Empagliflozin (Jardiance®) is a prescription medicine in the class of Sodium Glucose Co-Transporter 2 inhibitor (SGLT2i) given adjunct to lifestyle changes to reduce blood glucose in adults with type 2 diabetes, and also to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.

Empagliflozin (Jardiance®) should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
 

What must I know about Empagliflozin (Jardiance®)?

Empagliflozin (Jardiance®) can cause serious side effects, including:
 

• Hypoglycaemia. Empagliflozin (Jardiance®) when taken with sulfonylurea or insulin, can increase the risk of hypoglycaemia. The dose of sulfonylurea or insulin may need to be lowered. Advise your patients on the way to treat low blood glucose if they present any of the following symptoms: shaking, sweating, feeling very anxious or confused, fast heartbeat, excessive hunger, headache.


• Serious urinary tract infections. The overall frequency of urinary tract infection reported as adverse event was similar in patients treated with empagliflozin 25 mg and placebo and higher in patients treated with empagliflozin 10 mg. Complicated urinary tract infections including pyelonephritis and urosepsis have been reported in patients treated with empagliflozin. If your patients present with symptoms that are consistent with serious urinary tract infection, consider temporary interruption of empagliflozin.


• Genital mycotic infection Vaginal moniliasis, vulvovaginitis, balanitis and other genital infections were reported more frequently in patients treated with empagliflozin compared to placebo. These infections were reported more frequently in females treated with empagliflozin compared to placebo, and the difference in frequency was less pronounced in males. The genital tract infections were mild or moderate in intensity.


• Dehydration. Empagliflozin (Jardiance®) can cause dehydration in some patients, particularly in those who have low blood pressure, on anti-hypertensive medication, on diuretics, on low salt diet, have kidney diseases or insufficiency, are 75 years of age or older. Signs of dehydration include dizziness, feeling faint, light-headed, or weak, especially when changing positions from sitting, to standing.


• Diabetic ketoacidosis (increased ketones in the blood or urine). Diabetic ketoacidosis occurs more commonly in people with type 1 diabetes but can also occur in people with type 2 diabetes taking Empagliflozin (Jardiance®), even if blood sugar is less than 250 mg/dL or 13.9mmol/L. Diabetic ketoacidosis can be fatal. Advise your patients to stop taking Empagliflozin (Jardiance®) if they present any of the following symptoms, and if possible, check for ketones in their urine: nausea, vomiting, anorexia, stomach-area (a bdominal) pain, excessive thirst, confusion, tiredness, or trouble breathing.

Who should not take Empagliflozin (Jardiance®)?
 

• Do not give Empagliflozin (Jardiance®) to your patients if they are allergic to empagliflozin or any of the ingredients in Empagliflozin (Jardiance®).


• Do not give Empagliflozin (Jardiance®) if your patients have severe kidney problems or are on dialysis.


• Do not give Empagliflozin (Jardiance®) if your patients have type 1 diabetes or to treat diabetic ketoacidosis.

What should I check before I give Empagliflozin (Jardiance®) to my patient?
 

• Check your patient’s kidney function before and during your treatment with Empagliflozin (Jardiance®). Also check if they have liver problems; have a history of urinary tract infections or problems with urination; are going to have surgery; are eating less due to illness, surgery, or a change in diet; currently have or have had problems with the pancreas, including pancreatitis or surgery on the pancreas; have excessive alcohol consumption; have any other medical conditions; are pregnant or plan to become pregnant. Empagliflozin (Jardiance®) may harm an unborn baby. If the patient becomes pregnant while taking Empagliflozin (Jardiance®), tell your patient to inform you as soon as possible. Ask your patient if they are breastfeeding, or plan to breastfeed. Empagliflozin (Jardiance®) may pass into breast milk and may harm the baby. Tell your patient not to breastfeed while taking Empagliflozin (Jardiance®).


• Ask your patients about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Also ask your patients if they take water pills (diuretics) or medicines that can lower blood sugar such as sulfonylurea or insulin.

What are other possible common side effects of Empagliflozin (Jardiance®)?
 

• Increased urination. Passing more urine than usual or needing to pass urine more often.


• Allergic skin reaction. Rash or red skin. This may be itchy and include raised bumps, oozing fluid or blisters.


• Thirst.


• Increased fats (cholesterol) level in the blood.

 

For more information, please see Prescribing Information.