The pharmacological action – hypoglycemic.
The most important action of insulin, including and insulin glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose concentrations in stimulating glucose uptake by peripheral tissues (especially skeletal muscle and adipose tissue) and inhibition of glucose production in the liver. Insulin inhibits lipolysis in adipocytes (fat cells) and inhibits proteolysis, increasing the protein synthesis.
The pharmacodynamic characteristics
Insulin glargine is a human insulin analogue prepared by DNA recombination bacterial species Escherichia coli (strain K12) are used as producer strain. It has a low solubility in neutral medium. At pH 4 (in acidic medium) insulin glargine completely soluble. After administration subcutaneous fat acidic reaction solution is neutralized, leading to the formation mikropretsipitatov of which is constantly released small amounts of insulin glargine.
Valid p / to injected insulin glargine 100 U / ml was slower as compared with human insulin isophane, the curve of its action is smooth and devoid of peaks, and the duration of action was prolonged (data euglycemic clamp-studies conducted in healthy volunteers and patients sugar type 1) diabetes.
Hypoglycemic action of the drug after its Tudzheo SoloSTAR® s / c administration as compared to that when n / to the introduction of insulin glargine 100 U / ml was more constant in magnitude and more prolonged (36-h data cross-euglycemic clamp study carried out in 18 patients sugar type 1) diabetes. Effect of the drug Tudzheo SoloSTAR® lasted more than 24 hours (36 hours) when s / to a clinically relevant doses.
Prolonged hypoglycemic effect of the drug Tudzheo SoloSTAR® extending over 24 hours, to change the time of administration within 3 hour before or three hours after the normal time of patient injection, if necessary (see. “Dosage and Administration”).
Differences in the curves hypoglycemic drug action Tudzheo SoloSTAR® insulin glargine and 100 units / ml associated with a change in the release of insulin glargine precipitate.
For the same amount of insulin glargine injection volume of the drug Tudzheo SoloSTAR® units is one third of that of insulin glargine when administered 100 U / ml. This reduces the surface area of the precipitate, which provides a gradual release of the insulin glargine product precipitate Tudzheo SoloSTAR® compared to precipitate insulin glargine 100 U / ml.
The on / in the same dosage of insulin and human insulin glargine their hypoglycemic effect was the same.
Communication with the insulin receptors. Insulin glargine is metabolized to two active metabolites M1 and M2 (cm. “Pharmacokinetics”). In vitro studies have shown that the affinity of insulin glargine and its metabolites M1 and M2 for the human insulin receptor is similar to that of human insulin.
Communication with the IGF-1 receptor. The affinity of insulin glargine receptor IGF-1 at approximately 5-8 times higher than that of human insulin (but approximately 70-80 times lower than that of IGF-1), at the same time, compared with human insulin, Insulin glargine metabolites M1 and M2 have a somewhat lower affinity for the IGF-1 receptor. Total therapeutic insulin concentration (concentration of insulin glargine and its metabolites) defined in patients with type 1 diabetes was significantly lower than the concentration required for half maximal binding to receptors of IGF-1 and subsequent activation mitogenically-proliferative pathways triggered through receptors IGF-1 . Physiological concentrations of endogenous IGF-1 may activate mitogenically-proliferative way, however therapeutic insulin concentrations determined with insulin, including the treatment of drug Tudzheo SoloSTAR® significantly below pharmacological concentrations required for activation mitogenically-proliferative path.
The results obtained in all clinical studies, the drug Tudzheo SoloSTAR® conducted involving a total of 546 patients with type 1 diabetes and in 2474 patients with type 2 diabetes showed that a decrease in glycosylated hemoglobin values (HbAlc) compared with their initial values to the end of the study was not less than that of insulin glargine in the treatment of 100 U / ml.
The percentage of patients achieving target value indicator HbA1c (below 7%) was comparable in both treatment groups.
Reduction of plasma glucose concentrations to the end of the study with the preparation Tudzheo SoloSTAR® insulin glargine and 100 U / ml was the same, but in the treatment preparation Tudzheo SoloSTAR® was a more gradual decrease in the dose titration period.
Glycemic control, including improvement in HbAlc, at the administering Tudzheo SoloSTAR® morning or evening was comparable, and the change time of administration within 3 hour before or three hours after the usual no effect on its effectiveness for the patient the time of administration.
Patients receiving treatment with Tudzheo SoloSTAR®, by the end of the 6-month treatment period, change in body weight was observed, on average, less than 1 kg.
