Toujeo SoloStar solution for subcutaneous injection 300IU 1.5 ml syringe-pen, 5 pcs.

Composition

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1 ml of the solution contains:

Active ingredient:

insulin glargine 300 U (10.91 mg);

excipients:

metacresol (m-cresol) – 2.70 mg,

zinc chloride-0.19 mg (corresponds to 0.09 mg of zinc), glycerol (85%) – 20 mg,

sodium hydroxide-up to pH 4.0,

hydrochloric acid – up to pH 4.0,

water for injection – up to 1.0 ml

. Pharmacological action

Hypoglycemic agent – long-acting insulin analog

Indications

Diabetes mellitus in adults requiring insulin treatment.

Contraindications

• hypersensitivity to insulin glargine or any of the excipients of the drug;
• age up to 18 years (due to the lack of clinical data confirming the effectiveness and safety of the drug in children and adolescents).

Side effects

The following adverse reactions (HP) were observed during clinical trials conducted with Toujeo SoloStar® and during clinical administration of insulin glargine 100 U / ml.

These data are presented by organ system (according to the classification of the Medical Dictionary of Regulatory Activities (MedDRA)) in accordance with the following frequency gradations recommended by the World Health Organization (WHO):: very often (≥ 10%); often (≥ 1%; < 10%); infrequently (≥ 0,1%; < 1%); rarely (≥0,01%; <0,1%); very rare (

Metabolic and nutritional disorders

Hypoglycemia

Hypoglycemia, the most common adverse reaction with insulin therapy, can occur if the dose of insulin is too high compared to the need for it.

As with other insulins, episodes of severe hypoglycemia, especially recurrent ones, can lead to neurological disorders. Episodes of prolonged and severe hypoglycemia can be life-threatening.

In many patients, signs and symptoms of neuroglycopenia (fatigue, inadequate fatigue or weakness, decreased ability to concentrate, drowsiness, visual disturbances, headache, nausea, confusion or loss of consciousness, convulsive syndrome) are preceded by signs of adrenergic counterregulation (activation of the sympatho-adrenal system in response to hypoglycemia). : hunger, irritability, nervous excitement or tremor, restlessness, pallor of the skin, “cold” sweat, tachycardia, palpitations. Usually, the faster hypoglycemia develops, and the more severe it is, the more pronounced the symptoms of adrenergic counterregulation.

Visual disturbances A

significant improvement in glycemic control can cause temporary visual impairment due to a temporary violation of the turgor and refractive index of the lens of the eye.

Long-term improvement in glycemic control reduces the risk of diabetic retinopathy progression. However, as with any insulin regimen, the intensification of insulin therapy with a sharp improvement in glycemic control may be associated with a temporary aggravation of the course of diabetic retinopathy.

In patients with proliferative retinopathy, especially those who do not receive photocoagulation treatment, episodes of severe hypoglycemia can lead to temporary vision loss.

Skin and subcutaneous tissue disorders

As with any other insulin medication, lipodystrophy may develop at the injection site, which can slow down local insulin absorption. When using insulin therapy regimens including insulin glargine, lipodystrophy was observed in 1-2% of patients, and lipoatrophy was observed infrequently. A constant change of injection sites within the areas of the body recommended for subcutaneous administration of insulin may help to reduce the severity of this reaction or prevent its development.

Musculoskeletal and connective tissue disorders

Very rare: myalgia.

General disorders and disorders at the injection site

Local allergic reactions at the injection site

As with any insulin therapy, these reactions include skin redness, pain, itching, hives, rash, swelling, and inflammation. In clinical trials conducted with Toujeo SoloStar® in adult patients, the frequency of all injection site reactions in patients treated with Toujeo SoloStar® (2.5%) was similar to that in patients treated with insulin glargine 100 U/ml (2.8%). Most minor reactions at the insulin injection site usually resolve within a few days or a few weeks.

Immune system disorders

Systemic allergic reactions

Immediate-type allergic reactions to insulin are rare. Such reactions to insulin (including insulin glargine) or excipients may, for example, be accompanied by generalized skin reactions, angioedema( angioedema), bronchospasm, decreased blood pressure and shock, and may be life-threatening to the patient.

Other reactions

The use of insulin can cause the formation of antibodies to it. In clinical trials comparing Toujeo SoloStar and insulin glargine 100 U / ml, the formation of antibodies to insulin in both treatment groups was observed with the same frequency.

As with other insulins, in rare cases, the presence of such insulin antibodies may require a change in the dose of insulin in order to eliminate the tendency to develop hypoglycemia or hyperglycemia.

In rare cases, insulin can cause sodium retention and edema, especially if previously insufficient metabolic control is improved with the intensification of insulin therapy.

Children

The safety profile for children and adolescents under 18 years of age is currently not set.

Interaction

A number of drugs affect glucose metabolism, so that when they are used simultaneously with insulins, it may be necessary to adjust the dose of insulin and especially careful monitoring.

Medications that may increase the hypoglycemic effect of insulin and the tendency to develop hypoglycemia

Oral hypoglycemic agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, disopyramide; fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, sulfonamide antibiotics.

Concomitant administration of these medications with insulin glargine may require adjustment of the insulin dose.

Medications that may weaken the hypoglycemic effect of insulin

Glucocorticosteroids, danazol, diazoxide, diuretics, sympathomimetics (such as epinephrine, salbutamol, terbutaline); glucagon, isoniazid, phenothiazine derivatives, somatotropic hormone, thyroid hormones, estrogens and progestins (for example, in hormonal contraceptives), protease inhibitors and atypical neuroleptics (for example, olanzapine and clozapine).

