Buy NovoMix 30 FlexPen suspension subcutaneously 100 U/ml 3 ml No. 5 in pharmacies

Pharmacological properties of the drug Novomix 30 flexpen

NovoMix 30 FlexPen is a two-phase suspension consisting of a mixture of insulin analogues: insulin aspart (an analogue of short-acting human insulin) and protamine-insulin aspart (an analogue of medium-acting human insulin). A decrease in blood glucose levels under the influence of insulin aspart occurs after it binds to insulin receptors, which promotes the uptake of glucose into muscle and fat cells and at the same time inhibits the release of glucose from the liver. NovoMix 30 FlexPen is a two-phase suspension containing 30% soluble insulin aspart. This ensures a faster onset of action compared to soluble human insulin and allows the drug to be administered immediately before meals (from 0 to 10 minutes). The crystalline phase (70%) consists of protamine insulin aspart, which has the same activity profile as human neutral protamine Hagedorn insulin (NPH). NovoMix 30 FlexPen begins to act 10–20 minutes after subcutaneous injection. The maximum effect is achieved 1–4 hours after administration. Duration of action is up to 24 hours. The level of glycosylated hemoglobin in patients with type I and II diabetes mellitus who were administered NovoMix 30 for 3 months is the same as when administered biphasic human insulin. When administered in equal molar doses, insulin aspart matches the activity of human insulin. In a clinical study, patients with type II diabetes mellitus (341 people), divided into groups according to a randomized principle, received only NovoMix 30 FlexPen, or NovoMix 30 FlexPen in combination with metformin, or metformin in combination with a sulfonylurea. After 16 weeks of treatment, the levels of glycosylated hemoglobin HbA1c in patients receiving NovoMix 30 in combination with metformin or metformin in combination with sulfonylurea were the same. In this study, 57% of patients had HbA1c levels above 9%. In these patients, combined treatment with NovoMix 30 FlexPen and metformin caused a more pronounced decrease in HbA1c levels compared to the combination of metformin and sulfonylurea. In a study, patients with type II diabetes whose glycemic control was ineffective with oral hypoglycemic agents were treated with NovoMix 30 twice daily (117 patients) or insulin glargine once daily (116 patients). After 28 weeks of treatment with NovoMix 30, accompanied by dose adjustment, HbA1c levels decreased by 2.8% (average HbA1c values ​​at study entry = 9.7%). When treated with NovoMix 30, 66% of patients reached HbA1c levels below 7%, and 42% of patients reached levels below 6.5%; at the same time, the fasting plasma glucose concentration decreased by approximately 7 mmol/l (from 14.0 mmol/l before treatment to 7.1 mmol/l). Pharmacokinetics . In insulin aspart, the amino acid proline at position 28 of the B-chain of the insulin molecule is replaced by aspartic acid, which reduces the formation of hexamers formed in soluble human insulin preparations. In the soluble phase of NovoMix 30 FlexPen, the share of insulin aspart is 30% of total insulin. It is absorbed into the blood from subcutaneous tissue faster than soluble biphasic human insulin. The remaining 70% comes from the crystalline form of protamine insulin aspart, whose longer absorption rate is the same as that of human NPH insulin. The maximum concentration of insulin in the blood serum after administration of NovoMix 30 FlexPen is 50% higher, and the time to achieve it is half as short compared to biphasic human insulin 30. In healthy volunteers after subcutaneous administration of the drug NovoMix 30 at the rate of 0.20 U/kg body weight body, the maximum concentration of insulin aspart in the blood serum was achieved after 60 minutes and amounted to 140±32 pmol/l. The half-life of NovoMix 30, which reflects the rate of absorption of the protamine fraction, was 8–9 hours. The level of insulin in the blood serum returned to baseline 15–18 hours after subcutaneous administration. In patients with type II diabetes mellitus, the maximum concentration was reached 95 minutes after administration and remained above the initial concentration for at least 14 hours. Children and adolescents. The pharmacokinetics of NovoMix 30 FlexPen have not been studied in children and adolescents. However, the pharmacokinetics and pharmacodynamics of soluble insulin aspart were studied in children (6-12 years old) and adolescents (13-17 years old) with type 1 diabetes. It was rapidly absorbed in patients of both groups, and the time to reach maximum concentration was the same as in adults. At the same time, Cmax values ​​in different groups differed significantly, which indicates the importance of individual selection of doses of insulin aspart. The pharmacokinetics of NovoMix 30 has not been studied in the elderly, children and patients with impaired renal or hepatic function.

