8 mL/min/1.73 m2).

Table 1 shows common adverse reactions (excluding hypoglycemia) associated with the use of JARDIANCE. The adverse reactions were not present at baseline, occurred more commonly on JARDIANCE than on placebo and occurred in greater than or equal to 2% of patients treated with JARDIANCE 10 mg or JARDIANCE 25 mg.

Table 1 : Adverse Reactions Reported in ≥ 2% of Patients Treated with JARDIANCE and Greater than Placebo in Pooled Placebo-Controlled Clinical Studies of JARDIANCE Monotherapy or Combination Therapy

Thirst (including polydipsia) was reported in 0%, 1.7%, and 1.5% for placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively.

JARDIANCE causes an osmotic diuresis, which may lead to intravascular volume contraction and adverse reactions related to volume depletion. In the pool of five placebo-controlled clinical trials, adverse reactions related to volume depletion (e.g., blood pressure (ambulatory) decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolemia, orthostatic hypotension, and syncope) were reported by 0.3%, 0.5%, and 0.3% of patients treated with placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg respectively. JARDIANCE may increase the risk of hypotension in patients at risk for volume contraction [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

In the pool of five placebo-controlled clinical trials, adverse reactions of increased urination (e.g., polyuria, pollakiuria, and nocturia) occurred more frequently on JARDIANCE than on placebo (see Table 1). Specifically, nocturia was reported by 0.4%, 0.3%, and 0.8% of patients treated with placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively.

Treatment with JARDIANCE was associated with increases in serum creatinine and decreases in eGFR (see Table 2). Patients with moderate renal impairment at baseline had larger mean changes [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

In a long-term cardiovascular outcome trial, the acute impairment in renal function was observed to reverse after treatment discontinuation suggesting acute hemodynamic changes play a role in the renal function changes observed with empagliflozin.

Table 2 : Changes from Baseline in Serum Creatinine and eGFRa in the Pool of Four 24-week Placebo-Controlled Studies and Renal Impairment Study

The incidence of hypoglycemia by study is shown in Table 3. The incidence of hypoglycemia increased when JARDIANCE was administered with insulin or sulfonylurea [see WARNINGS AND PRECAUTIONS].

Table 3 : Incidence of Overalla and Severeb Hypoglycemic Events in Placebo-Controlled Clinical Studiesc

In the pool of five placebo-controlled clinical trials, the incidence of genital mycotic infections (e.g., vaginal mycotic infection, vaginal infection, genital infection fungal, vulvovaginal candidiasis, and vulvitis) was increased in patients treated with JARDIANCE compared to placebo, occurring in 0.9%, 4.1%, and 3.7% of patients randomized to placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively. Discontinuation from study due to genital infection occurred in 0% of placebo-treated patients and 0.2% of patients treated with either JARDIANCE 10 or 25 mg.

Genital mycotic infections occurred more frequently in female than male patients (see Table 1).

Phimosis occurred more frequently in male patients treated with JARDIANCE 10 mg (less than 0.1%) and JARDIANCE 25 mg (0.1%) than placebo (0%).

In the pool of five placebo-controlled clinical trials, the incidence of urinary tract infections (e.g., urinary tract infection, asymptomatic bacteriuria, and cystitis) was increased in patients treated with JARDIANCE compared to placebo (see Table 1). Patients with a history of chronic or recurrent urinary tract infections were more likely to experience a urinary tract infection. The rate of treatment discontinuation due to urinary tract infections was 0.1%, 0.2%, and 0.1% for placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively.

Urinary tract infections occurred more frequently in female patients. The incidence of urinary tract infections in female patients randomized to placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg was 16.6%, 18.4%, and 17.0%, respectively. The incidence of urinary tract infections in male patients randomized to placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg was 3.2%, 3.6%, and 4.1%, respectively [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

Laboratory Tests

Dose-related increases in low-density lipoprotein cholesterol (LDL-C) were observed in patients treated with JARDIANCE. LDL-C increased by 2.3%, 4.6%, and 6.5% in patients treated with placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively [see WARNINGS AND PRECAUTIONS]. The range of mean baseline LDL-C levels was 90.3 to 90.6 mg/dL across treatment groups.

