Stiglatra pills 5mg, 28pcs

Composition

1 film-coated tablet contains:

Dosage of 5 mg:

Active ingredient: ertugliflozin L-pyroglutamic acid 6,477 mg is equivalent to 5,000 mg of ertugliflozin.

Excipients: microcrystalline cellulose PH-102, lactose monohydrate, sodium carboxymethyl starch (type A), magnesium stearate.

Film coating: Opadray II Pink 330150000.

The composition of Rose Pollen II ZZG150000: hypromellose 2910 / hypromellose bsR, lactose monohydrate, macrogol / PEG 3350, triacetin, titanium dioxide, iron oxide red dye.

Pharmacological action

PHARMACOTHERAPY GROUP:  hypoglycemic agent for oral use – an inhibitor of the sodium-dependent glucose transporter type 2.

KODATH:  A 10 EKR 4

PHARMACOLOGICAL PROPERTIES

Mechanism of action

Sodium-dependent glucose transporter type 2 (NGLT2) is the predominant transporter responsible for reabsorption of glucose from glomerular filtrate back into the bloodstream. Ertugliflozin is a potent, selective and reversible inhibitor of NGLT2. By inhibiting NGLT2, ertugliflozin reduces the renal reabsorption of filtered glucose and lowers the renal threshold for glucose, thereby increasing the excretion of glucose by the kidneys.

Pharmacodynamics

Renal glucose excretion and urine volume

Dose-dependent increases in the amount of glucose excreted by the kidneys were observed in healthy volunteers and in patients with type 2 diabetes mellitus after taking single and multiple doses of ertugliflozin. Modeling of the dose-response relationship showed that ertugliflozin at 5 mg and 15 mg doses leads to almost maximum renal glucose excretion in patients with type 2 diabetes, providing 87% and 96% of the maximum inhibition, respectively.

Pharmacokinetics

The pharmacokinetic parameters of ertugliflozin are similar in healthy volunteers and in patients with type 2 diabetes mellitus. The mean steady-state values of the area under the concentration-time curve (AUC) and maximum concentration (Cmax) in blood plasma were 398 ng·h/ml and 81 ng/ml, respectively, when using ertugliflozin 5 mg once a day,1193 ng·h/ml and 268 ng / ml when using ertugliflozin 15 mg once a day. The equilibrium state is reached after 4-6 days of taking ertugliflozin once a day. Ertugliflozin is not characterized by time-dependent pharmacokinetic parameters and accumulates in blood plasma up to 10-40% after repeated use.

Suction

After a single oral use of ertugliflozin in doses of 5 mg and 15 mg, the maximum concentration of ertugliflozin in blood plasma (median time to reach the maximum concentration of Tmax) is reached 1 hour after taking the drug on an empty stomach. The cmax and AUC of ertugliflozin in blood plasma increase dose-proportionally after a single dose of 0.5 mg to 300 mg and after repeated doses of 1 mg to 100 mg. After oral use of ertugliflozin at a dose of 15 mg, the absolute bioavailability is approximately 100%.

Taking ertugliflozin together with a high-fat, high-calorie diet reduces ertugliflozin Stax by 29% and increases Tmax by 1 hour, but does not affect AUC compared to taking the drug on an empty stomach. The observed effect of food on the pharmacokinetic parameters of ertugliflozin is not considered clinically significant, and ertugliflozin can be taken regardless of food intake. In phase 3 clinical trials, ertugliflozin was administered independently of food intake.

Ertugliflozin is a substrate of p-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) transporters.

Distribution

The average volume of distribution of ertugliflozin at steady state after intravenous use is 86 liters. The degree of binding of ertugliflozin to plasma proteins is 93.6% and does not depend on the concentration of ertugliflozin in blood plasma. The degree of binding of ertugliflozin to plasma proteins does not significantly change in patients with impaired renal function or impaired liver function. The ratio of ertugliflozin concentrations in the blood to plasma concentrations is 0.66.

