LANTUS SoloStar

Active material: Insulin glargine
When ATH: A10AE04
CCF: A long-acting human insulin
ICD-10 codes (testimony): E10, E11
When CSF: 15.01.01.04
Manufacturer: SANOFI-AVENIS Germany GmbH (Germany)

Pharmaceutical form, composition and packaging

The solution for the p / to the introduction clear, colorless or near colorless.

Excipients: cresol (m-cresol), zinc chloride, glycerol (85%), Sodium hydroxide, hydrochloric acid, water d / and.

3 ml – flint glass cartridges (1) – spric-rucki SoloStar^® (5) – packs cardboard.

Pharmacological action

Insulin glargine is a human insulin analogue, received recombinant DNA bacteria species Escherichia coli (strains K12). It features a low solubility in a neutral environment. As part of Lantus^® SoloStar^® it is completely soluble, provided that the acidic medium solution for injection (pH = 4). After the introduction of subcutaneous fat solution because of its acidity reacts with the formation of neutralizing mikropretsipitatov, of which are constantly released small amounts of insulin glargine, providing a smooth (without peaks) profile curve “concentration-time”, as well as the prolonged effects of the drug.

Parameters binding to insulin receptors of insulin glargine and human insulin very close. Insulin glargine has a biological effect similar to endogenous insulin.

The most important action of insulin is the regulation of glucose metabolism. Insulin and its analogs lower blood glucose, stimulating glucose uptake by peripheral tissues (especially skeletal muscle and adipose tissue), and inhibiting glucose production in the liver (gluconeogenesis). Insulin inhibits lipolysis in adipocytes and proteolysis, while increasing protein synthesis.

Prolonged action of insulin glargina directly linked to reduced speeds its absorption, allowing you to use the drug 1 time / day. After p/to the introduction of the beginning of its activity there is, average, through 1 no. The average duration of 24 no, maximum – 29 no. Duration of insulin and its analogs (eg, insulin glargine) can vary significantly as in different patients, and one and the same patient.

Pharmacokinetics

A comparative study of concentrations of insulin glargine and insulin-Isophane after s / to the introduction in the serum of healthy people and patients with diabetes showed delayed significantly longer absorption, and no peak concentrations in insulin glargine compared with insulin isophane.

When s / c administration of the drug 1 time / day steady average concentration of insulin glargine in blood achieved through 2-4 SUT daily introduction.

The on / in a T_1/2 insulin glargine and human insulin are comparable.

The man in the subcutaneous fat insulin glargine was partially digested by the carboxyl terminus (From the end) The chain (beta chain) to form 21^A-Insulin and Gly- 21^A-Gly-des-30^B-Thr-insulin. The plasma contains both unmodified insulin glargine, and its cleavage products.

Testimony

- Diabetes, requiring insulin treatment, adult, adolescents and children over 6 years.

Dosage regimen

Adults and children over 6 years the drug is injected p/ 1 time / day, and always at the same time. Lantus^® SoloStar^® should be administered in subcutaneous fat belly, shoulder or hip. Injection site should be alternated at each new introduction of the drug within the recommended areas for s / c administration.

Dose and time of day for his conduct set individually. In patients with diabetes mellitus 2 type of Lantus^® SoloStar^® can be used as monotherapy, or in combination with other hypoglycemic drugs.

The transition from treatment other hypoglycemic drugs on lantus^® SoloStar^®

When transferring a patient with insulin or a long average duration to Lantus^® SoloStar^® It may require correction daily dose of basal insulin or antidiabetic therapy concomitant change (dosage and mode of administration of short-acting insulin or their analogues, as well as the dose of oral hypoglycemic drugs).

When transferring a patient with insulin-izofan twice on single administration of lantus^® SoloStar^® should reduce the daily dose of basal insulin 20-30% in the first weeks of treatment to reduce the risk of hypoglycemia during the night and early morning hours. During this period, a dose reduction Lantus ®^® should be compensated by increasing doses of short-acting insulin, followed by individual correction mode.

