Apidra SoloStar
Apidra 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: Apidra SoloStar
ATX code: A10AB06
Active ingredient: insulin glulisine (Insulinum glulisinum)
Manufacturer: Sanofi-Aventis Vostok, CJSC (Russia), Sanofi-Aventis Deutschland, GmbH (Sanofi-Aventis Deutschland, GmbH) (Germany)
Description and photo update: 2019-10-07
Prices in pharmacies: from 2015 rubles.
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Apidra SoloStar is a hypoglycemic drug for subcutaneous administration, a short-acting insulin analogue.
Release form and composition
Dosage form - solution for s / c (subcutaneous) administration: transparent, almost colorless or colorless (in a cardboard box 5 cartridges of colorless transparent glass, 3 ml each, mounted in disposable syringe pens, and instructions for use of Apidra SoloStar).
Composition of 1 ml solution:
- active substance: insulin glulisine - 100 units (units of action) (3.49 mg);
- auxiliary components: hydrochloric acid, m-cresol (m-cresol), sodium hydroxide, polysorbate 20, tromethamine (trometamol), sodium chloride, water for injection.
Pharmacological properties
Pharmacodynamics
Insulin glulisine - the active substance of Apidra SoloStar - is a recombinant analogue of human insulin, in terms of the effect it is equal to ordinary human insulin. The therapeutic effect of insulin glulisine after subcutaneous administration develops faster, the duration of the effect is shorter than with the use of soluble human insulin.
The most important action of insulin and its analogs, including insulin glulisine, is the regulation of glucose metabolism. Insulin helps to reduce the concentration of glucose in the blood, which occurs by stimulating the absorption of glucose by peripheral tissues, especially adipose tissue and skeletal muscle, as well as inhibiting the formation of glucose in the liver.
Insulin inhibits proteolysis and lipolysis in adipocytes and increases protein biosynthesis. According to the results of studies conducted in healthy volunteers and patients with diabetes (diabetes mellitus), insulin glulisine, when administered subcutaneously, begins to act faster than soluble human insulin. On average, it begins to develop in 10–20 minutes. The effects of decreasing blood glucose levels of soluble human insulin and insulin glulisine when administered intravenously do not differ in strength. 1 U of insulin glulisine has the same glucose-lowering activity as 1 U of soluble human insulin.
In phase I studies in patients with type 1 diabetes, the glucose-lowering profile of insulin glulisine and soluble human insulin was assessed, which were administered subcutaneously at different times at a dose of 0.15 U / kg relative to a standard 15-minute meal. According to the results obtained, insulin glulisine administered 2 minutes before a meal provides the same glycemic control after a meal as soluble human insulin administered 30 minutes before a meal. Insulin glulisine, when administered 2 minutes before a meal, provides better glycemic control after a meal, compared to soluble human insulin given 2 minutes before a meal. Injected 15 minutes after the start of a meal, insulin glulisine provides the same glycemic control after a meal as soluble human insulin.which is introduced 2 minutes before meals.
A phase I study conducted in a group of obese patients using insulin glulisine, insulin lispro and soluble human insulin demonstrated that insulin glulisine retained its rapid-response characteristics in this group of patients. The time to reach 20% of the total AUC (area under the concentration-time curve) and AUC (0-2 h) (also reflects early glucose-lowering activity) in this study was (respectively):
- insulin glulisine: 114 minutes; 427 mg / kg;
- insulin lispro: 121 minutes; 354 mg / kg;
- soluble human insulin: 150 minutes; 197 mg / kg.
Also, clinical studies were conducted in patients with type 1 and type 2 diabetes, comparing the effectiveness of the drug with other insulins.
During a 26-week phase III clinical trial in type 1 diabetes, the effects of insulin glulisine and insulin lispro were compared. Both drugs were administered shortly before meals (0-15 minutes) n / a. Comparable blood glucose values were noted. Unlike insulin lispro, when using insulin glulisine, an increase in the basal insulin dose was not required.
Also, on the basis of a 12-week phase III clinical study, the comparability of the effectiveness of insulin glulisine administration immediately after meals with that when it was used before meals (0-15 minutes) or the introduction of soluble human insulin 30-45 minutes before meals was confirmed.