Ertugliflozin is not a substrate for organic anion transporters (OATl, OATZ), organic cation transporters (OCTl, OST 2), or polypeptides that transport organic anions (OATR 1 In 1, OATRlVZ) in vitro.

Metabolism

Metabolism is the main mechanism of clearance for ertugliflozin. The main metabolic pathway for ertugliflozin is UGT1A9 – and UGT2B7-mediated O-glucuronidation with the formation of two glucuronides that are pharmacologically inactive at clinically significant concentrations. SUR-mediated (oxidative) metabolism of ertugliflogin_m: 1 shimal,1: 1( 12%).

Deduction

The average systemic clearance of ertugliflozin from blood plasma after intravenous use of a dose of 100 mcg was 11 l / h. Based on a population pharmacokinetic analysis, the mean elimination half-life in patients with type 2 diabetes mellitus with normal renal function was 17 hours.

After ingestion of a solution of [14C]-ertugliflozin by healthy volunteers, approximately 41% and 50% of the drug-associated radioactive isotope were excreted through the intestines and kidneys, respectively. Only 1.5% of the administered dose was excreted as unchanged ertugliflozin by the kidneys and 34% as unchanged ertugliflozin through the intestines, which is probably due to bile excretion of glucuronide metabolites and their subsequent hydrolysis to the starting substance.

Special patient groups

Impaired renal function

In a phase 1 clinical pharmacological study in patients with type 2 diabetes mellitus and mild, moderate, or severe renal impairment (based on estimated glomerular filtration rate (eGFR)) after a single dose of 15 mg of ertugliflozin, the AUC values of ertugliflozin on average increased by: ;; 1.7 times compared with patients with normal renal function.

These increases in ertugliflozin AUC are not considered clinically significant. There were no clinically significant differences in the Cmax values of ertugliflozin among groups of patients with different renal function. The daily excretion of glucose by the kidneys decreased as the severity of renal dysfunction increased. The degree of binding of ertugliflozin to plasma proteins did not change in patients with impaired renal function.

Liver failure

Moderate hepatic insufficiency (according to the Child-Pugh classification) did not lead to an increase in ertugliflozin exposure. The AUC value of ertugliflozin was reduced by approximately 13%, and the Cmax value was reduced by approximately 21% compared to patients with normal liver function. This reduction in ertugliflozin exposure is not considered clinically significant.

There is no experience of clinical use of ertugliflozin in patients with severe hepatic insufficiency (Child-Pugh class C). The degree of binding of ertugliflozin to plasma proteins did not change in patients with moderate hepatic impairment.

The pharmacokinetics of ertugliflozin in children have not been studied.

Influence of age, body weight, gender, and race

In a population pharmacokinetic analysis, no clinically significant effect of age, body weight, gender, or race on the pharmacokinetics of ertugliflozin was observed.

Drug interactions

Evaluation of ertugliflozin in vitro

In vitro studies, ertugliflozin and ertugliflozin glucuronides did not inhibit or inactivate 1A2,2C9,2C19,2C8,2B,2D6, or 4 cytochrome 450 isoenzymes (SUR), nor did they induce 1A2,2B6, or 4 SUR. Ertugliflozin and ertugliflozin glucuronides did not inhibit the activity of UDP-glucuronosyltransferases (UGT) lAb,1 A 9 or 2 B 7 in vitro.

Ertugliflozin was a weak inhibitor of UGT lAl and 1A4 in vitro at higher concentrations that were not clinically relevant. Ertugliflozin glucuronides had no effect on these isoforms. In general, the effect of ertugliflozin on the pharmacokinetics of concomitantly administered drugs that are eliminated by these enzymes seems unlikely.

Ertugliflozin and ertugliflozin glucuronides do not significantly inhibit P-gp, OST 2 transporters, OATl or OATZS, or OATPlBl and OATPlBZ-transporting polypeptides at clinically significant concentrations in vitro. In general, the effect of ertugliflozin and ertugliflozin glucuronides on the pharmacokinetics of concomitantly used drugs that are substrates of these transporters seems unlikely.

