Ongliza, 30 pcs., 5 mg, film-coated tablets

What is Ongliza intended for?

Type 2 diabetes is characterized by reduced sensitivity of pancreatic cells to glucose and a delay in the first phase of insulin synthesis (in response to carbohydrate foods). As the duration of the disease increases, the second phase of hormone production is gradually lost. It is believed that the primary cause of poor functioning of the beta cells that produce insulin is a lack of incretins. These are peptides that stimulate hormone secretion; they are produced in response to the influx of glucose into the blood.

Onglyza delays the action of the DPP-4 enzyme, which is necessary for the breakdown of incretins. As a result, they remain in the blood longer, which means that insulin is produced in greater quantities than usual. This effect helps to correct glycemia both on an empty stomach and after meals, bringing the impaired functioning of the pancreas closer to physiological. After administration of Onglyza, glycated hemoglobin in patients decreases by 1.7%.

The action of Onglyza is based on prolonging the work of its own hormones; the drug increases their concentration in the blood by less than 2 times. As soon as glycemia approaches normal, incretins stop influencing insulin synthesis. In this regard, there is practically no danger of hypoglycemia in diabetics taking the drug. Also, the undoubted advantage of Ongliza is its lack of effect on weight and the possibility of taking it with other glucose-lowering tablets.

In addition to the main effect, Ongliza has other positive effects on the body:

1. The drug reduces the rate of glucose flow from the intestines into the blood, thereby helping to reduce insulin resistance and sugar after meals in diabetes.
2. Participates in the regulation of eating behavior. According to patient reviews, Ongliza accelerates the feeling of satiety, which is especially important for obese diabetics.
3. Unlike sulfonylureas, which also increase insulin synthesis, Onglyza does not pose a risk to beta cells. Studies have revealed that it not only does not destroy pancreatic cells, but, on the contrary, protects and even increases their number.

Interaction with other drugs

Basic therapy is metformin with the need for lifestyle changes. If such treatment does not produce the expected effect, additional approved drugs are introduced.

Studies have been conducted showing that there is a relatively small risk of combining saxagliptin and other drugs.

Combined use with inducers of CYP 3A4/5 isoenzymes helps to reduce the content of saxagliptin metabolic products.

Taking sulfonylurea derivatives significantly reduces blood glucose concentrations. To avoid this risk, it is necessary to reduce the dose of Onglyza.

Studies regarding the effects of smoking, diet, and alcohol consumption on treatment with saxagliptin have not been conducted.

Composition and release form

The drug is manufactured in the USA by the Anglo-Swedish company AstraZeneca. The finished tablets can be packaged in Italy or the UK. The package contains 3 perforated blisters of 10 tablets each and instructions for use.

The active ingredient of the drug is saxagliptin. This is the newest DPP-4 inhibitor currently in use; it entered the market in 2009. Lactose, cellulose, magnesium stearate, croscarmellose sodium, and dyes are used as auxiliary components.

Ongliza has 2 dosages - 2.5; 5 mg. Tablets 2.5 mg are yellow in color; you can distinguish the original medicine by the inscriptions 2.5 and 4214 on each side of the tablet. Ongliza 5 mg is colored pink and marked with the numbers 5 and 4215.

The drug must be sold with a prescription, but this condition is not met in all pharmacies. The price for Ongliza is quite high - about 1900 rubles. per pack. In 2015, saxagliptin was included in the list of vital and essential drugs, so registered diabetics can try to get these tablets for free. Ongliza does not yet have generics, so they must issue the original drug.

How to use

Ongliza is prescribed for type 2 diabetes. Treatment must necessarily include diet and exercise. Do not forget that the drug acts very gently. With uncontrolled consumption of carbohydrates and a passive lifestyle, it is not able to provide the required compensation for diabetes mellitus.

The bioavailability of saxagliptin is 75%, the maximum concentration of the substance in the blood is observed after 150 minutes. The effect of the drug lasts at least 24 hours, so it is not necessary to take it with food. The tablets are film-coated and cannot be broken or crushed.

