Lantus, Solostar 100 me/ml syringe pen 3 ml, 5 pcs.

Composition

Active ingredient: insulin glargine 100 U (3,6378 mg)

Auxiliary substances: metacresol (m-cresol) — 2.7 mg; zinc chloride-0.0626 mg (corresponding to 30 mcg of zinc); glycerol (85%) – 20 mg; sodium hydroxide-up to pH 4; hydrochloric acid – up to pH 4; water for injection – up to 1 ml

. Pharmacological action

Pharmacodynamics

Insulin glargine is an analog of human insulin obtained by recombination of DNA from Escherichia coli bacteria (strains K 12).

Insulin glargine is developed as an analog of human insulin, characterized by low solubility in a neutral medium. As a part of Lantus® SoloStar®, it is completely soluble, which is provided by the acidic reaction of the solution for injection (pH 4). After injection into the subcutaneous fat, the acidic reaction of the solution is neutralized, which leads to the formation of microprecipitates, from which small amounts of insulin glargine are constantly released, providing a predictable, smooth (without peaks) profile of the concentration—time curve, as well as a prolonged effect of the drug.

Insulin glargine is metabolized to two active metabolites M1 and M2 (see “Pharmacokinetics”).

Binding to insulin receptors: the kinetics of binding to specific insulin receptors in insulin glargine and its metabolites-M1 and M2-is very close to that of human insulin, and therefore insulin glargine is able to perform a biological effect similar to that of endogenous insulin.

The most important effect of insulin and its analogs, including insulin glargine, is the regulation of glucose metabolism. Insulin and its analogs reduce the concentration of glucose in the blood, stimulating the absorption of glucose by peripheral tissues (especially skeletal muscle and adipose tissue) and inhibiting the formation of glucose in the liver.

Insulin suppresses lipolysis in adipocytes and inhibits proteolysis, while increasing protein synthesis.

The prolonged effect of insulin glargine is directly related to the reduced rate of its absorption, which allows the drug to be used once a day. After subcutaneous administration, the onset of its action occurs on average in 1 h. The average duration of action is 24 hours, the maximum is 29 hours. The duration of action of insulin and its analogs, such as insulin glargine, can vary significantly between individuals or in the same person.

Lantus SoloStar was shown to be effective in children over 2 years of age with type 1 diabetes mellitus. Moreover, in children aged 2-6 years, the incidence of hypoglycemia with clinical manifestations when using insulin glargine was lower both during the day and at night compared to the use of insulin-isophane (respectively, an average of 25.5 episodes versus 33 episodes in one patient during one year). During a five-year follow-up of patients with type 2 diabetes mellitus, there were no significant differences in the progression of diabetic retinopathy when treated with insulin glargine compared with insulin-isophane.

Communication with insulin-like growth factor 1 (IGF-1) receptors: the affinity of insulin glargine for the IGF-1 receptor is approximately 5-8 times higher than that of human insulin (but approximately 70-80 times lower than that of IGF-1), while the affinity of insulin glargine metabolites M1 and M2 for the IGF-1 receptor is slightly lower than that of human insulin.

The total therapeutic concentration of insulin (insulin glargine and its metabolites) determined in patients with type 1 diabetes was significantly lower than the concentration required for semi-maximal binding to IGF-1 receptors and subsequent activation of the mitogenic-proliferative pathway triggered by IGF-1 receptors. Physiological concentrations of endogenous IGF-1 can activate the mitogenic-proliferative pathway; however, therapeutic insulin concentrations determined by insulin therapy, including treatment with Lantus ® SoloStar®, are significantly lower than the pharmacological concentrations required to activate the mitogenic-proliferative pathway.

