Apidra SoloStar
Active material: Insulin glulisine
When ATH: A10AB06
CCF: Short-acting human insulin
ICD-10 codes (testimony): E10, E11
When CSF: 15.01.01.01
Manufacturer: SANOFI-AVENIS Germany GmbH (Germany)
Pharmaceutical form, composition and packaging
The solution for the p / to the introduction clear, colorless or near colorless.
| 1 ml | |
| insulin glulizin | 3.49 mg, |
| that corresponds to the content of human insulin | 100 ME |
Excipients: cresol (m-cresol), trometamol, sodium chloride, polysorbate 20, Sodium hydroxide, hydrochloric acid, water d / and.
3 ml – flint glass cartridges (1) – spric-rucki SoloStar® (5) – packs cardboard.
Pharmacological action
Insulin glulisine is a recombinant human insulin analog, which is the power of action is normal human insulin. Insulin glulizin starts to act faster and has less duration, than soluble human insulin.
The most important effect of insulin and insulin analogues, including insulin glulizin, is regulation of glucose. Insulin decreases the concentration of glucose in the blood, stimulating the absorption of glucose perifericescimi tissues, especially skeletal muscle and adipose tissue, and inhibiting glucose production in the liver. Insulin inhibits lipolysis in mainly, inhibits proteolysis, and enhances protein synthesis. Research, carried out in healthy volunteers and patients with diabetes mellitus, shown, that when s/to the introduction of insulin glulizin starts to act faster and has less duration, than soluble human insulin. When s/to the introduction of gipoglikemicescoe effect of insulin glulizina begins 10-20 m. When in/with the introduction of the effects of lowering blood glucose insulin glulizina and soluble human insulin are equal in strength. One unit of insulin glulizina has the same gljukozoponizhajushhuju activity, that and one unit of soluble human insulin.
Phase I study in patients with diabetes mellitus type 1 gljukozoponizhajushhie insulin glulizina profiles were evaluated and soluble human insulin, introduced subcutaneously at a dose of 0.15 U/kg at different times relative to the standard 15-minute meal. The results showed, What is insulin injected for glulizin 2 minutes before meals provided the same glycemic control after eating, that and the soluble human insulin, entered for 30 minutes before meals. In the introduction for the 2 minutes before mealtime insulin glulizin provided the best glycemic control after eating, than soluble human insulin, entered for 2 minutes before meals. Insulin glulisine, entered through the 15 minutes after the start of the meal gave the same glycemic control after eating, that and the soluble human insulin, the input for the 2 minutes before meals.
Obesity
Study of phase I , conducted with insulin glulizinom, insulin lizpro and soluble human insulin from a group of obese patients, demonstrated, these patients have insulin glulizin keeps its characteristics of quick action. In this study, time to reach 20% from the total AUC was 114 minutes for insulin glulizina, 121 minutes for insulin and lizpro 150 min for soluble human insulin, (a) the AUC(0-2 no), reflecting also an early gljukozoponizhajushhuju activity, respectively, was 427 mg/kg for insulin glulizina, 354 mg/kg for insulin lizpro, and 197 mg/kg for soluble human insulin.
Clinical studies
Diabetes 1 type
In the 26-minute weekly phase III clinical study, which compared insulin glulizina insulin lizpro, vvodivshimisja subcutaneously shortly before eating (for 0-15 m) Patients with diabetes mellitus 1 type, use as a basal insulin insulin glargine, insulin glulizin was comparable with insulin lizpro in regard to Glycemic Control, which was estimated by the change in the concentration of glycosylated hemoglobin (HbA1C) at the time of the study endpoint versus outcome. Experienced comparable blood glucose values, determined by self-monitoring. With the introduction of insulin glulizina in contrast to insulin treatment did not take lizpro increase dose of basal insulin.
12-week-long clinical study phase III, conducted in patients with diabetes mellitus 1 type, treated as basal insulin glargine therapy, found, that the effectiveness of insulin glulizina directly after a meal was comparable with that in the introduction of insulin glulizina immediately before the meal (for 0-15 m) or soluble human insulin (for 30-45 minutes before eating).
In the patient population, complied with the study protocol, in the Group of patients, received before meal insulin glulizin, more reliably observed reduction in HbA1C compared to patients, treated with soluble human insulin.