In type 2 diabetes, a phase III study was conducted to compare insulin glulisine with soluble human insulin administered subcutaneously to patients who also used insulin-isophane as basal. Most of the patients in this study mixed their short-acting insulin with isophane insulin just before injection. Compared to soluble human insulin, insulin glulisine showed a greater decrease in HbA 1c concentration from baseline.
In patients with type 1 diabetes with continuous infusion s / c administration of insulin using a pump device, the frequency of catheter occlusion with insulin glulisine and insulin aspart was low.
Pharmacokinetics
A faster absorption is facilitated by the substitution of the amino acid asparagine of human insulin in position B3 for lysine and lysine in position B29 for glutamic acid in insulin glulisine.
Pharmacokinetic curves of AUC in patients with type 1 and 2 diabetes and healthy volunteers demonstrated that the absorption of insulin glulisine in comparison with soluble human insulin was approximately 2 times faster with reaching up to twice the C max (maximum concentration of the substance).
According to the results of a study involving patients with type 1 diabetes, T max (time to reach the maximum concentration of the substance) after administration of insulin glulisine at a dose of 0.15 U / kg s.c. and soluble human insulin was 55 and 82 minutes, respectively, and C max in plasma - 82 ± 1.3 and 46 ± 1.3 μU / ml. Insulin glulisine has a shorter average residence time in the systemic circulation than normal human insulin (98 and 161 minutes, respectively).
In patients with type 2 diabetes after administration of 0.2 U / kg insulin glulisine sc C max is 91 μU / ml with an interquartile range in the range of 78-104 μU / ml.
Faster absorption is noted after the introduction of Apidra SoloStar into the anterior abdominal wall, in comparison with the introduction of the drug into the thigh. The absolute bioavailability of insulin glulisine is approximately 70% (from the anterior abdominal wall - 73%, from the deltoid muscle - 71%, from the thigh area - 68%), this indicator has low individual variability.
After intravenous administration, the distribution and excretion of insulin glulisine and soluble human insulin are similar and are, respectively: V d (volume of distribution) - 13 and 22 liters, T 1/2 (half-life) - 13 and 18 minutes.
In comparison with soluble human insulin, insulin glulisine after SC administration is excreted faster (apparent T 1/2 is 86 and 42 minutes, respectively). In healthy individuals and in patients with type 1 and 2 diabetes, the apparent T 1/2 of insulin glulisine in cross-sectional analysis of studies was in the range of 37–75 minutes.
In patients with renal insufficiency, the need for insulin may be reduced. In case of impaired hepatic function, pharmacokinetic parameters have not been studied.
There is very limited information on the pharmacokinetics of insulin glulisine in elderly patients with diabetes.
In children with type 1 diabetes, the pharmacokinetics and pharmacodynamics of insulin glulisine were studied in two age groups - 7-11 and 12-16 years. Rapid absorption of the substance was noted in both groups, and the values of C max and T max were similar to those in adults. As in adult patients, insulin glulisine, when administered immediately prior to a meal test, provided better postprandial blood glucose control than soluble human insulin.
Indications for use
Apidru SoloStar is prescribed for the treatment of diabetes mellitus requiring the use of insulin.
Contraindications
Absolute:
- hypoglycemia;
- age up to 6 years;
- individual intolerance to the components of the drug.
A relative contraindication (Apidra SoloStar is prescribed under medical supervision) is pregnancy.
Apidra SoloStar, instructions for use: method and dosage
Apidra SoloStar solution is administered s / c 0-15 minutes before meals or shortly after meals.
The drug is prescribed in treatment regimens that include either intermediate-acting insulin, long-acting insulin, or a long-acting insulin analog. Also Apidru SoloStar can be used in combination with oral hypoglycemic agents.
The dosage regimen should be selected individually.
The introduction of the Apidra SoloStar solution can occur in the form of a subcutaneous injection or a continuous infusion into the subcutaneous fat using a pump system.
Places of drug injection:
- s / c injection: in the area of the anterior abdominal wall, thigh or shoulder;
- continuous infusion: into the anterior abdominal wall.
With each new administration of the drug, the indicated injection / infusion sites must be alternated. The site of administration of Apidra SoloStar, physical activity and other changing conditions can affect the onset and duration of the drug. With subcutaneous injection into the abdominal wall, a slightly faster absorption is noted than with the introduction into the other areas of the body mentioned above.
In order to avoid getting Apidra SoloStar directly into the blood vessels, precautions must be taken. Do not massage the injection area. Patients need to follow the correct injection technique.