Improved HbA1s index is not dependent on sex, ethnicity, age, duration of diabetes (< 10 years and ≥10) indicator value at the end of HbAlc (< 8 or ≥8%) or BMI in the outcome.
Patients with type 2 diabetes results from clinical studies have demonstrated a lower incidence of severe and / or confirmed hypoglycemia and documented hypoglycemia flowing with clinical symptoms in the treatment of drug Tudzheo SoloSTAR® compared to treatment with insulin glargine 100 U / ml.
The advantage of the preparation Tudzheo SoloSTAR® before insulin glargine 100 IU / ml against the risk of reducing the heavy and / or confirmed nocturnal hypoglycemia have been shown in patients previously treated with oral hypoglycemic agents (23% reduction) or insulin at meal (21% risk reduction ) during the period from the 9th week to the end of the study, compared with treatment by insulin glargine 100 U / ml.
In the group of patients treated with the drug Tudzheo SoloSTAR® compared to patients treated with insulin glargine 100 U / ml, reducing the risk of hypoglycemia was observed in patients previously treated with insulin therapy, and in patients previously treated with insulin; reduced risk was greater during the first 8 weeks of treatment (first treatment period) and not dependent on age, gender, race, BMI and duration of diabetes (< 10 and ≥10 years).
Patients with type 1 diabetes incidence of hypoglycaemia during the treatment preparation Tudzheo SoloSTAR® was similar to that of patients treated with insulin glargine 100 U / ml. However, the incidence of nocturnal hypoglycemia (for all categories of hypoglycemia) during the initial treatment period was lower in patients treated with the drug Tudzheo SoloSTAR® compared to patients treated with insulin glargine 100 U / ml.
In clinical studies, single day during the administration of the drug Tudzheo SoloSTAR® evening, with a fixed time schedule of administration (at the same time), or flexible administration schedule (at least 2 times per week administration of drug was performed for 3 hours before or 3 hours after the usual the time of administration, resulting in intervals between administrations shortened to 18 hours or lengthened to 30 hours) exerted the same effect on figure HbA1c, plasma glucose concentration (FPG) and the average concentration predynektsionnoy glitch eskers in the blood plasma at self-determination. In addition, when using the drug Tudzheo SoloSTAR® with fixed or flexible hours of administration time was not observed any difference in the incidence of hypoglycemia in any time of day or nocturnal hypoglycemia. The research results indicated the presence of not any distinction related to the formation of antibodies to insulin, the efficacy, safety, or basal insulin dose between patients receiving treatment with drugs Tudzheo SoloSTAR® insulin glargine and 100 U / ml (see., “Side effects”) . ORIGIN study (Outcome Reduction with Initial Glargine Intervention) was an international, multicenter, randomized, conducted in 12537 patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or early stage of type 2 diabetes and confirmed cardiovascular disease. Study participants were randomly divided into groups – treated insulin glargine ≤100 IU / ml (n = 6264) which titrated to achieve a concentration GPN < 5,3 mmol, or standard treatment (n = 6273). the average value of the observation period was about 6.2 years.
Median baseline HbA1c values was 6.4%. The mean value of HbA1c index during treatment is in the range 5,9-6,4% in the insulin glargine and 6,2-6,6% in the standard treatment group throughout the observation period.
Study ORIGIN showed that treatment with insulin glargine 100 U / ml compared to a standard hypoglycemic therapy did not alter the risk of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or non-fatal stroke), the risk of revascularization procedures (coronary, carotid or peripheral arterial disease), or hospitalization for heart failure, the risk of microvascular complications (a composite indicator of microvascular complications: conducting la grain photocoagulation or vitrectomy, visual loss due to diabetic retinopathy, the progression of albuminuria or a doubling of the concentration of creatinine in the blood, or the occurrence of the need for dialysis).
In a study evaluating the effect of insulin glargine 100 U / ml for the development of diabetic retinopathy in a five-year monitoring of patients with type 2 diabetes mellitus were observed significant differences in the progression of diabetic retinopathy in the treatment of insulin glargine 100 U / ml compared to isophane insulin.
Special patient groups
Sex and race. There were no differences in efficacy and safety Tudzheo SoloSTAR® insulin glargine and 100 U / ml depending on the sex and race of patients.
