"Insulin Tresiba": reviews from diabetics, instructions and photos

Reviews about Tresiba Insulin should be of interest to all patients who have encountered such a serious disease as diabetes in their lives. This is a modern, ultra-long-acting drug produced by the international company Novo Nordisk, headquartered in a suburb of Copenhagen. Many claim that it is significantly more effective than many other known insulin-containing drugs, the effect of each injection lasts up to 42 hours. All this makes it even easier and more reliable to maintain blood sugar levels at a stable level. In this article we will present the main points of the instructions that come with this medicine, as well as reviews from patients who have already tried the drug on themselves.

Description

In reviews of Tresiba Insulin, many claim that they have already appreciated the effectiveness and benefits of this drug. In fact, it is an analogue of human insulin. It should be understood that the insulin molecule is not completely repeated. With the help of advances in biotechnology, it was possible to change it, which allowed it to acquire fundamentally new properties. It is known that initially this drug was created only for patients with type 2 diabetes mellitus, but now it turns out that it is successfully used in the first type of this disease.

The effect of Insulin Tresiba on the human body lasts more than 40 hours. However, manufacturers recommend daily injections, even though the drug works for more than one day.

On the territory of Russia, it is known under two INNs “Insulin Tresiba” - these are “Tresiba FlexTouch” and “Tresiba Penfill”. The first form is disposable pens that are thrown away after the insulin runs out. The second form is cartridges for reusable syringe pens. It is noteworthy that they are suitable not only for this drug, but also for NovoPen.

The new drug is recommended for use in type 1 and type 2 diabetes. It is worth remembering the existing contraindications; it should be used especially carefully by pregnant and lactating women, since its effects on their body have not yet been properly studied.

“If you put me on insulin, what am I going to do?”, diabetes is not just a disease for those with a sweet tooth

Every second Krasnoyarsk resident has heard that diabetes is a disease not only for those with a sweet tooth, but few understood the causes of this disease. Why do diabetics need insulin, what danger lies in oatmeal for them, and why it is important to keep weight under control - in an interview with Margarita Khaernasova, an endocrinologist at the Russian-Finnish medical center TERVE.

What kind of disease is diabetes?
Diabetes mellitus is a chronic non-infectious disease. It is characterized by increased levels of glucose in the blood, which occurs either due to a complete deficiency of insulin, or as a result of its incorrect interaction with the body's receptors. That is, when we talk about diabetes, we mean either type 1 diabetes, in which we do not have our own insulin, and we replace it, or type 2 diabetes, when we have our own insulin, but it does not work correctly at the level of hormones and receptors : either the receptors do not see insulin, or there are few receptors. Or there is insulin, there is a lot of it, but the receptors do not sense it well.

Type 1 diabetes is not anyone's fault—it's a genetic disorder. Most often it occurs in childhood, or immediately after birth, or before the age of 20. Now the detection limit for this type of diabetes has been increased to 35 years. But type 2 diabetes mellitus is multifactorial in nature, the threshold for its diagnosis is older people, 45 years and older. Since such patients acquire a whole baggage of chronic diseases, body weight increases, and the level of physical activity decreases.

“The question is in the tactics of treating diabetes: either we compensate for the lack of insulin, or we use medications that will improve the body’s mechanisms of sensitivity to it, or we remove excess sugar in the blood through urine”

Obese people have a several times higher risk of developing diabetes. For example, a person is not overweight, but has a parent with type 2 diabetes. And another, let’s say, was diagnosed with obesity, but his parents did not have the disease. So the likelihood of developing diabetes is higher in the second case.

Genetics plays a role, but lifestyle weighs heavily on this scale. If a person is active, eats within his normal caloric intake and consumes as much as he expends, then, despite having relatives with diabetes, he is less likely to develop this disease. And a person who has gained excess weight over 5 or 10 years and is far from any level of physical activity will most likely develop diabetes. The only question is the timing - when the body gets tired of compensating for the increase in excess body weight. “Either you are “dragging” or driving at high speed”

Adipose tissue itself is quite hormonally active and secretes a large amount of hormone-like substances. Food enters the human body and is broken down into fats, proteins and carbohydrates. In order to maintain a constant glucose level within a certain range, a compensatory body works - the pancreas secretes insulin in its own way. When a person eats more than normal, the pancreas secretes additional insulin. And when there is excess body weight, it is harder for insulin to work, because sensitivity to it decreases.

