- What are you using Jardiance for?
- Jardiance Side Effects
- CLINICAL PHARMACOLOGY
- Mechanism Of Action
- Specific Populations
- Drug Interactions
- Clinical Studies
- Glycemic Control
- Add-On Combination Therapy With Metformin
- Initial Combination Therapy With Metformin
- Add-On Combination Therapy With MetforminAnd Sulfonylurea
- In Combination With Linagliptin As Add-On To Metformin Therapy
- Active-Controlled Study Versus Glimepiride In Combination With Metformin
- Add-On Combination Therapy With Pioglitazone With Or Without Metformin
- Add-On Combination With Insulin With Or Without Metformin And/Or Sulfonylureas
- Add-On Combination With MDI InsulinWith Or Without Metformin
- Cardiovascular Outcomes In Patients With Type 2 Diabetes Mellitus And Atherosclerotic Cardiovascular Disease
- CLINICAL PHARMACOLOGY
- About Jardiance
- How does Jardiance help in type 2 diabetes
- Mechanism of action
- Who is Jardiance suitable for?
- Who should not take Jardiance?
- How should Jardiance be taken?
- What are the side effects of Jardiance?
- What to do if you take an overdose
- Long term safety
- FDA-Approved Jardiance for Type 2 Diabetes Also Boosts Weight Loss
- How Does Jardiance Work?
- Side Effects Include Yeast Infections, UTIs
- New Injection for Diabetic Macular Edema
- How does this medication work? What will it do for me?
- What form(s) does this medication come in?
- How should I use this medication?
- Who should NOT take this medication?
- What side effects are possible with this medication?
- Are there any other precautions or warnings for this medication?
- What other drugs could interact with this medication?
What are you using Jardiance for?
Frequent urination, dizziness, or lightheadedness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: signs of a urinary tract infection (such as burning/painful/frequent/urgent urination, pink/bloody urine), signs of kidney problems (such as change in the amount of urine).
Get medical help right away if you have any very serious side effects, including: unusual tiredness, nausea/vomiting, stomach/abdominal pain, trouble breathing.
This medication may cause a new yeast infection in the vagina or the penis. It may also cause a rare but very serious bacterial infection in the genital/anal area (Fournier’s gangrene). Tell your doctor right away if you have signs of a yeast infection in the vagina (such as unusual vaginal discharge/burning/itching/odor) or in the penis (such as redness/itching/swelling of the penis, unusual discharge from the penis). However, get medical help right away if you have any pain/redness/swelling in or around the genital/anal area, along with a fever or feeling unwell.
Empagliflozin does not usually cause low blood sugar (hypoglycemia). Low blood sugar may occur if this drug is prescribed with other diabetes medications, or if you do not consume enough calories from food, or if you do unusually heavy exercise. Talk with your doctor or pharmacist about whether the dose of your other diabetes medication needs to be lowered. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don’t have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.
Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your doctor may need to adjust your diabetes medications.
This medication may cause you to lose too much body water (dehydration). This can lead to serious kidney damage. Drink plenty of fluids to prevent dehydration. Tell your doctor or pharmacist right away if you are not able to drink fluids as usual, or losing fluid (such as due to vomiting, diarrhea, or heavy sweating). Also, tell your doctor right away if you have any signs of dehydration, such as urinating less than usual, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness/fainting.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US –
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Jardiance is the brand name of the generic drug empagliflozin, prescribed to lower blood sugar in people with type 2 diabetes.
Type 2 diabetes is a condition that occurs because your body doesn’t produce or use insulin normally.
Jardiance is in a class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. It works by prompting your kidneys to get rid of more glucose in your urine.
In addition to lowering blood sugar, Jardiance can also lower your A1C levels (the percentage of hemoglobin molecules in your blood that have glucose molecules attached to them).
The medication was approved by the Food and Drug Administration (FDA) in 2014.
The FDA approval was based on the results from more than 10 multinational clinical trials involving more than 13,000 people with type 2 diabetes.
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company manufacture Jardiance.
Jardiance is not used to treat people with type 1 diabetes or diabetic ketoacidosis (a life-threatening condition that can occur if high blood sugar isn’t treated).
This medicine controls type 2 diabetes, but it doesn’t cure the condition. You should continue to take Jardiance even if you feel well.
Don’t stop taking this drug without first talking to your doctor.
Before taking Jardiance, you should tell your doctor if you have or have ever had:
- Kidney disease (or if you are on dialysis)
- A urinary tract infection or problems with urination
- Low blood pressure (or if you are on a low-sodium diet)
- Yeast infections
- Liver disease
You should also tell your doctor if you have never had a circumcision before taking this drug. Some uncircumcised men have experienced swelling of the penis as a result of a Jardiance-related yeast infection.
This medicine may cause changes in your blood sugar. You should be aware of symptoms of high or low blood sugar and know what to do if you experience them.
Illnesses, injuries, and stress can all affect your blood sugar. Talk to your doctor about what to do if you experience any of these while taking Jardiance.
Check your blood sugar levels often while taking Jardiance. The drug may also cause your cholesterol levels to rise.
Your doctor will order other lab tests to check your response to the medicine. It’s important to keep all appointments with your doctor and laboratory while taking Jardiance.
Tell your surgeon you are taking this medicine before having any type of surgical procedure, including dental surgery. Also, tell any lab personnel you are taking Jardiance before having any tests performed.
Jardiance may cause dehydration in some people. It’s important to stay hydrated while taking this drug. Talk to your doctor about how much liquid you should consume throughout the day.
This medication may cause dizziness or fainting if you get up too quickly from a lying position.
To avoid this side effect, get out of bed slowly and rest your feet on the floor for a couple of minutes before standing up.
It’s not known whether Jardiance is safe or effective for children under 18 years of age.
Pregnancy and Jardiance
It’s not known if Jardiance might cause harm to an unborn baby.
You should talk to your doctor before using this medicine if you’re pregnant or might become pregnant.
It’s also not known whether Jardiance can harm a breastfeeding baby.
Talk to your doctor about breastfeeding before taking this drug.
Jardiance Side Effects
Visit your doctor or health care professional for regular checks on your progress.
This medicine can cause a serious condition in which there is too much acid in the blood. If you develop nausea, vomiting, stomach pain, unusual tiredness, or breathing problems, stop taking this medicine and call your doctor right away. If possible, use a ketone dipstick to check for ketones in your urine.
