Lantus Solostar solution for s/c injection 100 units/ml syringe pen 3 ml №5

Injection

Composition

In 1 ml of the solution for the s / c injection contains: insulin glargine 100 U (36378 mg).

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

Packaging

In 1 colorless glass cartridge 3 ml solution. In 1 syringe pen Solostar 1 cartridge. In a pack of cardboard 5 syringe pens.

Mechanism of action

Lantus Solostar - syringe pen with Insulin glargine. Insulin glargine is an analogue of human insulin, obtained by recombining the DNA of bacteria of the species Escherichia coli (strains K12). Differs in low solubility in the neutral environment. It is completely soluble in the composition of the drug Lantus SoloStar, which is ensured by the acidic medium of the injection solution (pH = 4). After injection into the subcutaneous fatty tissue, the solution, due to its acidity, enters into a neutralization reaction with the formation of micro-precipitates, from which small amounts of insulin glargine are constantly released, providing a smooth (no peak) profile of the concentration-time curve, as well as a prolonged effect of the drug.

The parameters for binding to insulin receptors of insulin glargine and human insulin are very close, so 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 analogues reduce blood glucose by stimulating glucose uptake by peripheral tissues (especially skeletal muscle and adipose tissue), as well as inhibiting glucose formation in the liver (gluconeogenesis). Insulin inhibits lipolysis in adipocytes and proteolysis, while simultaneously enhancing protein synthesis.

The prolonged action of insulin glargine is directly caused by the reduced rate of its absorption, which allows the use of the drug 1 time / day. After s / c administration, the onset of its action is observed, on average, after 1 h. The average duration of action is 24 hours, the maximum is 29 hours. The duration of action of insulin and its analogues (for example, insulin glargine) can vary significantly from one patient to another. and in the same patient.

Indications and usage

Diabetes mellitus requiring insulin treatment in adults, adolescents, and children over 6 years of age.

Contraindications

Children's age up to 6 years, due to the lack of clinical data on the application.
Hypersensitivity to the drug.

With caution should use the drug during pregnancy (the possibility of changing the need for insulin during pregnancy and after childbirth).

Pregnancy and Breastfeeding

Caution should be used Lantus SoloStar during pregnancy. Required careful monitoring of blood glucose levels.

For patients with previous or gestational diabetes, it is important to maintain glycemic control throughout pregnancy. In the first trimester of pregnancy, the need for insulin may decrease, and in the second and third trimesters it may increase. Immediately after birth, the need for insulin is reduced, and therefore the risk of hypoglycemia increases. Under these conditions, careful control of blood glucose is essential.

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

Controlled clinical studies on the safety of the drug Lantus SoloStar during pregnancy have not been conducted to date. 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 in pregnant women with diabetes who received other insulin preparations.

In women during breastfeeding, it may be necessary to adjust the insulin dosage regimen and diet.

Dosage and administration

Adults and children over 6 years old, the drug is administered n / a 1 time / day, always at the same time. Lantus SoloStar should be injected into the subcutaneous fatty tissue of the abdomen, shoulder, or thigh.Places for injection should alternate with each new injection of the drug within the recommended areas for sc injection of the drug. The dose of the drug and the time of day for its administration are set individually. In patients with type 2 diabetes, Lantus SoloStar can be used both as monotherapy and in combination with other hypoglycemic drugs.

When transferring a patient from insulin with a long or medium duration of action to Lantus SoloStar, it may be necessary to adjust the daily dose of basal insulin or change the concomitant antidiabetic therapy (doses and mode of administration of short-acting insulin or their analogues, as well as doses of oral hypoglycemic drugs). When transferring a patient from a double injection of insulin-isophane to a single dose of Lantus SoloStar, the daily dose of basal insulin should be reduced by 20-30% in the first weeks of treatment in order to reduce the risk of hypoglycemia during the night and early morning hours. During this period, a reduction in the dose of Lantus should be compensated for by increasing the doses of short-acting insulin followed by an individual correction of the dosing regimen. As with the use of other human insulin analogues, in patients receiving high doses of drugs due to the presence of antibodies to human insulin, when switching to Lantus Solostar, an increase in the response to insulin administration can be observed.During the transition to Lantus SoloStar and in the first weeks after it, careful monitoring of blood glucose and, if necessary, correction of insulin dosing regimen is required. In the case of improved regulation of the metabolism and the resulting increase in insulin sensitivity, further correction of the dosing regimen may be necessary. Dose adjustment may also be required, for example, when the patient's body weight, lifestyle, time of day for administration of the drug or other circumstances that increase the susceptibility to the development of hypo-or hyperglycemia.