The cells of the body do not sense this insulin well, because there are fewer of them. While insulin reaches the cell through the fat layer, time will pass, and sugar is no longer normal, the body again increases insulin production in an avalanche mode. Excess body weight is a certain ballast. When there is no fat layer, nothing interferes with the smooth communication between the receptors and insulin and glucose.

I would compare this process to a traffic jam: either you drive for a long time in a car and “drag” to your destination, or you drive on the highway at high speed and manage to do everything quickly, when there is no obesity.

How do people react when they find out they have diabetes?

When you tell a person that he has type 1 diabetes, you immediately explain to him the whole future situation. At first, the patient simply does not believe that he has such a disease, because you start talking about insulin, the need for lifestyle changes, but the person feels fine. It’s a little easier for people with type 2 diabetes. The person was often warned in clinics about such a development of events, he knew about the risk factors, was warned in advance that this could happen, and therefore perceives the situation more calmly. Of course, all patients are upset. The man lived, did not take any medications, did not think much about what he was eating. And now the doctor told him that he has diabetes and everything needs to be changed. Tragedies, tears and hysterics are rare, mostly among women. Men are generally more logical and less emotional, and upon learning about the illness they immediately ask - what to do?

“Some patients, upon learning that they have diabetes, take a tight rein on themselves. They control their diet and physical activity so well that we reduce the dosage of medications to a minimum. There are few of them, but they exist - they are very disciplined people."

The second category of patients is those who try, but from time to time give up treatment. The first time after they meet with the doctor, everything is fine, and then, after a year, they come back with a less rosy picture. It's simple: people are tired, burned out. Most often this is an age group - everyone has their own eating habits, their own way of life. Patients who are tired of controlling sugar and following prescriptions come with decompensation.

There is a third category of people: they are initially negative because they will have to take pills, so they choose to do nothing. We meet much more often than we would like, because they come with constant decompensation. Doctors' hands are tied: doctors do everything for patients - within the limits of what is possible, but a person with diabetes does not want to change anything. We cannot leave sugar to hang out, so we resort to insulin therapy. But here, too, difficulties arise, because patients do not want to plunge into active therapy. Such people consider insulin to be a narcotic substance: “If you get hooked on insulin, you’ll never take it off, what am I going to do then?” is a common phrase at appointments. There are even those who refuse treatment in principle, and then they are brought in by ambulance. And no one asks them there whether to take insulin or not. They bring themselves to a life-threatening state.

“Doshirak” with a bun for breakfast….

I had one patient. I couldn’t understand why his sugar levels were so high. I asked him to keep a food diary. I usually always recommend doing this, but here I strongly suggested that the person for a while vigilantly write down what he eats in a calorie counting app. The patient brought a food diary, and there was Doshirak with a bun for breakfast. But I still can’t understand why the sugar is dancing. And they ask me - why don’t the pills work?

A patient with type 1 diabetes mellitus sets insulin to the amount of carbohydrates he consumes, but only for the first time. A person first forms his food basket and understands his “blood sugar trends,” that is, he observes how sugar behaves with a certain amount of carbohydrates eaten, and calculates how much insulin is required for them. Then the patient adapts and navigates food calmly.

“With a person with type 2 diabetes, again, everything is somewhat simpler. It has its own secretion, so it is important to control the portion size and take into account the quantity and quality of carbohydrates. You need to understand what fast and complex carbohydrates are.” A person has a glucometer, and he knows how much blood sugar he should eat a piece of cake. He measures the sugar before and after taking it, and then looks at how much the sugar has increased. I have patients who eat chocolate in moderation, but they can't eat oatmeal because the sugar goes through the roof. The functioning of the gastrointestinal tract is individual for everyone, so a person with type 2 diabetes becomes a researcher of himself. For literally two weeks he constantly monitors his diet, and then the control turns into a routine, happening once or twice a week at different times - there is no need to constantly count calories. For some patients, we recommend calculating portions using the plate or palm method—this often works.