Insulin glulisine can be mixed with human isophane insulin, with Apidra SoloStar being drawn first into the syringe. S / C injection should be done immediately after mixing. Mixed insulins cannot be administered intravenously.
When carrying out a continuous subcutaneous infusion, Apidru SoloStar should not be mixed with other drugs, including insulins or solvents.
If necessary, the drug can be removed from the cartridge of the syringe pen and used for injection using a pump device for continuous subcutaneous insulin infusion.
The infusion set and reservoir used with the medication should be replaced at least every 48 hours in an aseptic manner. These recommendations may differ from the general instructions in the pump manuals. However, if these special recommendations are not followed, serious adverse events may develop.
It is necessary to take into account the possibility of breakage of the pump device used, for which there should be alternative systems for the administration of the drug and be able to correctly inject the p / c agent.
Due to a malfunction of the pump device, a malfunction of the infusion set, or an error in handling them, hyperglycemia, diabetic ketoacidosis and ketosis may develop rapidly. In such cases, it is necessary to quickly identify and eliminate the causes of these undesirable phenomena.
Instructions for the correct handling of pre-filled syringes must be followed carefully.
The syringe should be kept at room temperature for 1-2 hours before use (the use of refrigerated insulin is more painful). Before the introduction, you need to inspect the cartridge located inside the syringe pen. If there are visible solid particles, as well as when the color and consistency change, Apidru SoloStar cannot be used. After use, an empty pen must be disposed of (reuse is prohibited).
The filled pen cannot be transferred to another person, it should be used by only one patient, which will reduce the likelihood of infection.
A new needle must be connected to the pen before each use. A safety test should be performed (device and needle work well, air bubbles removed). Only compatible needles can be used.
The device accurately doses insulin and is safe to operate. The pen syringe should be protected from dust and dirt. The outside can be cleaned by wiping with a damp cloth. Do not immerse the syringe pen in liquid, lubricate and rinse.
When conducting a safety test, a dose corresponding to 2 U is measured (the inner and outer needle caps must be removed). The pen is positioned with the needle up and gently tap the insulin cartridge with your finger so that the air bubbles move in the direction of the needle. Then the button for drug administration is fully pressed. If the device is working properly, then insulin will appear at the tip of the needle.
After completion of the safety test, the dosage window should show "0". After that, you can set the required dose.
The dose can be set in the range from 1 to 80 units with an accuracy of 1 unit. If a large dose is needed, two or more injections are given.
The patient must be informed about the injection technique by a medical professional. The needle should be inserted under the skin. The injection button must be pressed fully. It is held in this position for another 10 seconds until the needle is removed. This ensures that the full specified dose of insulin is delivered.
In all cases, the needle should be removed and disposed of after each injection. This is to prevent contamination and / or infection, air entering the insulin container, and insulin leakage. After removing the needle, you must close the syringe pen with a cap.
The need for insulin against the background of impaired liver function may decrease, which is associated with a reduced ability to gluconeogenesis and a slowdown in insulin metabolism.
With renal failure, the need for insulin may decrease.
In elderly patients with diabetes, there is insufficient information on pharmacokinetics. With age, the likelihood of impaired renal function increases, which can lead to a decrease in insulin requirements.
Side effects
Adverse reactions that occur during the use of Apidra SoloStar are characteristic of drugs of this class and are common to any insulin.
Hypoglycemia is the most common side effect of insulin therapy. Violation may appear on the background of the use of high doses of insulin in excess of the need for it.
As a rule, symptoms of hypoglycemia develop suddenly. Symptoms of adrenergic counterregulation are usually observed first (the sympathoadrenal system is activated in response to hypoglycemia). They manifest themselves as a feeling of hunger, irritability, tremor or nervous excitement, anxiety, cold sweat, pallor of the skin, pronounced palpitations, tachycardia. The faster hypoglycemia develops and the more severe it proceeds, the stronger the severity of the symptoms of adrenergic counterregulation. In the future, neuropsychiatric disorders occur against the background of neuroglycopenia, which manifests itself as a feeling of fatigue, weakness or unusual fatigue, decreased ability to concentrate, visual disturbances, drowsiness, nausea, headache, convulsive syndrome, confusion or loss of consciousness.
Episodes of severe hypoglycemia, especially recurrent episodes, can damage the nervous system. Severe and prolonged hypoglycemia can be life-threatening, since even a fatal outcome is possible against the background of an increase in hypoglycemia.