The recommended daily dosage is 5 mg. For elderly patients with mild renal and hepatic insufficiency, no dose adjustment is required.

A lower dose (2.5 mg) is rarely prescribed:

• in renal failure with GFR<50. If you suspect kidney disease, it is recommended to undergo a kidney function test;
• temporarily, if necessary, take certain antibiotics, antiviral, antifungal agents, a complete list of them is indicated in the instructions.

Expert opinion

Arkady Alexandrovich

Experienced Endocrinologist Specialist

If a diabetic misses a pill, it can be taken throughout the day. Doubling the dose the next day is prohibited by the instructions. An overdose does not improve diabetes control, but does not pose a serious danger. No toxic effect was detected even with a single dose of 400 mg of saxagliptin.

Instructions:

Clinical and pharmacological group

15.014 (Oral hypoglycemic drug)

Release form, composition and packaging

Pale yellow to light yellow film-coated tablets, round, biconvex, marked “2.5” on one side and “4214” on the other side, printed with blue dye.

Excipients: lactose monohydrate 99 mg*, microcrystalline cellulose 90 mg, croscarmellose sodium 10 mg, magnesium stearate 1 mg**, hydrochloric acid 1 M or sodium hydroxide solution 1 M - required amount, Opadry II white (% w/w) 26 mg (polyvinyl alcohol 40%, titanium dioxide 25%, macrogol (PEG 3350) 20.2%, talc 14.8%), Opadry II yellow (% w/w) 7 mg (polyvinyl alcohol 40%, titanium dioxide 24.25%, macrogol (PEG) 3350) 20.2%, talc 14.8%, yellow iron oxide dye (E172) 0.75%), Opacode blue ink*** - required amount.

10 pieces. - blisters made of aluminum foil (3) - cardboard packs.

Pink film-coated tablets, round, biconvex, with the inscriptions “5” on one side and “4215” on the other side, printed with blue dye.

Excipients: lactose monohydrate 99 mg*, microcrystalline cellulose 90 mg, croscarmellose sodium 10 mg, magnesium stearate 1 mg**, hydrochloric acid 1 M or sodium hydroxide solution 1 M - required amount, Opadry II white (% w/w) 26 mg (polyvinyl alcohol 40%, titanium dioxide 25%, macrogol (PEG 3350) 20.2%, talc 14.8%), Opadry II pink (% w/w) 7 mg (polyvinyl alcohol 40%, titanium dioxide 24.25%, macrogol (PEG) 3350) 20.2%, talc 14.8%, red iron oxide dye (E172) 0.75%), Opacode blue ink*** - required amount.

10 pieces. - blisters made of aluminum foil (3) - cardboard packs.

* - The amount of lactose may vary depending on the amount of magnesium stearate used. ** - The amount of magnesium stearate can vary between 0.5-2 mg. The optimal amount is 1 mg.*** — Composition of Opacode blue ink (% w/w): shellac 45% in ethyl alcohol 55.4%, FD&C Blue #2/indigo carmine aluminum pigment (E132) 16%, n-butyl alcohol 15%, propylene glycol 10.5%, isopropyl alcohol 3%, 28% ammonium hydroxide 0.1%. Very small amounts of shellac and FD&C Blue #2/Indigo Carmine Aluminum pigment remain on the tablets during marking. The solvents contained in the ink are removed during the manufacturing process.

pharmachologic effect

Saxagliptin is a potent selective reversible competitive inhibitor of dipeptidyl peptidase-4 (DPP-4).

In patients with type 2 diabetes mellitus, taking saxagliptin leads to suppression of the activity of the DPP-4 enzyme within 24 hours. After oral glucose administration, inhibition of DPP-4 leads to a 2-3 fold increase in the concentration of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), a decrease in the concentration of glucagon and an increase in the glucose-dependent response of beta cells, which leads to an increase in the concentration of insulin and C-peptide.