A test called the HbA1C (A1C) will be monitored. This is a simple blood test. It measures your blood sugar control over the last 2 to 3 months. You will receive this test every 3 to 6 months.
Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.
Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.
Tell your doctor or health care professional if you have high blood sugar. You might need to change the dose of your medicine. If you are sick or exercising more than usual, you might need to change the dose of your medicine.
Do not skip meals. Ask your doctor or health care professional if you should avoid alcohol. Many nonprescription cough and cold products contain sugar or alcohol. These can affect blood sugar.
Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.
Mechanism Of Action
Sodium-glucose co-transporter 2 (SGLT2) is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Empagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
Urinary Glucose Excretion
In patients with type 2 diabetes, urinary glucose excretion increased immediately following a dose of JARDIANCE and was maintained at the end of a 4-week treatment period averaging at approximately 64 grams per day with 10 mg empagliflozin and 78 grams per day with 25 mg JARDIANCE once daily .
In a 5-day study, mean 24-hour urine volume increase from baseline was 341 mL on Day 1 and 135 mL on Day 5 of empagliflozin 25 mg once daily treatment.
In a randomized, placebo-controlled, active-comparator, crossover study, 30 healthy subjects were administered a single oral dose of JARDIANCE 25 mg, JARDIANCE 200 mg (8 times the maximum dose), moxifloxacin, and placebo. No increase in QTc was observed with either 25 mg or 200 mg empagliflozin.
The pharmacokinetics of empagliflozin has been characterized in healthy volunteers and patients with type 2 diabetes and no clinically relevant differences were noted between the two populations. After oral administration, peak plasma concentrations of empagliflozin were reached at 1.5 hours post-dose. Thereafter, plasma concentrations declined in a biphasic manner with a rapid distribution phase and a relatively slow terminal phase. The steady state mean plasma AUC and Cmax were 1870 nmol¡Ph/L and 259 nmol/L, respectively, with 10 mg empagliflozin once daily treatment, and 4740 nmol¡Ph/L and 687 nmol/L, respectively, with 25 mg empagliflozin once daily treatment. Systemic exposure of empagliflozin increased in a dose-proportional manner in the therapeutic dose range. The single-dose and steady-state pharmacokinetic parameters of empagliflozin were similar, suggesting linear pharmacokinetics with respect to time.
Administration of 25 mg empagliflozin after intake of a high-fat and high-calorie meal resulted in slightly lower exposure; AUC decreased by approximately 16% and Cmax decreased by approximately 37%, compared to fasted condition. The observed effect of food on empagliflozin pharmacokinetics was not considered clinically relevant and empagliflozin may be administered with or without food.
The apparent steady-state volume of distribution was estimated to be 73.8 L based on a population pharmacokinetic analysis. Following administration of an oral -empagliflozin solution to healthy subjects, the red blood cell partitioning was approximately 36.8% and plasma protein binding was 86.2%.
No major metabolites of empagliflozin were detected in human plasma and the most abundant metabolites were three glucuronide conjugates (2-O-, 3-O-, and 6-O-glucuronide). Systemic exposure of each metabolite was less than 10% of total drug-related material. In vitro studies suggested that the primary route of metabolism of empagliflozin in humans is glucuronidation by the uridine 5′-diphospho-glucuronosyltransferases UGT2B7, UGT1A3, UGT1A8, and UGT1A9.
The apparent terminal elimination half-life of empagliflozin was estimated to be 12.4 h and apparent oral clearance was 10.6 L/h based on the population pharmacokinetic analysis. Following once-daily dosing, up to 22% accumulation, with respect to plasma AUC, was observed at steady-state, which was consistent with empagliflozin half-life. Following administration of an oral -empagliflozin solution to healthy subjects, approximately 95.6% of the drug-related radioactivity was eliminated in feces (41.2%) or urine (54.4%). The majority of drug-related radioactivity recovered in feces was unchanged parent drug and approximately half of drug-related radioactivity excreted in urine was unchanged parent drug.
In patients with mild (eGFR: 60 to less than 90 mL/min/1.73 m2), moderate (eGFR: 30 to less than 60 mL/min/1.73 m2), and severe (eGFR: less than 30 mL/min/1.73 m2) renal impairment and subjects with kidney failure/end stage renal disease (ESRD) patients, AUC of empagliflozin increased by approximately 18%, 20%, 66%, and 48%, respectively, compared to subjects with normal renal function. Peak plasma levels of empagliflozin were similar in subjects with moderate renal impairment and kidney failure/ESRD compared to patients with normal renal function. Peak plasma levels of empagliflozin were roughly 20% higher in subjects with mild and severe renal impairment as compared to subjects with normal renal function. Population pharmacokinetic analysis showed that the apparent oral clearance of empagliflozin decreased, with a decrease in eGFR leading to an increase in drug exposure. However, the fraction of empagliflozin that was excreted unchanged in urine, and urinary glucose excretion, declined with decrease in eGFR.
In subjects with mild, moderate, and severe hepatic impairment according to the Child-Pugh classification, AUC of empagliflozin increased by approximately 23%, 47%, and 75%, and Cmax increased by approximately 4%, 23%, and 48%, respectively, compared to subjects with normal hepatic function.
Effect Of Age, Body Mass Index, Gender, And Race
Based on the population PK analysis, age, body mass index (BMI), gender and race (Asians versus primarily Whites) do not have a clinically meaningful effect on pharmacokinetics of empagliflozin .
Studies characterizing the pharmacokinetics of empagliflozin in pediatric patients have not been performed.
In Vitro Assessment Of Drug Interactions
Empagliflozin does not inhibit, inactivate, or induce CYP450 isoforms. In vitro data suggest that the primary route of metabolism of empagliflozin in humans is glucuronidation by the uridine 5′-diphosphoglucuronosyltransferases UGT1A3, UGT1A8, UGT1A9, and UGT2B7. Empagliflozin does not inhibit UGT1A1, UGT1A3, UGT1A8, UGT1A9, or UGT2B7. Therefore, no effect of empagliflozin is anticipated on concomitantly administered drugs that are substrates of the major CYP450 isoforms or UGT1A1, UGT1A3, UGT1A8, UGT1A9, or UGT2B7. The effect of UGT induction (e.g., induction by rifampicin or any other UGT enzyme inducer) on empagliflozin exposure has not been evaluated.