In a pool of four placebo-controlled studies, median hematocrit decreased by 1.3% in placebo and increased by 2.8% in JARDIANCE 10 mg and 2.8% in JARDIANCE 25 mg treated patients. At the end of treatment, 0.6%, 2.7%, and 3.5% of patients with hematocrits initially within the reference range had values above the upper limit of the reference range with placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively.

Postmarketing Experience

Additional adverse reactions have been identified during postapproval use of JARDIANCE. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Ketoacidosis [see WARNINGS AND PRECAUTIONS]
• Urosepsis and pyelonephritis [see WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for Jardiance (Empagliflozin Tablets)

• Diabetes (Type 1 and Type 2)
• Diabetes Treatment (Type 1 and Type 2 Medications and Diet)
• Oral Diabetes Prescription Medications

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For type 2 diabetes:
    • Adults—At first, 10 milligrams (mg) once a day, taken in the morning. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 25 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • To lower risk of death in patients with type 2 diabetes and heart disease:
    • Adults—At first, 10 milligrams (mg) once a day, taken in the morning. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 25 mg per day.
    • Children—Use and dose must be determined by your doctor.

Jardiance is a prescription medication used to treat type 2 diabetes in adults. This medication is also approved to reduce one's risk of cardiovascular death in adults with cardiovascular disease and type 2 diabetes mellitus.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Diuretics such as acetazolamide (Diamox), amiloride (Midamor), bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide, HCTZ), metolazone (Zaroxolyn), or torsemide (Demadex)
• Insulin or insulin-releasing drugs that can lower blood sugar such as glipizide (Glucotrol), glimepiride (Amaryl), repaglinide (Prandin), and nateglinide (Starlix)

This is not a complete list of Jardiance drug interactions. Ask your doctor or pharmacist for more information.

Before taking Jardiance, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Jardiance or to any of its ingredients
• have kidney problems
• are pregnant or breastfeeding

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

You should not use empagliflozin if you have severe kidney disease or if you are on dialysis, or if you have diabetic ketoacidosis. Empagliflozin is not for treating type 1 diabetes.

Taking empagliflozin can make you dehydrated, which could cause you to feel weak or dizzy (especially when you stand up).

Empagliflozin can also cause infections in the bladder or genitals (penis or vagina). Call your doctor if you have genital pain or itching, genital odor or discharge, increased urination, pain or burning when you urinate, or blood in your urine.

You should not use empagliflozin if you are allergic to it, or if you have:

• kidney disease (or if you are on dialysis); or

• diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure empagliflozin is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;

• a bladder infection;

• low blood pressure;

• heart problems;

• problems with your pancreas, including surgery;

• if you drink alcohol often; or

• if you are on a low salt diet.

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

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

Empagliflozin is not approved for use by anyone younger than 18 years old.

Empagliflozin is usually taken once per day in the morning. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take empagliflozin with or without food.

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.

Your blood sugar will need to be checked often, and you may also need to test the level of ketones your urine. Empagliflozin can cause life-threatening ketoacidosis (too much acid in the blood). Even if your blood sugar is normal, contact your doctor if a urine test shows that you have ketones in the urine.

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 empagliflozin.

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

Store at room temperature away from moisture and heat.

General

• Correct volume depletion prior to initiating empagliflozin; assess renal function prior to treatment and periodically thereafter.1

Administration

Oral Administration

Administer once daily in the morning, with or without food.1

If a dose is missed, take missed dose as soon as it is remembered followed by resumption of the regular schedule.1 14 If the missed dose is not remembered until it is almost time for the next dose, skip the missed dose and resume the regular schedule; do not double the dose to replace a missed dose.1 14

Dosage

Adults

Initially, 10 mg once daily in the morning.1

If well tolerated, increase dosage to 25 mg once daily in patients who require additional glycemic control.1

Special Populations

Hepatic Impairment

Mild, moderate, or severe: No dosage adjustment necessary.13

Renal Impairment

Estimated GFR (eGFR) ≥45 mL/minute per 1.73 m2: No dosage adjustment necessary.1

eGFR <45 mL/minute per 1.73 m2: Do not initiate drug.1 Discontinue drug if eGFR is persistently <45 mL/minute per 1.73 m2.1 (See Renal Impairment under Cautions.)