Release of insulin from pancreatic beta cells and decreased release of glucagon from pancreatic alpha cells results in decreased fasting and postprandial glycemia.

The effectiveness and safety of saxagliptin when taken in doses of 2.5 mg, 5 mg and 10 mg 1 time / day were studied in six double-blind, placebo-controlled studies involving 4148 patients with type 2 diabetes mellitus. Taking the drug was accompanied by a statistically significant improvement in glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) compared to the control.

Patients in whom the target glycemic level could not be achieved while taking saxagliptin as monotherapy were additionally prescribed metformin, glibenclamide or thiazolidinediones. When taking saxagliptin at a dose of 5 mg, a decrease in HbA1c was noted after 4 weeks and FPG after 2 weeks. In the group of patients receiving saxagliptin in combination with metformin, glibenclamide or thiazolidinediones, a decrease in HbA1c was also observed after 4 weeks and FPG after 2 weeks.

The effect of saxagliptin on the lipid profile was similar to that of placebo. No weight gain was observed during saxagliptin therapy.

Pharmacokinetics

In patients with type 2 diabetes mellitus and in healthy volunteers, similar parameters of the pharmacokinetics of saxagliptin and its main metabolite were noted.

Saxagliptin is rapidly absorbed after oral administration on an empty stomach, with Cmax of saxagliptin and the major metabolite in plasma achieved within 2 hours and 4 hours, respectively. As the dose of saxagliptin was increased, a proportional increase in the Cmax and AUC of saxagliptin and its main metabolite was observed. After a single 5 mg oral dose of saxagliptin to healthy volunteers, the mean AUC values ​​of saxagliptin and its major metabolite were 78 ng x h/ml and 214 ng x h/ml, and plasma Cmax values ​​were 24 ng/ml and 47 ng/ml, respectively. .

The mean terminal half-life of saxagliptin and its major metabolite was 2.5 hours and 3.1 hours, respectively, and the mean plasma DPP-4 inhibition T1/2 was 26.9 hours. Inhibition of plasma DPP-4 activity for at least 24 hours after taking saxagliptin is due to its high affinity for DPP-4 and long-term binding to it. No noticeable accumulation of saxagliptin and its main metabolite was observed during long-term administration of the drug once a day. There was no dependence of the clearance of saxagliptin and its main metabolite on the drug dose and duration of therapy when taking saxagliptin once a day in doses from 2.5 mg to 400 mg for 14 days.

Suction

After oral administration, at least 75% of the administered dose of saxagliptin is absorbed. Food intake did not have a significant effect on the pharmacokinetics of saxagliptin in healthy volunteers. A high-fat meal had no effect on saxagliptin Cmax, whereas AUC increased by 27% compared to fasting. The time to reach Cmax for saxagliptin increased by approximately 0.5 hours when taking the drug with food compared to taking it on an empty stomach. However, these changes are not clinically significant.

Distribution

The binding of saxagliptin and its main metabolite to serum proteins is insignificant, so it can be assumed that the distribution of saxagliptin will not be subject to significant changes due to changes in the protein composition of the blood serum, observed in liver or renal failure.

Metabolism

Saxagliptin is metabolized mainly with the participation of cytochrome P450 3A4/5 isoenzymes (CYP 3A4/5) with the formation of an active main metabolite, the inhibitory effect of which on DPP-4 is 2 times less pronounced than that of saxagliptin.

Removal

Saxagliptin is excreted in urine and bile. After a single dose of 50 mg of 14C-labeled saxagliptin, 24% of the dose was excreted by the kidneys as unchanged saxagliptin and 36% as the main metabolite of saxagliptin. The total radioactivity detected in the urine corresponded to 75% of the dose taken. The mean renal clearance of saxagliptin was approximately 230 ml/min, and the mean glomerular filtration rate was approximately 120 ml/min. For the main metabolite, renal clearance was comparable to mean glomerular filtration values.