The drug should not be administered in / in. In / in the introduction of the usual dose, intended for s / to the introduction, can cause the development of severe hypoglycemia.

Lantus SoloStar should not be mixed with other insulin preparations or diluted. You must ensure that the syringes do not contain residues of other drugs. When mixed or diluted, the action profile of insulin glargine may change over time. Mixing with other insulins can cause precipitation.

The duration of action of the drug Lantus SoloStar depends on the localization of the place of his s / to the introduction.

Terms of use of pre-filled syringe pens SoloStar: Before first use the syringe pen should be held at room temperature for 1-2 hours. Before use, inspect the cartridge inside the syringe pen.It should be used only if the solution is clear, colorless, does not contain visible solid particles and resembles water in consistency. Empty SoloStar syringe pens should not be reused and should be destroyed. To prevent infection, a pre-filled syringe pen should be used only by one patient and not transferred to another person. Before using the SoloStar syringe pen, you should carefully read the information on use. Before each use, you need to carefully connect the new needle to the pen and perform a safety test. Only needles that are compatible with SoloStar should be used. Special precautions must be taken to avoid needle-related accidents and the possibility of infection transmission. In no case should the SoloStar syringe handle be used when it is damaged or if it is unsure that it will work properly. You should always have a spare SoloStar syringe pen available in case of loss or damage to the existing SoloStar syringe pen. If the SoloStar pen is kept in the refrigerator, it should be taken 1-2 hours before the intended injection so that the solution reaches room temperature. The introduction of chilled insulin is more painful. Used SoloStar pen should be destroyed. The syringe handle SoloStar must be protected from dust and dirt. The outside of the SoloStar syringe can be cleaned by wiping it with a damp cloth. Do not immerse in a liquid, rinse and lubricate the Solostar syringe pen, as this can damage it. The syringe handle SoloStar precisely doses insulin and is safe in work. It also requires careful handling. Situations in which damage to the SoloStar syringe pen may occur should be avoided. If you suspect damage to an existing copy of the SoloStar syringe pen, you should use a new syringe pen.
Stage 1. Insulin Monitoring You need to check the label on the SoloStar syringe pen to make sure that it contains the appropriate insulin. For Lantus, the SoloStar syringe pen is gray with a purple button for injection. After removing the cap of the syringe, the pens control the appearance of the insulin contained in it: the insulin solution must be clear, colorless, free of visible solid particles and resemble water in consistency.

Stage 2. Needle connection. Only needles that are compatible with the SoloStar syringe pen should be used. For each subsequent injection, always use a new sterile needle. After removing the cap, the needle must be carefully installed on the pen.

Stage 3. Performing a safety test Before the introduction of each injection, it is necessary to carry out a safety test and make sure that the pen and needle work well and the air bubbles are removed. Measure out the dose equal to 2 units. The outer and inner needle caps must be removed.Positioning the needle with a needle up, gently tap on the insulin cartridge with your finger so that all the air bubbles are directed towards the needle. Fully press the injection button. If insulin appears at the tip of the needle, this means that the pen and needle work correctly. If insulin does not appear at the needle tip, then stage 3 can be repeated until insulin appears at the needle tip.

Stage 4. Dose Selection A dose can be set with an accuracy of 1 unit from the minimum dose (1 unit) to the maximum dose (80 units). If a dose of more than 80 units is needed, 2 or more injections should be given. The dosing window should show “0” after completing the safety test. After that the necessary dose can be established.

Stage 5. Dose Administration The patient should be informed about the injection technique by a medical professional. The needle must be inserted under the skin. The injection button must be fully depressed. 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.

Stage 6. Extraction and ejection of the needle In all cases, the needle after each injection must be removed and discarded. This ensures the prevention of contamination and / or the introduction of infection, the ingress of air into the insulin container and insulin leakage.Special care should be taken when removing and discarding the needle. Follow the recommended safety precautions for removing and discarding needles (for example, using one hand to put the cap on) to reduce the risk of needle-related accidents and to prevent infection. After removing the needle, close the Solostar syringe with a cap.