Elderly age. In controlled clinical studies of 716 patients (23% of the population for evaluation of safety) to diabetes mellitus type 1 and 2 were aged ≥65 years and 97 patients (3%) were aged ≥75 years. In general, there were no differences in efficacy and safety between these patients and younger patients. Elderly patients with diabetes to prevent hypoglycemic reactions, the initial and maintenance doses should be lower, and the increase in dose performed slowly. Elderly patients may have difficulty in recognizing hypoglycemia. Recommended careful monitoring of blood glucose and insulin dose should be adjusted individually (see. “Dosage and Administration” and “Pharmacokinetics”).
Renal insufficiency. In controlled clinical trials subgroup analysis based on renal function (defined in the outcome of GFR < 60 or ≥60 mL / min / 1.73 m2 of body surface) showed no differences between the safety and efficacy of the drug and insulin Tudzheo SoloSTAR® glargine 100 U / ml. Recommended careful monitoring of blood glucose and insulin dose should be adjusted individually (see. “Dosage and Administration” and “Pharmacokinetics”).
Patients with obesity. In clinical studies, subgroup analysis based on BMI (up to 63 kg / m2) showed no difference in the effectiveness and safety of the drug between Tudzheo SoloSTAR® insulin glargine and 100 U / ml.
Children. Information on the application Tudzheo SoloSTAR® no drug in children.
Absorption and distribution. After n / k the injection Tudzheo SoloSTAR® healthy volunteers and patients with diabetes mellitus the insulin serum concentration indicating a much slower and more prolonged absorption, which leads to a flatter curve AUC for up to 36 hours as compared to 100 U insulin glargine / ml. AUC curve preparation Tudzheo SoloSTAR® curve corresponded its pharmacodynamic activity. Css concentrations within the therapeutic range is achieved after 3-4 days of daily drug application Tudzheo SoloSTAR®.
After n / k the injection Tudzheo SoloSTAR® variability in one and the same patient, the systemic exposure is defined as the coefficient of variation of insulin for 24 hours in a state achieve Css, was low (17.4%).
Metabolism. In humans, after s / c injection Tudzheo SoloSTAR® insulin glargine is rapidly metabolized by the carboxyl terminus (C-terminal) β-chain to form two active metabolite M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B -Thr-insulin). Advantageously, the plasma circulating metabolite M1. Systemic exposure metabolite M1 increases with increasing dose Tudzheo SoloSTAR®. Comparison of the pharmacokinetics and pharmacodynamics data showed that the effect of the drug is mainly carried out due to systemic exposure metabolite M1. The vast majority of patients are not able to detect insulin glargine and M2 metabolite in the systemic circulation. In cases where the still could be detected in blood insulin glargine and M2 metabolite concentrations were independent of the dose and dosage forms of insulin glargine.
Withdrawal. T1 / 2 metabolite M1, quantitatively predominant metabolite preparation Tudzheo SoloSTAR®, after s / c injection of the drug is 18-19 hours, regardless of the dose.
Special patient groups
Sex and race. Information about the impact of race and gender on the pharmacokinetics of insulin glargine offline (cm. “Pharmacodynamics”).
Elderly age. The effect of age on the pharmacokinetics of the drug Tudzheo SoloSTAR® currently unknown. In elderly patients with diabetes mellitus, in order to avoid hypoglycemic reactions, the initial dose and the maintenance dose should be lower, and the increase in dose should be conducted slowly (cm. “Pharmacodynamics” and “Dosage and Administration”).
Children. Pediatric pharmacokinetics Tudzheo SoloSTAR® currently unknown.
Kidney and liver failure. Effect on the pharmacokinetics of the drug Tudzheo SoloSTAR® kidney and liver failure at the moment unknown. However, in some studies conducted with human insulin, it has been shown to increase insulin concentrations in patients with renal or hepatic insufficiency. Recommended careful monitoring of glucose concentrations in blood, and individual dose adjustment of insulin (see. “Dosage and Administration” and “Pharmacodynamics”).
1 ml of solution contains:
300 IU insulin glargine (10.91 mg);
m-cresol (m-cresol) – 2.70 mg
Zinc chloride – 0.19 mg (corresponding to 0.09 mg of zinc),
glycerol (85%) – 20 mg,
Sodium hydroxide – to pH 4,0,
hydrochloric acid – up to pH 4,0,
Water for injection – up to 1.0 ml.
Diabetes mellitus in adults, requiring insulin treatment.
hypersensitivity to insulin glargine or to any of the excipients of the drug;
age 18 years (due to the lack of clinical data supporting the efficacy and safety of the drug in children and adolescents).