Why do you need an insulin pump?

There are several ways to administer insulin - using syringe pens and an insulin pump. The latter is not always needed and not for everyone. It is most often used by patients with type 1 diabetes. For them, it is more convenient to live with such a device. This is possible when the patient is ready to learn how to use it, because it is the same as any gadget - if you give an elderly person a new smartphone and an old phone, it is unlikely that he will delve into the technical complexities and nuances. An insulin pump does not replace the pancreas; it injects a certain amount of insulin into a person at a constant rate. A person adjusts this feed speed in the settings. Therefore, it is very important to understand what the carbohydrate coefficient and the insulin sensitivity factor are, for example. You need to be able to navigate certain situations. For example, the patient’s insulin supply has ended, and for some this can play a critical role. A person who does not maintain sugar on his own noticed this after 5 hours - hyperglycemia is rapidly developing. If the patient notices in time, he can take some independent steps, but if not, then there is a threat of emergency.

Kate Moss's 18-year-old daughter, Lila, walked at the joint show of luxury brands Fendi and Versace with an insulin pump on her hip: the girl has type 1 diabetes.

For patients with type 2 diabetes, the pump is not entirely suitable. Such people generally avoid insulin therapy - and are very afraid of it. They are prescribed insulin therapy most often in emergency situations when it comes to resuscitation. Or in situations where a person does not follow a diet, and all medications have already been tried, the only option left is insulin therapy. Alas, there is still an opinion among adults that there is a magic pill that will completely reverse the process - body weight will decrease, blood sugar will be normal. But that's not true.

What are the worst consequences of diabetes?

These are diabetic retinopathy (severe eye disease), decreased vision up to blindness, diabetic foot (the appearance of deep non-healing ulcers on its skin), changes in the skeletal system against the background of constant hyperglycemia, poor compensation, which can lead to amputation of the lower extremities, polyneuropathy (multiple peripheral nerve damage). In general, the dysfunction of the nervous system itself can manifest itself in different ways - in the form of constant pain in the arms and legs, numbness, burning, and ulcers may also appear because a person has difficulty feeling the places of excess pressure from shoes on the fabric. In extreme cases - kidney damage, increased blood pressure, hemodialysis... But such patients, fortunately, are very few.

How to protect yourself from diabetes?

If you notice a combination of symptoms such as excess body weight, constant dry mouth, frequent urination both day and night, prolonged healing of wounds, furunculosis, this is a reason to consult an endocrinologist. Or you discovered that you are losing weight, although you don’t change your diet - you eat, but you can’t get enough. These are also “bells” to visit a specialist.

A healthy person needs to monitor the quantity and quality of food consumed, eat in moderation, according to hunger, and not overeat. Monitor your own body weight. You need to eat a balanced diet, not bypassing seasonal fruits, berries and vegetables. It is imperative to ensure that fiber is in your diet.

It is important for any person to know what free sugars are. We must control them. This is the sugar that manufacturers add to the product - to the sauce, for example, because it is a good preservative. I would advise you to look at what this or that product consists of, now they write the composition everywhere. Not always those products that say “sugar-free” are actually sugar-free. Fructose, sucrose, and starch can be added to them. It's all carbohydrates and sugars.

Ideally, plan your meals, that is, at least know approximately what you will eat for breakfast, lunch and dinner, so as not to overeat and not be hungry. It is also very important to be socially and physically active in the long term - find any activity you like that you can do regularly, then the likelihood that you will suddenly find out about your own type 2 diabetes is extremely small.