Compound

NovoMix® 30 Penfill®

NovoMix® 30 FlexPen®

Use of the drug Novomix 30 flexpen

Insulin dosage is individual and determined by the doctor in accordance with the patient's needs. Since the effect of NovoMix 30 FlexPen occurs faster than biphasic human insulin, it should be administered immediately before meals. If necessary, NovoMix 30 FlexPen can be administered a short period of time after meals. On average, a patient's need for insulin is, depending on body weight, from 0.5 to 1.0 IU/kg/day. It can be fully or partially achieved by administering the drug NovoMix 30 FlexPen. The daily need for insulin may increase in patients with insulin resistance (for example, obesity) and decrease in patients with remaining residual production of endogenous insulin. NovoMix 30 FlexPen is usually injected subcutaneously into the thigh area. You can also make injections into the area of ​​the anterior abdominal wall, buttocks or deltoid muscle of the shoulder. To avoid lipodystrophy, injection sites should be changed even within the same body area. Like other insulin medications, the duration of action may vary depending on the dose, injection site, blood flow rate, temperature and level of physical activity. The dependence of the absorption rate on the site of drug administration has not been studied. For patients with type II diabetes mellitus, NovoMix 30 FlexPen can be prescribed both as monotherapy and in combination with hypoglycemic agents (GLDs) in cases where the blood glucose level cannot be effectively regulated with GLDs alone. For patients with type II diabetes mellitus, the recommended initial dose of NovoMix 30 FlexPen in combination with metformin is 6 units before breakfast and 6 units before dinner. You can begin its administration with a dose of 12 units before dinner. After reaching a dose of 30 units, it is usually recommended to switch from a single injection to two injections per day of 15 units before breakfast and dinner. Then you can safely switch to three injections per day and administer half the morning dose before breakfast and lunch. When selecting doses, it is recommended to be guided by the data in the table below

You should focus on the lowest glucose concentrations over the last three days. If there were episodes of hypoglycemia during this period, the insulin dose is not increased. The dose is adjusted once a week until the target HbA1c level is achieved. The adequacy of the previous dose is assessed by the glucose concentration values ​​before meals. Impaired liver or kidney function may reduce the patient's need for insulin. NovoMix 30 FlexPen can be used in children and adolescents aged 10 years and older, when the administration of a mixture of insulin is preferable. Data from clinical studies on the use of the drug in children 6-9 years of age are limited. Studies have not been conducted in children under 6 years of age. NovoMix 30 FlexPen can be used in elderly patients; however, experience with its use in combination with PSS in individuals over 75 years of age is limited. NovoMix 30 FlexPen should never be administered intravenously. Instructions for use of the drug NovoMix 30 FlexPen for a patient The need to thoroughly mix the insulin suspension before use should be emphasized. After mixing, the suspension should be uniformly white and cloudy. NovoMix 30 FlexPen is intended for individual use only. Do not refill NovoMix 30 FlexPen. NovoMix 30 FlexPen is used with short NovoFine® needles. Before using NovoMix 30 FlexPen: you must check the label to see if the type of insulin you are using is correct. Always use a new needle for each injection. Do not use NovoMix 30 FlexPen:

• in insulin pumps;
• if the FlexPen syringe pen has been dropped, if it is damaged or deformed, since in these cases insulin leakage may occur;
• if the syringe pen was stored incorrectly or was frozen; if after stirring the suspension does not become uniformly white and cloudy; if the product has white clumps or hard white particles stuck to the bottom or walls of the cartridge, giving it the appearance of being frozen.