Empagliflozin is a substrate for P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP), but it does not inhibit these efflux transporters at therapeutic doses. Based on in vitro studies, empagliflozin is considered unlikely to cause interactions with drugs that are P-gp substrates. Empagliflozin is a substrate of the human uptake transporters OAT3, OATP1B1, and OATP1B3, but not OAT1 and OCT2. Empagliflozin does not inhibit any of these human uptake transporters at clinically relevant plasma concentrations and, therefore, no effect of empagliflozin is anticipated on concomitantly administered drugs that are substrates of these uptake transporters.
In Vivo Assessment Of Drug Interactions
No dose adjustment of JARDIANCE is recommended when coadministered with commonly prescribed medicinal products based on results of the described pharmacokinetic studies. Empagliflozin pharmacokinetics were similar with and without coadministration of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, and simvastatin in healthy volunteers and with or without coadministration of hydrochlorothiazide and torsemide in patients with type 2 diabetes (see Figure 1). The observed increases in overall exposure (AUC) of empagliflozin following coadministration with gemfibrozil, rifampicin, or probenecid are not clinically relevant. In subjects with normal renal function, coadministration of empagliflozin with probenecid resulted in a 30% decrease in the fraction of empagliflozin excreted in urine without any effect on 24-hour urinary glucose excretion. The relevance of this observation to patients with renal impairment is unknown.
Figure 1: Effect of Various Medications on the Pharmacokinetics of Empagliflozin as Displayed as 90% Confidence Interval of Geometric Mean AUC and Cmax Ratios
aempagliflozin, 50 mg, once daily; bempagliflozin, 25 mg, single dose; cempagliflozin, 25 mg, once daily; dempagliflozin, 10 mg, single dose
Empagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, digoxin, ramipril, simvastatin, hydrochlorothiazide, torsemide, and oral contraceptives when coadministered in healthy volunteers (see Figure 2).
Figure 2: Effect of Empagliflozin on the Pharmacokinetics of Various Medications as Displayed as 90% Confidence Interval of Geometric Mean AUC and Cmax Ratios
aempagliflozin, 50 mg, once daily; bempagliflozin, 25 mg, once daily; cempagliflozin, 25 mg, single dose; dadministered as simvastatin; eadministered as warfarin racemic mixture; fadministered as Microgynon®; gadministered as ramipril
JARDIANCE has been studied as monotherapy and in combination with metformin, sulfonylurea, pioglitazone, linagliptin, and insulin. JARDIANCE has also been studied in patients with type 2 diabetes with mild or moderate renal impairment.
In patients with type 2 diabetes, treatment with JARDIANCE reduced hemoglobin A1c (HbA1c), compared to placebo. The reduction in HbA1c for JARDIANCE compared with placebo was observed across subgroups including gender, race, geographic region, baseline BMI and duration of disease.
A total of 986 patients with type 2 diabetes participated in a double-blind, placebo-controlled study to evaluate the efficacy and safety of JARDIANCE monotherapy.
Treatment-naive patients with inadequately controlled type 2 diabetes entered an open-label placebo run-in for 2 weeks. At the end of the run-in period, patients who remained inadequately controlled and had an HbA1c between 7 and 10% were randomized to placebo, JARDIANCE 10 mg, JARDIANCE 25 mg, or a reference comparator.
At Week 24, treatment with JARDIANCE 10 mg or 25 mg daily provided statistically significant reductions in HbA1c (p-value <0.0001), fasting plasma glucose (FPG), and body weight compared with placebo (see Table 4 and Figure 3).
Table 4: Results at Week 24 From a Placebo-Controlled Monotherapy Study of JARDIANCE
Figure 3: Adjusted Mean HbA1c Change at Each Time Point (Completers) and at Week 24 (mITT Population) – LOCF
At Week 24, the systolic blood pressure was statistically significantly reduced compared to placebo by -2.6 mmHg (placebo-adjusted, p-value=0.0231) in patients randomized to 10 mg of JARDIANCE and by -3.4 mmHg (placebo-corrected, p-value=0.0028) in patients randomized to 25 mg of JARDIANCE.
Add-On Combination Therapy With Metformin
A total of 637 patients with type 2 diabetes participated in a double-blind, placebo-controlled study to evaluate the efficacy and safety of JARDIANCE in combination with metformin.
Patients with type 2 diabetes inadequately controlled on at least 1500 mg of metformin per day entered an open-label 2 week placebo run-in. At the end of the run-in period, patients who remained inadequately controlled and had an HbA1c between 7 and 10% were randomized to placebo, JARDIANCE 10 mg, or JARDIANCE 25 mg.
At Week 24, treatment with JARDIANCE 10 mg or 25 mg daily provided statistically significant reductions in HbA1c (p-value <0.0001), FPG, and body weight compared with placebo (see Table 5).
Table 5: Results at Week 24 From a Placebo-Controlled Study for JARDIANCE used in Combination with Metformin
Initial Combination Therapy With Metformin
A total of 1364 patients with type 2 diabetes participated in a double-blind, randomized, active-controlled study to evaluate the efficacy and safety of JARDIANCE in combination with metformin as initial therapy compared to the corresponding individual components.
Treatment-naive patients with inadequately controlled type 2 diabetes entered an open-label placebo run-in for 2 weeks. At the end of the run-in period, patients who remained inadequately controlled and had an HbA1c between 7 and 10.5% were randomized to one of 8 active-treatment arms: JARDIANCE 10 mg or 25 mg; metformin 1000 mg, or 2000 mg; JARDIANCE 10 mg in combination with 1000 mg or 2000 mg metformin; or JARDIANCE 25 mg in combination with 1000 mg or 2000 mg metformin.
At Week 24, initial therapy of JARDIANCE in combination with metformin provided statistically significant reductions in HbA1c (p-value <0.01) compared to the individual components (see Table 6).
Table 6: Glycemic Parameters at 24 Weeks in a Study Comparing JARDIANCE and Metformin to the Individual Components as Initial Therapy
Add-On Combination Therapy With MetforminAnd Sulfonylurea
A total of 666 patients with type 2 diabetes participated in a double-blind, placebo-controlled study to evaluate the efficacy and safety of JARDIANCE in combination with metformin plus a sulfonylurea.