About 22% of the total radioactivity was found in feces.

Pharmacokinetics in special clinical situations

In patients with mild renal failure, the AUC values ​​of saxagliptin and its main metabolite were 1.2 and 1.7 times higher, respectively, than those in individuals with normal renal function. This increase in AUC values ​​is not clinically significant and therefore no dose adjustment is required.

In patients with moderate to severe renal impairment, as well as in patients on hemodialysis, the AUC values ​​of saxagliptin and its main metabolite were 2.1 and 4.5 times higher, respectively, than those in individuals with normal renal function. For patients with moderate to severe renal impairment, as well as for patients on hemodialysis, the dose of saxagliptin should be 2.5 mg 1 time / day.

In patients with mild, moderate and severe hepatic impairment, no clinically significant changes in the pharmacokinetic parameters of saxagliptin were detected, therefore no dose adjustment is required for such patients.

In patients aged 65-80 years, there were no clinically significant differences in the pharmacokinetic parameters of saxagliptin compared to younger patients (18-40 years), so no dose adjustment is required in elderly patients. However, it should be borne in mind that this category of patients is more likely to have a decrease in renal function.

Dosage

The drug is prescribed orally, regardless of food intake.

For monotherapy, the recommended dose of saxagliptin is 5 mg 1 time / day.

In combination therapy, the recommended dose of saxagliptin is 5 mg 1 time / day in combination with metformin, thiazolidinediones or sulfonylurea derivatives.

When starting combination therapy with metformin, the recommended dose of saxagliptin is 5 mg 1 time / day, the initial dose of metformin is 500 mg / day. In case of inadequate response, the dose of metformin may be increased.

If you miss taking Ongliza®, the missed tablet should be taken as soon as the patient remembers, but you should not take a double dose of the drug within one day.

For patients with mild renal failure (creatinine clearance >50 ml/min), no dose adjustment is required. For patients with moderate or severe renal failure (creatinine clearance ≤50 ml/min), as well as for patients on hemodialysis, the recommended dose of Ongliza® is 2.5 mg 1 time / day. The drug should be taken at the end of the hemodialysis session. The use of saxagliptin in patients undergoing peritoneal dialysis has not been studied. It is recommended that renal function be assessed before initiating saxagliptin therapy and during treatment.

For mild, moderate and severe liver dysfunction, no dose adjustment is required.

No dose adjustment is required in elderly patients. However, when choosing a dose, it should be taken into account that in this category of patients a decrease in renal function is more likely.

The safety and effectiveness of the drug in patients under 18 years of age have not been studied.

When used concomitantly with strong CYP 3A4/5 inhibitors, such as ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir and telithromycin, the recommended dose of Onglyza® is 2.5 mg 1 time / day.

Overdose

Symptoms of intoxication are not described with long-term use of the drug in doses up to 80 times higher than recommended.

Treatment: in case of overdose, symptomatic therapy should be used. Saxagliptin and its main metabolite are eliminated from the body by hemodialysis (removal rate: 23% of the dose in 4 hours).

Drug interactions

Analysis of data from clinical studies suggests that the risk of clinically significant interactions between saxagliptin and other drugs when used together is low.

The metabolism of saxagliptin is predominantly mediated by the cytochrome P450 3A4/5 isoenzyme system (CYP3A4/5). In vitro studies have shown that saxagliptin and its main metabolite do not inhibit CYP isoenzymes 1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1 and 3A4 and do not induce CYP isoenzymes 1A2, 2B6, 2C9, and 3A4. In studies involving healthy volunteers, the pharmacokinetic parameters of saxagliptin and its main metabolite were not significantly changed by metformin, glibenclamide, pioglitazone, digoxin, simvastatin, diltiazem, ketoconazole, omeprazole, a combination of aluminum hydroxide, magnesium hydroxide and simethicone, as well as famotidine. Saxagliptin does not significantly change the pharmacokinetic parameters of metformin, glibenclamide, pioglitazone, digoxin, simvastatin, diltiazem or ketoconazole.