NovoMix 30 FlexPen is intended for subcutaneous injection. The drug should not be administered intravenously or directly into the muscle. To avoid the formation of infiltrates, injection sites should be constantly changed. The best places for injection are the anterior abdominal wall, buttocks, anterior thigh or shoulder. Insulin works faster when injected into the waist area.

Pharmacodynamics

NovoMix® 30 Penfill®/FlexPen® is a biphasic suspension consisting of soluble insulin aspart (30% short-acting insulin analogue) and insulin aspart protamine crystals (70% intermediate-acting insulin analogue). The active substance of NovoMix® 30 Penfill®/FlexPen® is insulin aspart, produced by recombinant DNA biotechnology using the Saccharomyces cerevisiae strain.

Insulin aspart is equipotential to soluble human insulin based on molarity.

A decrease in blood glucose levels occurs due to an increase in its intracellular transport after binding of insulin aspart to insulin receptors in muscle and fat tissues and simultaneous inhibition of glucose production by the liver. After subcutaneous administration of NovoMix® 30 Penfill®/FlexPen®, the effect develops within 10–20 minutes. The maximum effect is observed within 1 to 4 hours after injection. The duration of action of the drug reaches 24 hours.

In a three-month comparative clinical study involving patients with type 1 and type 2 diabetes mellitus who received NovoMix® 30 Penfill®/FlexPen® and biphasic human insulin 30, 2 times a day, before breakfast and dinner, it was shown that NovoMix® 30 Penfill ®/FlexPen® more strongly reduces postprandial blood glucose levels (after breakfast and dinner).

A meta-analysis of data obtained from 9 clinical studies involving patients with type 1 and type 2 diabetes mellitus showed that NovoMix® 30 Penfill®/FlexPen®, when administered before breakfast and dinner, provides better control of postprandial blood glucose levels (mean increase in prandial glucose levels after breakfast, lunch and dinner) compared with human biphasic insulin 30. Although fasting glucose levels were higher in patients using NovoMix® 30 Penfill®/FlexPen®, overall NovoMix® 30 Penfill®/FlexPen® has the same effect on glycosylated hemoglobin (HbA1c) concentration as biphasic human insulin 30.

In a clinical trial involving 341 patients with type 2 diabetes, patients were randomized to NovoMix® 30 Penfill®/FlexPen® alone, NovoMix® 30 Penfill®/FlexPen® in combination with metformin, and metformin in combination with a sulfonylurea derivative. The HbA1c concentration after 16 weeks of treatment did not differ between patients receiving NovoMix® 30 Penfill®/FlexPen® in combination with metformin and in patients receiving metformin in combination with a sulfonylurea derivative. In this study, 57% of patients had a baseline HbA1c concentration greater than 9%; in these patients, therapy with NovoMix® 30 Penfill®/FlexPen® in combination with metformin led to a more significant decrease in HbA1c concentrations than in patients receiving metformin in combination with a sulfonylurea derivative.

In another study, patients with type 2 diabetes mellitus with poor glycemic control and taking oral hypoglycemic agents were randomized to receive NovoMix® 30 twice daily (117 patients) or to receive insulin glargine once daily (116 patients). After 28 weeks of drug use, the average decrease in HbA1c concentration in the NovoMix® 30 Penfill®/FlexPen® group was 2.8% (the initial average value was 9.7%). In 66% and 42% of patients using NovoMix® 30 Penfill®/FlexPen®, at the end of the study, HbA1c values ​​were below 7 and 6.5%, respectively. Mean fasting plasma glucose decreased by approximately 7 mmol/L (from 14 mmol/L at baseline to 7.1 mmol/L).