As with other analogs of human insulin, patients, receiving high doses of the drugs because of the presence of antibodies to human insulin, when switching to Lantus^® SoloStar^® may experience increased response to insulin. In the process of transition to Lantus^® SoloStar^® and during the first week after it requires careful control of blood glucose and if necessary – correction dosing regimen of insulin.

In the case of improving the regulation of metabolism and the resulting increase in insulin sensitivity may be a need for further correction mode. Dose adjustment may also be required, eg, Change in body weight, his lifestyle, the time of day for administration of the drug or when other circumstances, contributing to increased susceptibility to the development of hypo-- or hyperglycemia.

The drug should not be administered in /. In / in a normal dose, designed to s / c administration, It can cause the development of severe hypoglycemia.

Lantus^® SoloStar^® not to be confused with any other insulin or breeding. You must make sure, in syringes that do not contain residues of other drugs. When mixing or dilution could change action profile of insulin glargina in time. Mixing with other insulinami can cause precipitation.

The duration of action of Lantus^® SoloStar^® depends on the location where the p/to the introduction.

Terms of use and the treatment of previously completed spric-Rucka SoloStar^®

Before first use you must handle syringe-hold at room temperature 1-2 no.

Before use, inspect the cartridge inside the pen. It should be used only in case of, if the solution is clear, bestsveten, It does not contain visible particles and the consistency of water.

Empty spric-rucki SoloStar^® must not be reused and shall be destroyed.

To prevent infection pre-completed autoinjector must be used only in one patient and not transferable.

Before using spric-rucki SoloStar^® You should carefully read the information on the use of.

Before each use, be careful to connect a new needle to the syringe handle and test for safety. You only need to use needles, compatible with SoloStar^®.

You must take special precautions to avoid accidents, associated with the use of needles, and the ability to transfer the infection.

In any case do not use the syringe handle SoloStar^® When it is damaged or when the uncertainty in the, that it will work properly.

You should always have a spare syringe SoloStar pen^® in case of loss of or damage to your instance spric-rucki SoloStar^®.

If the autoinjector SoloStar^® stored in the refrigerator, You should get it for 1-2 hours before the alleged injection, that the solution adopted at room temperature. The introduction of refrigerated insulin is more painful. Used autoinjector SoloStar^® shall be destroyed.

Syringe pen SoloStar^® you want to protect from dust and dirt. Exterior spric-rucki SoloStar^® You can clear the, wiping it with a damp cloth. Do not immerse in liquid, cleaned and lubricated syringe SoloStar pen^®, Since this can damage the.

Autoinjector SoloStar^® the exact doses of insulin and is safe to work. It also requires careful treatment. To avoid situations, which can result in damage to the spric-rucki SoloStar^®. If you damage your instance spric-rucki SoloStar^®, You should use a new syringe pen.

Stage 1. Insulin control

You must check the label on the syringe handle SoloStar^® for, To make sure, that it contains the appropriate insulin. For Lantusa^®autoinjector SoloStar^®grey color with purple button for injection. After removing the cap of the syringe-knobs control the appearance of its insulin: insulin solution must be transparent, bestsveten, did not contain visible particles and the consistency to resemble water.

Stage 2. Attaching the needle

You only need to use needles, compatible with spric-Rucka SoloStar^®. For each subsequent injections always apply a new sterile needle. After removal of Cap m 5 needle syringe should be carefully installed on- handle.

Stage 3. Perform safety tests

Before each injection to test for safety and make sure, that the autoinjector and needle work well and air bubbles have been removed.

Measure the dose, equal 2 units.

The outer and inner needle caps should be removed.

Possessing a syringe pen needle up, gently tap on the insulin cartridge finger so, that all air bubbles are headed toward the needle.

Fully press the button of injection.

If insulin appears at the tip of the needle, it means, that the autoinjector and needle work correctly.