The effect of inducers of CYP 3A4/5 isoenzymes on the pharmacokinetics of saxagliptin has not been studied. However, the combined use of saxagliptin and inducers of CYP 3A4/5 isoenzymes, such as carbamazepine, dexamethasone, phenobarbital, phenytoin and rifampicin, may lead to a decrease in the concentration of saxagliptin in plasma and an increase in the concentration of its main metabolite.

The effects of smoking, dietary intake, herbal preparations and alcohol consumption on saxagliptin therapy have not been studied.

Use during pregnancy and lactation

Due to the fact that the use of saxagliptin during pregnancy has not been studied, the drug should not be prescribed during this period.

It is not known whether saxagliptin passes into breast milk. Due to the fact that the possibility of saxagliptin passing into breast milk cannot be excluded, breastfeeding should be stopped during treatment with saxagliptin or therapy should be discontinued, taking into account the balance of risk for the child and benefit for the mother.

Side effects

The overall incidence of adverse events when taking Onglyza 5 mg alone and when added to therapy with metformin, thiazolidinedione or glibenclamide was comparable to that in the placebo group.

Adverse reaction frequency scale: very often (≥1/10); often (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000).

The table shows the side effects identified in patients with type 2 diabetes mellitus when taking Ongliza® at a dose of 5 mg during clinical studies. Side effects are presented based on a pooled analysis of five placebo-controlled clinical trials of Onglyza®.

The incidence of hypersensitivity reactions observed at week 24 of therapy was 1.5% in patients receiving Onglyza 5 mg and 0.4% in patients receiving placebo. Hypersensitivity reactions that occurred in patients taking Ongliza® did not require hospitalization and were assessed by the attending physicians as not life-threatening.

Side effects of Ongliza® in combination therapy

In a study of the combined use of saxagliptin and glibenclamide, the frequency of confirmed episodes of hypoglycemia in the saxagliptin 5 mg (0.8%) and placebo (0.7%) groups was not statistically different. The incidence of confirmed hypoglycemic episodes in patients receiving Onglyza 5 mg in two saxagliptin monotherapy studies, a saxagliptin and metformin combination study, and a saxagliptin and thiazolidinedione combination study was comparable to that observed with placebo.

In a study of saxagliptin with thiazolidinediones, the incidence of peripheral edema was higher in the saxagliptin 5 mg group compared with the placebo group (8.1% and 4.3%, respectively). Peripheral edema was mild or moderate and did not lead to discontinuation of treatment. The incidence of peripheral edema in patients treated with Onglyza 5 mg during clinical trials of saxagliptin monotherapy and combination therapy with metformin or glibenclamide was comparable to that observed with placebo (1.7% and 2.4%, respectively).

During initial combination therapy with saxagliptin 5 mg and metformin, cases of nasopharyngitis and headache were frequently reported. The incidence of nasopharyngitis was higher with combination therapy (6.9%) compared with monotherapy with saxagliptin 10 mg (4.2%) and metformin (4%). Headache was more common in the group of patients on combination therapy with metformin and saxagliptin 5 mg (7.5%) compared with the monotherapy groups with saxagliptin 10 mg (6.3%) and metformin (5.2%).

Laboratory studies: In clinical studies, the incidence of changes in laboratory parameters was comparable between saxagliptin 5 mg and placebo. There was a slight decrease in lymphocyte counts, but the mean absolute lymphocyte count remained stable and within the normal range when taking saxagliptin daily for up to 102 weeks. The decrease in the number of lymphocytes was not accompanied by clinically significant adverse reactions. The clinical significance of the decrease in lymphocyte counts during saxagliptin therapy is not known.

Storage conditions and periods

The drug should be stored out of the reach of children at a temperature not exceeding 30°C. Shelf life: 3 years.

Do not use after the expiration date stated on the package.