Precautions: Pregnant women (the possibility of changing insulin requirements during pregnancy and after childbirth), elderly patients (see “Pharmacokinetics”, “Pharmacodynamics”, “Dosage and administration” and “Special instructions.”); Patients with uncompensated endocrine disorders (such as hypothyroidism, the adenohypophysis and adrenocortical insufficiency); diseases accompanied by vomiting or diarrhea; severe stenosis of the coronary arteries or the cerebral vessels; proliferative retinopathy (particularly if patients have not been evaluated photocoagulation); renal failure; severe hepatic insufficiency (see. “Special instructions»).
seemed less undesirable reactions (NO) were observed during clinical studies conducted with a preparation Tudzheo SoloSTAR® and during clinical use of insulin glargine 100 U / ml. These HP represented by organ systems (according to the MedDRA classification according to WHO recommended following gradations frequency of occurrence: very often (≥10%); often (≥1; < 10%); infrequently (≥0,1; < 1%), rare (≥0,01; < 0,1%); rarely (< 0,01%), the frequency is unknown (HP determine the frequency of occurrence of the available data is not possible).
On the part of metabolism and nutrition: hypoglycemia. Hypoglycemia, the most common adverse reaction when insulin may occur if the insulin dose is too high compared to the need for it. As with other insulins, episodes of severe hypoglycemia, especially repetitive, can lead to neurological disorders.
Episodes long and expressed hypoglycemia may endanger patients’ lives.
In many patients, the signs and symptoms neyroglikopenii (fatigue, inadequate fatigue or weakness, decreased ability to concentrate, drowsiness, visual disturbances, headache, nausea, confusion or loss, convulsions) are preceded by signs of adrenergic kontrregulyatsii (activation of the sympathetic-adrenal systems in response to hypoglycemia) – hunger, irritability, nervous agitation or tremor, anxiety, pallor, cold sweat, tachycardia, expressed zhennoe heartbeat. Generally, the faster developing hypoglycemia, and the heavier it is, the more pronounced the symptoms of adrenergic kontrregulyatsii.
From a sight organ: a significant improvement in glycemic control may cause temporary visual impairment due to temporary disruption of turgor and the refractive index of the lens eye.
Long-term improved glycemic control decreases the risk of progression of diabetic retinopathy. However, as with any allocation scheme insulin intensification of insulin therapy with abrupt improvement in glycemic control may be associated with temporary worsening of diabetic retinopathy.
In patients with proliferative retinopathy, especially not receiving treatment photocoagulation, episodes of severe hypoglycemia can cause transient loss of vision.
Skin and subcutaneous tissue disorders: as in the treatment of any other insulin preparations, injection site may develop lipodystrophy that can slow down the local absorption of insulin. In applying circuits insulin comprising insulin glargine, lipodystrophy observed in 1-2% of patients and lipoatrophy observed infrequently. Constant change of injection locations within body regions recommended for p / insulin administration, can reduce the severity of the reaction or to prevent its development.
On the part of the musculoskeletal and connective tissue disorders: very rarely – myalgia.
General disorders and administration in place: local allergic reactions at the injection site. As with any insulin therapy, such reactions include redness, pain, itching, hives, rash, swelling and inflammation. In clinical studies conducted in adult patients, the incidence of injection site reactions in patients receiving treatment with Tudzheo SoloSTAR® (2.5%) was similar to that in patients treated with insulin glargine 100 U / ml (2.8% ). Most minor reactions at the site of insulins is usually held for a few days or a few weeks.
Immune system: systemic allergic reactions. Immediate type allergic reactions to insulin are rare. Such reactions to insulin (including insulin glargine) or auxiliary substances may for example be accompanied by generalized skin reactions, angioedema (Quincke’s edema), bronchospasm, decrease blood pressure and shock and threaten the patient’s life.
Other reactions: application of insulin can induce the formation of antibodies thereto. In clinical trials comparing drug Tudzheo SoloSTAR® insulin glargine and 100 U / ml of antibodies to insulin in both treatment groups was observed with the same frequency. As with other insulins, in rare cases, the presence of such antibodies to insulin may require changes in insulin dosage in order to eliminate the tendency to hypoglycemia or hyperglycemia.
In rare cases, insulin can cause sodium retention and the occurrence of edema, in particular in improving metabolic control of previously insufficient insulin at intensification.
Children. The safety profile for children and adolescents younger than 18 years are not currently installed.