Side effects associated with the effect on carbohydrate metabolism: very often - hypoglycemia (especially if the insulin dose exceeds the need for it). Symptoms of hypoglycemia usually occur suddenly. However, neuroglycopenia (feeling tired, unusual fatigue or weakness, diminished ability to concentrate, drowsiness, visual disturbances, headache, nausea, confusion or his loss, convulsive syndrome) are often preceded by symptoms of adrenergic counterregulation (activation of the sympathoadrenal system). in response to hypoglycemia): feeling of hunger, irritability, nervous agitation or tremor, anxiety, pallor of the skin, "cold" n from, tachycardia, marked heartbeat (the faster hypoglycemia develops and the harder it is, the more pronounced the symptoms of adrenergic counterregulation). Attacks of severe hypoglycemia, especially recurring, can lead to damage to the nervous system. Episodes of prolonged and severe hypoglycemia can threaten the lives of patients, becausewith an increase in hypoglycemia, even fatal outcome is possible.

Allergic reactions: rarely - immediate-type allergic reactions to insulin (including insulin glargine) or auxiliary components of the drug - generalized skin reactions, angioedema, bronchospasm, arterial hypotension, shock. These reactions may pose a threat to the patient's life. The use of insulin can cause the formation of antibodies to it. The formation of antibodies that cross-reacted with human insulin was observed with the same frequency when insulin isophane and insulin glargine were used. In rare cases, the presence of such antibodies to insulin may necessitate dose adjustment in order to eliminate the tendency to develop hypo- or hyperglycemia.

From the nervous system: very rarely - dysgeusia.

On the part of the organ of vision: rarely - visual disturbances, retinopathy. Significant changes in the regulation of glucose in the blood can cause temporary visual impairment due to changes in tissue turgor and the index of refraction of the lens of the eye. Long-term normalization of blood glucose reduces the risk of progression of diabetic retinopathy. On the background of insulin therapy, accompanied by sharp fluctuations in blood glucose, a temporary deterioration in the course of diabetic retinopathy is possible. 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.

Dermatological reactions: often (1-2%) - as with the treatment of any other insulin preparations, lipodystrophy is possible, which can slow down the local absorption of insulin. Sometimes - lipoatrophy. A constant change of injection sites within the areas of the body recommended for subcutaneous injection of insulin may help reduce the severity of this reaction or prevent its development.

From the musculoskeletal system: very rarely - myalgia.

Metabolism: rarely, sodium retention, edema (especially if intensified insulin therapy leads to an improvement in previously insufficient regulation of metabolic processes).

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

The safety profile for patients under 18 is generally similar to the safety profile for patients over 18. In patients younger than 18 years old, the reactions at the injection site and skin reactions (rash, urticaria) occur more frequently. Safety data for children under 6 years old is not available.

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

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

In the case of ineffective control over the level of glucose in the blood, as well as if there is a tendency to develop hypo- or hyperglycemia, before proceeding with the correction of the dosing regimen, you should check the accuracy of adherence to the prescribed treatment regimen, drug injection sites and proper injection technique. , considering all factors affecting it.

Hypoglycemia: The time of development of hypoglycemia depends on the action profile of the insulin used and can, therefore, change when the treatment regimen changes. Due to the prolonged intake of long-acting insulin when using the drug Lantus SoloStar, we should expect less likelihood of developing nighttime hypoglycemia, whereas in the early morning hours this probability is higher. If hypoglycemia occurs in patients receiving Lantus Solostar, consider the possibility of slowing the release of hypoglycemia due to the prolonged action of insulin glargine. In patients in whom episodes of hypoglycemia may have particular clinical significance, including with severe stenosis of the coronary arteries or cerebral vessels (risk of cardiac and cerebral complications of hypoglycemia), as well as patients with proliferative retinopathy, especially if they do not receive photocoagulation treatment (risk of transient loss of vision due to hypoglycemia), special precautions should be observed and carefully monitored blood glucose. Patients should be warned about conditions in which symptoms-precursors of hypoglycemia may decrease, become less pronounced or be absent in certain risk groups, which include: patients who have markedly improved blood glucose regulation; patients in whom hypoglycemia develops gradually; elderly patients; patients transferred from animal insulin to human insulin; patients with neuropathy; patients with a long course of diabetes; patients with 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 the patient realizes that he develops hypoglycemia.