Operating principle

Tresiba FlexTouch insulin has a working principle that is almost the same as the drug Lantus, which is well known to many diabetics. After the molecules enter the human body, they combine into larger formations, which are also called multichambers. They create a drug depot. Then small pieces break off from it, which makes it possible to achieve such a long-lasting effect.

Manufacturers claim that the duration of action of the drug is more than 40 hours. According to some studies, it can even reach exactly two days. In this regard, it may seem that this drug can be used less frequently than regular insulin. Not every day, but once every two days. But in reality this is not the case. Experts strongly advise not to skip daily injections, so as not to weaken the action and effect produced by this drug.

Studies of the new “Insulin Tresiba” have proven that the drug is equally effective in young and elderly patients. Also, there were no negative reviews from patients who were also concerned about problems with the liver and kidneys.

The main active ingredient of the extended-release Insulin Tresiba, degludec, has shown itself to be beneficial. Compared to glargine, which is used in Lantus, it causes significantly fewer cases of hypoglycemia.

Dosage

The instructions for use of Insulin Tresiba detail the dosage for each category of patients. The drug is administered exclusively subcutaneously; intravenous administration is contraindicated. This should be done once a day.

It is worth noting that the drug is compatible with all glucose-lowering drugs that are available in tablets, as well as with various other types of insulin. As a result, it is prescribed separately, and in some cases as part of complex therapy.

If the patient is injecting insulin initially, the dose should be 10 units. Then it is gradually corrected, which will depend on the individual needs of each person.

If the patient receives some other type of insulin and then decides to switch to Tresiba, the initial dose is calculated in a one-to-one ratio. This means that the same amount of insulin degludec should be administered as basal insulin.

If the patient has been on a double regimen of basal insulin for a certain time, the dose should be determined with the attending physician on an individual basis. There is a possibility that it will decrease. The same situation will be observed if the patient’s glycated hemoglobin level is less than 8%.

Of course, in the future the patient will definitely need individual dose adjustments under the control of blood sugar levels.

Tresiba®

Doses

Tresiba® is a long-acting insulin analogue. The drug is administered subcutaneously once a day at any time of the day, but it is preferable to administer the drug at the same time every day.

In patients with type 2 diabetes, Tresiba can be used either as monotherapy or in combination with oral hypoglycemic agents (OHAGs), glucagon-like peptide-1 (GLP-1) receptor agonists and bolus insulin (see Clinical Efficacy and Safety).

For patients with type 1 diabetes, Tresiba® is prescribed in combination with short-acting/ultra-short-acting insulin to cover the need for prandial insulin.

The dose of Tresiba® should be determined individually according to the needs of the patient. To optimize glycemic control, it is recommended to adjust the drug dose based on fasting plasma glucose levels.

As with any insulin preparation, dose adjustment of Tresiba may also be necessary if the patient increases physical activity, changes his usual diet, or has a concomitant illness.

Tresiba® 100 U/ml and Tresiba® 200 U/ml

Tresiba® is available in two dosages. For both dosages, the required dose of the drug is set in units. However, the dose increments differ between the two dosages of Tresiba®.

— The FlexTach® syringe pen, pre-filled with Tresiba® 100 IU/ml, allows you to administer doses from 1 to 80 IU in increments of 1 IU in one injection.

— The FlexPen® syringe pen, pre-filled with Tresiba® 100 IU/ml, allows you to administer doses from 1 to 60 IU in increments of 1 IU in one injection.

— The FlexTach® syringe pen, pre-filled with Tresiba® 200 IU/ml, allows you to administer doses from 2 to 160 IU in increments of 2 IU in one injection. The dose of insulin is contained in half the volume of solution compared to basal insulin preparations of 100 U/ml.

The dose counter shows the number of units regardless of the dosage; there is no need to recalculate the dose when transferring patients to a new dosage.

Flexible dosing regimen

In cases where it is not possible to administer the drug at the same time, Tresiba® allows you to change the time of its administration (see Clinical Efficacy and Safety). In this case, the interval between injections should be at least 8 hours. There is no clinical experience with flexible dosing regimens of Tresiba® in children and adolescents.