Patients with inadequately controlled type 2 diabetes on at least 1500 mg per day of metformin and on a sulfonylurea, entered a 2 week open-label placebo run-in. At the end of the run-in, patients who remained inadequately controlled and had an HbA1c between 7% and 10% were randomized to placebo, JARDIANCE 10 mg, or JARDIANCE 25 mg.
Treatment with JARDIANCE 10 mg or 25 mg daily provided statistically significant reductions in HbA1c (pvalue <0.0001), FPG, and body weight compared with placebo (see Table 7).
Table 7: Results at Week 24 from a Placebo-Controlled Study for JARDIANCE in Combination with Metformin and Sulfonylurea
In Combination With Linagliptin As Add-On To Metformin Therapy
A total of 686 patients with type 2 diabetes participated in a double-blind, active-controlled study to evaluate the efficacy and safety of JARDIANCE 10 mg or 25 mg in combination with linagliptin 5 mg compared to the individual components.
Patients with type 2 diabetes inadequately controlled on at least 1500 mg of metformin per day entered a single-blind placebo run-in period for 2 weeks. At the end of the run-in period, patients who remained inadequately controlled and had an HbA1c between 7 and 10.5% were randomized 1:1:1:1:1 to one of 5 active-treatment arms of JARDIANCE 10 mg or 25 mg, linagliptin 5 mg, or linagliptin 5 mg in combination with 10 mg or 25 mg JARDIANCE as a fixed dose combination tablet.
At Week 24, JARDIANCE 10 mg or 25 mg used in combination with linagliptin 5 mg provided statistically significant improvement in HbA1c (p-value <0.0001) and FPG (p-value <0.001) compared to the individual components in patients who had been inadequately controlled on metformin. Treatment with JARDIANCE/linagliptin 25 mg/5 mg or JARDIANCE/linagliptin 10 mg/5 mg daily also resulted in a statistically significant reduction in body weight compared to linagliptin 5 mg (p-value <0.0001). There was no statistically significant difference in body weight compared to JARDIANCE alone.
Active-Controlled Study Versus Glimepiride In Combination With Metformin
The efficacy of JARDIANCE was evaluated in a double-blind, glimepiride-controlled, study in 1545 patients with type 2 diabetes with insufficient glycemic control despite metformin therapy.
Patients with inadequate glycemic control and an HbA1c between 7% and 10% after a 2-week run-in period were randomized to glimepiride or JARDIANCE 25 mg.
At Week 52, JARDIANCE 25 mg and glimepiride lowered HbA1c and FPG (see Table 8, Figure 4). The difference in observed effect size between JARDIANCE 25 mg and glimepiride excluded the pre-specified non-inferiority margin of 0.3%. The mean daily dose of glimepiride was 2.7 mg and the maximal approved dose in the United States is 8 mg per day.
Table 8: Results at Week 52 from an Active-Controlled Study Comparing JARDIANCE to Glimepiride as Add-On Therapy in Patients Inadequately Controlled on Metformin
Figure 4: Adjusted mean HbA1c Change at Each Time Point (Completers) and at Week 52 (mITT Population) – LOCF
At Week 52, the adjusted mean change from baseline in systolic blood pressure was -3.6 mmHg, compared to 2.2 mmHg for glimepiride. The differences between treatment groups for systolic blood pressure was statistically significant (p-value <0.0001).
At Week 104, the adjusted mean change from baseline in HbA1c was -0.75% for JARDIANCE 25 mg and -0.66% for glimepiride. The adjusted mean treatment difference was -0.09% with a 97.5% confidence interval of (-0.32%, 0.15%), excluding the pre-specified non-inferiority margin of 0.3%. The mean daily dose of glimepiride was 2.7 mg and the maximal approved dose in the United States is 8 mg per day. The Week 104 analysis included data with and without concomitant glycemic rescue medication, as well as off-treatment data. Missing data for patients not providing any information at the visit were imputed based on the observed off-treatment data. In this multiple imputation analysis, 13.9% of the data were imputed for JARDIANCE 25 mg and 12.9% for glimepiride.
At Week 104, JARDIANCE 25 mg daily resulted in a statistically significant difference in change from baseline for body weight compared to glimepiride (-3.1 kg for JARDIANCE 25 mg vs. +1.3 kg for glimepiride; ANCOVA-LOCF, p-value <0.0001).
Add-On Combination Therapy With Pioglitazone With Or Without Metformin
A total of 498 patients with type 2 diabetes participated in a double-blind, placebo-controlled study to evaluate the efficacy and safety of JARDIANCE in combination with pioglitazone, with or without metformin.
Patients with inadequately controlled type 2 diabetes on metformin at a dose of at least 1500 mg per day and pioglitazone at a dose of at least 30 mg per day were placed into an open-label placebo run-in for 2 weeks. Patients with inadequate glycemic control and an HbA1c between 7% and 10% after the run-in period were randomized to placebo, JARDIANCE 10 mg, or JARDIANCE 25 mg.
Treatment with JARDIANCE 10 mg or 25 mg daily resulted in statistically significant reductions in HbA1c (pvalue <0.0001), FPG, and body weight compared with placebo (see Table 9).
Table 9: Results of Placebo-Controlled Study for JARDIANCE in Combination Therapy with Pioglitazone
Add-On Combination With Insulin With Or Without Metformin And/Or Sulfonylureas
A total of 494 patients with type 2 diabetes inadequately controlled on insulin, or insulin in combination with oral drugs participated in a double-blind, placebo-controlled study to evaluate the efficacy of JARDIANCE as add-on therapy to insulin over 78 weeks.
Patients entered a 2-week placebo run-in period on basal insulin (e.g., insulin glargine, insulin detemir, or NPH insulin) with or without metformin and/or sulfonylurea background therapy. Following the run-in period, patients with inadequate glycemic control were randomized to the addition of JARDIANCE 10 mg, JARDIANCE 25 mg, or placebo. Patients were maintained on a stable dose of insulin prior to enrollment, during the run-in period, and during the first 18 weeks of treatment. For the remaining 60 weeks, insulin could be adjusted. The mean total daily insulin dose at baseline for JARDIANCE 10 mg, 25 mg, and placebo was 45 IU, 48 IU, and 48 IU, respectively.
JARDIANCE used in combination with insulin (with or without metformin and/or sulfonylurea) provided statistically significant reductions in HbA1c and FPG compared to placebo after both 18 and 78 weeks of treatment (see Table 10). JARDIANCE 10 mg or 25 mg daily also resulted in statistically significantly greater percent body weight reduction compared to placebo.