If the advent of insulin on the tip of the needle is not observed, the stage 3 may be repeated until, While insulin does not appear on the tip of the needle.

Stage 4. Dose selection

Dose can be determined with an accuracy of 1 units of the minimum dose (1 Unit) up to a maximum dose of (80 units). If you need to enter the dose, exceeding 80 units, should conduct 2 or more injection.

Dosing box should show “0” After completing safety tests. Then can be installed required dose.

Stage 5. Introduction dose

The patient should be informed about the technique of holding the injection by a medical worker.

You must enter the needle under the skin.

Injection button should be pressed completely. It is held in this position for another 10 seconds until the needle extraction. Thus the introduction of the selected dose insulin completely.

Stage 6. Removing and discarding needles

In all cases, the needle after each injection should be removed and discarded. This ensures that pollution prevention and/or infection, ingress of air into the insulin and insulin leaks.

When you uninstalled and discarded needles should be taken special precautions. Observe the recommended safety measures for removal and disposal of needles (eg, the technique of donning the CAP with one hand) for, to reduce the risk of accidents, associated with the use of needles, as well as preventing infection.

After removing the needle syringe should be closed-handle SoloStar^® Cap.

Side effect

Determination of the frequency of adverse reactions: Often (≥ 10%), often (≥ 1%, <10); sometimes (≥ 0.1%, < 1%); rarely (≥ 0.01%, < 0.1%), rarely (< 0.01%).

Side effects, related to the effect on carbohydrate metabolism: Often – gipoglikemiâ (especially in the case of, if the insulin dose exceeds the demand for it).

Symptoms gipoglikemii usually occur suddenly. Often, however, against the background of violations nejroglikopenii psycho-neurological (feeling tired, unusual fatigue or weakness, decreased ability to concentrate, drowsiness, visual disturbances, headache, nausea, confusion or its loss, convulsions) usually preceded by symptoms of adrenergic counterregulation (activation of the sympathoadrenal system in response to hypoglycemia): hunger, irritability, nervous agitation or tremor, anxiety, pale skin, “cold” sweat, tachycardia, expressed palpitation (Hypoglycemia develops faster and harder than she, the more pronounced the symptoms of adrenergic counterregulation).

Attacks of severe hypoglycemia, especially repetitive, can lead to shock the nervous system. Episodes long and expressed hypoglycemia may endanger patients' lives, tk. at increasing Hypoglycemia is possible even fatal.

Allergic reactions: rarely – immediate type allergic reactions to insulin (including insulin glargine) or formulation auxiliary components – generalized skin reactions, angioedema, bronchospasm, hypotension, shock. These reactions can be life-threatening patient.

The use of insulin can induce the formation of antibodies thereto. Antibody formation, cross-react with human insulin, observed with the same frequency when applying insulin-izofana and insulin glargina. In rare cases, the presence of antibodies to insulin may necessitate dose adjustment in order to eliminate the tendency to the development of hypo- or hyperglycemia.

From the nervous system: rarely – disgevziya.

On the part of the organ of vision: rarely – visual impairment, retinopathy.

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

The long-term normalization of blood glucose reduces the risk of progression of diabetic retinopathy. Against the background of insulin, accompanied by sharp fluctuations in blood glucose, possible temporary worsening of diabetic retinopathy. Patients with proliferative retinopathy, especially untreated photocoagulation, episodes of severe hypoglycemia can lead to the development of transient loss of vision.

Dermatological reactions: often – as well as in the treatment of any other insulin preparations, vozmozhnы lipodystrophy (1-2%) and delay local insulin absorption; sometimes – lipoatrophy. Constant change of the injection site within the body regions, recommended for s / c insulin, It can reduce the severity of this reaction or prevent its development.

On the part of the musculoskeletal system: rarely – myalgia.

Metabolism: rarely – sodium retention, swelling (especially, If Intensified insulin therapy leads to an improvement in the previously inadequate regulation of metabolic processes).