The results of a meta-analysis of data obtained from clinical trials involving patients with type 2 diabetes mellitus demonstrated a reduction in the total number of episodes of nocturnal hypoglycemia and severe hypoglycemia when using NovoMix® 30 Penfill®/FlexPen® compared with biphasic human insulin 30. At the same time, the overall risk of daytime hypoglycemia in patients receiving NovoMix® 30 Penfill®/FlexPen® was higher.

Children and teenagers. A 16-week clinical study was conducted comparing postprandial blood glucose levels with NovoMix® 30 (pre-meal), human insulin/biphasic human insulin 30 (pre-meal) and isophane insulin (administered at bedtime). The study involved 167 patients aged 10 to 18 years. Mean HbA1c values ​​in both groups remained close to baseline values ​​throughout the study. Also, when using NovoMix® 30 Penfill®/FlexPen® or biphasic human insulin 30, no differences in the incidence of hypoglycemia were observed.

A double-blind crossover study was also conducted in a population of patients aged 6 to 12 years (a total of 54 patients, 12 weeks for each type of treatment). The incidence of hypoglycemia and an increase in glucose levels after meals in the group of patients using NovoMix® 30 Penfill®/FlexPen® were significantly lower compared to the values ​​in the group of patients using biphasic human insulin 30. HbA1c values ​​at the end of the study in the group using biphasic insulin human insulin 30 were significantly lower than in the group of patients using NovoMix® 30 Penfill®/FlexPen®.

Elderly patients. The pharmacodynamics of NovoMix® 30 Penfill®/FlexPen® have not been studied in elderly and senile patients. However, a randomized, double-blind, crossover study conducted in 19 patients with type 2 diabetes mellitus aged 65–83 years (mean age 70 years) compared the pharmacodynamics and pharmacokinetics of insulin aspart and soluble human insulin. Relative differences in the values ​​of pharmacodynamics indicators (maximum glucose infusion rate - GIRmax and the area under the curve of its infusion rate within 120 minutes after administration of insulin preparations - AUCGIR, 0–120 min) between insulin aspart and human insulin in elderly patients were similar to those in healthy volunteers and in younger patients with diabetes.

Preclinical safety data

Preclinical studies have not demonstrated any hazard to humans based on generally accepted pharmacological safety, repeated use toxicity, genotoxicity and reproductive toxicity studies.

In vitro tests, including binding to insulin and IGF-1 receptors and effects on cell growth, showed that insulin aspart had properties similar to those of human insulin. The study results also showed that the dissociation of insulin aspart binding to insulin receptors is equivalent to that of human insulin.

Side effects of the drug Novomix 30 flexpen

Adverse reactions observed in patients using NovoMix 30 FlexPen are mainly related to the size of the administered dose of the drug and are a manifestation of the pharmacological action of insulin. The most common side effect of insulin therapy is hypoglycemia. It may appear if the dose significantly exceeds the patient's need for insulin. Severe hypoglycemia can cause loss of consciousness and/or seizures, followed by temporary or permanent impairment of brain function and even death. According to the results of clinical studies, as well as data recorded after the drug was marketed, the incidence of severe hypoglycemia varies in different patient groups and with different dosage regimens; The incidence of severe hypoglycemia in patients receiving insulin aspart is the same as in patients receiving human insulin. Below is the frequency of adverse reactions that, according to clinical studies, may be associated with the administration of NovoMix 30 FlexPen. Based on the frequency of occurrence, these reactions are divided into those observed sometimes (1/1000, ≤1/100) and rarely (1/10,000, ≤1/1000). Individual spontaneous cases are classified as very rare (≤1/10,000). From the immune system Very rare: anaphylactic reactions. Sometimes: urticaria, itching, skin rashes. Generalized hypersensitivity reactions may include skin rashes, itching, sweating, gastrointestinal disturbances, angioedema, difficulty breathing, palpitations and decreased blood pressure. These reactions are potentially life-threatening. From the nervous system. Rarely: peripheral neuropathies. Rapid improvement in blood glucose control may result in acute painful neuropathy, which is usually transient. Visual disturbances : Sometimes: refractive errors; may occur at the beginning of insulin therapy and are transient. Sometimes: diabetic retinopathy. Long-term maintenance of good glycemic control reduces the risk of progression of diabetic retinopathy. However, intensifying insulin therapy to rapidly improve glycemic control may cause a temporary exacerbation of diabetic retinopathy. From the skin and subcutaneous tissue: Sometimes: lipodystrophy; may occur at injection sites as a result of non-compliance with the recommendation to change drug injection sites within the same area; local hypersensitivity. When insulin is administered, manifestations of local hypersensitivity (redness, swelling and itching at the injection sites) may occur. These reactions are usually transient and disappear with continued treatment. Generalized disorders and reactions at injection sites Sometimes : local swelling; may develop at the beginning of insulin therapy. These symptoms are usually temporary.