Indications

Type 2 diabetes mellitus in addition to diet and exercise to improve glycemic control as:

— monotherapy;

— initial combination therapy with metformin;

- addition to monotherapy with metformin, thiazolidinediones, sulfonylurea derivatives, in the absence of adequate glycemic control on this therapy.

Contraindications

- type 1 diabetes mellitus (use not studied);

- use in combination with insulin (not studied);

- diabetic ketoacidosis;

- congenital galactose intolerance, lactase deficiency and glucose-galactose malabsorption;

- pregnancy;

- lactation;

- age under 18 years (safety and effectiveness have not been studied);

- increased individual sensitivity to any component of the drug.

The drug should be prescribed with caution in cases of moderate to severe renal failure, in elderly patients, and also in combination with sulfonylurea derivatives.

special instructions

The use of Ongliza® in combination with insulin, as well as as part of triple therapy with metformin and thiazolidinediones or metformin and sulfonylurea derivatives, has not been studied.

Patients with impaired renal function

Dose adjustment is recommended for patients with moderate to severe renal impairment, as well as for patients on hemodialysis. Before starting therapy and periodically during treatment with the drug, it is recommended to evaluate renal function.

Use in combination with drugs that can cause hypoglycemia

Sulfonylureas may cause hypoglycemia; therefore, a reduction in the dose of sulfonylureas may be necessary to reduce the risk of hypoglycemia when used concomitantly with Onglyza.

Hypersensitivity reactions

The drug should not be prescribed to patients who have had serious hypersensitivity reactions when using other DPP-4 inhibitors.

Elderly patients

According to clinical studies, efficacy and safety rates in patients aged 65 years and older did not differ from those in younger patients. However, increased individual sensitivity to saxagliptin in some elderly patients cannot be excluded.

Saxagliptin and its main metabolite are partially eliminated by the kidneys, so it must be taken into account that elderly patients are more likely to have decreased renal function.

Ongliza® contains lactose. Patients with congenital galactose intolerance, lactase deficiency and glucose-galactose malabsorption should not take this drug.

Impact on the ability to drive vehicles and operate machinery

No studies have been conducted to study the effect of saxagliptin on the ability to drive vehicles and operate machinery.

Please note that saxagliptin may cause dizziness.

Use for renal impairment

For patients with mild renal failure (creatinine clearance >50 ml/min), no dose adjustment is required. For patients with moderate or severe renal failure (creatinine clearance <50 ml/min), as well as for patients on hemodialysis, the recommended dose of Ongliza® is 2.5 mg 1 time / day. The drug should be taken at the end of the hemodialysis session. The use of saxagliptin in patients on peritoneal dialysis has not been studied. It is recommended that renal function be assessed before initiating saxagliptin therapy and during treatment.

Use for liver dysfunction

For mild, moderate and severe liver dysfunction, no dose adjustment is required.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Contraindications for use and harm

Ongliza is not prescribed:

1. During pregnancy, lactation. The effect of the drug on fetal development and the possibility of penetration into milk have not yet been studied.
2. If the patient's age is less than 18 years. There are no safety data due to the lack of studies in children.
3. If hypersensitivity reactions to saxagliptin, other drugs from the same group, or auxiliary components of the tablet have previously occurred. According to the manufacturer, the risk of such reactions is 1.5%. All of them did not require placing the patient in a medical institution and were not life-threatening.
4. For lactose intolerance.
5. Patients who have completely stopped producing their own insulin (type 1 diabetes, pancreatic surgery).

The drug is temporarily replaced with insulin therapy for severe ketoacidosis, major operations and injuries.

Ongliza has a high level of security. This is one of the few antidiabetic drugs that has virtually no side effects. According to the results of the studies, the number of adverse reactions in patients on saxagliptin was the same as in the control group taking placebo. However, the instructions for use reflect all the problems that patients have encountered: respiratory and urinary tract infections, dizziness, diarrhea, vomiting, abdominal pain, rash, itching, fatigue.

