Lantus SoloStar
Lantus SoloStar: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Lantus SoloStar
ATX code: A10AE04
Active ingredient: insulin glargine (Insulin glargine)
Manufacturer: Sanofi-Aventis Vostok, CJSC (Russia), Sanofi-Aventis Deutschland, GmbH (Sanofi-Aventis Deutschland, GmbH) (Germany)
Description and photo updated: 2018-29-11
Prices in pharmacies: from 2890 rubles.
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Lantus SoloStar is a long-acting hypoglycemic drug, analog of human insulin.
Release form and composition
The drug is available in the form of a solution for subcutaneous (s / c) administration: a clear colorless or almost colorless liquid (3 ml each in glass cartridges without color (type I), which are mounted in disposable syringe pens SoloStar with a gray body and a purple button for administration of the drug, in a cardboard box with a cardboard retainer, 5 syringe pens and instructions for the use of Lantus SoloStar).
1 ml of solution contains:
- active substance: insulin glargine - 100 units (unit of action) or 3.637 8 mg;
- auxiliary components: metacresol (m-cresol), glycerol 85%, zinc (in the form of zinc chloride), hydrochloric acid, sodium hydroxide, water for injection.
Pharmacological properties
Pharmacodynamics
Lantus SoloStar is a hypoglycemic agent. The active ingredient of the drug is insulin glargine, which is an analogue of human insulin. It is obtained by recombination of DNA (deoxyribonucleic acid) of bacteria of the type Escherichia coli (K12 strains), it is characterized by poor solubility in a neutral medium.
The complete solubility of insulin glargine in Lantus SoloStar is due to the acidic reaction of the solution for injection, which, after injection into the subcutaneous tissue, is neutralized. This promotes the formation of micro-precipitates, which provide a prolonged action of the drug as a result of the constant gradual release of small portions of insulin glargine and maintaining the profile of the concentration-time curve.
As a result of biotransformation, two active metabolites are formed - M1 and M2. In insulin glargine and its active metabolites, the mechanism of binding to specific insulin receptors is very similar to human insulin, therefore insulin glargine can perform a biological effect similar to that of endogenous insulin.
In the body, the main role of insulin and its analogs, including insulin glargine, is to regulate glucose metabolism. It lowers blood glucose levels by stimulating peripheral tissues (especially skeletal muscle and adipose tissue) to absorb glucose and inhibiting the formation of glucose in the liver. Insulin inhibits lipolysis in fat cells (adipocytes), inhibits proteolysis and increases protein synthesis.
The reduced rate of absorption of insulin glargine creates conditions for the prolonged action of Lantus SoloStar and allows its use once a day. After administration, the effect begins to appear, on average, after 1 hour and lasts for 24 hours, the maximum duration is 29 hours. The duration of action of insulin glargine can vary significantly.
The use of insulin Lantus SoloStar in syringe pens is shown for the treatment of type 1 diabetes mellitus in children over the age of 2 years. Its effectiveness in the age group 2–6 years old is confirmed by a significant decrease in the incidence of hypoglycemia with clinical manifestations both during the day and at night.
A five-year follow-up of patients with type 2 diabetes mellitus taking Lantus SoloStar did not reveal significant differences in the progression of diabetic retinopathy compared with insulin isophane.
The affinity of insulin glargine for the receptor for insulin-like growth factor 1 (IGF-1) is about 8 times higher than that of human insulin, but for metabolites M1 and M2 it is slightly less.
In type 1 diabetes mellitus, the level of the total therapeutic concentration of insulin glargine and its metabolites is noticeably lower than the level required for half-maximal binding to IGF-1 receptors and triggering the subsequent activation of the mitogen-proliferative pathway through them. Physiological concentrations of endogenous IGF-1 can activate the mitogenic-proliferative pathway. However, the therapeutic concentrations of insulin achieved during treatment with Lantus SoloStar are significantly inferior to the pharmacological concentrations required to activate the mitogenic-proliferative pathway.
An international multicenter, randomized trial was conducted in 12,537 patients with impaired fasting glycemia (FGN), impaired glucose tolerance (IGT) or early-stage type 2 diabetes mellitus and a high risk of cardiovascular disease. The study participants were divided into two equal groups, one of which took insulin glargine, its dose was titrated until the fasting blood glucose concentration (FGC) reached 5.3 mmol or less. The second group of patients received standard therapy.
The first study endpoint was the time to the development of cardiovascular death, the first development of nonfatal stroke, or nonfatal myocardial infarction. It was found that the use of insulin glargine does not alter the risk of cardiovascular complications or cardiovascular mortality compared with standard hypoglycemic therapy.
The second endpoint was the time to the first occurrence of any complication of nonfatal myocardial infarction or nonfatal stroke, the period before the procedure for revascularization of the coronary, peripheral or carotid arteries, or before hospitalization for the development of heart failure. There was no difference in the scores for any component constituting the endpoints, combined scores for microvascular outcomes, and all-cause mortality.
The median values of glycated hemoglobin (Hb A1c), which is 6.4% at the beginning of treatment, throughout the observation period in the insulin glargine group ranged from 5.9% to 6.4%, in the standard treatment group - from 6.2 % to 6.6%.
The results of the studies showed that with the use of insulin glargine, the development of severe hypoglycemia per 100 patient-years of treatment was 1.05 episodes, against the background of standard hypoglycemic therapy - 0.3 episodes. Monitoring of patients receiving insulin glargine for 6 years did not reveal any cases of hypoglycemia in 42% of patients.
The median change in body weight at the last treatment visit was 2.2 kg higher than the outcome in the insulin glargine group than in the standard therapy group.
Pharmacokinetics
After subcutaneous administration, absorption of insulin glargine in comparison with insulin isophane occurs more slowly and for a longer time, and also does not reach the peak concentration. The equilibrium concentration of Lantus SoloStar in blood plasma against the background of a single daily administration is achieved in 2-4 days. Serum insulin levels are comparable to those injected into the abdomen, upper arms, or thigh.
Insulin glargine is characterized by less variability of the pharmacokinetic profile in one and in different patients.
In the subcutaneous fat, insulin glargine is partially cleaved from the carboxyl end of the beta chain to form two active metabolites: M1 (21 A -Gly-insulin) and M2 (21 A -Gly-des-30 B- Thr-insulin). The metabolite M1 predominantly circulates in the blood plasma; with an increase in the dose of the drug, its systemic exposure increases. The effect of the drug is mainly due to systemic exposure to the M1 metabolite. In the systemic circulation, insulin glargine and the M2 metabolite are practically not detected, or their concentrations do not depend on the administered dose of Lantus SoloStar.
The T ½ (half-life) of insulin glargine is comparable to the T ½ of human insulin.
Age, sex of the patient or smoking does not cause differences in the safety and effectiveness of Lantus SoloStar.
Obesity in patients does not affect the safety and efficacy of insulin glargine.
It was found that the use of Lantus SoloStar in children aged 2–6 years with type 1 diabetes mellitus does not cause accumulation of insulin glargine and its metabolites in blood plasma.
Indications for use
The use of Lantus SoloStar is indicated for patients with diabetes mellitus requiring insulin treatment.
Contraindications
Absolute:
- age up to 2 years;
- hypersensitivity to the components of the drug.
It is recommended with caution to prescribe insulin Lantus SoloStar in syringe pens to patients with proliferative retinopathy, pronounced stenosis of the coronary arteries or cerebral vessels, during pregnancy.
Lantus SoloStar, instructions for use: method and dosage
The solution is intended only for subcutaneous administration by injection into the subcutaneous fat in the abdomen, thighs or shoulders. The procedure is performed daily, once a day at a convenient (but always the same) time of day for the patient. The injection sites must be regularly rotated.
Do not administer Lantus SoloStar intravenously!
For the correct safe self-execution of the procedure, it is necessary to carefully study the sequence of actions and strictly follow it.
First of all, when using the pen for the first time, you must first take it out of the refrigerator and hold it at room temperature for 1-2 hours. During this time, the solution will warm up to room temperature, which will avoid the painful injection of cooled insulin.
Before the procedure, you must make sure that the insulin is consistent by examining the label on the syringe pen. After removing the cap, you should conduct a thorough visual assessment of the quality of the contents of the cartridge of the syringe pen. The drug can be used if the solution has a transparent, colorless structure without visible solid particles.
If damage to the body is found or there are doubts about the quality of the pen, it is strictly forbidden to use it. In this case, it is recommended to remove the solution from the cartridge into a new syringe that is suitable for 100 IU / ml insulin and to inject.
SoloStar compatible needles must be used.
Each injection is made with a new sterile needle, which is installed before the direct injection of Lantus SoloStar.
To make sure that there are no air bubbles and that the syringe pen and needle work well, a preliminary safety test is mandatory. To do this, removing the outer and inner needle caps and measuring the dose corresponding to 2 units, the pen is placed with the needle up. By gently tapping the insulin cartridge with your finger, all air bubbles are directed towards the needle and fully depress the injection button. The appearance of insulin at the tip of the needle indicates the correct operation of the pen and needle. If the release of insulin does not take place, then the attempt should be repeated until the desired result is achieved.
The pen-syringe contains 80 IU of insulin and precisely doses it. To establish the required dose, use a scale that allows you to maintain an accuracy of up to 1 unit. At the end of the safety test, the number 0 should be in the dosage window, after which the required dose can be set. In cases where the amount of the drug in the syringe pen is less than the required dose for administration, two injections are performed using the remainder in the started syringe pen, and the missing amount from a new syringe pen.
The healthcare professional must inform the patient about the injection technique and make sure that it is performed correctly.
For injection, the needle is inserted under the skin and the injection button is pressed all the way, holding in this position for 10 seconds. This is necessary for the full administration of the selected dose, then the corner is removed.
After injection, the needle is removed from the pen and discarded, and the cartridge is closed with a cap. Failure to follow these guidelines increases the risk of air and / or infection in the cartridge, contamination and insulin leakage.
The pen is intended for use by one patient only! It must be stored in a sterile environment, free from dust and dirt. You can use a damp cloth to clean the outside of the pen. It must not be immersed in liquids, washed or lubricated!
The patient should always have a spare syringe pen in case of damage to the used specimen or its loss.
An empty syringe pen or one containing an expired drug should be disposed of.
Do not refrigerate a syringe pen prepared for injection.
After opening, the contents of the pen can be used within 4 weeks, it is recommended to indicate the date of the first injection of Lantus SoloStar on the label.
The dose is prescribed individually, taking into account clinical indications and concomitant therapy.
During the period of use of the drug, the patient should take into account that the onset and duration of insulin action can change under the influence of physical activity and other changes in the state of his body.
In type 2 diabetes mellitus, the use of Lantus SoloStar is indicated as monotherapy and in combination with other hypoglycemic agents.
Doses, timing of insulin administration and intake of hypoglycemic agents should be determined and adjusted individually, taking into account the target values of blood glucose concentration.
Dose adjustments should be made in order to prevent the development of hypo- or hyperglycemia, for example, when changing the time of administration of the dose of insulin, body weight and / or lifestyle of the patient. Any changes in insulin dose should only be done under medical supervision and with caution.
Lantus SoloStar is not the insulin of choice for the treatment of diabetic ketoacidosis, in this case, short-acting intravenous insulin should be preferred. If the treatment regimen includes injections of basal and prandial insulin, then insulin glargine is indicated as basal insulin in a dose that corresponds to 40-60% of the daily dose of insulin.
The initial daily dose of insulin glargine for patients with type 2 diabetes mellitus in combination therapy with oral hypoglycemic agents should be 10 IU. Further, the dose is adjusted individually.
In all patients, drug treatment should be accompanied by monitoring of blood glucose concentration.
When a patient switches to a treatment regimen using Lantus SoloStar after a treatment regimen with medium-acting or long-acting insulin, it may be necessary to adjust the daily dose and time of administration of short-acting insulin or its analogue and change the doses of hypoglycemic agents for oral administration.
If the patient was on previous Tujeo therapy (300 U of insulin glargine in 1 ml), then in order to reduce the risk of hypoglycemia when switching to Lantus SoloStar, the initial dose of the drug should not exceed 80% of the Tujeo dose.
When switching from a single injection of insulin isophane during the day, the initial dose of insulin glargine is usually used in the amount of the amount of IU of the drug being withdrawn.
If the previous treatment regimen provided for a double administration of insulin isophane during the day, then when the patient is transferred to a single administration of Lantus SoloStar before bedtime, to reduce the likelihood of hypoglycemia at night and early morning, its initial dose is prescribed in the amount of 80% of the daily dose of insulin isophane. During therapy, the dose is adjusted depending on the patient's response.
The transition from human insulin should be done under medical supervision. During the first weeks of insulin glargine use, it is recommended to conduct careful metabolic monitoring of blood glucose concentration and adjust the insulin dosing regimen as needed. Particular attention should be paid to patients with antibodies to human insulin requiring high doses of human insulin. In this category of patients, while using insulin glargine, a significant improvement in the response to insulin administration is possible.
As metabolic control improves and tissue sensitivity to insulin increases, the dosage regimen is adjusted.
Mixing and diluting insulin glargine with other insulins is contraindicated.
When prescribing Lantus SoloStar, elderly patients are advised to use lower initial doses, their increase to a maintenance dose should be slow. It should be borne in mind that in old age it is difficult to recognize the developing hypoglycemia.
Side effects
- from the side of metabolism: very often - hypoglycemia;
- from the immune system: rarely - allergic reactions, including a decrease in blood pressure (BP), bronchospasm, generalized skin reactions, angioedema, shock (including fatal cases);
- from the nervous system: very rarely - dysgeusia;
- on the part of the organ of vision: rarely - transient visual impairment, retinopathy;
- dermatological reactions: often - lipodystrophy; infrequently - lipoatrophy;
- from the musculoskeletal system: very rarely - myalgia;
- violations at the injection site: often - pain, redness, itching, swelling, inflammation, urticaria;
- general disorders: rarely - sodium retention, edema.
Overdose
Symptoms: hypoglycemia, including severe, prolonged and life-threatening episodes.
Treatment: Immediate ingestion of fast-digesting carbohydrates often helps relieve symptoms of mild hypoglycemia. If necessary, a change should be made to the insulin dosing regimen, diet or physical activity. Episodes of severe hypoglycemia, accompanied by neurological disorders, convulsions or coma, require the administration of glucagon (intramuscularly or subcutaneously), concentrated dextrose solution (i.v.), and the appointment of carbohydrates. The patient needs careful supervision of a specialist, since after a visible clinical improvement, a relapse of hypoglycemia is possible.
special instructions
The limited experience of using Lantus SoloStar does not allow a reliable assessment of its efficacy and safety in the treatment of diabetic patients with impaired liver function or moderate / severe renal failure.
The development of hypoglycemia may be indicated by such symptoms of adrenergic counterregulation as hunger, nervous excitement, tremors, irritability, anxiety, cold sweat, pallor of the skin, palpitations, tachycardia. Usually, symptoms of hypoglycemia develop suddenly. Their severity depends on the rate of development and the severity of hypoglycemia.
Further, the condition can be aggravated by the following neuropsychiatric disorders: weakness, headache, fatigue, drowsiness, nausea, unusual fatigue, decreased ability to concentrate, visual disturbances, confusion or loss of consciousness, convulsive syndrome.
Severe hypoglycemic episodes, especially recurrent ones, can damage the nervous system. With prolonged and severe episodes of hypoglycemia, the threat to the life of patients increases, with an increase in hypoglycemia, a lethal outcome is possible.
Episodes of severe hypoglycemia in proliferative retinopathy, especially in patients not receiving photocoagulation treatment, can cause transient visual loss.
It should be borne in mind that the use of Lantus SoloStar can cause the formation of antibodies that cross-react with human insulin and insulin glargine. Their presence may lead to the need to revise the dosage regimen in order to prevent a tendency to develop hypo- or hyperglycemia.
To begin adjusting the dosage regimen if control over blood glucose levels is ineffective, after checking the accuracy of the patient's prescribed treatment regimen and a thorough analysis of all factors that may affect the blood glucose concentration. It is necessary to make sure that the instructions for the injection sites and the correctness of the SC injection technique are followed.
Against the background of the use of Lantus SoloStar, the time of long-acting insulin intake into the body increases, so the likelihood of developing nocturnal hypoglycemia is lower than in the early morning hours.
It should be borne in mind that if hypoglycemia occurs while taking Lantus SoloStar, it is possible to slow down the patient's exit from the hypoglycemic state, due to the prolonged action of insulin glargine.
Patients should be informed about the following conditions and situations, against which a decrease in the severity of symptoms-precursors of hypoglycemia may occur, or they may be completely absent:
- switching to human insulin from animal insulin;
- marked improvement in the regulation of blood glucose concentration;
- the gradual development of hypoglycemia;
- autonomic neuropathy;
- long course of diabetes mellitus;
- the presence of mental disorders;
- concomitant therapy with other drugs;
- elderly age.
The presence of normal or decreased levels of glycated hemoglobin indicates an increased risk of developing unrecognized recurrent attacks of hypoglycemia, especially at night.
The tendency to hypoglycemia increases with the following factors:
- change in the area of insulin injection;
- hypersensitivity to insulin (including when eliminating stress factors);
- physical activity (increased, unusual or prolonged);
- intercurrent diseases that are accompanied by vomiting and / or diarrhea;
- violation of diet and diet;
- skipping meals;
- alcohol consumption;
- hypothyroidism, insufficiency of the adenohypophysis or adrenal cortex and other uncompensated disorders of the endocrine system;
- simultaneous use of other drugs.
In patients with these risk factors, insulin dose adjustment may be required. With strict adherence to the diet, dosing regimen and the correct administration of insulin and the timely determination of symptoms-precursors of hypoglycemia, patients are much less at risk of developing this disease.
Patients with intercurrent diseases should not completely stop the administration of insulin. This category requires more intensive monitoring of blood glucose; in many cases, correction of the insulin dosing regimen is shown and urine studies for the presence of ketone bodies.