Special instructions for the use of Novomix 30 Flexpen

Inadequate dosage or discontinuation of treatment (especially in type I diabetes mellitus) can lead to hyperglycemia and diabetic ketoacidosis; These conditions are potentially fatal. Patients who have significantly improved blood glucose control, for example through intensive care, may notice a change in the usual symptoms that are warning signs of hypoglycemia, about which patients should be warned in advance. NovoMix 30 FlexPen should be administered immediately before meals. The rapid onset of action of the drug should be taken into account when treating patients with concomitant diseases or taking medications that can slow down the absorption of food in the gastrointestinal tract. Concomitant diseases, especially infections and fevers, increase the patient's need for insulin. When transferring a patient to other types of insulin, early warning symptoms may change or be less pronounced than when taking the usual insulin drug. Transferring a patient to another type or type of insulin is carried out under strict medical supervision. Changes in the concentration, type (manufacturer), type, origin of insulin (animal, human or human insulin analogue) and/or production method may require dose adjustment. When switching to NovoMix 30 FlexPen injections, patients may need to change their usual insulin dose. The need to adjust the dose may arise both when a new drug is first introduced and during the first few weeks or months of its use. Skipping meals, sudden changes in diet, or unexpected intense physical activity can lead to hypoglycemia. Compared to biphasic human insulin, injection of NovoMix 30 FlexPen leads to a more pronounced hypoglycemic effect, which can last up to 6 hours. This may necessitate the selection of insulin doses and/or diet. The need to adjust the dose of the drug may arise with increased physical activity or changes in diet. Exercising immediately after eating increases the risk of hypoglycemia. Insulin suspensions should not be used in insulin pumps for continuous subcutaneous insulin administration. During pregnancy and breastfeeding. Clinical experience with the use of insulin aspart during pregnancy is limited. Animal studies have shown that insulin aspart, like human insulin, does not have embryotoxic or teratogenic effects. Enhanced monitoring is recommended when treating pregnant women with diabetes mellitus throughout the entire period of pregnancy, as well as if pregnancy is suspected. The need for insulin usually decreases in the first trimester of pregnancy and increases significantly in the second and third trimester. After childbirth, insulin requirements quickly return to baseline levels. There are also no restrictions on the treatment of diabetes mellitus with insulin during breastfeeding, since treatment of a nursing mother does not pose a risk to the child. However, it may be necessary to adjust the dose of NovoMix 30 FlexPen. Impact on the ability to drive vehicles and machinery. The patient's responsiveness and ability to concentrate may be impaired by hypoglycemia. This may become a risk factor in situations where these abilities are of particular importance (for example, when driving a car or operating machinery). Patients should be advised to take measures to prevent hypoglycemia before driving. This is especially important for those who have mild or no symptoms - warning signs of hypoglycemia or episodes of hypoglycemia occur frequently. Under such circumstances, the advisability and safety of driving should be weighed.

Use during pregnancy and breastfeeding

Clinical experience with the use of NovoMix® 30 Penfill®/FlexPen® during pregnancy is limited.