For those patients who forget to take their insulin dose on time, it is recommended that they take the dose as soon as they notice it, and then return to their usual once-a-day dosing time.

Tresiba® starting dose

Patients with type 2 diabetes mellitus

The recommended initial daily dose of Tresiba® is 10 units, followed by selection of an individual dose of the drug.

Patients with type 1 diabetes mellitus

Tresiba® is prescribed once a day in combination with prandial insulin, which is administered with meals, followed by selection of an individual dose of the drug.

Transfer from other insulin preparations

Careful monitoring of blood glucose concentrations is recommended during transfer and in the first weeks of therapy with Tresiba®. It may be necessary to adjust concomitant hypoglycemic therapy (dose and time of administration of short-acting and ultra-short-acting insulin or other simultaneously used hypoglycemic drugs).

Patients with type 2 diabetes mellitus

When switching to Tresiba® in patients with T2DM who are on a basal or basal-bolus insulin regimen, or on a regimen of ready-made insulin mixtures/self-mixed insulins, the dose of Tresiba® should be calculated based on the dose of basal insulin that the patient received before the transfer to a new type of insulin, on a unit by unit basis, and then adjusted according to the individual needs of the patient.

A dose reduction of 20% from the previous dose of basal insulin should be considered, followed by adjustment according to the individual needs of the patient in the following cases:

— transfer from basal insulin, which was administered 2 times a day, to Tresiba®;

— transfer from insulin glargine (300 U/ml) to Tresiba®.

Patients with type 1 diabetes mellitus

When transferring patients with T1DM to Tresiba®, a dose reduction of 20% should be considered from the previous dose of basal insulin or the basal component of continuous subcutaneous insulin infusions (CSII). The dose is then adjusted to the individual needs of the patient based on glycemic levels.

Use of Tresiba® in combination with GLP-1 receptor agonists in patients with type 2 diabetes mellitus

When adding Tresiba® to treatment with GLP-1 receptor agonists, the recommended initial daily dose is 10 units, followed by individual dose adjustment.

When adding GLP-1 receptor agonists to treatment with Tresiba, it is recommended to reduce the dose of Tresiba by 20% to minimize the risk of hypoglycemia. Subsequently, the dose should be adjusted.

Special patient groups

Elderly patients (over 65 years old)

Tresiba® can be used in elderly patients. Blood glucose concentrations should be carefully monitored and the insulin dose adjusted individually (see Pharmacokinetics).

Patients with impaired renal and hepatic function

Tresiba® can be used in patients with impaired renal and hepatic function. Blood glucose concentrations should be carefully monitored and the insulin dose adjusted individually (see Pharmacokinetics).

Children and teenagers

Tresiba® can be used to treat adolescents and children over 1 year of age (see Clinical Efficacy and Safety). When switching from basal insulin to Tresiba®, the need to reduce the dose of basal and bolus insulin should be considered in each individual case to minimize the risk of hypoglycemia (see Side effects).

Mode of application

Tresiba® is for subcutaneous administration only.

Tresiba® should not be administered intravenously as this may lead to severe hypoglycemia.

Tresiba® cannot be administered intramuscularly, as this will alter the absorption of the drug.

Tresiba® should not be used in insulin pumps.

It is not allowed to remove Tresiba® with a syringe from the cartridge of a pre-filled syringe pen (see Directions for use of the drug).

Tresiba® is injected subcutaneously into the thigh, shoulder, or anterior abdominal wall. You should constantly change injection sites within the same anatomical area to reduce the risk of developing lipodystrophy and cutaneous amyloidosis (see Special instructions and Side effects).

Patients should be advised to always use a new needle. Reusing insulin pen needles increases the risk of the needles becoming clogged, which can lead to under- or overdosing. If the needles become blocked, the patient should follow the instructions in the patient instructions for use of the drug, which are included with the syringe pen (see Directions for use of the drug).

FlexTouch® or FlexPen® syringe pens, pre-filled with Tresiba®, are designed for use with NovoFine® injection needles.