How to accept, acceptance rate and dosage
Units Tudzheo SoloSTAR® preparation (insulin glargine 300 U / ml) only refer to a preparation Tudzheo SoloSTAR® not equivalent to other units expressing virtue of other insulin analogues. The drug should be administered Tudzheo SoloSTAR® n / k 1 times a day at any time of the day, preferably in one and the same time. Tudzheo SoloSTAR® preparation in a single administration during the day allows to have a flexible schedule of injection: if necessary, patients may spend injection within 3 hour before or three hours after the normal time for them to carry it out.
Target values of blood glucose concentration, dose, and time of reception / administration of hypoglycemic drugs to be determined and adjusted individually.
Dose adjustment may also be required, for example when the body weight of the patient changes his lifestyle change timing of insulin administration, or other conditions that may increase susceptibility to developing hypo- or hyperglycemia (see. “special instructions”). Any change of insulin dose should be conducted with caution and only under medical supervision. The drug Tudzheo SoloSTAR® is not the insulin of choice for the treatment of diabetic ketoacidosis. In this case, preference should be given to / in the introduction of short-acting insulin.
All patients with diabetes is recommended to monitor blood glucose levels.
The beginning of the drug Tudzheo SoloSTAR®
Patients with diabetes mellitus type 1. Preparation Tudzheo SoloSTAR® should be applied 1 time a day in combination with insulin, administered during a meal, and requires individual dose adjustment.
Patients with diabetes mellitus type 2. The recommended initial dose of 0.2 U / kg 1 time a day, followed by individual dose adjustment.
Transition from insulin glargine 100 units / ml of the drug Tudzheo SoloSTAR® the other hand, with drug Tudzheo SoloSTAR® insulin glargine 100 U / ml
Insulin glargine 100 U / ml and the drug Tudzheo SoloSTAR® nebioekvivalentny directly interchangeable.
– Transition to insulin glargine 100 units / ml of the drug Tudzheo SoloSTAR® can be performed based on one unit, but to achieve the target range of plasma glucose concentrations may require a higher dose Tudzheo SoloSTAR®.
– When switching from the drug Tudzheo SoloSTAR® insulin glargine 100 IU / ml to reduce the risk of hypoglycemia dose should be reduced (approximately 20%) and then adjusting the dose if necessary.
Recommended thorough metabolic monitoring during and for several weeks after the first transition from one of these preparations on the other.
Transition from other basal insulin to the drug Tudzheo SoloSTAR®
Coming with insulin regimens with intermediate and long duration of action in the treatment regimen with a preparation Tudzheo SoloSTAR® may need to change basal insulin and correction simultaneously carried hypoglycemic therapy (change of doses and the time of administration of short-acting insulins or insulin analogues speed or hypoglycemic doses neinsulinovyh preparations).
– Moving from a single administration during the day basal insulin for a single day during the administration of the preparation can be carried Tudzheo SoloSTAR® unit based on previously input unit dose basal insulin.
– When changing from twice during the day basal insulin for a single administration of the drug Tudzheo SoloSTAR® recommended initial dose Tudzheo SoloSTAR® is 80% of the total daily dose of basal insulin therapy which stops. Patients with high doses of insulin, due to their having antibodies to human insulin may have improved response to the drug Tudzheo SoloSTAR®.
During the transition to the drug Tudzheo SoloSTAR® and within a few weeks after it recommended a careful metabolic monitoring.
With improved metabolic control and resulting from this increase in insulin sensitivity may require additional correction of dosing regimen. Correction dosage regimen may also be required, for example when the body weight change or life-style of the patient, administration time when changing insulin dosage or other conditions arise that increase susceptibility to developing hypo- and hyperglycemia.
Transition from injection Tudzheo SoloSTAR® other basal insulins
During the transition from the injection Tudzheo SoloSTAR® to use other basal insulins and within a few weeks after it is recommended careful medical supervision and metabolic monitoring.
It is recommended to refer to the instructions for use of the drug to which the patient is transferred.
Mixing & Thinning
Tudzheo SoloSTAR® drug should not be mixed with any other insulin. Mixing leads to a change in the profile of the drug Tudzheo SoloSTAR® in time and cause precipitation. The drug Tudzheo SoloSTAR® can not breed. Breeding may change the profile of the drug Tudzheo SoloSTAR® time.
Special patient groups
Children. Safety and efficacy Tudzheo SoloSTAR® in children and adolescents up to 18 years to the present day has not been established (see. “Pharmacokinetics”).