Geriatric Patients

No dosage adjustment necessary based solely on age.1

Recommended Dosage

The recommended dose of Jardiance is 10 mg once daily in the morning, taken with or without food.  In patients tolerating Jardiance, the dose may be increased to 25 mg [see Clinical Studies (14)].

In patients with volume depletion, correcting this condition prior to initiation of Jardiance is recommended [see Warnings and Precautions (5.1), Use in Specific Populations (8.5), and Patient Counseling Information (17)].

Patients with Renal Impairment

Assessment of renal function is recommended prior to initiation of Jardiance and periodically thereafter.

Jardiance should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m2.

No dose adjustment is needed in patients with an eGFR greater than or equal to 45 mL/min/1.73 m2.

Jardiance should be discontinued if eGFR is less than 45 mL/min/1.73 m2 [see Warnings and Precautions (5.1, 5.3), and Use in Specific Populations (8.6)].

Pregnancy

Risk Summary
Based on animal data showing adverse renal effects, Jardiance is not recommended during the second and third trimesters of pregnancy.

Limited data available with Jardiance in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage.  There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations].

In animal studies, adverse renal changes were observed in rats when empagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. Doses approximately 13-times the maximum clinical dose caused renal pelvic and tubule dilatations that were reversible. Empagliflozin was not teratogenic in rats and rabbits up to 300 mg/kg/day, which approximates 48-times and 128-times, respectively, the maximum clinical dose of 25 mg when administered during organogenesis [see Data].

The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20-25% in women with HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations
Disease-associated maternal and/or embryo/fetal risk: Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity.

Data
Animal Data
Empagliflozin dosed directly to juvenile rats from postnatal day (PND) 21 until PND 90 at doses of 1, 10, 30 and 100 mg/kg/day caused increased kidney weights and renal tubular and pelvic dilatation at 100 mg/kg/day, which approximates 13-times the maximum clinical dose of 25 mg, based on AUC.  These findings were not observed after a 13 week drug-free recovery period. These outcomes occurred with drug exposure during periods of renal development in rats that correspond to the late second and third trimester of human renal development.

In embryo-fetal development studies in rats and rabbits, empagliflozin was administered for intervals coinciding with the first trimester period of organogenesis in humans. Doses up to 300 mg/kg/day, which approximates 48-times (rats) and 128-times (rabbits) the maximum clinical dose of 25 mg (based on AUC), did not result in adverse developmental effects. In rats, at higher doses of empagliflozin causing maternal toxicity, malformations of limb bones increased in fetuses at 700 mg/kg/day or 154-times the 25 mg maximum clinical dose.  In the rabbit, higher doses of empagliflozin resulted in maternal and fetal toxicity at 700 mg/kg/day, or 139-times the 25 mg maximum clinical dose.

In pre- and postnatal development studies in pregnant rats, empagliflozin was administered from gestation day 6 through to lactation day 20 (weaning) at up to 100 mg/kg/day (approximately 16 times the 25 mg maximum clinical dose) without maternal toxicity.  Reduced body weight was observed in the offspring at greater than or equal to 30 mg/kg/day (approximately 4 times the 25 mg maximum clinical dose).

Lactation

Risk Summary
There is no information regarding the presence of Jardiance in human milk, the effects of Jardiance on the breastfed infant or the effects on milk production.  Empagliflozin is present in the milk of lactating rats [see Data].  Since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney.

Because of the potential for serious adverse reactions in a breastfed infant, advise women that use of Jardiance is not recommended while breastfeeding.

Data
Empagliflozin was present at a low level in rat fetal tissues after a single oral dose to the dams at gestation day 18. In rat milk, the mean milk to plasma ratio ranged from 0.634 -5, and was greater than one from 2 to 24 hours post-dose. The mean maximal milk to plasma ratio of 5 occurred at 8 hours post-dose, suggesting accumulation of empagliflozin in the milk. Juvenile rats directly exposed to empagliflozin showed a risk to the developing kidney (renal pelvic and tubular dilatations) during maturation.

Pediatric Use

The safety and effectiveness of Jardiance in pediatric patients under 18 years of age have not been established.

Geriatric Use

No Jardiance dosage change is recommended based on age [see Dosage and Administration (2)].  In studies assessing the efficacy of empagliflozin in improving glycemic control in patients with type 2 diabetes, a total of 2721 (32%) patients treated with empagliflozin were 65 years of age and older, and 491 (6%) were 75 years of age and older.  Jardiance is expected to have diminished glycemic efficacy in elderly patients with renal impairment [see Use in Specific Populations (8.6)].  The risk of volume depletion-related adverse reactions increased in patients who were 75 years of age and older to 2.1%, 2.3%, and 4.4% for placebo, Jardiance 10 mg, and Jardiance 25 mg.  The risk of urinary tract infections increased in patients who were 75 years of age and older to 10.5%, 15.7%, and 15.1% in patients randomized to placebo, Jardiance 10 mg, and Jardiance 25 mg, respectively [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

Renal Impairment

The efficacy and safety of Jardiance were evaluated in a study of patients with mild and moderate renal impairment [see Clinical Studies (14.1)].  In this study, 195 patients exposed to Jardiance had an eGFR between 60 and 90 mL/min/1.73 m2, 91 patients exposed to Jardiance had an eGFR between 45 and 60 mL/min/1.73 m2 and 97 patients exposed to Jardiance had an eGFR between 30 and 45 mL/min/1.73 m2.  The glucose lowering benefit of Jardiance 25 mg decreased in patients with worsening renal function.  The risks of renal impairment [see Warnings and Precautions (5.3)], volume depletion adverse reactions and urinary tract infection-related adverse reactions increased with worsening renal function.

In a large cardiovascular outcomes study, there were 1819 patients with eGFR below 60 mL/min/1.73 m2.  The cardiovascular death findings in this subgroup were consistent with the overall findings [see Clinical Studies (14.2)].

The efficacy and safety of Jardiance have not been established in patients with severe renal impairment, with ESRD, or receiving dialysis.  Jardiance is not expected to be effective in these patient populations [see Dosage and Administration (2.2), Contraindications (4) and Warnings and Precautions (5.1, 5.3)].

Hepatic Impairment

Jardiance may be used in patients with hepatic impairment [see Clinical Pharmacology (12.3)].

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Instructions
Instruct patients to read the Patient Information 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.

Inform female patients of reproductive potential that the use of Jardiance during pregnancy has not been studied in humans, and that Jardiance should only be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Based on animal data, Jardiance may cause fetal harm in the second and third trimesters.  Instruct patients to report pregnancies to their physicians as soon as possible.

Inform nursing mothers to discontinue Jardiance or nursing, taking into account the importance of the drug to the mother.  It is not known if Jardiance is excreted in breast milk; however, based on animal data, Jardiance may cause harm to nursing infants.

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. Cases of ketoacidosis have been reported during use of Jardiance. 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 advice 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)].

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 (5.6)].

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 (5.6)].

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 trademarks referenced are owned by third parties not affiliated with Boehringer Ingelheim Pharmaceuticals, Inc.

Copyright © 2016 Boehringer Ingelheim International GmbH
ALL RIGHTS RESERVED

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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Applies to empagliflozin: oral tablet

Along with its needed effects, empagliflozin (the active ingredient contained in Jardiance) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking empagliflozin:

• Bladder pain
• bloody or cloudy urine
• change in the color, amount, or odor of vaginal discharge
• difficult, burning, or painful urination
• frequent urge to urinate
• itching, stinging, or redness of the vaginal area
• lower back or side pain
• pain during sexual intercourse

• Discharge with a strong odor from the penis
• increased volume of pale, dilute urine
• redness, itching, swelling, or pain around the penis
• waking to urinate at night

• Anxiety
• blurred vision
• chills
• cold sweats
• confusion
• decreased urination
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast heartbeat
• headache
• increased hunger
• nausea
• nightmares
• rapid breathing
• seizures
• shakiness
• slurred speech
• sweating
• unusual tiredness or weakness

• Dry mouth
• fever
• flushed, dry skin
• frequent or painful urination
• fruit-like breath odor
• increased thirst
• loss of appetite
• loss of consciousness
• stomach pain
• swelling of the face, fingers, or lower legs
• troubled breathing
• unexplained weight loss
• vomiting
• weight gain

Some side effects of empagliflozin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Body aches or pain
• cough
• loss of voice
• muscle pain or stiffness
• nasal congestion