Directions for use of the drug

Tresiba® is for individual use only. The pen cartridge must not be refilled.

Do not use the drug if the solution is no longer transparent and colorless. Do not use the drug if it has been frozen.

A new needle must be used for each injection. Needles must not be reused. The patient should throw away the needle after each injection.

If the needles become blocked, the patient should follow the directions in the instructions for use, see the Patient Instructions for Use.

Follow local regulations for disposal of used medical supplies. Tresiba® in the FlexTouch® pre-filled pen is available in two dosages. The label of the pen and the carton clearly states “Tresiba® FlexTouch® 100 U/ml” or “Tresiba® FlexTouch® 200 U/ml”.

FlexTach® 100 U/ml syringe pen is a pre-filled syringe pen designed for use with NovoFine® needles up to 8 mm in length. Allows you to administer doses from 1 to 80 units in 1 unit increments.

For detailed instructions for use, see Patient Instructions for Use of Tresiba® 100 U/ml FlexTouch® Pen.

FlexPen® 100 U/ml syringe pen is a pre-filled syringe pen designed for use with NovoFine® needles up to 8 mm in length. Allows you to administer doses from 1 to 60 units in 1 unit increments.

For detailed instructions for use, see Patient Instructions for Use of Tresiba® 100 U/ml FlexPen®.

FlexTach® 200 U/ml Syringe Pen is a pre-filled syringe pen designed for use with NovoFine® needles up to 8 mm in length. Allows you to administer doses from 2 to 160 units in 2 unit increments.

For detailed instructions for use, see Patient Instructions for Use of Tresiba® 200 U/ml FlexTouch® Pen.

Instructions for patients on the use of the drug

Tresiba®, subcutaneous solution 100 U/ml in FlexTouch® pen Read these instructions carefully before using Tresiba® in a pre-filled FlexTouch® pen. If you do not follow the instructions carefully, you may give too little or too much insulin, which could cause your blood glucose levels to be too high or too low.

Use a pen only after you have learned how to use it under the guidance of a doctor or nurse. First, check the label on your pen to make sure it contains Tresiba® 100 U/mL, and then look at the illustrations below that show the parts of the pen and needle.

If you are visually impaired or have severe vision problems and cannot see the numbers on the dose counter, do not use the pen without assistance. You can be assisted by a person without visual impairments who has been trained in the proper use of the FlexTouch® pre-filled injector pen. The pre-filled FlexTach® Tresiba® 100 IU/ml pen contains 300 IU of insulin degludec. The maximum dose you can set is 80 units in 1 unit increments. The syringe pen is designed for use with disposable NovoFine® or NovoTwist® needles up to 8 mm in length. Needles are not included in the package.

Important information

Pay attention to the information marked with such icons, this is very important for the correct use of the pen.

1 Preparing the syringe pen for use

Check the name and strength on the pen label to make sure it contains Tresiba® 100 U/mL. This is especially important if you use different types of insulin. If you give another type of insulin by mistake, your blood glucose levels may become too high or too low.

— Remove the cap from the syringe pen.

— Make sure that the insulin preparation in the syringe pen is transparent and colorless.

Look at the insulin remaining scale window. If the drug is cloudy, the pen syringe cannot be used.

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— Take a new disposable needle and remove the protective sticker.

— Place the needle on the pen and turn it so that the needle fits tightly onto the pen.

Remove the outer needle cap, but do not throw it away. You will need it after completing the injection to properly remove the needle from the syringe pen.

— Remove and discard the inner needle cap. If you try to put the inner cap back on the needle, you may accidentally inject yourself.

A drop of insulin may appear at the end of the needle. This is normal, however, you should still check your insulin supply.

Use a new needle for each injection.

This reduces the risk of contamination, infection, leakage of insulin, clogged needles, and injecting the wrong dose of medication.

Never use a needle if it is bent or damaged.

2 Checking insulin delivery

— Before each injection, check the supply of insulin.

This will help you ensure that the full dose of insulin has been administered.