Indications

Stiglatra is indicated for use in patients with type 2 diabetes aged 18 years and older in addition to diet and exercise to improve glycemic control:

• as monotherapy in patients who are not indicated for the use of metformin due to intolerance or contraindications.
• as a combination therapy with metformin, sulfonylurea derivatives, dipeptidyl peptidase 4 (DPP-4) inhibitors (including in combination with metformin) and insulin preparations in the absence of adequate glycemic control on this therapy.

Use during pregnancy and lactation

Pregnancy

There are limited data on the use of ertugliflozin in pregnant women. Based on animal studies, ertugliflozin may affect kidney development and maturation. In this regard, the use of Stiglatra during pregnancy is contraindicated.

Breast-feeding period

There is no information on the presence of ertugliflozin in human breast milk, on the effects on a breastfed child, or on the effects on breast milk production. Ertugliflozin was present in the milk of lactating rats and had an effect on the offspring of lactating rats. Pharmacologically mediated effects were observed in immature rats.

Due to the fact that human kidney maturation occurs in utero and during the first 2 years of life, when exposure through breast milk is possible, the risk for newborns and children cannot be excluded. The use of Stiglatra during breastfeeding is contraindicated.

Fertility

The effect of ertugliflozin on human reproductive function has not been studied. No effect on reproductive function was observed in animal studies.

Contraindications

• Hypersensitivity to ertugliflozin or any other component of the drug;
• Severe hepatic insufficiency (no efficacy or safety data available);
• Impaired renal function with an eGFR consistently below 45 ml / min/1.73 m2 or with a creatinine clearance of less than 45 ml / min or patients on dialysis;
• Diabetic ketoacidosis;
• Type 1 diabetes mellitus;
• Children under 18 years of age (safety and efficacy data are not available);
• Pregnancy and lactation;
• Lactase deficiency, galactose intolerance, glucose-galactose malabsorption.

WITH CAUTION

• Impaired renal function with eGFR below 60 ml / min/1.73 m2 or creatinine clearance below 60 ml / min (to start therapy).

Side effects

Summary of item Q. Q. f_il of security

Summary of data from placebo-controlled trials evaluating the safety of Stiglatra 5 mg and 15 mg.

The initial safety assessment was based on data from three 26-week placebo-controlled trials.

Ertugliflozin was used as monotherapy in one study and as adjunctive therapy in two studies. In these studies,1029 patients received ertugliflozin with an average duration of therapy of about 25 weeks. Patients received ertugliflozin 5 mg (N = 519), ertugliflozin 15 mg

(N = 518), or placebo (N = 515) once daily.

The most frequently reported adverse reactions during clinical trials were vulvovaginal fungal infections and other fungal infections of the female genital organs. Cases of severe diabetic ketoacidosis have rarely been reported.

Table of adverse reactions

The adverse reactions listed below are classified according to frequency and organ-system class. The occurrence frequency categories are defined as follows: very common (1/10), common( 1/100 and< 1/10), uncommon ( 1/1000 and< 1/100), rare (::: 1/1 About LLC and < 1/1 LLC), very rare (

Very often Vulvovaginal fungal infections and other fungal infections of the genitals in women, Candida balanitis and other often fungal infections of the genitals in men,

often Hypoglycemia

Rarely Diabetic ketoacidosis

Often Decreased BCC

Often Rapid urination Often Dysuria, increased blood creatinine concentration/ decreased glomerular filtration

rate Often Vulvovaginal itching

Often Thirst

Often Changes in blood lipidoserum concentration increased hemoglobin concentration.