Table 10: Results at Week 18 and 78 for a Placebo-Controlled Study for JARDIANCE in Combination with Insulin
Add-On Combination With MDI InsulinWith Or Without Metformin
A total of 563 patients with type 2 diabetes inadequately controlled on multiple daily injections (MDI) of insulin (total daily dose >60 IU), alone or in combination with metformin, participated in a double-blind, placebo-controlled study to evaluate the efficacy of JARDIANCE as add-on therapy to MDI insulin over 18 weeks.
Patients entered a 2-week placebo run-in period on MDI insulin with or without metformin background therapy. Following the run-in period, patients with inadequate glycemic control were randomized to the addition of JARDIANCE 10 mg, JARDIANCE 25 mg, or placebo. Patients were maintained on a stable dose of insulin prior to enrollment, during the run-in period, and during the first 18 weeks of treatment. The mean total daily insulin dose at baseline for JARDIANCE 10 mg, JARDIANCE 25 mg, and placebo was 88.6 IU, 90.4 IU, and 89.9 IU, respectively.
JARDIANCE 10 mg or 25 mg daily used in combination with MDI insulin (with or without metformin) provided statistically significant reductions in HbA1c compared to placebo after 18 weeks of treatment (see Table 11).
Table 11: Results at Week 18 for a Placebo-Controlled Study for JARDIANCE in Combination with Insulin and with or without Metformin
During an extension period with treatment for up to 52 weeks, insulin could be adjusted to achieve defined glucose target levels. The change from baseline in HbA1c was maintained from 18 to 52 weeks with both JARDIANCE 10 mg and 25 mg. After 52 weeks, JARDIANCE 10 mg or 25 mg daily resulted in statistically greater percent body weight reduction compared to placebo (p-value <0.0001). The mean change in body weight from baseline was -1.95 kg for JARDIANCE 10 mg, and -2.04 kg for JARDIANCE 25 mg.
A total of 738 patients with type 2 diabetes and a baseline eGFR less than 90 mL/min/1.73 m2 participated in a randomized, double-blind, placebo-controlled, parallel-group to evaluate the efficacy and safety of JARDIANCE in patients with type 2 diabetes and renal impairment. The trial population comprised of 290 patients with mild renal impairment (eGFR 60 to less than 90 mL/min/1.73 m2), 374 patients with moderate renal impairment (eGFR 30 to less than 60 mL/min/1.73 m2), and 74 with severe renal impairment (eGFR less than 30 mL/min/1.73 m2). A total of 194 patients with moderate renal impairment had a baseline eGFR of 30 to less than 45 mL/min/1.73 m2 and 180 patients a baseline eGFR of 45 to less than 60 mL/min/1.73 m2.
The glucose lowering efficacy of JARDIANCE 25 mg decreased with decreasing level of renal function in the mild to moderate range. Least square mean Hb1Ac changes at 24 weeks were -0.6%, -0.5%, and -0.2% for those with a baseline eGFR of 60 to less than 90 mL/min/1.73 m2, 45 to less than 60 mL/min/1.73 m2, and 30 to less than 45 mL/min/1.73 m2, respectively . For placebo, least square mean HbA1c changes at 24 weeks were 0.1%, -0.1%, and 0.2% for patients with a baseline eGFR of 60 to less than 90 mL/min/1.73 m2, 45 to less than 60 mL/min/1.73 m2, and 30 to less than 45 mL/min/1.73 m2, respectively.
Table 12: Results at Week 24 (LOCF) of Placebo-Controlled Study for JARDIANCE in Patients with Type 2 Diabetes and Renal Impairment
|Mild and Moderate Impairmentb|
|JARDIANCE 25 mg|
|Number of patients||n=284|
|Comparison vs placebo (adjusted mean) (95% CI)||-0.5a (-0.6, -0.4)|
| a p-value <0.0001 (HbA1c: ANCOVA model includes baseline HbA1c, treatment, renal function, and background medication)
b eGFR 30 to less than 90 mL/min/1.73 m2- Modified intent to treat population. Last observation on study (LOCF) was used to impute missing data at Week 24. At Week 24, 24.6% and 26.2% was imputed for patients randomized to JARDIANCE 25 mg and placebo, respectively.
For patients with severe renal impairment, the analyses of changes in HbA1c and FPG showed no discernible treatment effect of JARDIANCE 25 mg compared to placebo .
The effect of JARDIANCE on cardiovascular risk in adult patients with type 2 diabetes and established, stable, atherosclerotic cardiovascular disease was evaluated in the EMPA-REG OUTCOME study, a multicenter, multi-national, randomized, double-blind parallel group trial. The study compared the risk of experiencing a major adverse cardiovascular event (MACE) between JARDIANCE and placebo when these were added to and used concomitantly with standard of care treatments for diabetes and atherosclerotic cardiovascular disease. Coadministered antidiabetic medications were to be kept stable for the first 12 weeks of the trial. Thereafter, antidiabetic and atherosclerotic therapies could be adjusted, at the discretion of investigators, to ensure participants were treated according to the standard care for these diseases.
A total of 7020 patients were treated (JARDIANCE 10 mg = 2345; JARDIANCE 25 mg = 2342; placebo = 2333) and followed for a median of 3.1 years. Approximately 72% of the study population was Caucasian, 22% was Asian, and 5% was Black. The mean age was 63 years and approximately 72% were male.
All patients in the study had inadequately controlled type 2 diabetes mellitus at baseline (HbA1c greater than or equal to 7%). The mean HbA1c at baseline was 8.1% and 57% of participants had had diabetes for more than 10 years. Approximately 31%, 22% and 20% reported a past history of neuropathy, retinopathy and nephropathy to investigators respectively and the mean eGFR was 74 mL/min/1.73 m2. At baseline, patients were treated with one (~30%) or more (~70%) antidiabetic medications including metformin (74%), insulin (48%), and sulfonylurea (43%).