— Dial 2 units of the drug by turning the dose selector. Make sure the dose counter shows “2”.

Holding the pen with the needle facing up, lightly tap the top of the pen several times with your fingertip to force air bubbles upward.

— Press the start button and hold it in this position until the dose counter returns to “0”.

“0” should be opposite the dose indicator.

A drop of insulin should appear at the end of the needle.

There may be a small air bubble at the end of the needle, but it will not be introduced during the injection.

If a drop of insulin does not appear at the end of the needle, repeat operations 2A - 2C, but no more than 6 times. 2A - 2C again

If a drop of insulin does not appear at the end of the needle, do not use this pen. Use a new syringe pen.

Before each injection, make sure that a drop of insulin appears at the end of the needle. This ensures the supply of insulin.

If a drop of insulin does not appear, the dose will not be administered, even if the dose counter moves. This may indicate that the needle is blocked or damaged.

Before each injection, check your insulin supply. If you do not check your insulin supply, you may give insufficient or no insulin, which can cause your blood glucose levels to become too high.

3. Setting the dose

— Before starting the injection, make sure that the dose counter is set to position “0”.

“0” should be opposite the dose indicator.

— Rotate the dose selector to set the dose you need, as prescribed by your doctor.

If you have set the wrong dose, you can turn the dose selector forward or

back until you have set the correct dose.

The maximum dose you can set is 80 units.

The dose selector sets the number of units. Only the dose counter and dose indicator show the number of units of insulin in the dose you have taken.

The maximum dose you can set is 80 units.

If the remaining insulin in the pen is less than 80 units, the dose counter will stop at the number of insulin units remaining in the pen.

Each time you turn the dose selector, clicks are heard; the sound of the clicks depends on which direction the dose selector is rotated (forward, backward, or if the dialed dose exceeds the number of units of insulin remaining in the pen). Don't count those clicks.

Before each injection, check how many units of insulin you have taken using the dose counter and dose indicator.

Don't count the clicks of the syringe pen. If you set and administer the wrong dose, your blood glucose concentration may become too high or too low. The insulin remaining scale shows the approximate amount of insulin remaining in the pen, so it cannot be used to measure insulin doses.

4. Insulin administration

— Insert the needle under the skin using the injection technique recommended by your doctor or nurse.

— Make sure that the dose counter is in your field of vision.

Do not touch the dose counter with your fingers. This may interrupt the injection.

— Press the start button all the way and hold it in this position until the dose counter returns to “0”.

“0” should be exactly opposite the dose indicator.

You may hear or feel a clicking sound.

- After injection, leave the needle under the skin for at least 6 seconds to ensure that the full dose of insulin has been administered.

— Remove the needle from under the skin by pulling the syringe pen up.

If blood appears at the injection site, lightly press a cotton swab onto the injection site. Do not massage the injection site.

After the injection is complete, you may see a drop of insulin at the end of the needle.

This is normal and does not affect the dose of the drug you administered.

Always check the dose counter to see how many units of insulin you have given.

The dose counter will show the exact number of units. Do not count the number of clicks of the pen. After injection, hold down the trigger button until the dose counter returns to “0”. If the dose counter stops before reading 0, the full dose of insulin has not been delivered, which may result in blood glucose concentrations that are too high.

5. After completing the injection

— With the outer needle cap on a flat surface, insert the tip of the needle into the cap without touching it or the needle.

— When the needle enters the cap, carefully place the cap on the needle.

— Unscrew the needle and throw it away, taking precautions.

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— After each injection, put a cap on the pen to protect the insulin it contains from exposure to light.

Throw away used pens with the needle removed as directed by your doctor, nurse, pharmacist, or local regulations.

Never try to put the inner cap back on the needle. You can inject yourself .

After each injection, always remove the needle and store the pen with the needle removed.

This reduces the risk of contamination, infection, insulin leakage, needle blockage, and injecting the wrong dose.

6. How much insulin is left?

The insulin remaining scale shows the approximate amount of insulin remaining in the pen.