Description of individual adverse reactions

BCC reduction

Taking ertugliflozin causes osmotic diuresis, which can lead to a reduction in intravascular volume and undesirable reactions associated with a decrease in BCC. According to a summary of placebo-controlled studies, the incidence of adverse events associated with BCC reduction (dehydration, postural vertigo, pre-syncope, syncope, hypotension, and orthostatic hypotension) was low ( 

Based on a subgroup analysis of a broader scope of phase 3 studies in patients with eGFR  In patients with eGFR

;  in patients with eGFR from 45 to

Hypoglycemia

According to generalized data from placebo-controlled studies, the frequency of reported hypoglycemia was higher in the 5 mg and 15 mg ertugliflozin groups (5.0% and 4.5%) compared to the placebo group (2.9%). In this population, the incidence of severe hypoglycemia was 0.4% in each group.

When taking ertugliflozin as monotherapy, the incidence of hypoglycemia was 2.6% in both ertugliflozin groups and 0.7% in the placebo group. When taking ertugliflozin in combination with metformin, the incidence of hypoglycemia was 7.2% in the 5 mg ertugliflozin group,7.8% in the 15 mg ertugliflozin group, and 4.3% in the placebo group.

When comparing the combination of ertugliflozin and metformin with sulfonylureas, the incidence of hypoglycemia was higher in patients taking sulfonylureas (27%) compared to patients taking ertugliflozin (5.6% and 8.2% in the 5 mg and 15 mg ertugliflozin groups, respectively).

In patients with moderate renal impairment treated with insulins, sulfonylureas, or meglitinides as background therapy, the reported incidence of hypoglycemia was 36%,27%, and 36% in the 5 mg ertugliflozin group,15 mg ertugliflozin group, and placebo group, respectively.

Diabetic ketoacidosis

As part of the clinical program, ketoacidosis was detected in 3 out of 3409 patients (0.1%) treated with ertugliflozin, and none of the patients (0.0%) treated with comparison drugs.

Increased blood creatinine concentration/decreased glomerular filtration rate and events related to renal function

Patients treated with ertugliflozin usually experienced a temporary initial increase in mean creatinine concentration and a decrease in mean eGFR during continuous treatment. Patients with baseline moderate renal impairment had large changes in mean values that did not return to baseline at week 26; these changes returned to baseline after discontinuation of treatment.

Adverse reactions related to renal function (for example, acute kidney injury, impaired renal function, acute prerenal renal failure) may occur in patients receiving ertugliflozin therapy, especially in patients with moderate renal impairment, in whom the frequency of adverse reactions related to renal function was 2.5%,1.3% and 0.6% in patients in the ertugliflozin 5 mg group, in the ertugliflozin 15 mg group and in the placebo group, respectively.

Fungal infections of the genitals

According to the combined data of three placebo-controlled studies, fungal infections of the genital organs in women (nagI, i:> p, genital candidiasis, fungal infection of the genital organs, vaginal infection, vulvitis, vulvovaginal candidiasis, vulvovaginal fungal infection, vulvovaginitis) were observed in 9.1%,12% and 3.0% of women who received ertugliflozin at a dose of 5 mg, ertugliflozin at a dose of 15 mg mg and placebo, respectively. Interruption of treatment due to fungal infections of the genitals was required in 0.6% and 0% of women treated with ertugliflozin and placebo, respectively.

In the same data set, fungal infections of the genitals in men (for example, candidal balanitis, balanoposthitis, genital infection, fungal infection of the genitals) were observed in 3.7%,4.2% and 0.4% of men who received ertugliflozin at a dose of 5 mg, ertugliflozin at a dose of 15 mg and placebo, respectively. Fungal infections of the genitals were more common in uncircumcised men.

Interruption of treatment due to fungal infections of the genitals was required in 0.2% and 0% of men treated with ertugliflozin and placebo, respectively. Phimosis was rarely reported, and in some cases circumcision was performed.

Interaction

Pharmacodynamic interaction

Diuretics

Ertugliflozin may increase the diuretic effect of diuretics and increase the risk of dehydration and hypotension.

Insulin and insulin secretagogue preparations

Insulin and insulin secretagogue medications (such as sulfonylureas) are known to cause hypoglycemia. Ertugliflozin may increase the risk of hypoglycemia when used in combination with insulin and/or insulin secretagogues. Therefore, it may be necessary to reduce the dose of insulin or secretagogue insulin to reduce the risk of hypoglycemia when used in combination with ertugliflozin.