Local hypersensitivity reactions to insulin include hyperemia, itching and swelling at the injection site of Apidra SoloStar. Usually these reactions disappear after a few days / weeks of using the drug. In some patients, they are not associated with insulin, but with skin irritation due to its antiseptic treatment before injection or improper subcutaneous injection.
Systemic hypersensitivity reactions to Apidru SoloStar are characterized by the appearance of a rash all over the body (including accompanied by itching), a feeling of tightness in the chest, suffocation, a decrease in blood pressure, profuse sweating or an increase in heart rate. In severe cases of generalized allergy, including anaphylactic reactions, life-threatening conditions may develop.
As with any other insulins, lipodystrophy may appear at the injection site, which can lead to a slowdown in the absorption of the drug. The development of this undesirable phenomenon can be facilitated by non-observance of the rule of alternation of places of introduction of Apidra SoloStar. To reduce and prevent the appearance of lipodystrophy can be a constant alternation of injection sites within one of the injection areas (shoulder, thigh, anterior abdominal wall).
There is information about the accidental introduction of other insulins instead of Apidra SoloStar, in particular this applies to long-acting insulins.
Overdose
There are no special data regarding an overdose of insulin glulisine. When using doses of Apidra SoloStar exceeding the need for insulin, hypoglycemia may occur.
Therapy: for mild episodes of hypoglycemia, glucose or sugar-containing foods are effective. Therefore, diabetic patients are advised to carry cookies, sweets, sugar cubes or sweet fruit juice with them at all times.
Severe hypoglycemia may be accompanied by coma, neurological disorders and seizures, and the patient may lose consciousness during the episode. To relieve symptoms, you can use:
- glucagon: injected subcutaneously or intramuscularly by a person who has received the appropriate instructions, at a dose of 0.5-1 mg;
- concentrated (20%) glucose (dextrose) solution: administered intravenously by a healthcare professional.
In order to prevent the development of a repeated episode of hypoglycemia, which may occur after an apparent clinical improvement, the patient is recommended to take carbohydrates by mouth after recovering consciousness.
In order to determine the cause of severe hypoglycemia and prevent the development of other similar episodes, the patient's condition after glucagon administration should be monitored in a hospital.
special instructions
The transfer of a patient to insulin from another manufacturer or a new type of insulin must be carried out under strict medical supervision, since this may require a dosage adjustment. This may be necessary due to the following changes:
- insulin concentration;
- type of insulin (of animal origin);
- type of insulin (insulin isophane, soluble insulin, etc.);
- mode of production;
- trade mark (manufacturer).
It is also possible to make changes in concomitant oral hypoglycemic therapy. Discontinuation of treatment or the use of inadequate doses of insulin, especially in patients with type 1 diabetes, can cause diabetic ketoacidosis and hyperglycemia (conditions that are potentially life-threatening).
The time after which the symptoms of hypoglycemia appear is determined by the speed of the onset of the effect of the insulin used, therefore, when changing the treatment regimen, it can change.
Conditions that can change or reduce the severity of the precursors of the development of hypoglycemia:
- the use of certain drugs, such as beta-blockers;
- long-term existence of SD;
- diabetic neuropathy;
- intensification of insulin therapy;
- transfer of the patient to human insulin from insulin of animal origin.
Dose adjustments may also be necessary if patients make changes to their normal eating habits or increase physical activity. Exercise performed immediately after a meal can increase the risk of hypoglycemia. After injection of fast-acting insulin analogs, compared to soluble human insulin, hypoglycemia may develop faster.
An uncompensated hyperglycemic / hypoglycemic reaction can cause loss of consciousness, coma, or death.
With emotional overload or illness, the need for insulin may change.
After the first use, the shelf life of Apidra SoloStar in a disposable syringe pen is 4 weeks. It is recommended to mark the date of the first administration of the drug on the label. Do not cool the pen syringe before use.
Disposable syringe pens after use should be stored at temperatures up to 25 ° C in a place protected from light and out of the reach of children.
Influence on the ability to drive vehicles and complex mechanisms
During the period of therapy, there is a risk when driving. This is due to the likelihood of hyperglycemia and hypoglycemia, as well as visual disturbances observed during the development of these conditions. This is especially dangerous for debilitated patients, as well as patients who have no symptoms or have frequent episodes of hypoglycemia. To make a decision about the possibility / impossibility for the patient to drive vehicles, these factors must be assessed in each specific case. In order to avoid the possibility of developing hypoglycemia, patients are advised to take precautions while driving.