The ORIGIN (Outcome Reduction with Initial Glargine INtervention) trial was an international, multicenter, randomized trial conducted in 12537 patients with a high risk of developing cardiovascular diseases and impaired fasting glycemia (NGN), impaired glucose tolerance (HTG), or early-stage type 2 diabetes mellitus. Study participants were randomly assigned to groups (1:1): the group of patients receiving insulin glargine (n=6264), which was titrated until the fasting blood glucose (GKN) concentration was < 5.3 mmol, and a group of patients receiving standard treatment (n=6273). The first endpoint of the study was the time before the development of cardiovascular death, the first development of non-fatal myocardial infarction or non-fatal stroke, and the second endpoint was the time before the first occurrence of any of the above complications or before revascularization procedures (coronary, carotid or peripheral arteries), or before hospitalization for the development of heart failure.

Secondary endpoints were all-cause mortality and combined microvascular outcomes. The ORIGIN study showed that treatment with insulin glargine compared with standard hypoglycemic therapy did not change the risk of cardiovascular complications or cardiovascular mortality; there were no differences in the indicators of any component that makes up the endpoints, all-cause mortality, and the combined indicator of microvascular outcomes.

At the beginning of the study, the median HbA1c was 6.4%. The median HbA1c values during treatment ranged from 5.9% to 6.4% in the insulin glargine group and 6.2% to 6.6% in the standard treatment group during the entire follow-up period. In the group of patients receiving insulin glargine, the incidence of severe hypoglycemia was 1.05 episodes per 100 patient-years of therapy, and in the group of patients receiving standard hypoglycemic therapy — 0.3 episodes per 100 patient-years of therapy. The incidence of mild hypoglycemia was 7.71 episodes per 100 patient-years of therapy in the group of patients receiving insulin glargine, and 2.44 episodes per 100 patient — years of therapy in the group of patients receiving standard hypoglycemic therapy. In a 6-year study,42% of patients in the insulin glargine group did not experience any hypoglycemia.

The median change in body weight compared to outcome at the last treatment visit was 2.2 kg higher in the insulin glargine group than in the standard treatment group.

PharmacokineticsA comparative study of the concentrations of insulin glargine and insulin-isophane in blood plasma in healthy people and patients with diabetes mellitus after subcutaneous administration of drugs revealed slower and significantly longer absorption, as well as the absence of a peak concentration in insulin glargine compared with insulin-isophane. With a single subcutaneous injection of Lantus® SoloStar® during the day, the Css of insulin glargine in the blood is achieved after 2-4 days with daily administration.

When administered intravenously, T1 / 2 of insulin glargine and human insulin were comparable. When insulin glargine was administered to the abdomen, shoulder, or thigh, no significant differences in serum insulin concentrations were found. Compared to human insulin of average duration of action, insulin glargine is characterized by a lower variability in the pharmacokinetic profile, both in the same and in different patients. In humans, in subcutaneous adipose tissue, insulin glargine is partially cleaved from the carboxyl end (C-end) of the beta-chain (beta-chain) to form two active metabolites M1 (21 A G1 y-insulin) and M2 (21 A G1 y-des-30 B-Thg-insulin). The M1 metabolite circulates mainly in the blood plasma. The systemic exposure of the M1 metabolite increases with increasing dose of the drug.

A comparison of pharmacokinetic and pharmacodynamic data showed that the drug’s action is mainly due to systemic exposure to the M1 metabolite. In the vast majority of patients, it was not possible to detect insulin glargine and the M2 metabolite in the systemic circulation. In cases where insulin glargine and the M2 metabolite were still detected in the blood, their concentrations did not depend on the administered dose of Lantus® SoloStar®.

Special patient groups

Age and gender. There is no information on the effect of age and gender on the pharmacokinetics of insulin glargine. However, these factors did not cause differences in the safety and efficacy of the drug.

Smoking. In clinical trials, subgroup analysis did not reveal any differences in the safety and efficacy of insulin glargine for this group of patients compared to the general population.

Obesity. No differences were shown in the safety and efficacy of insulin glargine and insulin-isophane in obese patients compared to normal-weight patients.

Children. In children with type 1 diabetes mellitus aged 2 to 6 years, the concentrations of insulin glargine and its main metabolites M1 and M2 in the blood plasma before the next dose were similar to those in adults, which indicates that there is no accumulation of insulin glargine and its metabolites with constant use of insulin glargine in children.

Indications

Diabetes mellitus requiring insulin treatment in adults, adolescents, and children over 2 years of age.

Use during pregnancy and lactation

Patients should inform the attending physician about their current or planned pregnancy.

No randomized controlled clinical trials have been conducted on the use of insulin glargine in pregnant women.

A large number of observations (more than 1000 pregnancy outcomes with retrospective and prospective follow-up) with post-marketing use of insulin glargine showed that it does not have any specific effects on the course and outcome of pregnancy or on the condition of the fetus or the health of newborns.

In addition, to evaluate the safety of insulin glargine and insulin-isofan in pregnant women with pre-existing or gestational diabetes mellitus, a meta-analysis of eight observational clinical trials was conducted, including women who had been treated with insulin glargine during pregnancy (n=331) and insulin isofan (n=371). This meta-analysis found no significant differences regarding maternal or newborn health safety when using insulin glargine and insulin-isophane during pregnancy.

In animal studies, there were no direct or indirect data on the embryotoxic or fetotoxic effects of insulin glargine.

For patients with pre-existing or gestational diabetes mellitus, it is important to maintain adequate regulation of metabolic processes throughout pregnancy in order to prevent the occurrence of undesirable outcomes associated with hyperglycemia.

Lantus ® SoloStar® can be used during pregnancy according to clinical indications.

The need for insulin may decrease in the first trimester of pregnancy and, in general, increase during the second and third trimesters.

Immediately after delivery, the need for insulin decreases rapidly (the risk of hypoglycemia increases). Under these conditions, careful monitoring of blood glucose concentrations is essential.

Patients who are breast-feeding may need to adjust their insulin dosage and diet.

Contraindications

Hypersensitivity to insulin glargine or any of the auxiliary components of the drug;

Children under 2 years of age (no clinical data on use).

With caution: pregnant women (possible changes in the need for insulin during pregnancy and after childbirth).

Side effects

The following undesirable effects are given by organ systems in accordance with the following gradations frequency of their occurrence (in accordance with the classification of MedDRA): very often — ≥10%; often — ≥1–<10%; infrequently — ≥0,1–<1%; rarely — ≥0.01 to<Of the 0.1%; very rarely — ≤0,01%.

From the side of metabolism: very often — 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.

Symptoms of hypoglycemia usually occur suddenly. However, neuropsychiatric disorders associated with neuroglycopenia (fatigue, unusual fatigue or weakness, decreased ability to concentrate, drowsiness, visual disturbances, headache, nausea, confusion or loss of consciousness, convulsive syndrome) are usually preceded by symptoms of adrenergic counterregulation (activation of the sympathoadrenal system in response to hypoglycemia) — hunger, irritability, nervous excitement or tremor, restlessness, pallor of the skin, cold sweat, tachycardia, pronounced palpitations (the faster hypoglycemia develops and the more severe it is, the more pronounced the symptoms of adrenergic counterregulation).

Attacks of severe hypoglycemia, especially repeated ones, can lead to damage to the nervous system. Episodes of prolonged and severe hypoglycemia can be life-threatening, as if hypoglycemia increases, even death is possible.

Immune systemdisorders: rarely-allergic reactions. Immediate-type allergic reactions to insulin are rare. Such reactions to insulin (including insulin glargine) or excipients may result in generalized skin reactions, angioedema, bronchospasm, hypotension, or shock, and thus may be life-threatening.

The use of insulin can cause the formation of antibodies to it. The formation of antibodies that cross-react with human insulin and insulin glargine is observed with the same frequency when using insulin-isophane and insulin glargine. In rare cases, the presence of such antibodies to insulin may cause the need to adjust the dosage regimen in order to eliminate the tendency to develop hypo – or hyperglycemia.

Nervous system disorders: very rarely — dysgeusia (violation or perversion of taste sensations).

From the side of the visual organ: rarely-visual disturbances, retinopathy.

Significant changes in the regulation of blood glucose can cause temporary visual disturbances due to changes in tissue turgor and refractive index of the lens of the eye.

Long-term normalization of blood glucose reduces the risk of diabetic retinopathy progression. Insulin therapy, accompanied by sharp fluctuations in blood glucose, may be accompanied by a temporary deterioration in 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 the development of transient vision loss.

Skin and subcutaneous fat disorders: often-lipodystrophy (in 1-2% of patients). As with treatment with any other insulin preparation, lipodystrophy may develop at the injection site, which can slow down local insulin absorption; infrequently, lipoatrophy — 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 rarely — myalgia.

General disorders and reactions at the injection site: often-reactions at the injection site (3-4%) (redness, pain, itching, urticaria, swelling or inflammation). Most minor reactions at the insulin injection site usually resolve within a few days to several weeks; rarely-sodium retention, edema (especially if intensive insulin therapy leads to improvement of previously insufficient metabolic control).

The safety profile for patients under 18 years of age is generally similar to that for patients over 18 years of age. Patients younger than 18 years of age are relatively more likely to experience injection site reactions and skin reactions (rash, urticaria).

There are no safety data available in patients younger than 2 years of age.

Interaction

Oral hypoglycemic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates, and sulfonamide antimicrobials can enhance the hypoglycemic effect of insulin and increase the predisposition to hypoglycemia. Concomitant administration with insulin glargine may require adjustment of the insulin dose.

CORTICOSTEROIDS, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens and progestogens (for example in hormonal contraceptives), phenothiazine derivatives, somatotropin, sympathomimetics (for example epinephrine, salbutamol, terbutaline) and thyroid hormones, protease inhibitors, atypical neuroleptics (for example olanzapine or clozapine) — may weaken the hypoglycemic effect of insulin. Concomitant administration with insulin glargine may require adjustment of the insulin glargine dose.

Beta-blockers, clonidine, lithium salts, or alcohol may either enhance or weaken the hypoglycemic effect of insulin.

Pentamidine-when combined with insulin, it can cause hypoglycemia, which sometimes gives way to hyperglycemia.

Sympatholytic drugs, such as beta-blockers, clonidine, guanethidine, and reserpine, may reduce or eliminate signs of adrenergic counterregulation (activation of the sympathetic nervous system) when hypoglycemia develops.

Pharmaceutical interaction

When mixing Lantus SoloStar with other medicinal substances, including other insulins, as well as diluting the drug, sediment may form or the drug’s action profile may change over time.

How to take, course of administration and dosage

of subcutaneous injection. Adults and children over 2 years old.

General recommendations

Lantus ® SoloStar® should be administered subcutaneously once a day at any time of the day, but every day at the same time.

Starting the use of Lantus® SoloStar®

Patients with type 1 diabetes mellitus. Lantus ® SoloStar® should be used once a day in combination with insulin administered during meals with individual dose adjustment.

Patients with type 2 diabetes mellitus. In patients with type 2 diabetes mellitus, Lantus ® SoloStar® can be used either as monotherapy or in combination with other hypoglycemic drugs.

Target values of blood glucose concentration, as well as the dose and time of administration or administration of hypoglycemic drugs should be determined and adjusted individually.

Dose adjustment may also be necessary, for example, if the patient’s body weight, lifestyle, time of administration of insulin, or other conditions that may increase the predisposition to hypo – or hyperglycemia (see “Special Instructions”). Any changes in the insulin dose should be made with caution and under medical supervision.

Lantus SoloStar is not the insulin of choice for the treatment of diabetic ketoacidosis. In this case, preference should be given to intravenous administration of short-acting insulin.

In treatment regimens that include injections of basal and prandial insulin,40-60% of the daily dose of insulin in the form of insulin glargine is usually administered to meet the need for basal insulin.

In patients with type 2 diabetes mellitus who use oral hypoglycemic drugs, combination therapy begins with a dose of insulin glargine 10 UNITS 1 time per day, and then the treatment regimen is adjusted individually.

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

Switching from treatment with other hypoglycemic drugs to Lantus ® SoloStar®

When transferring a patient from a medium-acting or long-acting insulin regimen to a Lantus SoloStar treatment regimen, it may be necessary to adjust the amount (dose) and time of administration of short-acting insulin or its analog during the day, or to change the doses of oral hypoglycemic drugs.

Switching from insulin-isophane once a day to Lantus® SoloStar®

When transferring patients from a single daily dose of insulin-isofan to a single daily dose of Lantus® SoloStar®, the initial dose of insulin is usually unchanged (i. e., the amount of units/day of Lantus® SoloStar® equal to the amount of IU/day of insulin-isofan is used).

Switching from insulin-isophane 2 times a day to Lantus ® SoloStar®

When patients are transferred from twice-daily administration of insulin-isophane to a single dose of Lantus® SoloStar® at bedtime in order to reduce the risk of hypoglycemia at night and in the early morning, the initial daily dose of insulin glargine is usually reduced by 20% (compared to the daily dose of insulin-isophane), and then it is adjusted depending on the patient’s reaction.

Transfer from Toujeo SoloStar® (insulin glargine 300 U / ml) to Lantus SoloStar®

Insulin glargine 100 U / ml and Toujeo SoloStar® are not equivalent in their pharmacokinetic, pharmacodynamic characteristics and clinical effects. In this regard, switching from Toujeo SoloStar® to insulin glargine 100 U / ml and vice versa requires medical supervision, careful metabolic monitoring and individual dose adjustment of the drug. In order to reduce the risk of hypoglycemia when transferring patients from a single daily dose of Toujeo SoloStar® (insulin glargine 300 U / ml) to a single daily dose of Lantus® SoloStar®, the recommended starting dose of Lantus® SoloStar® should be reduced by approximately 20%. During the first weeks of treatment, this reduction in the dose of Lantus ® SoloStar® can be partially compensated by increasing the dose of prandial insulin. At the end of this period, the treatment regimen should be adjusted individually. When switching to a different treatment regimen and for several subsequent weeks, careful metabolic monitoring (monitoring of blood glucose concentration) is recommended under medical supervision, with adjustments to the insulin dosage regimen if necessary.

As with all human insulin analogues, this is especially important for patients who, due to their presence of antibodies to human insulin, need to use high doses of human insulin. In such patients, when using insulin glargine, there may be a significant improvement in the response to insulin. With improved metabolic control and the resulting increase in tissue sensitivity to insulin, it may be necessary to adjust the insulin dosage regimen.

Mixing and dilution

Lantus SoloStar should not be mixed with other insulins. Mixing can change the time profile (time/action ratio) of Lantus® SoloStar®, as well as lead to precipitation.

Lantus ® SoloStar® should not be diluted. Dilution may lead to a change in the drug’s action profile over time.

Special patient groups

are children. Lantus SoloStar can be used in children over 2 years of age. Use in children under 2 years of age has not been studied.

Elderly patients. In elderly patients with diabetes mellitus, moderate initial doses, slow increases, and moderate maintenance doses are recommended. Elderly patients may have difficulty recognizing developing hypoglycemia (see “Special instructions”). Careful monitoring of blood glucose concentration with individual selection of the insulin dose is recommended. In elderly patients, progressive deterioration of renal function can lead to a permanent decrease in the need for insulin.

Patients with renal insufficiency. Insulin glargine can be used in patients with renal insufficiency, and careful monitoring of blood glucose concentrations with individual dose selection is recommended. In patients with renal insufficiency, the need for insulin may decrease due to a slowdown in insulin metabolism.

Patients with hepatic insufficiency. Insulin glargine can be used in patients with hepatic insufficiency, while careful monitoring of blood glucose concentrations with individual dose selection is recommended. In patients with hepatic insufficiency, the need for insulin may decrease due to a decrease in gluconeogenesis and a slowdown in insulin metabolism.

Starting withthe use of Lantus® SoloStar®

Lantus ® SoloStar® is administered as subcutaneous injections. It is not intended for intravenous administration. The long duration of action of insulin glargine is observed only when it is introduced into the subcutaneous fat. Intravenous administration of the usual subcutaneous dose may cause severe hypoglycemia. Lantus SoloStar should be injected into the subcutaneous fat of the abdomen, shoulders, or thighs. Injection sites should alternate with each new injection within the recommended areas for subcutaneous administration of the drug.

As with other types of insulin, the degree of absorption, and therefore the onset and duration of its action, may change due to physical exertion and other changes in the patient’s condition.

Lantus ® SoloStar® is a clear solution, not a suspension. Therefore, resuspending before use is not required.

If the Lantus ® SoloStar® pen fails, insulin glargine can be removed from the cartridge into a syringe (suitable for 100 IU / ml insulin) and the desired dose of the drug can be administered. At the same time, the syringe should not contain residues of other drugs.

Do not reuse the needles. A new sterile needle should be attached before each injection. Repeated use of needles increases the risk of blockage, which can lead to a lower dose or overdose. Using a new sterile needle for each injection minimizes the risk of contamination and infection. To avoid possible transmission of blood-borne diseases, insulin syringes should not be used by more than one patient, even if the needle is replaced. Before each injection, check the label on the syringe handle and indicate the date of its first use.

Instructions for the patient

Instructions for use and handling of the pre-filled SoloStar®syringe pen

Before using the pen for the first time, keep it at room temperature for 1-2 hours.

The cartridge inside the pen should be examined before use. It should only be used if the solution is clear, colorless, does not contain visible solid particles and has a consistency similar to water.

Empty SoloStar ® syringe pens should not be reused and should be disposed of.

To prevent infection, a pre-filled syringe pen should only be used by one patient and should not be passed on to another person.

Handling the SoloStar®syringe pen

Please read the instructions for use carefully before using the SoloStar® pen.

Important information on using the SoloStar®pen

Before each use, you should carefully connect a new needle to the syringe handle and perform a safety test. Use only SoloStar ® compatible needles, which are purchased separately.

Special precautions must be taken to avoid accidents associated with the use of the needle and the possibility of transmission of infection.

Never use the SoloStar ® syringe pen if it is damaged or if you are not sure that it will work properly.

A spare SoloStar® pen should always be available in case of loss or damage to the previous copy of the SoloStar®pen.

Storage Instructions

Please read the section “Storage conditions”regarding the storage rules for the SoloStar ® pen.

If the SoloStar® pen is stored in the refrigerator, remove it 1-2 hours before the intended injection to allow the solution to reach room temperature. Administration of chilled insulin is more painful.

The used SoloStar® syringe pen must be destroyed.

Operation

The SoloStar® pen must be protected from dust and dirt.

The outside of the SoloStar ® pen can be cleaned by wiping it with a damp cloth.

Do not immerse the SoloStar® pen in liquid, wash or lubricate it, as this may damage the SoloStar®pen.

The SoloStar ® syringe pen accurately dispenses insulin and is safe to use.It also requires careful handling. Avoid situations where damage to the SoloStar ® pen may occur. If you suspect that the SoloStar® pen you are using is damaged, you should use a new pen.

Stage 1: Insulin control

You should check the label on the SoloStar® pen to make sure that it contains the appropriate insulin. For Lantus®, the SoloStar ® syringe pen is grey in color with a purple button for injection. After removing the cap of the syringe pen, the appearance of the insulin contained in it is monitored: the insulin solution should be transparent, colorless, contain no visible solid particles and resemble water in consistency.

Step 2: Connecting the needle

Only use needles that are compatible with the SoloStar ® pen.

A new sterile needle is always used for each subsequent injection. After removing the cap, the needle must be carefully placed on the syringe handle.

Stage 3: Performing a safety test

Before each injection is administered, a safety test should be performed to ensure that the pen and needle are working well and that air bubbles are removed.

Measure the dose equal to 2 units.

The outer and inner needle caps must be removed.

Placing the syringe pen with the needle facing up, gently tap the insulin cartridge with your finger so that all air bubbles are directed towards the needle.

Fully press the injection button.

If the insulin appears at the tip of the needle, it means that the pen and needle are working correctly.

If no insulin appears at the tip of the needle, then step 3 can be repeated until the insulin appears at the tip of the needle.

Stage 4: Dose selection

The dose can be set with an accuracy of 1 unit, from the minimum dose (1 unit) to the maximum (80 units). If a dose exceeding 80 units is required,2 or more injections should be given.

The dosage window should show “0” after the safety test is completed. After that, the required dose can be set.

Stage 5. Dose administration

The patient should be informed about the injection technique by a healthcare professional.

The needle must be inserted under the skin.

The injection button must be pressed completely. It is held in this position for another 10 seconds until the needle is removed. This ensures that the selected dose of insulin is fully administered.

Step 6: Removing and discarding the needle

In all cases, the needle should be removed and discarded after each injection. This prevents contamination and / or infection, air entering the insulin container, and insulin leakage.

Special precautions should be taken when removing and discarding the needle. Follow the recommended safety measures for removing and discarding needles (such as the one-handed capping technique) in order to reduce the risk of accidents associated with needle use, as well as to prevent infection.

After removing the needle, close the SoloStar® pen with the cap.

Overdose

An overdose of insulin can lead to severe and sometimes long-term hypoglycemia, which threatens the patient’s life.

Treatment: Episodes of moderate hypoglycemia are usually stopped 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, require intravenous or subcutaneous administration of glucagon, as well as intravenous administration of a concentrated dextrose (glucose) solution. Long-term carbohydrate intake and specialist supervision may be required, since after a visible clinical improvement, a recurrence of hypoglycemia is possible.

Description

Clear, colorless or almost colorless liquid.

Special instructions

Lantus SoloStar is not the drug of choice for the treatment of diabetic ketoacidosis. In such cases, intravenous administration of short-acting insulin is recommended.

Due to limited experience with Lantus SoloStar, it was not possible to evaluate its efficacy and safety in the treatment of patients with impaired liver function or with moderate or severe renal insufficiency.

In patients with impaired renal function, the need for insulin may decrease due to a slowdown in its elimination. In elderly patients, progressive deterioration of renal function can lead to a persistent decrease in the need for insulin.

In patients with severe hepatic insufficiency, the need for insulin may be reduced due to a decrease in the ability to gluconeogenesis and a slowdown in insulin biotransformation.

In case of insufficient control of blood glucose levels, 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 and the correct technique of subcutaneous injection, taking into account all factors affecting this.

Hypoglycemia

The time of hypoglycemia development depends on the action profile of the insulins used and may thus change with a change in the treatment regimen. Due to the increased time of ingestion of long-acting insulin when using Lantus ® SoloStar®, you should expect a lower probability of developing nocturnal hypoglycemia, while in the early morning hours this probability of developing hypoglycemia is higher. If hypoglycemia occurs in patients receiving Lantus SoloStar, consideration should be given to the possibility of slowing the recovery from hypoglycemia due to the prolonged effect of insulin glargine.

Patients in whom episodes of hypoglycaemia may be of particular clinical significance, such as patients with severe coronary or cerebral stenosis (risk of cardiac and cerebral complications of hypoglycaemia), as well as patients with proliferative retinopathy, especially if they do not receive photocoagulation treatment (risk of transient vision loss following hypoglycaemia), should exercise special caution and intensify blood glucose monitoring.

Patients should be warned about conditions in which the symptoms that are harbingers of hypoglycemia may decrease. In patients of certain risk groups, the symptoms of hypoglycemia may change, become less pronounced, or be absent. These include:

– patients who have significantly improved the regulation of glucose in the blood;

– patients in whom hypoglycaemia develops gradually;

the elderly patients;

– patients transferred from animal insulin to human insulin;

– patients with neuropathy;

patients with a long history of diabetes;

patients with mental disorders;

– patients receiving concomitant treatment with other drugs (see “Interaction”).

Such situations can lead to the development of severe hypoglycemia (with possible loss of consciousness) before the patient realizes that he is developing hypoglycemia.

If normal or reduced levels of glycosylated Hb are observed, the possibility of recurrent unrecognized episodes of hypoglycemia (especially at night) should be considered.

Patients ‘ compliance with the dosage and dietary regimen, proper administration of insulin, and knowledge of the symptoms that are harbingers of hypoglycemia contribute to a significant reduction in the risk of hypoglycemia.

Factors that increase the tendency to hypoglycemia, in the presence of which particularly careful monitoring is required and an adjustment of the insulin dose may be necessary:

– change of insulin;

– increased sensitivity to insulin (for example, when you troubleshoot stress factors);

– unaccustomed, increased or prolonged physical activity;

– intercurrent disease, accompanied by vomiting, diarrhoea;

– violation of diet and nutrition;

– skipping meals;

– the consumption of alcohol;

– certain uncompensated endocrine disorders (e. g. hypothyroidism, a lack of anterior pituitary or the adrenal cortex);

– concomitant treatment with certain drugs (see “Interaction”).

Intercurrent diseases

Intercurrent diseases require more intensive control of blood glucose levels. In many cases, an analysis for the presence of ketone bodies in the urine is indicated, and correction of the insulin dosage regimen is also often required. The need for insulin often increases. Patients with type 1 diabetes should continue to regularly consume at least a small amount of carbohydrates, even if they are only able to consume small amounts of food or cannot eat at all, or have vomiting, etc., and they should never completely stop injecting insulin.

Recommendations for handling the drug

When storing Lantus SoloStar in the refrigerator, make sure that the containers do not come directly into contact with the freezer compartment or frozen packages.

Before first use, the Lantus® SoloStar® pen should be kept at room temperature for 1-2 hours.

Used SoloStar ® disposable syringe pens should be stored at a temperature not exceeding 30 °C and protected from light.

Do not cool the pre-filled SoloStar® pen.

The shelf life of the drug in a single-use SoloStar® syringe pen after the first use is 4 weeks. It is recommended to mark the date of the first drug administration on the label.

Influence on the ability to drive vehicles and mechanisms. Patients ‘ ability to concentrate and respond quickly may be impaired by developing conditions such as hypoglycemia, hyperglycemia, or visual impairment. This can pose a risk in situations where these abilities are particularly important (for example, driving a car or operating other mechanisms). Patients are advised to take precautions to avoid the development of hypoglycemia when driving vehicles. This is especially important for those patients who have mild or no symptoms that are harbingers of developing hypoglycemia, or for patients with frequent cases of hypoglycemia. Such circumstances should be taken into account when driving a car.

Form of production

Solution for subcutaneous administration,100 U / ml.3 ml of the drug in a clear, colorless glass cartridge (type 1). The cartridge is capped on one side with a bromobutyl stopper and compressed with an aluminum cap, on the other side with a bromobutyl plunger.

The cartridge is mounted in a SoloStar ® disposable syringe pen.5 SoloStar®syringe pens are placed in a cardboard pack equipped with a cardboard retainer.

Storage conditions

Store in a dark place at a temperature of 2-8 °C (do not freeze). After use, store at a temperature not exceeding 25 °C in a cardboard box (but not in the refrigerator). Keep out of reach of children.

Shelf

life is 3 years. After autopsy — 4 weeks. Do not use after the expiration date indicated on the package.

Active ingredient

Insulin glargine

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Weight

Weight: 169 g.