Local reactions: often (3-4%) – redness, pain, itch, hives, swelling or inflammation at the injection site. In most cases, minor reactions resolved within a period of from several days to several weeks.

The safety profile for patients younger than 18 years, in General, similar security profile for patients over 18 years. In patients younger than 18 years of relatively more likely to have injection site reactions and skin reactions (rash, hives). The safety data in children under 6 missing years.

Contraindications

- Children up to age 6 years (the lack of clinical data on the use of);

-increased sensitivity to insulino glarginu or any of the supporting components of the drug.

FROM caution the drug should be used during pregnancy (the ability to change the need for insulin during pregnancy and after childbirth).

Pregnancy and lactation

Caution should be used Lantus^® SoloStar^®Pregnancy. Mandatory careful monitoring of blood glucose.

For patients with previously existing or gestational diabetes mellitus during pregnancy it is important to maintain glycemic control. In the I trimester of pregnancy, insulin requirements may be reduced, in II and III trimesters – increase. Immediately after delivery insulin requirements decreased, and therefore increases the risk of hypoglycemia. Under these conditions is essential careful monitoring of blood glucose.

IN experimental studies animal has been received direct or indirect data embryotoxic or foetotoxic effect of insulin glargine.

Controlled clinical studies safety of Lantus^®SoloStar^® when pregnancy has not been so far. There is evidence of the use of Lantus ®^®SoloStar^® in 100 Pregnant women with diabetes. The course and outcome of pregnancy in these patients did not differ from those of pregnant women with diabetes, receiving other insulin preparations.

In women during the period of breast-feeding may require correction dosing regimen of insulin and diet.

Cautions

Lantus^® SoloStar^® not the drug of choice for the treatment of diabetic ketoacidosis. In such cases, in / in a short-acting insulin.

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

In patients with renal impairment, insulin requirements may be reduced due to the weakening of its elimination. Elderly patients progressive deterioration of renal function may lead to a permanent reduction in insulin requirements.

In patients with severe hepatic insufficiency need for insulin may be reduced due to the reduced capacity for glûkoneogenezu and deceleration of biotransformation of insulin.

In the case of poor control of glucose levels in the blood, as well as a trend towards the development of hypo- or hyperglycemia, before embarking on the correct dosing regimen, check the accuracy of compliance with prescribed regimens, Places of administration and technology literate of s / c injection, taking into account all the factors affecting.

Gipoglikemiâ

Time of hypoglycemia depends on the action profile of insulin and may be used, thus, changed by changing the treatment regimen. Due to the increase of time of exposure of long-acting insulin Lantus ® when used^® SoloStar^®, expect less likelihood of nocturnal hypoglycemia, whereas in the early hours of this probability is higher. In the event of hypoglycemia in patients, receiving Lantus^® SoloStar^®, should consider the possibility of slowing down the output from the state of hypoglycaemia due to the prolonged action of insulin glargine.

Patients, who have hypoglycemia may be of particular clinical relevance, incl. in severe stenosis of the coronary arteries or blood vessels of the brain (the risk of cardiac and cerebral complications of hypoglycaemia), as well as patients with proliferative retinopathy, especially if they do not receive treatment photocoagulation (risk of transient loss of vision due to hypoglycemia), should take special precautions and carefully monitored blood glucose.

Patients should be warned about the states, in which the symptoms of hypoglycemia-precursors may be reduced, be less pronounced or be absent in certain risk groups, which include:

- Patients, which significantly improved the regulation of blood glucose;

- Patients, who hypoglycaemia develops gradually;

- Elderly patients;

- Patients, Translated animal insulin to human insulin;

- Patients with neuropathy;

- Patients with a long history of diabetes;

- Patients, mental disorders;

- Patients, receiving concomitant treatment with other drugs.

Such situations can lead to the development of severe hypoglycemia (with possible loss of consciousness) before that, the patient understands, he develops hypoglycemia.

When, If there is normal or reduced performance of glycated hemoglobin, you must consider the possibility of repeating unrecognized hypoglycemia (especially at night).