Pharmacokinetic interaction

Effect of other medicinal products on ertugliflozin farlucokineticsMetabolism involving UGTIA9 and UGT2B7 isoenzymes is the main mechanism of ertugliflozin clearance.

Interaction studies in healthy volunteers with a single dose suggest that sitagliptin, metformin, glimepiride, or simvastatin do not alter the pharmacokinetics of ertugliflozin. use of multiple doses of rifampicin (an inducer of UGT and SUR) reduces the AUC and Cmax of ertugliflozin by 39% and 15%, respectively. This reduction in exposure is not considered clinically significant, and therefore dose adjustment is not recommended. A clinically significant effect from interaction with other inducers (for example, carbamazepine, phenytoin, phenobarbital) is not expected.

The effect of UGT inhibitors on the pharmacokinetics of ertugliflozin has not been studied in a clinical setting, but a possible increase in ertugliflozin exposure due to UGT inhibition is not considered clinically significant.

Effect of ertugliflozin on the pharmacokinetics of other drugsInteraction studies in healthy volunteers suggest that ertugliflozin does not have a clinically significant effect on the pharmacokinetics of sitagliptin, metformin, and glimepiride.

Co-use of simvastatin and ertugliflozin resulted in an increase in the AUC and Cmax of simvastatin by 24% and 19%, respectively, and an increase in the AUC and Cmax of simvastatin acid by 30% and 16%, respectively. The mechanism of a slight increase in the parameters of simvastatin and simvastatin acid is unknown and is not the result of inhibition of OATR by ertugliflozin. This increase is not considered clinically significant.

How to take, course of use and dosage

Inside.

Method of application

Stiglatra should be taken orally once a day in the morning, regardless of food intake. In case of problems with swallowing, the tablet can be broken or crushed, since the drug is available in an immediate-release dosage form.

Dosage regimen

The recommended starting dose of Stiglatra is 5 mg once a day in the morning, regardless of food intake. In patients who are well-tolerated with Stiglatra 5 mg once daily, the dose may be increased to 15 mg once daily if increased glycemic control is necessary.

When ertugliflozin is used in combination with insulin or with an insulin secretagogue, it may be necessary to use lower doses of insulin or an insulin secretagogue to reduce the risk of hypoglycemia.

In patients with reduced circulating blood volume (BCC), it is recommended to correct this condition before starting the use of ertugliflozin.

If a dose is missed, it should be taken as soon as possible after the patient remembers it. Do not take two doses of Stiglatra on the same day.

Special patient groups

Impaired renal function

It is recommended to evaluate renal function before starting therapy with Stiglatra and periodically during treatment. Patients with eGFR less than 60 ml/min/1.73 m2 or creatinine clearance less than 60 ml/min are not recommended to start therapy with Stiglatra.

Stiglatra should be discontinued if eGFR is consistently less than 45 ml / min/1.73 m2 or creatinine clearance is consistently less than 45 ml / min.

Stiglatra should not be used in patients with severe renal impairment, end-stage renal failure (ESRD), or in patients undergoing dialysis, as the drug is expected to be ineffective in these patients.

Liver failure

No dose adjustment is required for patients with mild or moderate hepatic insufficiency. The use of ertugliflozin has not been studied in patients with severe hepatic insufficiency and is not recommended in this group of patients.

Elderly patients P-65 years)

There is no need to adjust the dose of ertugliflozin according to age. Renal function and the risk of BCC reduction should be taken into account. Experience with Stiglatra in patients aged 75 years is limited.

Children

The safety and efficacy of ertugliflozin in children under 18 years of age have not been studied. No data available.

Overdose

No evidence of ertugliflozin toxicity was observed in healthy volunteers when administered orally in single doses up to 300 mg and multiple doses up to 100 mg daily for 2 weeks. No potential acute symptoms or signs of overdose were identified.