Studies on the use of NovoMix® 30 Penfill® in pregnant women have not been conducted.

However, data from two randomized controlled clinical trials (157 and 14 pregnant women, respectively, receiving basal-bolus insulin aspart) did not show any adverse effects of insulin aspart on pregnancy or fetal/newborn health compared with soluble human insulin. Additionally, a clinical randomized trial of 27 women with gestational diabetes treated with insulin aspart and soluble human insulin (insulin aspart in 14 women, human insulin in 13) demonstrated similar safety profiles for both types of insulin.

During the period of possible pregnancy and throughout its entire duration, it is necessary to carefully monitor the condition of patients with diabetes mellitus and monitor the concentration of glucose in the blood. The need for insulin, as a rule, decreases in the first trimester and gradually increases in the second and third trimesters of pregnancy. Shortly after birth, insulin requirements quickly return to pre-pregnancy levels.

During breastfeeding, NovoMix® 30 Penfill®/FlexPen® can be used without restrictions. Administration of insulin to a nursing mother does not pose a threat to the baby. However, it may be necessary to adjust the dose of NovoMix® 30 Penfill®/FlexPen®.

Interactions of the drug Novomix 30 flexpen

A number of drugs affect glucose metabolism, which should be taken into account when determining the dose of insulin. Drugs that reduce the need for insulin: oral hypoglycemic agents, octreotide, MAO inhibitors, non-selective beta-blockers, ACE inhibitors, salicylates, alcohol, anabolic steroids and sulfonamides. Drugs that increase the need for insulin: oral contraceptives, thiazides, corticosteroids, thyroid hormones, sympathomimetics and danazol. β-adrenergic receptor blockers can mask the symptoms of hypoglycemia, while alcohol can enhance and prolong the hypoglycemic effect of insulin. Incompatibility. Adding some drugs to insulin can cause it to break down, such as drugs containing thiols or sulfites. NovoMix 30 FlexPen cannot be added to infusion solutions.

Interaction

There are a number of drugs that affect the need for insulin. The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, non-selective beta-blockers, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, salicine ilats.

The hypoglycemic effect of insulin is weakened by oral contraceptives, corticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, somatropin, danazol, clonidine, CCB, diazoxide, morphine, phenytoin, nicotine.

Beta blockers may mask the symptoms of hypoglycemia.

Octreotide/lanreotide can either increase or decrease the body's need for insulin.

Alcohol can increase or decrease the hypoglycemic effect of insulin.

Incompatibility. Since compatibility studies have not been conducted, NovoMix® 30 Penfill®/FlexPen® should not be mixed with other drugs.

Overdose of the drug Novomix 30 flexpen, symptoms and treatment

Although there is no specific definition of insulin overdose, hypoglycemia may occur when administered in excess. Mild hypoglycemia can be treated by ingesting glucose or sweet foods. Therefore, patients with diabetes are recommended to always have a few pieces of sugar, candy, cookies or sweet fruit juice with them. In case of severe hypoglycemia, when the patient is unconscious, it is necessary to administer intramuscular or subcutaneous injections of glucagon (0.5 to 1 mg) by a person who has received appropriate instructions. A healthcare worker can also administer intravenous glucose to the patient if the patient does not respond to glucagon administration within 10–15 minutes. After the patient regains consciousness, he should take carbohydrates orally to prevent relapse of hypoglycemia.

Storage conditions for the drug Novomix 30 flexpen

Shelf life - 2 years. The used syringe pen with NovoMix 30 FlexPen should not be stored in the refrigerator. A syringe pen that is used or carried in reserve should be stored for no more than 4 weeks (at a temperature not exceeding 30 ° C). An unused syringe pen with NovoMix 30 FlexPen should be stored in the refrigerator at a temperature of 2–8 ° C (not too close to the freezer). Do not freeze. To protect from light, store the syringe pen with the cap on.

List of pharmacies where you can buy Novomix 30 Flexpen:

• Moscow
• Saint Petersburg