Important information for patients with a history or high risk of heart failure, impaired renal function, including diabetic nephropathy: studies have shown that in these groups of diabetics, treatment with Onlyza increases the risk of hospitalization due to heart failure (by an average of 1%, from 3 to 4%). The FDA issued a warning in 2021, and the latest version of the label includes this information.

Features of application

At the initial stage of changes in kidney function, there is no need to change the dosage. For more severe disorders, hemodialysis, the recommended dose of Ongliza is 2.5 mg per day. The medication is recommended to be administered when the blood purification procedure is completed. Before starting treatment and during it, it is necessary to evaluate the condition of the kidneys.

The effect of Ongliza on the body during the intracorporeal method of blood purification has not been studied.

If there are changes in liver activity, regardless of severity, there is no need to adjust the single dose.

The effect of using Onglyza in diabetics over 65 years of age is similar to the effect in young patients. In old age, you need to take the usual daily dosage. It is important to remember that at this stage of development the functioning of the kidneys decreases; the active component is excreted in some quantity by them.

There is no data on the possible dangers and positive effects of Ongliza in people under 18 years of age.

The co-administration of Onglyse with insulin during treatment has not been studied. There is no data regarding the effect of the drug on driving vehicles and operating mechanized systems. You may feel dizzy after taking the medicine.

The effect of the active substance on the body of pregnant and lactating women has not been studied. There is no information whether the active substance is able to penetrate through the placenta to the fetus and into breast milk, so the medicine is not prescribed during this period. If you cannot avoid using Onglyza, stop breastfeeding while taking the medication. This takes into account the possible danger to the child and the likely positive effect for the mother.

Sulfonylurea derivatives significantly lower glucose levels. To avoid such pathology during combined treatment with Onglyza, it is necessary to reduce the dose of sulfonylurea or insulin.

If diabetics have a history of serious high-sensitivity reactions (including immediate allergic reactions and angioedema) do not use Ongliza while using other DPP-4 inhibitors. It is necessary to identify the probable causes of hypersensitivity and recommend alternative treatment (analogues of Onglyza).

There is information about manifestations of acute pancreatitis when using the drug. Patients should be informed about such reactions when prescribing Onglyza. If there is a possibility that the first signs of pancreatitis will appear, the medication should be discontinued.

The tablets contain lactose, so diabetics with genetic intolerance to galactose or lactase deficiency cannot take Ongliza.

Use with other medications

To prevent the numerous complications of diabetes in millions of patients, new drugs and treatment regimens are regularly introduced into clinical practice. Metformin + lifestyle changes are currently considered basic therapy. If this set is not enough, combination therapy is started: one of the approved drugs is added to the existing treatment.

Unfortunately, not all of them are safe and quite effective:

Ongliza is equal in effectiveness to the above drugs, and in terms of safety and minimum contraindications, it is significantly superior to them, so it is expected that it will be increasingly prescribed to patients.

The Russian Association of Endocrinologists has approved the use of DPP-4 inhibitors in combination with metformin for diabetes as the first line of treatment. Both of these drugs do not contribute to hypoglycemia, they act on the cause of high sugar from different sides: they affect both insulin resistance and beta cell dysfunction.

Research results: Ongliza reduces GG by an average of 1.7%, metformin - by 2%, their combination - by 2.5%.

To simplify the treatment regimen, the same manufacturer created Comboglise Prolong. The tablets contain 500 or 1000 mg extended-release metformin and 2.5 or 5 mg saxagliptin. The price of a monthly package is about 3,300 rubles. A complete analogue of the drug is the combination of Onglyza and Glucophage Long, it will cost a thousand rubles less.

If both medications at the maximum dosage do not provide the desired effect for diabetes mellitus, it is allowed to add sulfonylureas, glitazones, and insulin to the treatment regimen.

ONGLYZA: SIDE EFFECTS

The overall incidence of adverse events when taking Onglyza 5 mg alone and when added to therapy with metformin, thiazolidinedione or glibenclamide was comparable to that in the placebo group.