Concomitant administration of these medications with insulin glargine may require adjustment of the insulin dose.

Beta-blockers, clonidine, lithium salts, and ethanol can both enhance and weaken the hypoglycemic effect of insulin. Pentamidine in combination with insulin can cause hypoglycemia, which sometimes gives way to hyperglycemia.

Sympatholytic drugs-under the influence of sympathomimetic agents, such as beta-blockers, clonidine, guanethidine and reserpine, signs of adrenergic counterregulation (activation of the sympathetic nervous system in response to the development of hypoglycemia) may decrease or be absent.

Interaction with pioglitazone

When using pioglitazone in combination with insulin, cases of heart failure have been reported, especially in patients at risk of developing heart failure (see the section “Special instructions”). If cardiac symptoms develop or become more severe, the use of pioglitazone should be discontinued.

How to take, course of administration and dosage

Units of the drug Toujeo SoloStar® (insulin glargine 300 U/ml) refer only to the drug Toujeo SoloStar and are not equivalent to other units that express the strength of other insulin analogues. Toujeo SoloStar should be administered subcutaneously once a day at any time of the day, preferably at the same time. The drug Toujeo SoloStar with a single injection during the day allows you to have a flexible schedule of injections: if necessary, patients can inject for 3 hours before or 3 hours after the usual time for them.

Monitoring of blood glucose levels is recommended in all patients with diabetes mellitus.

The beginning of the use of the drug Toujeo SoloStar:

• Patients with type 1 diabetes mellitus. The drug Toujeo SoloStar should be used once a day in combination with insulin administered during meals, and requires individual dose adjustment.
• Patients with type 2 diabetes mellitus. The recommended initial dose is 0.2 U / kg once a day, followed by individual dose adjustment.

Switching from insulin glargine 100 U / ml to Toujeo SoloStar and, conversely, from Toujeo SoloStar® to insulin glargine 100 U / ml

Insulin glargine 100 U / ml and Toujeo SoloStar are non-bioequivalent and not directly interchangeable.

• Switching from insulin glargine 100 U / ml to Toujeo SoloStar can be performed on a unit-by-unit basis, but a higher dose of Toujeo SoloStar may be required to reach the target range of plasma glucose concentrations.
• When switching from Toujeo SoloStar to insulin glargine 100 U / ml to reduce the risk of hypoglycemia, the dose should be reduced (by approximately 20%), followed by dose adjustment if necessary.

Careful metabolic monitoring is recommended during and during the first few weeks after switching from one of these drugs to another.

Switching from other basal insulins to Toujeo SoloStar

When switching from the treatment regimen with intermediate and long-acting insulins to the treatment regimen with Toujeo SoloStar, it may be necessary to change the dose of basal insulin and adjust the simultaneous hypoglycemic therapy (changing the doses and time of administration of short-acting insulins or fast-acting insulin analogues, or doses of non-insulin hypoglycemic drugs).

• Switching from a single daily administration of basal insulins to a single daily administration of the drug Toujeo SoloStar can be carried out at the rate of one unit per unit of the previously administered dose of basal insulin.
• When switching from twice daily administration of basal insulins to a single dose of Toujeo SoloStar, the recommended initial dose of Toujeo SoloStar is 80% of the total daily dose of basal insulin that is discontinued. Patients with high doses of insulin, due to the presence of antibodies to human insulin, may have an improved response to the drug Toujeo SoloStar.

Careful metabolic monitoring is recommended during the transition to the drug Toujeo SoloStar and for several weeks after it.

Overdose

Symptoms

An overdose of insulin (an excess of insulin relative to food intake, energy consumption, or both) can lead to severe and sometimes long-term and life-threatening hypoglycemia.

Treatment

Moderate episodes of hypoglycemia are usually relieved by ingesting fast-digesting carbohydrates. It may be necessary to change the dosage regimen of the drug, the diet or physical activity.

Episodes of more severe hypoglycemia, such as coma, seizures, or neurological disorders, can be relieved by intramuscular or subcutaneous administration of glucagon or intravenous administration of a concentrated dextrose (glucose) solution. Long-term carbohydrate intake and specialist supervision may be required, as after a visible clinical improvement, a recurrence of hypoglycemia is possible.

Special instructions

Patients should have self-monitoring skills for diabetes mellitus, including monitoring blood glucose concentrations, as well as adhere to the correct technique of subcutaneous injections and be able to stop the development of hypoglycemia and hyperglycemia. Insulin therapy requires constant vigilance against the possibility of developing hyperglycemia or hypoglycemia.

In case of insufficient control of blood glucose concentration, as well as if there is a tendency to develop hypo – or hyperglycemia, before starting to adjust the dosage regimen, it is necessary to check the accuracy of the prescribed treatment regimen, compliance with the instructions regarding the drug administration sites, the correct technique for subcutaneous injections and handling the SoloStar syringe pen, as well as the possibility of all other factors that can cause this condition.

Form of production

Solution for subcutaneous administration,300 U / ml. 1.5 ml of the drug in a colorless glass cartridge. The cartridge is mounted in a disposable SoloStar pen.

Active ingredient

Insulin glargine

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Purpose

For pregnant women as prescribed by a doctor, For adults as prescribed by a doctor, For nursing mothers as prescribed by a doctor, For Children as prescribed by a doctor

Indications

Type 1 Diabetes, Type 2 Diabetes

Weight

Weight: 200 gr.