Jardiance® [Empagliflozin]

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Jardiance® [Empagliflozin]

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Monotherapy or combination therapy

The recommended initial dose is 10 mg (1 tablet dosage of 10 mg) once a day, by mouth.

If the daily dose of 10 mg does not provide adequate glycemic control, the dose may be increased to 25 mg (1 tablet with a dosage of 25 mg 1 time per day). The maximum daily dose is 25 mg.

The drug Jardiance® can be taken regardless of the meal at any time of the day.

Actions to skip taking one or more doses of the drug

When you skip a dose, the patient should take the drug as soon as he remembers. You should not take a double dose in one day.

Special patient groups

Withrenal failure with GFR from 45 to 90 ml / min / 1.73 m² dose adjustment is not required.

Patients with renal insufficiency with GFR less than 45 ml / min / 1.73 m² use of the drug is not recommended due to inefficiency.

Patients withimpaired liver function dose adjustment is not required.

Adverse reactions

The overall incidence of adverse events in patients receiving empagliflozin or placebo was similar in clinical studies. The most common adverse reaction was hypoglycemia, which was observed with the use of empagliflozin in combination with sulfonylurea or insulin derivatives (see the description of some undesirable reactions).

The adverse reactions observed in patients receiving empagliflozin in placebo-controlled studies are presented below in the Table (unwanted reactions were classified by organs and systems and in accordance with MedDRA preferred terms) indicating their absolute frequency. Frequency categories are defined as follows: very frequent (≥1 / 10), frequent (from ≥1 / 100 to

Table. Side effects reported in placebo controlled studies

Classification by organs and systems	Very frequent	Frequent
Infectious and parasitic diseases		Vaginal candidiasis, vulvovaginitis, balanitis and other genital infections Urinary tract infections
Metabolic and nutritional disorders	Hypoglycemia (when used together with sulfonylurea derivatives or insulin)	Hypovolemia
Kidney and urinary tract disorders		Frequent urination

Description of individual unwanted reactions

Hypoglycemia

The frequency of hypoglycemia depended on the concomitant hypoglycemic therapy used.

Mild hypoglycemia (blood glucose 3.0 - 3.8 mmol / l (54-70 mg / dL))

The incidence of mild hypoglycemia was similar in patients taking empagliflozin or placebo as monotherapy, as well as when empagliflozin was added to metformin and when empagliflozin was added to pioglitazone (± metformin). When empagliflozin was prescribed in combination with metformin and sulfonylurea derivatives, the incidence of hypoglycemia was higher (10 mg: 10.3%; 25 mg: 7.4%) than when prescribed placebo in the same combination (5.3%).

Severe hypoglycemia (blood glucose below 3 mmol / L (54 mg / dL))

The incidence of severe hypoglycemia was similar in patients taking empagliflozin and placebo as monotherapy. In the case of empagliflozin in combination with metformin and sulfonylurea derivatives, the incidence of hypoglycemia was higher (10 mg: 5.8%; 25 mg: 4.1%) than when prescribed placebo in the same combination (3.1%).

Frequent urination

Frequency of frequent urination (symptoms such as pollakiuria, polyuria, nocturia) were higher in the case of empagliflozin (at a dose of 10 mg: 3.4%, at a dose of 25 mg: 3.2%) than in the case of placebo (1 %). The incidence of nocturia was comparable in the group of patients taking empagliflozin and in the group of patients taking placebo (less than 1%). The intensity of these side effects was mild or moderate.

Urinary tract infections

The incidence of urinary tract infections was similar in the case of empagliflozin 25 mg and placebo (7.6%), but higher in the case of empagliflozin 10 mg (9.3%). As with placebo, urinary tract infections with empagliflozin were more common in patients with a history of chronic and recurrent urinary tract infections. The intensity of urinary tract infections was similar in patients taking empagliflozin and placebo. Urinary tract infections are more common in women.

Genital infections

The incidence of adverse events such as vaginal candidiasis. vulvovaginitis, balanitis, and other genital infections were higher with empagliflozin (10 mg: 4.1%, 25 mg: 3.7%) than placebo (0.9%). Genital infections are more common in women. The intensity of genital infections was mild or moderate.

Hypovolemia

The incidence of hypovolemia (expressed as a decrease in blood pressure, orthostatic hypotension, dehydration, fainting) was similar in the case of empagliflozin (at a dose of 10 mg: 0.5%. At a dose of 25 mg: 0.3%) and placebo (0.3%). ). In patients older than 75 years, the incidence of hypovolemia was comparable in patients taking empagliflozin at a dose of 10 mg (2.3%) and placebo (2.1%), but higher in patients who took empagliflozin at a dose of 25 mg (4.4% ).

Contraindications

Carefully

• patients at risk of developing hypovolemia (use of antihypertensive drugs with a history of arterial hypotension);
• in diseases of the gastrointestinal tract, leading to fluid loss;
• age over 75 years;
• use in combination with sulfonylureas or insulin;
• infections of the genitourinary system.

Drug interactions

Evaluation of drug interactions in vitro

Empagliflozin does not inhibit, does not inactivate and does not induce CYP450 isoenzymes. The main pathway of human metabolism of empagliflozin is glucuronidation involving uridine-5'-diphospho-glucuronosyltransferase UGT2B7, UGT1A3, UGT1A8 and UGT1A9. Empagliflozin does not inhibit UGT1A1. Drug interactions of empagliflozin and drugs, which are substrates of CYP450 and UGT1A1 isoenzymes, are considered unlikely.

Empagliflozin is a substrate for glycoprotein P (P-gp) and the protein that determines breast cancer resistance (BCRP), but does not inhibit these proteins in therapeutic doses. Based on the data obtained in invitro studies, it is believed that the ability of empagliflozin to interact with drugs that are substrates for the glycoprotein P (P-gp). unlikely. Empagliflozin is a substrate for organic anionic carriers: OAT3, OATP1B1 and OATP1B3, but is not a substrate for organic anionic carriers 1 (OAT1) and organic cationic carriers 2 (OCT2). However, drug interactions of empagliflozin with drugs, which are substrates for the above carrier proteins, are considered unlikely.

Evaluation of drug interactions in vivo

The pharmacokinetics of empagliflozin do not change in healthy volunteers when used together with metformin. glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, Torsemide and hydrochlorothiazide. When empagliflozin was used together with gemfibrozil, rifampicin and probenecid, the AUC value of empagliflozin increased by 59%, 35% and 53%, respectively, however, these changes were not considered clinically significant.

Empagliflozin has no clinically significant effect on the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, digoxin, ramipril, simvastatin, hydrochlorothiazide, Torsemide, and oral contraceptive preparations.

Diuretics

Empagliflozin may enhance the diuretic effect of thiazide and “loop” diuretics, which in turn may increase the risk of dehydration and hypotension.

Insulin and drugs that increase its secretion

Insulin and secretion enhancing drugs, such as sulfonylurea derivatives, may increase the risk of hypoglycemia. Therefore, with simultaneous use of empagliflozin with insulin and drugs that increase its secretion, it may be necessary to reduce their dose, in order to avoid the risk of hypoglycemia.

Pregnancy and Lactation

Special instructions

Overdosage