If normal or reduced glycated hemoglobin levels are noted, the possibility of recurring unrecognized episodes of hypoglycemia (especially at night) must be considered.

Patient adherence to the dosing regimen, diet and diet, the proper use of insulin, and control of the onset of symptoms of hypoglycemia contribute to a significant reduction in the risk of hypoglycemia. In the presence of factors that increase the predisposition to hypoglycemia, especially careful observation is necessary, since may require a dose adjustment of insulin.These factors include: changing the place of insulin administration; increased insulin sensitivity (for example, while eliminating stress factors); unusual, increased or prolonged physical activity; intercurrent diseases involving vomiting, diarrhea; violation of diet and diet; skipped meals; alcohol consumption; some uncompensated endocrine disorders (for example, hypothyroidism, insufficiency of the adenohypophysis or the adrenal cortex); concomitant treatment with some other drugs.

For intercurrent diseases, more intensive monitoring of blood glucose is required. In many cases, analysis of the presence of ketone bodies in the urine is shown, and often correction of the insulin dosing regimen is required. The need for insulin often increases. Patients with diabetes mellitus type 1 should continue to regularly consume at least a small amount of carbohydrates, even when eating only in small amounts or when there is no possibility to eat food, as well as vomiting. These patients should never completely stop administering insulin.

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

In patients with impaired renal function, the need for insulin may decrease due to the weakening of its elimination processes.

In older patients, progressive deterioration in renal function may lead to a persistent decrease in insulin requirements.

Oral hypoglycemic agents, ACE inhibitors, disopyramide, fibrates, Fluoxetine , MAO inhibitors , Pentoxifylline , propoxyphene, salicylates, and sulfanilamide antimicrobial agents can increase the hypoglycemic effect of insulin and increase the susceptibility to the development of hypoglycemia. With these combinations, you may need a dose adjustment of insulin glargine.

GCS, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens, gestagens, phenothiazine derivatives, somatotropin, sympathomimetics (for example, epinephrine, Salbutamol , terbutaline), thyroid hormones, inhibitors of proteases, some neuroleptics (olanepathy, olantamol, terbutaline), thyroid gland hormones, proteases inhibitors, some neuroleptics (for example, olantamin, terbutaline) hypoglycemic effect of insulin. With these combinations, you may need a dose adjustment of insulin glargine.

With simultaneous use of the drug Lantus SoloStar with beta-blockers, clonidine, lithium salts, ethanol, it is possible both to strengthen and weaken the hypoglycemic effect of insulin.

Pentamidine when combined with insulin can cause hypoglycemia, which is sometimes replaced by hyperglycemia.

With simultaneous use with drugs that have a sympatolytic effect, such as beta-blockers, clonidine, guanfacine and reserpine, it is possible to reduce or absence of signs of adrenergic counter-regulation (activation of the sympathetic nervous system) with the development of hypoglycemia.

Lantus SoloStar should not be mixed with other insulin preparations, with any other drugs or diluted. When mixed or diluted, the profile of its action over time may change; in addition, mixing with other insulins may cause precipitation.

Symptoms: moderate and severe hypoglycemia, accompanied by coma, convulsions or neurological disorders.
Treatment: episodes of moderate hypoglycemia are usually stopped by ingesting fast-absorbing carbohydrates. It may be necessary to change the dosage regimen of the drug, diet or physical activity. Episodes of more severe hypoglycemia, accompanied by coma, convulsions, or neurological disorders, require IM or GI injection of glucagon, as well as intravenous administration of a concentrated dextrose solution. May require long-term carbohydrate intake and specialist supervision, because possible recurrence of hypoglycemia after apparent clinical improvement.

Store in a dark place at a temperature of from 2 ° to 8 ° C; do not freeze. When storing the drug Lantus SoloStar in the refrigerator you need to ensure that the containers do not directly come into contact with the freezer compartment or frozen packages. Solosstar disposable syringe pens should be stored in a dark place at a temperature not exceeding 25 ° C.Pre-filled syringe pen SoloStar should not be cooled. Before first use, the Lantus SoloStar syringe pen should be kept at room temperature for 1-2 hours. It is recommended to mark the date of the first injection of the drug on the label.

3 years. The shelf life of the drug in a disposable pen SoloStar after the first use is 4 weeks.