In case of overdose, the usual supportive measures should be applied (for example, remove unabsorbed substance from the gastrointestinal tract, conduct clinical monitoring and prescribe maintenance treatment) based on the patient’s clinical condition. Removal of ertugliflozin by hemodialysis has not been studied.

Description

Pink biconvex tablets of triangular shape, film-coated, engraved “701” on one side, smooth on the other side.

Special instructions

Hypotension/reduction O. UK

Ertugliflozin causes osmotic diuresis, which can lead to a reduction in intravascular volume. In this regard, symptomatic hypotension may occur after starting Stiglatra, especially in patients with impaired

renal function (eGFR m, en -. bO-msmin/1.73 m2 or clearance creatinine is less than 60 ml/min), elderly patients ( 65 years), patients taking diuretics or in patients receiving antihypertensive therapy with a history of hypotension. Before starting therapy with Stiglatra, it is necessary to assess the condition of the BCC and, if necessary, correct it. Signs and symptoms should be monitored after starting therapy.

By virtue of its mechanism of action, ertugliflozin induces osmotic diuresis, increases serum creatinine concentration, and reduces eGFR. An increase in serum creatinine and a decrease in eGFR were more pronounced in patients with mild to moderate renal impairment.

In the presence of conditions that can lead to fluid loss (for example, in the presence of gastrointestinal diseases), it is recommended to carefully monitor the BCC status and electrolyte concentrations in patients receiving ertugliflozin (for example, conduct a physical examination, measure blood pressure, perform laboratory diagnostics, including hematocrit determination). Consideration should be given to temporarily discontinuing ertugliflozin therapy until fluid loss is corrected.

Diabetic ketoacidosis (DKA)

Rare cases of DKA, including life-threatening and fatal cases, have been reported in clinical trials and in the post-marketing period in patients treated with NGLT2 inhibitors. Cases of DKA have been reported in clinical trials using ertugliflozin. In some cases, atypical development of the condition was observed with only moderately elevated blood glucose concentrations (below 14 mmol / l (250 mg / dl)).

It is not known whether DKA may occur more frequently with higher doses of ertugliflozin.

The risk of developing diabetic ketoacidosis should be evaluated if there are non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or drowsiness. If these symptoms are present, patients should be immediately evaluated for ketoacidosis, regardless of their blood glucose concentration.

In patients with suspected or diagnosed DKA, treatment with ertugliflozin should be discontinued immediately.

Treatment of patients who are hospitalized for extensive surgical procedures or for serious acute illnesses should be interrupted. In both cases, treatment with ertugliflozin can be resumed after the patient’s condition has stabilized.

Before starting therapy with ertugliflozin, you should consider factors in the patient’s history that may predispose to ketoacidosis.

Patients at increased risk of developing DKA include patients with a low functional reserve of beta cells (for example, patients with type 2 diabetes with a low concentration of C-peptide or latent adult autoimmune diabetes (LADA) or patients with a history of pancreatitis), patients with conditions that lead to food restriction or severe dehydration, patients who have reduced insulin doses and patients who require an increase in insulin doses due to acute diseases, surgery or abuse alcohol.

In this category of patients, NGLT2 inhibitors should be used with caution.

Resumption of therapy with an NGLT2 inhibitor in patients with a history of DKA on the background of NGLT2 therapy is not recommended, except in cases where another provoking factor is clearly established and eliminated.

The safety and efficacy of ertugliflozin in patients with type 1 diabetes mellitus has not been established, and ertugliflozin should not be used for the treatment of patients with type 1 diabetes mellitus. Limited data from clinical studies suggest that DKA occurs frequently during treatment with NGLT2 inhibitors in patients with type 1 diabetes mellitus.

USPA!Sh!AI of the lower extremities

In long-term clinical trials with another NGLT2 inhibitor, an increase in amputations of the lower extremities (mainly toes) was observed. It is not known whether this is a class effect.As with all patients with diabetes mellitus, it is important for patients receiving ertugliflozin therapy to make recommendations on regular preventive foot care.