In the diet of patients with type 1 diabetes mellitus, at least a small amount of carbohydrates should be regularly present, including in the absence of the possibility of eating or taking it in small amounts, as well as in case of vomiting.
Application during pregnancy and lactation
The use of Lantus SoloStar is allowed during the gestation period according to clinical indications.
The research results indicate the absence of any undesirable specific effects on the course of pregnancy, as well as on the condition of the fetus or the health of the newborn.
A woman should inform her attending physician about the presence or planning of pregnancy.
It should be borne in mind that in the first trimester of pregnancy, the need for insulin may decrease, and in the second and third trimesters, it may increase.
Close monitoring of blood glucose concentration is required immediately after delivery due to the rapid decrease in insulin requirements.
During lactation, consideration should be given to adjusting the insulin dosing regimen and diet.
With pre-existing or gestational diabetes mellitus during pregnancy, it is necessary to maintain adequate regulation of metabolic processes during the entire period of gestation in order to prevent the occurrence of undesirable outcomes due to hyperglycemia.
Pediatric use
The appointment of Lantus SoloStar is contraindicated for children under 2 years of age.
There are no clinical data on the use of insulin glargine in children under 6 years of age.
In patients under the age of 18, reactions at the injection site and allergic reactions in the form of rash and urticaria occur relatively more often.
With impaired renal function
With impaired renal function, the processes of insulin elimination can be weakened, which leads to a decrease in the need for it.
For violations of liver function
It should be borne in mind that in severe hepatic insufficiency, the need for insulin may be reduced due to a slowdown in its biotransformation.
Use in the elderly
When prescribing Lantus SoloStar, elderly patients are advised to use lower initial doses, their increase to a maintenance dose should be slow. It should be borne in mind that in old age it is difficult to recognize the developing hypoglycemia.
The progressive deterioration of renal function in elderly patients can contribute to a persistent decrease in insulin requirements.
Drug interactions
- oral hypoglycemic agents, angiotensin-converting enzyme inhibitors, fluoxetine, disopyramide, fibrates, pentoxifylline, propoxyphene, monoamine oxidase inhibitors, sulfonamide antimicrobial agents, salicylates: may increase the hypoglycemic effect of insulin and increase the predisposition to hypoglycemia. Use caution and adjust the dose of insulin glargine as needed;
- danazol, diazoxide, glucocorticosteroids, diuretics, isoniazid, estrogens, glucagon, gestagens (including hormonal contraceptives), phenothiazine derivatives, somatotropin, sympathomimetics (including epinephrine or adrenaline, terbutaline, salbutamol, some thyroid hormone inhibitors) olanzapine, clozapine): may decrease the hypoglycemic effect of insulin;
- lithium salts, beta-blockers, clonidine, ethanol: can affect the hypoglycemic effect of insulin, weakening or increasing it;
- pentamidine: increases the risk of hypoglycemia, which can be followed by hyperglycemia.
Concomitant therapy with drugs with sympatholytic effect (including clonidine, beta-blockers, guanfacine, reserpine) with the development of hypoglycemia may partially or completely hide the signs of adrenergic counterregulation.
Analogs
Lantus SoloStar analogues are: Tujeo SoloStar, Biosulin P, Actrapid NM, Actrapid MS, Rosinsulin P, Vozulim-R, Gensulin P, Humodar P, Insulin MK, Monosuinsulin (MK, MP), Gansulin P, Insulin-Ferein Rapid ChRuman GT, NovoRapid Penfill, NovoRapid FlexPen, Humalog, etc.
Terms and conditions of storage
Keep out of the reach of children.
Store at 2–8 ° C in a dark place, do not freeze.
The used pen should be stored at temperatures up to 30 ° C, protected from light. After opening, the contents of the pen can be used within 4 weeks.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Lantus SoloStar
Reviews about Lantus SoloStar are positive. All patients note the clinical efficacy of the drug, ease of use, and a low incidence of adverse events. Indicate the need for strict compliance with all doctor's prescriptions. This is due to the fact that the introduction of insulin against a background of dietary disorders or excessive physical activity is not able to protect the patient from surges in blood sugar or the development of hypoglycemia.
Price for Lantus SoloStar in pharmacies
The price of Lantus SoloStar for a package containing 5 syringe pens, 3 ml each, can be 2937–3418 rubles.
Lantus SoloStar: prices in online pharmacies
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Drug name Price Pharmacy |
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Lantus SoloStar 100 U / ml solution for subcutaneous administration 3 ml 5 pcs. 2890 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