All patients had established atherosclerotic cardiovascular disease at baseline including one (82%) or more (18%) of the following; a documented history of coronary artery disease (76%), stroke (23%) or peripheral artery disease (21%). At baseline, the mean systolic blood pressure was 136 mmHg, the mean diastolic blood pressure was 76 mmHg, the mean LDL was 86 mg/dL, the mean HDL was 44 mg/dL, and the mean urinary albumin to creatinine ratio (UACR) was 175 mg/g. At baseline, approximately 81% of patients were treated with renin angiotensin system inhibitors, 65% with beta-blockers, 43% with diuretics, 77% with statins, and 86% with antiplatelet agents (mostly aspirin).
The primary endpoint in EMPA-REG OUTCOME was the time to first occurrence of a Major Adverse Cardiac Event (MACE). A major adverse cardiac event was defined as occurrence of either a cardiovascular death or a nonfatal myocardial infarction (MI) or a nonfatal stroke. The statistical analysis plan had pre-specified that the 10 and 25 mg doses would be combined. A Cox proportional hazards model was used to test for non-inferiority against the pre-specified risk margin of 1.3 for the hazard ratio of MACE and superiority on MACE if non-inferiority was demonstrated. Type-1 error was controlled across multiples tests using a hierarchical testing strategy.
JARDIANCE significantly reduced the risk of first occurrence of primary composite endpoint of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (HR: 0.86; 95% CI 0.74, 0.99). The treatment effect was due to a significant reduction in the risk of cardiovascular death in subjects randomized to empagliflozin (HR: 0.62; 95% CI 0.49, 0.77), with no change in the risk of non-fatal myocardial infarction or non-fatal stroke (see Table 13 and Figure 5 and 6). Results for the 10 mg and 25 mg empagliflozin doses were consistent with results for the combined dose groups.
Table 13: Treatment Effect for the Primary Composite Endpoint, and its Componentsa
Figure 5: Estimated Cumulative Incidence of First MACE
Figure 6: Estimated Cumulative Incidence of Cardiovascular Death
The efficacy of JARDIANCE on cardiovascular death was generally consistent across major demographic and disease subgroups.
Vital status was obtained for 99.2% of subjects in the trial. A total of 463 deaths were recorded during the EMPA-REG OUTCOME trial. Most of these deaths were categorized as cardiovascular deaths. The non-cardiovascular deaths were only a small proportion of deaths, and were balanced between the treatment groups (2.1% in patients treated with JARDIANCE, and 2.4% of patients treated with placebo).
Correct volume depletion and assess for volume contraction before initiating. Monitor for symptomatic hypotension after starting therapy (esp. elderly, renal impairment or low systolic BP, or on diuretics); more frequently if volume contraction expected. Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected, evaluate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). Evaluate renal function prior to starting and monitor periodically thereafter; more frequently if eGFR <60mL/min/1.73m2. Risk of acute kidney injury in hypovolemia, chronic renal insufficiency, CHF, and concomitant drugs (eg, diuretics, ACEIs, ARBs, NSAIDs). Consider temporarily discontinuing in reduced oral intake or fluid losses; monitor for acute kidney injury; discontinue and treat if occurs. Necrotizing fasciitis of the perineum (Fournier’s gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Increased risk of genital mycotic infections, UTIs, or elevated LDL-C; monitor and treat as appropriate. Discontinue if hypersensitivity reaction occurs; treat promptly and monitor until resolve. Elderly. Pregnancy (avoid during 2nd & 3rd trimesters). Nursing mothers: not recommended.
Jardiance is a once-daily oral medication that is used to control blood glucose levels in people with type 2 diabetes.
This is achieved through helping the kidneys remove glucose from the bloodstream through the urine.
Jardiance is not for weight loss or blood pressure management, but it can help with both. It is used as part of a treatment plan that may include exercise, diet and special medical care.
The drug was approved by the European Commission in May 2014. Being a relatively new drug, the long-term effects over several years are not yet known.
- Trade name: Jardiance
- Generic name: Empagliflozin
- Drug class: SGLT2 inhibitors
- Manafacturer: Boehringer Ingelheim and Lilly Diabetes
How does Jardiance help in type 2 diabetes
By removing excessive glucose from the body through urine, Jardiance helps to improve glycemic control among patients with type 2 diabetes. This can result in improved HbA1c levels, which can reduce the risk of diabetes-related complications.
As calories in glucose are also excreted from the body, weight loss can occur from the use of Jardiance. As type 2 diabetes is closely associated with weight – roughly 90 per cent of newly diagnosed type 2s are above their ideal weight – this is beneficial in maintaining a healthy weight.
Jardiance is used as part of a treatment plan, and it is important to maintain other aspects, such as physical exercise, alongside Jardiance treatment.
Mechanism of action
Empagliflozin is an SGLT2 inhibitor, a drug class which helps to stop sodium-glucose transport proteins that have been filtered out of the blood by the kidneys being reabsorbed back into the blood.
Empagliflozin allows a significant amount of sugar to be removed through urination. The SGLT2 proteins are responsible for 90 per cent of the glucose that is reabsorbed into the blood.
Who is Jardiance suitable for?
Jardiance is recommended by the National Institute of Clinical Excellence (NICE) as a treatment for type 2 diabetes under the following conditions:
- When diet and exercise do not provide adequate glycemic control
- When metformin is not appropriate due to patient intolerance
Jardiance is also recommended alongside metformin if a patient is at significant risk of hypoglycemia or cannot take a sulfonylurea. It can also be taken with either metformin or a sulfonylurea.
Who should not take Jardiance?
You should not take Jardiance if you have:
- Type 1 diabetes
- Severe kidney problems
Before taking Jardiance, you should inform your doctor if you:
- Have kidney problems
- Are pregnant, or planning to become pregnant
- Are breastfeeding, or planning to breastfeed
- Have liver problems
- Have low blood pressure
- Take blood pressure medication
- Have high cholesterol levels
- Have a history of urinary tract infections
- Are 65 years old or older
- Are on a low-salt diet
How should Jardiance be taken?
Jardiance is administered orally and usually taken once-daily in the morning – it can be taken with or without food.
The drug is initially prescribed as a 10mg dose, the maximum dose is 25mg. While your doctor may change your dose to ensure you get the best results, you should not take Jardiance in larger or smaller doses than recommended.
If you miss a dose, you should take it as soon as you remember. However, you should not take an extra dose to compensate for your missed medication, and if it is almost time for your next scheduled dose, you should skip the previously missed dose.
Jardiance should be stored at room temperature away from moisture and heat and kept in its original container. You must ensure that it is kept out of the sight and reach of children.
What are the side effects of Jardiance?
The side effects of Jardiance include:
- Problems with urination – either a frequent urge to urinate, or little to no urinating
- Increased likelihood of urinary tract infections
- Signs of a genital infection – such as pain, itching or a rash
- Hypoglycemia – if taken with a medication that reduces blood glucose levels
- Increased cholesterol
- Feeling tired or light-headed
Please note the list above is not exhaustive. You should refer to the patient information leaflet in the medication for a full list of side effects.
What to do if you take an overdose
If you take an overdose of Jardiance, contact your health team immediately for advice.
Long term safety
There are questions as to whether SGLT2 inhibitors have a detrimental long-term effect on the kidneys. Invokana, which is in the same drug class as Jardiance, has been linked with a drop in eGFR, which is a marker used to measure kidney function.
According to the European Medicines Agency, the most frequently reported adverse reaction to Jardiance was hypoglycemia – this occurred when used with sulphonylurea or insulin.
The American Association of Clinical Endocrinologists will be investigating whether SGLT2 inhibitors are the reason for reported high incidences of diabetic ketoacidosis. They plan to conduct this assessment in the autumn of 2015.
FDA-Approved Jardiance for Type 2 Diabetes Also Boosts Weight Loss
Type 2 diabetes affects about 26 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk of serious complications, including heart disease, blindness, and nerve and kidney damage.
Dr. Curtis J. Rosebraugh of the FDA’s Center for Drug Evaluation and Research said in a press statement, “Jardiance provides an additional treatment option for the care of patients with Type 2 diabetes. It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes.”
“This drug blocks a limited amount of reabsorption so that glucose does spill into the urine. The glucose level in the blood is reduced, and some calories are wasted. Over time that could mean a better A1c and a slow, safe loss of weight.” — Dr. Gerald Bernstein
How Does Jardiance Work?
Jardiance is a sodium glucose co-transporter 2 (SGLT2) inhibitor. It works by blocking the reabsorption of glucose (blood sugar) by the kidneys, increasing glucose excretion in urine, and lowering blood sugar levels in people with diabetes. The drug’s safety and effectiveness were studied in seven clinical trials of 4,480 patients with Type 2 diabetes. The trials showed that Jardiance improved hemoglobin A1c levels (a measure of blood sugar control) compared to a placebo.
Dr. Gerald Bernstein, director of the diabetes management program at the Friedman Diabetes Institute at Beth Israel Medical Center, and an associate clinical professor of medicine at the Icahn School of Medicine at Mount Sinai in New York, told Healthline, “Years ago, a primary goal of diabetes treatment was to keep glucose out of the urine. The ability to do self-blood testing is a much better way to monitor, and people don’t have to check their urine as much. In recent years, a new category of drug that causes the body to spill glucose in the urine in a controlled way has emerged. It is normal for a lot of glucose to enter the kidney, but before it gets into the urine, it is reabsorbed back into the bloodstream.”
Bernstein added, “ is an additional drug in that category. This drug blocks a limited amount of that reabsorption so that glucose does spill into the urine. Two things occur. The glucose level in the blood is reduced, and some calories are wasted. Over time that could mean a better A1c and a slow, safe loss of weight. It is approved for use in addition to good nutrition and exercise. It is always good to have an additional version of a drug. The fact that its cousin has been in use and has so far been safe should ease its clinical acceptance.”
Find Out About the Importance of A1c Tests “
Jerry Meece, R.Ph., CDE, and owner of Clinical Services at Plaza Pharmacy and Wellness Center in Gainesville, Tex., who has incorporated diabetes care into his pharmacy practice, told Healthline, “Jardiance is the third SGLT2 inhibitor introduced; the other two are Invokana (canagliflozin) and Farxiga (dapagliflozin). What we used to think was a bad thing, having a lot of glucose in the urine, ends up being a sign of new possibilities. It drops A1c in the neighborhood of one percent.”
According to Meece, SGLT2 inhibitors are unique in that they are the only class of drug that is insulin independent. “Every other oral drug requires some relationship with insulin. This drug works as an insulin independent drug, meaning that regardless of where you are in the disease state, or how long you’ve had diabetes, it works basically the same way. The only limiting factor being renal disease, or renal involvement,” said Meece.
One of the benefits of Jardiance is that it helps with weight loss without causing hypoglycemia, or a dangerous drop in blood sugar levels, said Meece. “When you are basically urinating glucose, you are urinating calories, and you lose 200 to 300 calories per day taking this drug. It does it without causing hypoglycemia, and that’s not a small thing to overlook, because hypoglycemia itself ends up causing a lot of admissions every year to the emergency department,” he said.
Meece is also enthusiastic that Jardiance is what he dubs “durable.” “You take it now and a year from now it is working like when you started taking it. That’s a good thing. With a lot of drugs, when you start taking them it’s just a matter of months to a year when they are not as effective as they were,” he said.
Jardiance can also contribute to a slight reduction in blood pressure, according to Meece.
Learn More About Drugs that Block Glucose Absorption “
Side Effects Include Yeast Infections, UTIs
According to the FDA, Jardiance has been studied as a stand-alone therapy and in combination with other Type 2 diabetes drugs, including metformin, sulfonylureas, pioglitazone, and insulin. The FDA states in a press release that Jardiance should not be used to treat people with Type 1 diabetes; for those who have diabetic ketoacidosis; or for those with severe renal impairment, end stage renal disease, or for patients on dialysis.
The FDA is requiring four post-marketing studies for Jardiance:
- an ongoing cardiovascular outcomes trial
- a study of how the drug works in the bodies of children and teens
- a pediatric safety and efficacy study
- and a nonclinical (animal) juvenile toxicity study with a focus on renal development, bone development, and growth
Find the Best Medications for Type 2 Diabetes “
According to the FDA, Jardiance can cause dehydration, leading to a drop in blood pressure (hypotension) that can result in dizziness or fainting, and a decline in renal function. The elderly, patients with impaired kidney function, and patients taking diuretics to treat other conditions appeared to be more susceptible to this side effect.
The most common side effects of Jardiance are urinary tract infections and female genital infections, especially in those who are prone to these infections.