Impaired renal function

Since the efficacy of ertugliflozin depends on renal function, efficacy is reduced in patients with moderate renal impairment and probably absent in patients with severe renal impairment.

Medication  Stiglatra should not be initiated in patients with eGFR below 60 ml / min/1.73 m2 or creatinine clearance below 60 ml/min. Stiglatra should be discontinued if eGFR is consistently less than 45 ml / min/1.73 m2 or creatinine clearance is consistently less than 45 ml / min, due to reduced efficacy.

It is recommended to monitor renal function as follows:

Prior to ertugliflozin and periodically during treatment;

More often in patients with eGFR below 60 ml / min/1.73 m2 or creatinine clearance below 60 ml / min.

Hypoglycemia when used concomitantly with insulin or insulin secretagogues

Ertugliflozin may increase the risk of hypoglycemia when used in combination with insulin and / or the insulin secretagogue, which may cause hypoglycemia. Therefore, it may be necessary to reduce the dose of insulin or insulin secretagogue to minimize the risk of hypoglycemia when used in combination with ertugliflozin.

Fungal infections of the genitals

Ertugliflozin increases the risk of fungal infections of the genitals. In studies using NGLT2 inhibitors, fungal infections of the genitals were more likely to develop in patients with a history of fungal infections of the genitals and in uncircumcised men. Patients should be carefully monitored and treated accordingly.

Urinary tract infections

Elimination of glucose by the kidneys may be associated with an increased risk of urinary tract infections. The incidence of urinary tract infections did not significantly differ in the ertugliflozin 5 mg and 15 mg groups (4.0% and 4.1%) and in the placebo group (3.9%). In most cases, the infections were mild to moderate in severity, but there were no reports of severe cases. During the treatment of pyelonephritis or urosepsis, the possibility of temporarily stopping the use of ertugliflozin should be considered.

Elderly patients

Elderly patients may have an increased risk of BCC reduction. In patients aged 65 years and older who received ertugliflozin therapy, the incidence of adverse reactions associated with a decrease in BCC was higher compared to younger patients. It is expected that the effectiveness of ertugliflozin in elderly patients with impaired renal function is reduced.

Heart failure

There is limited experience of use in patients with Class I-II heart failure according to the New York Heart Association (NUNA) classification; there is no experience of use in clinical trials for class III-IV heart failure according to the NUNA classification.

Laboratory tests of urine

In accordance with the mechanism of action of the drug, the result of a urine test for the presence of glucose in the urine of patients taking Stiglatra will be positive. Alternative methods should be used to monitor glycemic control. Effect on the analysis for the content of 1,5-anhydroglucitol (1,5-AH)

Monitoring of glycemic control using an l,5-AH assay is not recommended, as measuring 1.5-AH is not a reliable way to assess glycemic control in patients taking NGLT2 inhibitors. Alternative methods should be used to monitor glycemic control.

IMPACT ON THE ABILITY TO DRIVE VEHICLESMEANS AND MECHANISMS

Ertugliflozin does not affect the ability to drive vehicles and work with mechanisms, or has a slight effect. Patients should be warned about the risk of hypoglycemia when using Stiglatra in combination with insulin or insulin secretagogue and about the increased risk of adverse reactions associated with a decrease in BCC, such as postural vertigo.

Form of production

Film-coated tablets,5 mg,15 mg.

7 tablets in a blister of Al / PVC / oPA/Al. 4 blisters together with the instructions for use in a cardboard pack.

1 O tablets in a blister of Al / PVC / oPA/ Al. 3 blisters together with instructions for use in a cardboard pack.

In order to control the first opening, stickers are pasted on the cardboard pack.

Storage conditions

Store at a temperature not exceeding 30 °C in the original packaging (in a blister). Keep out of reach of children.

Shelf

life is 2 years. Do not use after the expiration date.

Active ingredient

Ertugliflozin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets