Data from FDA - Curated by Marshall Pearce - Last updated 12 January 2018

Indication(s)

1 INDICATIONS AND 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. Limitations of Use JARDIANCE is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. 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)

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Advisory information

contraindications
4 CONTRAINDICATIONS History of serious hypersensitivity reaction to empagliflozin or any of the excipients in JARDIANCE [see Warnings and Precautions (5.7)]. Severe renal impairment, end-stage renal disease, or dialysis [see Use in Specific Populations (8.6)]. History of serious hypersensitivity reaction to empagliflozin or any of the excipients in JARDIANCE (4) Severe renal impairment, end-stage renal disease, or dialysis (4)
Adverse reactions
6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Hypotension [see Warnings and Precautions (5.1)] Ketoacidosis [see Warnings and Precautions (5.2)] Acute Kidney Injury and Impairment in Renal Function [see Warnings and Precautions (5.3)] Urosepsis and Pyelonephritis [see Warnings and Precautions (5.4)] Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.5)] Genital Mycotic Infections [see Warnings and Precautions (5.6)] Hypersensitivity Reactions [see Warnings and Precautions (5.7)] Increased Low-Density Lipoprotein Cholesterol (LDL-C) [see Warnings and Precautions (5.8)] The most common adverse reactions associated with JARDIANCE (5% or greater incidence) were urinary tract infections and female genital mycotic infections (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or 1-800-459-9906 TTY, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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. Pool of Placebo-Controlled Trials evaluating JARDIANCE 10 and 25 mg 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 (14)]. 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 a Predefined adverse event grouping, including, but not limited to, urinary tract infection, asymptomatic bacteriuria, cystitis bFemale genital mycotic infections include the following adverse reactions: vulvovaginal mycotic infection, vaginal infection, vulvitis, vulvovaginal candidiasis, genital infection, genital candidiasis, genital infection fungal, genitourinary tract infection, vulvovaginitis, cervicitis, urogenital infection fungal, vaginitis bacterial. Percentages calculated with the number of female subjects in each group as denominator: placebo (N=481), JARDIANCE 10 mg (N=443), JARDIANCE 25 mg (N=420). cPredefined adverse event grouping, including, but not limited to, polyuria, pollakiuria, and nocturia dMale genital mycotic infections include the following adverse reactions: balanoposthitis, balanitis, genital infections fungal, genitourinary tract infection, balanitis candida, scrotal abscess, penile infection. Percentages calculated with the number of male subjects in each group as denominator: placebo (N=514), JARDIANCE 10 mg (N=556), JARDIANCE 25 mg (N=557). Number (%) of Patients Placebo N=995 JARDIANCE 10 mg N=999 JARDIANCE 25 mg N=977 Urinary tract infectiona 7.6% 9.3% 7.6% Female genital mycotic infectionsb 1.5% 5.4% 6.4% Upper respiratory tract infection 3.8% 3.1% 4.0% Increased urinationc 1.0% 3.4% 3.2% Dyslipidemia 3.4% 3.9% 2.9% Arthralgia 2.2% 2.4% 2.3% Male genital mycotic infectionsd 0.4% 3.1% 1.6% Nausea 1.4% 2.3% 1.1% Thirst (including polydipsia) was reported in 0%, 1.7%, and 1.5% for placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively. Volume Depletion 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 (5.1) and Use in Specific Populations (8.5, 8.6)]. Increased Urination 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. Acute Impairment in Renal Function 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 (5.3) and Use in Specific Populations (8.5, 8.6)]. 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 a Observed cases on treatment. bSubset of patients from renal impairment study with eGFR 30 to less than 60 mL/min/1.73 m2 cApproximately 3 weeks after end of treatment. Pool of 24-Week Placebo-Controlled Studies Placebo JARDIANCE 10 mg JARDIANCE 25 mg Baseline Mean N 825 830 822 Creatinine (mg/dL) 0.84 0.85 0.85 eGFR (mL/min/1.73 m2) 87.3 87.1 87.8 Week 12 Change N 771 797 783 Creatinine (mg/dL) 0.00 0.02 0.01 eGFR (mL/min/1.73 m2) -0.3 -1.3 -1.4 Week 24 Change N 708 769 754 Creatinine (mg/dL) 0.00 0.01 0.01 eGFR (mL/min/1.73 m2) -0.3 -0.6 -1.4 Moderate Renal Impairmentb Placebo JARDIANCE 25 mg Baseline Mean N 187 -- 187 Creatinine (mg/dL) 1.49 -- 1.46 eGFR (mL/min/1.73 m2) 44.3 -- 45.4 Week 12 Change N 176 -- 179 Creatinine (mg/dL) 0.01 -- 0.12 eGFR (mL/min/1.73 m2) 0.1 -- -3.8 Week 24 Change N 170 -- 171 Creatinine (mg/dL) 0.01 -- 0.10 eGFR (mL/min/1.73 m2) 0.2 -- -3.2 Week 52 Change N 164 -- 162 Creatinine (mg/dL) 0.02 -- 0.11 eGFR (mL/min/1.73 m2) -0.3 -- -2.8 Post-treatment Changec N 98 -- 103 Creatinine (mg/dL) 0.03 -- 0.02 eGFR (mL/min/1.73 m2) 0.16 -- 1.48 Hypoglycemia 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 (5.5)]. Table 3 Incidence of Overalla and Severeb Hypoglycemic Events in Placebo-Controlled Clinical Studiesc aOverall hypoglycemic events: plasma or capillary glucose of less than or equal to 70 mg/dL bSevere hypoglycemic events: requiring assistance regardless of blood glucose cTreated set (patients who had received at least one dose of study drug) dInsulin dose could not be adjusted during the initial 18 week treatment period Monotherapy (24 weeks) Placebo (n=229) JARDIANCE 10 mg (n=224) JARDIANCE 25 mg (n=223) Overall (%) 0.4% 0.4% 0.4% Severe (%) 0% 0% 0% In Combination with Metformin (24 weeks) Placebo + Metformin (n=206) JARDIANCE 10 mg + Metformin (n=217) JARDIANCE 25 mg + Metformin (n=214) Overall (%) 0.5% 1.8% 1.4% Severe (%) 0% 0% 0% In Combination with Metformin + Sulfonylurea (24 weeks) Placebo (n=225) JARDIANCE 10 mg + Metformin + Sulfonylurea (n=224) JARDIANCE 25 mg + Metformin + Sulfonylurea (n=217) Overall (%) 8.4% 16.1% 11.5% Severe (%) 0% 0% 0% In Combination with Pioglitazone +/- Metformin (24 weeks) Placebo (n=165) JARDIANCE 10 mg + Pioglitazone +/- Metformin (n=165) JARDIANCE 25 mg + Pioglitazone +/- Metformin (n=168) Overall (%) 1.8% 1.2% 2.4% Severe (%) 0% 0% 0% In Combination with Basal Insulin +/- Metformin (18 weeksd) Placebo (n=170) JARDIANCE 10 mg (n=169) JARDIANCE 25 mg (n=155) Overall (%) 20.6% 19.5% 28.4% Severe (%) 0% 0% 1.3% In Combination with MDI Insulin +/-Metformin (18 weeksd) Placebo (n=188) JARDIANCE 10 mg (n=186) JARDIANCE 25 mg (n=189) Overall (%) 37.2% 39.8% 41.3% Severe (%) 0.5% 0.5% 0.5% Genital Mycotic Infections 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%). Urinary Tract Infections 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 (5.4) and Use in Specific Populations (8.5)]. Laboratory Tests Increase in Low-Density Lipoprotein Cholesterol (LDL-C) 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 (5.8)]. The range of mean baseline LDL-C levels was 90.3 to 90.6 mg/dL across treatment groups. Increase in Hematocrit 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. 6.2 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 (5.2)] Urosepsis and pyelonephritis [see Warnings and Precautions (5.4)] Angioedema [see Warnings and Precautions (5.7)] Skin reactions (e.g., rash, urticaria)