Diabetes 2 type
26-Tee week clinical study phase III followed him 26-minute weekly continuation in the form of a study on security was held for comparison of insulin glulizina (for 0-15 minutes before meals) with soluble human insulin (for 30-45 minutes of the meal), imposed p/c in patients with diabetes mellitus 2 type, Besides use as a basal insulin insulin isophane. The average body mass index of patients was 34.55 kg / m2. Insulin glulizin showed himself to be comparable with soluble human insulin on changes of concentrations of Hbas1C through 6 months of treatment compared with the outcome of the (-0.46% for insulin and glulizina -0.30% for soluble human insulin, r = 0.0029) and by 12 months of treatment compared with the outcome of the (-0.23% for insulin and glulizina -0.13% for soluble human insulin, distinction not authentically). In this study, most patients (79%) mixed his insulin, a short-acting insulin-izofanom immediately before injection. 58 at the time of randomization patients used oral gipoglikemicakie preparations and got a instructions for the continuation of their admission in the same (unmodified) dose.
Race and gender
In controlled clinical trials in adults did not show differences in safety and efficacy of insulin glulizina in a subgroup analysis, selected race floor.
Pharmacokinetics
Insulin glulizine substitution of the amino acid asparagine at position B3 human insulin on lysine and lysine in position B29 on glutamic acid helps faster absorption.
Absorption and distribution
AUC in healthy volunteers and patients with diabetes mellitus 1 and 2 type demonstrated, that absorption of insulin glulizina compared with soluble human insulin was approximately 2 times faster, and (C) achievedmax was approximately 2 times.
The study, conducted in patients with diabetes mellitus 1 type, After p/to the introduction of insulin glulizina dose 0.15 U/kg Cmax was 82 ± 1.3 mkED/ml achieved within 55 m, compared to Cmax, component of 46 ± 1.3 mkED/ml and dostigajushhejsja within 82 m, for soluble human insulin. Average commuting time systemic blood insulin glulizina have been shorter (98 m), than the soluble human insulin (161 m).
In a study in patients with diabetes mellitus 2 After p/to the introduction of insulin glulizina dose 0.2 U/kg Cmax was 91 mkED/ml (from 78 to 104 mkED/ml).
When s/to the introduction of insulin glulizina in the region of the anterior abdominal wall, hip or shoulder (in the area of the deltoid muscle) absorption was quicker with the introduction in the region of the anterior abdominal wall, compared with the introduction of the drug in the thigh area. The removals of the deltoid area was staging. The absolute bioavailability of insulin glulizina after s/to the introduction was approximately 70% (73% from the area of the anterior abdominal wall, 71 from the field of deltoid muscle and 68% of the thigh) and have a low variability in different patients.
Distribution and excretion
Distribution and excretion of insulin glulizina and soluble human insulin after the on/in the introduction are similar, with Vd, components 13 and l 22 l, and T1/2, components 13 and 18 m, respectively.
After p/to the introduction of insulin glulizin is displayed faster, than soluble human insulin, having seemingly T1/2, component 42 m, compared to the seeming T1/2 soluble human insulin, component 86 m. Cross-analysis studies of insulin glulizina, in healthy individuals, and in patients with diabetes mellitus 1 and 2 type, seems T1/2 ranged from 37 to 75 m.
Pharmacokinetics in special clinical situations
In a clinical study, held in individuals without diabetes with a wide range of functional condition of kidneys (CC > 80 ml / min, 30-50 ml / min, < 30 ml / min), in General, the speed of onset of effect of insulin glulizina continued. However, the need for insulin in the presence of renal failure can be reduced.
In patients with impaired liver pharmacokinetic performance isn't studied.
There are very limited data on the pharmacokinetics of insulin glulizina in elderly patients with diabetes mellitus.
Pharmacokinetic and pharmacodynamic properties of insulin glulizina have been investigated in children (7-11 years) and adolescents (12-16 years) diabetic 1 type. In both age groups insulin glulizin rapidly absorbed from tmax and Cmax similar to those of adults. As in adults, in introducing directly before the test with meal insulin glulizin provides the best control of blood glucose after a meal, than soluble human insulin. Increasing the concentration of glucose in the blood after eating (AUC0-6 no) was 641 mg /(h × DL) for insulin and glulizina 801 mg /(h × DL) for soluble human insulin.
Testimony
- Diabetes, requiring insulin treatment (adult).
Dosage regimen
Product Apidra® SoloStar® should be added shortly (for 0-15 m) before or shortly after a meal.
Product Apidra® SoloStar® should be used in treatment regimens, include or insulin average duration or long-acting insulin or long-acting insulin analog. Besides drug Apidra® SoloStar® can be used in conjunction with oral gipoglikemicakimi means.
The dosage of the drug Apidra® SoloStar® selected individually.
The introduction of the drug
Product Apidra® SoloStar® type or by using the p/to the injections or by continuous infusion in the subcutaneous fatty tissue using a pumping system.
P/to the injections of the drug Apidra® SoloStar® should be done in the area of the anterior abdominal wall, shoulder or hip, and the introduction of the drug by continuous infusion in the subcutaneous fatty tissue produced in the region of the anterior abdominal wall. Place injections and infusions in the above-mentioned areas locations (anterior abdominal wall, thigh or shoulder) must alternate with each new drug introduction. The speed of absorption and, respectively, at the beginning and duration can influence: place introduction, physical activity and other changing conditions. P/to the introduction in the abdominal wall provides a somewhat more rapid absorption, Introduction to other parts of the body above.
It is necessary to observe safety precautions for exceptions into drugs directly into the blood vessels. After the introduction of the drug do not produce massage area introduction. Patients should be trained in proper injection technique.
Mixing with insulinami
Product Apidra® SoloStar® should not be mixed with any other drug, In addition to human izofan-insulin.
Pump-action device for conducting continuous p/infusion
Using drugs Apidra® SoloStar® with pumping insulin infusion system cannot be mixed with other drugs.
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. 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, is provided by 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
Gipoglikemiâ – the most frequent undesirable effects of insulin therapy, that can occur if you apply too high doses of insulin, exceeding requirement in it.
Observed in the clinical trials adverse reactions, associated with the introduction of the drug, listed below are the systems and organs in order of decreasing frequency. When describing the frequency of occurrence of the following criteria are used: Often – > 10%; often – > 1% and < 10%; sometimes – > 0.1% and < 1%; rarely – > 0.01% and < 0.1%; rarely – < 0.01%.
Metabolism: Often – gipoglikemiâ. Symptoms gipoglikemii usually occur suddenly. However, usually amid violations nejroglikopenii psycho-neurological (feeling tired, unusual fatigue or weakness, decreased ability to concentrate, drowsiness, visual disturbances, headache, nausea, confusion or its loss, convulsions) preceded by adrenergic symptoms kontrreguljacii (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, as at increasing Hypoglycemia is possible even fatal.
Local reactions: often – local reactions of hypersensitivity (hyperemia, swelling and itching at the injection site). These reactions are usually transitory and disappear during continued treatment; rarely – lipodystrophy (as a result of a breach of alternating seats insulin in any of the areas/introduction of the drug at the same place/).
Allergic reactions: sometimes – hives, chest tightness, bronchospasm, atopic dermatitis, itch. Severe cases of generalized allergy (including anaphylactic) It can be life-threatening.
Contraindications
- Gipoglikemiâ;
-increased sensitivity to insulino glulizinu or any of the components of the drug.
FROM caution It should be used during pregnancy.
Pregnancy and lactation
In appointing the drug during pregnancy, you should be careful. Mandatory careful monitoring of blood glucose. Not enough information on the use of insulin glulisine in pregnant women. Clinical data on the use of insulin glulizina during pregnancy are not available.
Patients with diabetes mellitus (incl. gestational) necessary during pregnancy to maintain optimal glycemic control. In the first trimester of pregnancy may decrease the need for insulin, and in II and III trimestrah it, usually, may increase. Immediately after delivery insulin requirement rapidly declining.
IN experimental studies reproduction, no differences between the influence of the use of insulin and glulizina human insulin during pregnancy, development of the embryo and fetus, rodы and development postnatalynoe.
During the period of lactation (breast-feeding) may require correction doses of insulin and diet.
Cautions
Transfer the patient to a new type of insulin or insulin another manufacturer must be used under strict medical supervision, tk. the dose may need to be modified due to changes in the concentration of insulin, brand (Manufacturer), types of insulin (Instant, insulin-izofan etc.), types of insulin (Animal) and/or method of production. Besides, may require correction of concomitant oral hypoglycemic therapy. The use of inadequate doses or discontinuation of insulin treatment, especially in patients with diabetes mellitus 1 type, It can lead to the development of hyperglycemia and diabetic ketoacidosis – states, which are potentially life threatening.
Time, through which develops hypoglycemia, depends on the speed of onset of effect used insulin and, concerning, may change when the treatment regimen. For conditions, that can change or make less pronounced harbingers of hypoglycemia, relate: the prolonged existence of diabetes, intensification of insulin therapy, the presence of diabetic neuropathy, taking certain medications, such as beta-blockers, or transfer of the patient from animal insulin to human insulin.
Correction doses of insulin may also be required in the case of, If patients are increasing physical activity or alter his usual routine of mealtimes. Exercise stress, performed immediately after a meal, may increase the risk of hypoglycemia. Compared with soluble human insulin after injections of insulin analogues in force quickly hypoglycaemia can develop before.
Nekompensirovannыe gipoglikemicheskaя or giperglikemicheskaя reactions Mughals hello k Potter soznaniя, coma or death.
The need for insulin may be altered when diseases or emotional overload.
Overdose
Symptoms: There are no specific data on overdose of insulin glulizina; may develop hypoglycemia of varying degrees of severity.
Treatment: episodes of mild Hypoglycemia may be treated using admission glucose or products, containing sugar. Therefore, we recommend that you, patients with diabetes constantly had pieces of sugar, candy, biscuits or sugary fruit juice. Episodes of severe hypoglycemia, during which the patient loses consciousness, may be cropped in/m or m/to the introduction 0.5-1 mg glukagona or in/with the introduction dekstrozy (Glucose). If the patient does not respond to glucagon during introduction 10-15 m, You must also enter the dextrose/in. After regaining consciousness, we recommend that you give the patient the carbohydrates inside to prevent the recurrence of hypoglycemia. After the introduction of glucagon to determine the cause of this severe hypoglycemia and prevent the development of other similar episodes, the patient should be observed in the hospital.
Drug Interactions
Research on farmakokineticheskomu drug interaction drug is not conducted. Based on available empirical knowledge of other similar drugs the occurrence of clinically significant pharmacokinetic interaction unlikely. Some substances may affect glucose metabolism, that may require insulin dose adjustment and particularly close monitoring glulizina therapy and the patient's condition.
When combined oral hypoglycemic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoksyfen, salitsilatы and sulyfanilamidnыe protivomikrobnыe means Mughals usilivaty gipoglikemicheskoe insulin action and povыshaty predraspolozhennosty k gipoglikemii.
At joint application Valium, danazol, diazoksid, Diuretic, Isoniazid, phenothiazines, somatropin, sympathomimetic (eg, Epinephrine/adrenaline/, salbutamol, terbutaline), thyroid hormones, Estrogens, progestins (eg, oral contraceptives), protease inhibitors and antipsychotic drugs (eg, olanzapine and clozapine) may reduce the hypoglycemic effect of insulin.
Beta-blockers, klonidin, lithium salts or ethanol, or may potentiate or weaken the hypoglycemic effect of insulin. Pentamidine may cause hypoglycemia followed by hyperglycemia c.
When using products with sympatholytic activity (beta-blockers, klonidin, guanethidine and reserpine) Symptoms reflex adrenergic activation during hypoglycemia may be less pronounced or absent.
Pharmaceutical interaction
In connection with the lack of research the compatibility of insulin glulizin should not be confused with any other drugs except human izofan-insulin.
With the introduction of using infusion pumps product Apidra® SoloStar® should not be mixed with other drugs.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
The drug should be stored in the dark, out of reach of children at a temperature from 2° c to 8° c. Do not freeze! Shelf life – 2 year.
Shelf life in disposable syringe handle Apidra® SoloStar® After the first use – 4 of the week. It is recommended that you mark the date on the label of the first injection.
After starting to use disposable spric-rucki Apidra® SoloStar® should be stored at a temperature of no higher than 25° c, out of reach of children, protect from light.