Elderly age. Tudzheo SoloSTAR® drug can be used in elderly patients. Recommended careful monitoring of blood glucose and insulin dose should be individualized. Elderly patients a progressive deterioration of renal function may lead to a permanent decrease in insulin requirements (see. “Special Instructions”, “Pharmacodynamics” and “Pharmacokinetics”).
Renal insufficiency. Tudzheo SoloSTAR® drug can be used in patients with renal insufficiency. Recommended careful monitoring of blood glucose concentration and insulin dose should be individualized. In patients with renal impairment, insulin requirements may be reduced due to the slowing of insulin metabolism (see. “Special Instructions”, “Pharmacodynamics” and “Pharmacokinetics”).
Liver failure. Tudzheo SoloSTAR® drug can be used in patients with hepatic insufficiency. Recommended careful monitoring of blood glucose concentration and insulin dose should be individualized. In patients with hepatic impairment, insulin requirements may be reduced due to a reduction in gluconeogenesis and insulin metabolism slowing (see. “Pharmacodynamics”, “Pharmacokinetics” and “Cautions”).
Mode of application
Tudzheo SoloSTAR® drug is injected into the subcutaneous fat of the abdomen, shoulders or hips. Injection sites should alternate with every new injection within the recommended area for drug administration.
Tudzheo SoloSTAR® drug is not intended for in / in the introduction. Prolonged action of insulin glargine is only observed when administered in subcutaneous fat. B / in a conventional n / a dose can cause severe hypoglycemia. Tudzheo SoloSTAR® drug is not intended to be administered via an insulin infusion pump.
Preparation Tudzheo SoloSTAR® a clear solution instead of suspension, so resuspension prior to use is required. With the pen Tudzheo SoloSTAR® dose may be administered between 1 and 80 IU per injection dose increments of 1 IU:
– counter-dose pen Tudzheo SoloSTAR® shows the number Tudzheo SoloSTAR® ED drug to be injected. Injection pen Tudzheo SoloSTAR® was developed specifically for the preparation Tudzheo SoloSTAR®, and therefore requires no additional dose recalculation;
– Tudzheo SoloSTAR® drug should never be removed from the cartridge pen into the syringe (see “Special Instructions”.);
– You can not use the needle again. should attach a new sterile needle before each injection. Reusing needle increases the risk of blockage, which may lead to the introduction of a lower dose or overdose. In addition, using a new sterile needle for each injection to minimize the risk of contamination and infection;
– in case of clogging of the needle patient should follow the instructions in step 3 (see Instructions for use of the syringe-pen Tudzheo SoloSTAR®.).
In order to avoid possible transmission of diseases transmitted through the blood insulin pen should not be used by more than one patient, even if the replacement of the needle.
For correct use of the syringe-pen Tudzheo SoloSTAR® cm. Instruction for use syringe pen Tudzheo SoloSTAR®. In order to preclude erroneous (random) administration of another type of insulin preparation instead Tudzheo SoloSTAR® should always be checked before each injection syringe label on the handle (label autoinjector Tudzheo SoloSTAR® concentration “300 U / ml” isolated honey-gold background ).
The term drug use in disposable pen Tudzheo SoloSTAR® after the first application – 4 weeks, when stored in a dark place. It is recommended to indicate on the label of the pen the date of its first application.
Instructions for use of the syringe-pen Tudzheo SoloSTAR® (glargine insulin 300 U / ml)
Injection pen Tudzheo SoloSTAR® comprises glargine insulin concentration of 300 units / ml.
1. Never use a needle again. With repeated use of the needle due to the fact that the needle is clogged, the patient may not receive his desired dose (administration of a lower dose) or have too large dose (overdose).
2. Do not use the syringe for extraction of insulin from the pen. In this case, the patient can get an overdose of insulin. The scale on the most insulin syringes intended only for unconcentrated insulins.
1. Do not use a syringe-pen at the same time with other people, even if the replacement of the needle. The patient may get a serious infection from other people or give them serious infection transmitted through blood.
2. Never use a syringe-handle if it is damaged or if the patient is not sure that it is working.
3. Always carry out the test for safety.
4. Always have a spare pen syringe and needle replacement in case they are lost or become defective.
5. Before using the syringe-pen check with your health care professional on how to properly s / c injection.
6. In the case of a patient eye problems it may need the assistance of other persons able to follow all the recommendations of the instructions for use syringe pen Tudzheo SoloSTAR®.