Adverse reaction frequency scale: very often (≥1/10); often (≥1/100,

The table shows the side effects identified in patients with type 2 diabetes mellitus when taking Ongliza® at a dose of 5 mg during clinical studies. Side effects are presented based on a pooled analysis of five placebo-controlled clinical trials of Onglyza®.

The incidence of hypersensitivity reactions observed at week 24 of therapy was 1.5% in patients receiving Onglyza 5 mg and 0.4% in patients receiving placebo. Hypersensitivity reactions that occurred in patients taking Ongliza® did not require hospitalization and were assessed by the attending physicians as not life-threatening.

Side effects of Ongliza® in combination therapy

In a study of the combined use of saxagliptin and glibenclamide, the frequency of confirmed episodes of hypoglycemia in the saxagliptin 5 mg (0.8%) and placebo (0.7%) groups was not statistically different. The incidence of confirmed hypoglycemic episodes in patients receiving Onglyza 5 mg in two saxagliptin monotherapy studies, a saxagliptin and metformin combination study, and a saxagliptin and thiazolidinedione combination study was comparable to that observed with placebo.

In a study of saxagliptin with thiazolidinediones, the incidence of peripheral edema was higher in the saxagliptin 5 mg group compared with the placebo group (8.1% and 4.3%, respectively). Peripheral edema was mild or moderate and did not lead to discontinuation of treatment. The incidence of peripheral edema in patients treated with Onglyza 5 mg during clinical trials of saxagliptin monotherapy and combination therapy with metformin or glibenclamide was comparable to that observed with placebo (1.7% and 2.4%, respectively).

During initial combination therapy with saxagliptin 5 mg and metformin, cases of nasopharyngitis and headache were frequently reported. The incidence of nasopharyngitis was higher with combination therapy (6.9%) compared with monotherapy with saxagliptin 10 mg (4.2%) and metformin (4%). Headache was more common in the group of patients on combination therapy with metformin and saxagliptin 5 mg (7.5%) compared with the monotherapy groups with saxagliptin 10 mg (6.3%) and metformin (5.2%).

Laboratory studies: In clinical studies, the incidence of changes in laboratory parameters was comparable between saxagliptin 5 mg and placebo. There was a slight decrease in lymphocyte counts, but the mean absolute lymphocyte count remained stable and within the normal range when taking saxagliptin daily for up to 102 weeks. The decrease in the number of lymphocytes was not accompanied by clinically significant adverse reactions. The clinical significance of the decrease in lymphocyte counts during saxagliptin therapy is not known.

Upper respiratory tract infections Common Urinary tract infections Common Gastroenteritis Common Sinusitis Common Vomiting Common Headache Common

Is it possible to replace it with something?

Now you can grow real royal roses right at home!
MORE >>

Ongliza is the only saxagliptin drug currently available. It is too early to talk about the emergence of inexpensive analogues, since new drugs are subject to patent protection that prohibits copying the original. In this way, the manufacturer is given the opportunity to recoup expensive research and stimulate further development of pharmaceuticals. You shouldn’t expect Ongliza to become cheaper just yet.

In Russian pharmacies, in addition to Ongliza, you can buy tablets from the same group, Galvus and Januvia. These drugs have a similar effect on diabetes mellitus; comparison in terms of safety and effectiveness did not reveal significant differences between them. According to reviews from diabetics, it is not possible to receive them for free in all regions, despite the fact that all of them are annually included in the list of Vital and Essential Drugs.

Buying these medications on your own will not be cheap:

You can order these tablets cheaper from online pharmacies. The largest of them offer the possibility of free self-pickup of the drug from pharmacies located near your home.

In 2021, the release of a combination drug with saxagliptin and dapagliflozin, called Qtern, was announced. It combines the advantages of some of the most modern drugs for diabetes - Forxiga and Onglyza. The new tablets have not yet been registered in Russia.