Application during pregnancy and lactation
The experience of using Apidra SoloStar in pregnant women is insufficient. According to a limited amount of data (less than 300 pregnancy outcomes), the drug does not adversely affect either the course of pregnancy, or the intrauterine development of the fetus, or the newborn baby. In reproductive studies in animals, no differences were found between insulin glulisine and human insulin in relation to the course of pregnancy, embryonic / fetal development, childbirth and postnatal development.
Apidru SoloStar in pregnant women should be used with caution with mandatory monitoring of blood glucose concentration and maintenance of glycemic control.
Women with pre-pregnancy or gestational diabetes need to maintain glycemic control throughout gestation. The need for insulin during the first trimester of pregnancy may decrease, and during the second-third trimesters - increase. Immediately after delivery, there is a rapid decrease in insulin requirements.
There is no information to confirm or deny that insulin glulisine is excreted in breast milk. During lactation, it may be necessary to adjust the diet and insulin dosing regimen.
Pediatric use
Since the clinical information on the use of Apidra SoloStar in children under 6 years of age is limited, the drug is not prescribed for this age group of patients.
With impaired renal function
With renal failure, the need for insulin may decrease.
For violations of liver function
The need for insulin against the background of impaired liver function may decrease, which is associated with a reduced ability to gluconeogenesis and a slowdown in insulin metabolism.
Use in the elderly
In elderly patients with diabetes, there is insufficient information on the pharmacokinetics of Apidra SoloStar. With age, the likelihood of impaired renal function increases, which can lead to a decrease in insulin requirements.
Drug interactions
Special studies on pharmacokinetic interactions have not been conducted. Based on the available empirical knowledge in relation to other similar drugs, it is believed that the development of clinically significant drug interactions is unlikely. Some substances / drugs may affect glucose metabolism, in such cases, dose adjustment of Apidra SoloStar and especially careful monitoring of treatment may be required.
Medicines affecting the hypoglycemic effect of insulin:
- increase (including an increase in susceptibility to hypoglycemia): angiotensin-converting enzyme inhibitors, propoxyphene, oral hypoglycemic agents, disopyramide, fluoxetine, fibrates, pentoxifylline, monoamine oxidase inhibitors, sulfa antimicrobial agents, salicylates;
- reduction: somatropin, glucocorticosteroids, diazoxide, danazol, isoniazid, diuretics, phenothiazine derivatives, sympathomimetics, progestins, estrogens, thyroid hormones, antipsychotic drugs, protease inhibitors.
Other possible interactions:
- clonidine, beta-blockers, alcohol, lithium salts: when used together, potentiation or weakening of the hypoglycemic effect of insulin is possible;
- pentamidine: hypoglycemia may occur with the subsequent development of hyperglycemia;
- clonidine, beta-blockers, reserpine, guanethidine: when combined with drugs with sympatholytic activity, symptoms of reflex adrenergic activation may be less pronounced or absent.
Insulin glulisine should not be mixed with any drugs other than human insulin isophane.
If administered with an infusion pump, Apidru SoloStar must not be mixed with solvents and other insulin preparations.
Analogs
The analogues of Apidra SoloStar are: Apidra, Insulin lispro, Humalog, Brinsulrapi MK 40 U / ml, Actrapid HM Penfill, etc.
Terms and conditions of storage
Store in a place protected from light at a temperature of 2-8 ° C. Do not freeze. Keep out of the reach of children.
Shelf life is 2 years.
After the first use, the shelf life of Apidra SoloStar in a disposable syringe pen is 4 weeks. Disposable syringe pens after use should be stored at temperatures up to 25 ° C in a place protected from light and out of the reach of children.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Apidre SoloStar
Reviews about Apidre SoloStar are mostly positive. Ease of use and rapid development of action are noted.
The price of Apidru SoloStar in pharmacies
The approximate price for Apidru SoloStar (5 syringe-pens in the package) is 1,851-2,100 rubles.
Apidra SoloStar: prices in online pharmacies
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Drug name Price Pharmacy |
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Apidra SoloStar 100 U / ml solution for subcutaneous administration 3 ml 5 pcs. 2015 RUB Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, 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!