“If you leak urine, which is mostly going to happen in older people, when that urine dries, you are going to leave sugar on the skin. In the pelvic area, where it is moist, it is a setup for fungal and bacterial infections,” Bernstein said. “I always advise the drug companies to institute programs of hygiene so that people understand what they need to do and make sure there is no glucose deposited on the skin. They can use a wash and dry, or a washcloth with water, at least a couple times a day. The glucose is totally soluble so all of it will go away.”
Get All the Facts About Type 2 Diabetes “
Meece thinks that despite these side effects, the new drug will be embraced. “It’s an effective drug. This could well be a second drug eventually added on to metformin, as a one-two punch,” he said. “I think you will see more of that used.”
Bernstein agreed that the new drug has benefits. “You are not only lowering the blood sugar; in Type 2 that does two things. It actually increases the sensitivity of the insulin to the beta cells, because as the sugar comes back towards normal, the beta cell, within its genetic capability, functions better,” he said. “You are putting out about 250 calories a day, so you are losing weight at a very slow pace, which is best for the body, so the body adapts and doesn’t get into trouble. It’s turning out to be an advantageous drug.”
New Injection for Diabetic Macular Edema
In related news, the FDA has also cleared Regeneron Pharmaceuticals’ Eylea (aflibercept) injection to treat diabetic macular edema (DME). Eylea is a vascular endothelial growth factor (VEGF) inhibitor.
DME, or “swelling of the macula,” is a common eye condition for patients with diabetes. It is the most frequent cause of vision loss in patients with diabetes and can eventually lead to blindness.
DME occurs when blood vessels in the retina are damaged by chronic high blood sugar levels caused by diabetes. This allows fluid from blood vessels to leak into the retina, causing macular swelling. The macula is the part of the retina responsible for central, fine vision.
Dr. George D. Yancopoulos, chief scientific officer of Regeneron and president of Regeneron Laboratories, said in a press statement, “Diabetic macular edema is a leading cause of vision loss among working-age adults in the United States, and we are pleased to be able to offer a new treatment option to these patients.Our clinical studies have demonstrated that treatment with Eylea can help improve and maintain vision with every eight-week dosing after five initial monthly doses. Eylea is the first VEGF inhibitor approved for dosing on a less than monthly basis for the treatment of DME.”
How does this medication work? What will it do for me?
Empagliflozin belongs to the class of medications called oral antihyperglycemic agents. It works in the kidneys to increase the amount of glucose removed from the body by the kidneys.
Empagliflozin is used alone or in combination with other medications for people with type 2 diabetes to control their blood glucose. This medication should be used as part of an overall diabetes management plan that includes a diet and exercise program.
Empagliflozin is also used for people with type 2 diabetes who also have cardiovascular disease. It is used in addition to diet, exercise and other medications to reduce the risk of dying from cardiac disease.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each pale yellow, round, biconvex and bevelled-edged, film-coated tablet, debossed with “S10” on one side and the Boehringer Ingelheim company symbol on the other side, contains 10 mg of empagliflozin. Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, macrogol, microcrystalline cellulose, titanium dioxide, talc, and yellow ferric oxide.
Each pale yellow, oval, biconvex, film-coated tablet, debossed with “S25” on one side and the Boehringer Ingelheim company symbol on the other side, contains 25 mg of empagliflozin. Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, macrogol, microcrystalline cellulose, titanium dioxide, talc, and yellow ferric oxide.
How should I use this medication?
The usual starting dose of empagliflozin is 10 mg taken by mouth once a day. Depending on how effectively it reduces your blood glucose, your doctor may increase the dose to 25 mg taken once a day.
Empagliflozin may be taken at any time of the day, with or without food. The tablet must be swallowed whole. Do not cut or chew the tablets.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is less than 12 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you:
- are allergic to empagliflozin or any ingredients of the medication
- have severely decreased kidney function or end-stage kidney disease, or are on dialysis
- have type I diabetes
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- dizziness when rising from a sitting or lying position
- increased urination
- symptoms of yeast infection of the penis (e.g., red, swollen, itchy head of penis, unpleasant odour, discharge under foreskin, pain passing urine or during sexual activity)
- symptoms of vaginal yeast infection (e.g., itching, burning, soreness, whitish-grey discharge)
- unusual thirst
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Stop taking the medication and seek immediate medical attention if any of the following occur:
- symptoms of diabetic ketoacidosis (DKA; e.g., difficulty breathing, extreme thirst, vomiting, nausea, loss of appetite, stomach pain, confusion, unusual tiredness)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
May 16, 2016
Health Canada has issued new information concerning the use of Jardiance (empagliflozin). To read the full Health Canada Advisory, visit Health Canada’s web site at www.hc-sc.gc.ca.
Diabetic ketoacidosis (DKA): Empagliflozin has been associated with DKA. This is a potentially life-threatening condition caused by not having enough insulin in the blood to use the glucose in the bloodstream. When this happens, the body starts to burn ketones for fuel and can make the blood acidic. This condition is more likely to develop if you are following a very low carbohydrate diet, are dehydrated or have consumed a large amount of alcohol. Symptoms of DKA include:
- difficulty breathing
- abdominal pain
- loss of appetite
- excessive thirst
- unusual fatigue or sleepiness
If you experience these symptoms, get immediate medical help.
Low blood pressure: Empagliflozin causes an increased amount of fluid to be removed from the body through the urine. As a result, it can cause decreases in blood pressure that, in turn, cause dizziness, especially when rising from a sitting or lying position. To reduce the possibility of dizziness or fainting, rise slowly from sitting or lying down.
Drowsiness/reduced alertness: Empagliflozin may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how this medication affects you.
Fluid and electrolyte balance: Empagliflozin causes increased urine production that may cause the levels of electrolytes such as potassium, sodium, magnesium, chloride, and calcium in the blood to change while taking this medication. If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible. Your doctor will do blood tests regularly to monitor the levels of these electrolytes in your blood while you are taking this medication.
Glucose control: When empagliflozin is taken along with other medications for diabetes, glucose levels may drop too far, causing confusion, cold sweats, cool and pale skin, headache, fast heartbeat, or weakness. Your doctor may suggest decreasing the dose of your other medications when you first start taking empagliflozin. If you take other medications for diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Kidney function: Empagliflozin may cause a decrease in kidney function. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if empagliflozin passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
Seniors: Seniors are at an increased risk of experiencing urinary tract infections and decreases in blood pressure while taking this medication.
What other drugs could interact with this medication?
There may be an interaction between empagliflozin and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Jardiance