Before you use the pen should read all instructions. If the patient does not follow all the recommendations, he can get either too much or too little insulin.
The patient is additionally required: A new sterile needle (see Step 2.) Alcohol wetted wipe, puncture resistant container for used needles and syringes.
A number of drugs affect the metabolism of glucose, resulting in their simultaneous application with insulins may require adjustment of insulin doses, and especially closely monitored.
Drugs that may increase the hypoglycaemic effect of insulin and a tendency to develop hypoglycemia. Oral hypoglycemic agents, ACE inhibitors, salicylates, disopyramide; fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, sulfa antibiotics. Simultaneous administration of these drugs with insulin glargine may require adjustment of insulin dose.
PM, which can weaken the hypoglycemic effect of insulin. Corticosteroids, danazol, diazoxide, diuretics, sympathomimetics (such as epinephrine, salbutamol, terbutaline); glucagon, isoniazid, phenothiazine derivatives, growth hormone, thyroid hormones, estrogens and progestogens (such as hormonal contraceptives), protease inhibitors and atypical antipsychotics (e.g., olanzapine and clozapine). Simultaneous administration of these drugs with insulin glargine may require adjustment of insulin dose.
Beta-blockers, clonidine, lithium salt and ethanol – may both amplification and attenuation hypoglycemic action of insulin.
Pentamidine in combination with insulin may cause hypoglycemia which is sometimes replaced by hyperglycemia.
Sympatholytic drugs – under the influence of sympatholytic drugs such as beta-blockers, clonidine, guanethidine and reserpine, may be reduced or absent signs of adrenergic kontrregulyatsii (activation of the sympathetic nervous system in response to hypoglycemia).
Interaction with pioglitazone. In the application of pioglitazone in combination with insulin reported cases of heart failure, particularly in patients at risk of developing heart failure (see. “Special Instructions”). When the weighting or cardiac symptoms pioglitazone should be discontinued.
Patients must have the skills self diabetes mellitus, including blood glucose monitoring, but also adhere to proper engineering of p / injection and able to arrest the development of hypoglycemia and hyperglycemia. Insulin therapy requires constant vigilance with regard to the possibility of the development of hyperglycemia or hypoglycemia.
In the event of insufficient control of the concentration of glucose in the blood, as well as a trend towards the development of hypo- or hyperglycemia, before embarking on the accuracy of the prescribed treatment regimen should be checked for correct dosing regimen, compliance guidance on injection site, proper technique of subcutaneous injections and treatment with syringe pen SoloSTAR®, as well as to consider the possibility of other factors that can cause this condition.
Time of hypoglycemia depends on the profile of action of insulin used, and can thus be varied by varying the treatment regimen. It should be particularly careful and intensified monitoring of blood glucose concentration when using the drug in patients who have episodes of hypoglycaemia may be of particular clinical value, such as patients with severe stenosis of the coronary arteries or cerebrovascular disease (risk of cardiac and cerebral hypoglycemia complications), and and patients with proliferative retinopathy, particularly if they do not receive treatment photocoagulation (risk of transient vision loss after hypoglycemia). As with all insulins, in some states of the symptoms-harbingers of hypoglycemia may be changed, becoming less pronounced or absent.
– a marked improvement in glycemic control;
– gradual development of hypoglycemia;
– elderly age;
– the presence of autonomic neuropathy;
– a long history of diabetes;
– the presence of mental disorders;
– simultaneous use of insulin glargine with certain other drugs (see “Interaction.”).
Such situations can lead to the development of severe hypoglycemia (with the possible loss of consciousness) before the patient is aware that he develops hypoglycemia.
It will be appreciated that prolonged effect of the drug Tudzheo SoloSTAR® when s / to a patient may delay the output from the state of hypoglycemia.
If have normal or reduced performance of glycated Hb, it is necessary to consider the possibility of repeating unrecognized episodes of hypoglycemia (especially at night).
Patient compliance with the dosing regimen and diet, correct insulin administration and awareness of hypoglycaemia symptoms-precursors contribute to a significant reduction in the risk of hypoglycemia.