Respect for patient dosing, diet and nutrition, the correct use of insulin and control symptoms of hypoglycemia contributed significantly reduce the risk of hypoglycaemia. In the presence of factors, increase susceptibility to hypoglycaemia, It must be particularly careful observation, tk. may require dose adjustment of insulin. These factors include:

- Change of insulin;

- Increase insulin sensitivity (eg, while eliminating stress factors);

- Unaccustomed, increased or prolonged physical activity;

- Intercurrent illness, accompanied by vomiting, diarrhea;

- Violation of diet and nutrition;

- Skipping meals;

- Alcohol consumption;

- Certain uncompensated endocrine disorders (eg, gipotireoz, lack of anterior pituitary or the adrenal cortex);

- Other concomitant therapy with certain drugs.

Intercurrent disease

When intercurrent diseases require more intensive control of blood glucose. In many cases, the analysis indicated the presence of ketone bodies in urine, often requires correction dosing regimen of insulin. Insulin requirements often increases. Diabetics type 1 We should continue to regular consumption, at least, a small amount of carbohydrates, even when eating only in small amounts, or without the possibility to eat, and at vomiting. These patients should never completely stop insulin.

Overdose

Symptoms: sometimes heavy and prolonged hypoglycemia, threatening the life of the patient.

Treatment: episodes of moderate hypoglycemia usually cropped by ingestion of fast utilizable carbohydrates. It may be necessary to change the dosing of the drug, diet and physical activity.

Episodes of more severe hypoglycemia, accompanied by coma, convulsions or neurological disorders, demand / m or s / c injection of glucagon, and / in the introduction 40% dextrose. You may need long-term use of carbohydrates and surveillance specialist, tk. possible recurrence of hypoglycaemia after apparent clinical improvement.

Drug Interactions

Oral hypoglycemic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoksyfen, salitsilatы and sulyfanilamidnыe protivomikrobnыe means Mughals usility gipoglikemicheskoe insulin action and povыsity predraspolozhennosty k razvitiyu gipoglikemii. In these combinations may require dose adjustment of insulin glargine.

GCS, danazol, diazoksid, Diuretic, glucagon, Isoniazid, Estrogens, progestins, phenothiazines, somatotropin, sympathomimetic (eg, epinephrine, salbutamol, terbutaline), thyroid hormones, protease inhibitors, Some antipsychotics (eg, olanzapine or clozapine) may reduce the hypoglycemic effect of insulin. In these combinations may require dose adjustment of insulin glargine.

With simultaneous use of Lantus^® SoloStar^® with beta-blockers, clonidine, lithium salts, ethanol as a possible enhancement, and the weakening of the hypoglycemic action of insulin. Pentamidine in combination with insulin can cause hypoglycaemia, which is sometimes replaced by hyperglycemia.

In an application with drugs, having sympatholytic action, such as beta- adrenoblokatorы, klonidin, guanfacine and reserpine may decrease or absence of signs of adrenergic counterregulation (Activation of the sympathetic nervous system) the development of hypoglycemia.

Pharmaceutical interaction

Lantus^® SoloStar^® should not be mixed with other insulin preparations, with any other drugs or breed. When mixing or breeding may change the profile of its actions in time, Besides, A mixture with other insulin can cause precipitation.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children, dark place at a temperature of 2 ° to 8 ° C; Do not freeze. Shelf life – 3 year.

When storing of lantus^® SoloStar^® in the refrigerator you want to monitor, that containers do not directly come into contact with the refrigeration compartment or frozen packages.

Used disposable SoloStar spric-rucki^® should be stored in a dark place at a temperature of no higher than 25° c. Pre-filled syringe SoloStar pen^® should not be cool. Before using the syringe handle Lantus^® SoloStar^® should be kept at room temperature 1-2 no.

Shelf life in disposable syringe handle SoloStar^® After the first use – 4 of the week. It is recommended that you mark the date on the label of the first injection.