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION The recommended dose of JARDIANCE is 10 mg once daily, taken in the morning, with or without food (2.1) Dose may be increased to 25 mg once daily (2.1) Assess renal function before initiating JARDIANCE. Do not initiate JARDIANCE if eGFR is below 45 mL/min/1.73 m2 (2.2) Discontinue JARDIANCE if eGFR falls persistently below 45 mL/min/1.73 m2 (2.2) 2.1 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)]. 2.2 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 persistently less than 45 mL/min/1.73 m2 [see Warnings and Precautions (5.1, 5.3) and Use in Specific Populations (8.6)].
Use in special populations
8 USE IN SPECIFIC POPULATIONS Pregnancy: Advise females of the potential risk to a fetus especially during the second and third trimesters (8.1) Lactation: JARDIANCE is not recommended when breastfeeding (8.2) Geriatric patients: Higher incidence of adverse reactions related to volume depletion and reduced renal function (5.1, 5.3, 8.5) Patients with renal impairment: Higher incidence of adverse reactions related to reduced renal function (2.2, 5.3, 8.6) 8.1 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, stillbirth, 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. Empagliflozin crosses the placenta and reaches fetal tissues in rats. 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). 8.2 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, including the potential for empagliflozin to affect postnatal renal development, 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. 8.4 Pediatric Use The safety and effectiveness of JARDIANCE in pediatric patients under 18 years of age have not been established. 8.5 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)]. 8.6 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)]. 8.7 Hepatic Impairment JARDIANCE may be used in patients with hepatic impairment [see Clinical Pharmacology (12.3)].

Interactions

7 DRUG INTERACTIONS 7.1 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)]. 7.2 Insulin or Insulin Secretagogues Coadministration of empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia [see Warnings and Precautions (5.5)]. 7.3 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. 7.4 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.

More information

Category Value
Authorisation number NDA204629
Agency product number HDC1R2M35U
Orphan designation No
Product NDC 0597-0153,0597-0152
Date Last Revised 21-12-2017
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder Boehringer Ingelheim Pharmaceuticals, Inc.