Factors that increase the tendency to hypoglycemia, the presence of which requires especially careful monitoring and correction may be required insulin dose:
– change the site of administration of insulin;
– increased sensitivity to insulin (e.g. while eliminating stress factors);
– unaccustomed, increased or prolonged physical activity;
– intercurrent illness accompanied by vomiting, diarrhea;
– inadequate food intake;
– consumption of ethanol;
– some uncompensated endocrine disorders (such as hypothyroidism, anterior pituitary insufficiency or adrenocortical insufficiency);
– simultaneous use of insulin glargine with certain other drugs (see “Interaction.”).
In patients with renal failure, insulin requirements can be reduced by slowing down the metabolism of insulin (see. “Pharmacodynamics”, “Pharmacokinetics” and “Dosage and Administration”). Elderly patients progressive deterioration of renal function may lead to a steady decline in insulin requirements (see. “Pharmacodynamics”, “Pharmacokinetics” and “Dosage and Administration”).
In patients with severe liver failure, insulin requirements may be reduced due to reduced capacity for gluconeogenesis and deceleration insulin metabolism (see. “Pharmacodynamics”, “Pharmacokinetics” and “Dosage and Administration”).
Hypoglycemia may be generally extemporaneously solved bystrousvaivaemyh carbohydrates. Since the initial steps of correction must be carried out immediately hypoglycemia, patients should always have a minimum of 20 g bystrousvaivaemyh carbohydrates.
When intercurrent diseases require more intensive control of blood glucose concentration. In many cases, the analysis shows the presence of ketone bodies in urine, are also often required insulin correction dosing regimen. In the event of intercurrent illness insulin requirement is often increased. Patients with type 1 diabetes must continue to receive carbohydrates on a regular basis, even if they are able to eat food only in small portions or in general do not take food or in case of vomiting; Patients with type 1 diabetes should never completely skip insulin.
The combination of insulin glargine with pioglitazone
In the application of pioglitazone in combination with insulin reported cases of heart failure, particularly in patients at risk of developing heart failure. This information should be taken into account when considering the application of a combination of pioglitazone with drug Tudzheo SoloSTAR®. In applying such a combination, patients should be monitored for the appearance of signs and symptoms of heart failure, such as weight gain, occurrence of edema. When the weighting or cardiac symptoms pioglitazone should be discontinued.
Preventing error when administered insulin formulations
Not to mix the drug Tudzheo SoloSTAR® with other insulins, you should always check the markings on the syringe-pen before each injection. It reported when accidentally mistakenly introduced other insulins, particularly short-acting insulins, instead of long-acting insulin.
To avoid metering errors and possible overdose, patients should never use a syringe to extract the medication from the syringe Tudzheo® pens SoloSTAR® (cm. “Dosage and Administration” “Overdose”).
As with other insulin pens, patients must visually check the number dialed dose units per dose indicator window on the injection pen. Blind or visually impaired patients should receive assistance from other people with good eyesight and are able to use a syringe-handle Tudzheo SoloSTAR®.
Storage Recommendations pen Tudzheo SoloSTAR®
During storage of the preparation Tudzheo SoloSTAR® refrigerated (unopened / prior to use) must be ensured that the packages of injection pens are not in direct contact with the freezing compartment or of frozen products, since the drug must not be frozen. If insulin has been frozen, it can not be used, and the pen must be disposed of.
As used pen SoloSTAR® should be stored at a temperature not higher than 30 ° C, protected from light and heat.
Effects on ability to drive and engage in other potentially hazardous activities. The patient’s ability to concentrate and speed psychomotor reactions may be violated, for example as a result of hypoglycemia or hyperglycemia, as well as a result of visual impairment. This may constitute a risk in situations where these abilities are particularly important (eg driving or operating other mechanisms). Patients are advised to take precautions to avoid hypoglycaemia during the time of driving a vehicle. This is especially important for those who have mild or no symptoms, is a harbinger of developing hypoglycemia, or for patients with frequent episodes of hypoglycemia occurring. These features of the patient should be taken into account when deciding on the possibility of management of vehicles.
Symptoms: an overdose of insulin (excess of insulin relative to food intake, energy expenditure, or both together) can lead to severe and sometimes long-term and life-threatening hypoglycaemia patient.
Treatment: hypoglycemia episodes of moderate severity usually stoped by ingestion bystrousvaivaemyh carbohydrates. You may need to change the drug dosing regimen, diet or physical activity.
More severe hypoglycemia episodes, manifested coma, seizures or neurological disorders may be cropped / m or p / glucagon administration or on / in a concentrated dextrose (glucose). It may require prolonged intake of carbohydrates and surveillance specialist since after apparent clinical improvement possible relapse hypoglycemia.