— To find out exactly how much insulin is left in your pen, use the dose counter:

Rotate the dose selector until the dose counter stops.

If the dose counter shows 80, this means that there are at least 80 units of insulin left in your pen.

If the dose counter shows less than 80, this means that your syringe pen contains

Exactly the number of insulin units left that is displayed on the dose counter.

Rotate the dose selector in the opposite direction until the dose counter shows “0”.

— If the insulin remaining in the syringe pen is not enough to administer the full dose, you can administer the dose you need in two injections using two syringe pens.

Be very careful when calculating the remaining insulin dose you need.

If in doubt, it is better to inject yourself with a full dose of insulin using a new pen. If you miscalculate, you may give too little or too much insulin, which can cause your blood glucose levels to become too high or too low.

Important information

— Always carry a syringe pen with you.

— Always carry a spare pen and new needles with you in case they are lost or damaged.

— Keep the syringe pen and needles out of the reach of everyone, and especially children.

— Never share your syringe pen and its needles with others. This may lead to cross-infection.

- Never share your pen with others. Your drug may harm their health.

— Caregivers should handle used needles with extreme care to reduce the risk of needle sticks and cross-infection.

Syringe pen care

Handle the pen with care. Careless or improper handling may result in incorrect dosing, which may result in glucose concentrations that are too high or too low.

— Do not leave your pen in a car or any other place where it may be exposed to extremely hot or cold temperatures.

— Protect the syringe pen from dust, dirt and all types of liquids.

— Do not wash the pen, immerse it in liquid or lubricate it. If necessary, the syringe pen can be cleaned with a damp cloth moistened with soft

detergent.

— Do not drop or hit the pen on a hard surface.

If you drop your pen or are unsure about its functionality, attach a new needle and check the insulin flow before injecting.

— Do not attempt to refill the pen. An empty syringe pen must be thrown away.

— Do not try to repair the syringe pen yourself or take it apart.

Instructions for patients on the use of the drug

Tresiba®, subcutaneous solution 200 U/ml in FlexTouch® pen Read these instructions carefully before using Tresiba® in a pre-filled FlexTouch® pen. If you do not follow the instructions carefully, you may give too little or too much insulin, which could cause your blood glucose levels to be too high or too low.

Use a pen only after you have learned how to use it under the guidance of a doctor or nurse. First, check the label on your pen to make sure it contains Tresiba® 200 U/mL, and then look at the illustrations below for parts of the pen and needle.

If you are visually impaired or have severe vision problems and cannot see the numbers on the dose counter, do not use the pen without assistance. You can be assisted by a person without visual impairments who has been trained in the proper use of the FlexTouch® pre-filled injector pen. The pre-filled FlexTach® Tresiba® 200 IU/ml pen contains 600 IU of insulin degludec. The maximum dose you can set is 160 units in 2 unit increments. The dose counter shows the exact number of insulin units. There is no need to recalculate the dose. The syringe pen is designed for use with disposable NovoFine® or NovoTwist® needles up to 8 mm in length. Needles are not included in the package.

Important information

Pay attention to the information marked with such icons, this is very important for the correct use of the pen.

1 Preparing the syringe pen for use

— Check the name and dosage on the pen label to ensure it contains Tresiba® 200 U/mL. This is especially important if you use different types of insulin. If you give another type of insulin by mistake, your blood glucose levels may become too high or too low.

— Remove the cap from the syringe pen.

— Make sure that the insulin preparation in the syringe pen is transparent and colorless.

Look at the insulin remaining scale window. If the drug is cloudy, the pen syringe cannot be used.

— Take a new disposable needle and remove the protective sticker.

— Place the needle on the pen and turn it so that the needle fits tightly onto the pen.

— Remove the outer needle cap, but do not throw it away. You will need it after completing the injection to properly remove the needle from the syringe pen.

— Remove and discard the inner needle cap. If you try to put the inner cap back on the needle, you may accidentally inject yourself.

A drop of insulin may appear at the end of the needle. This is normal, however, you should still check your insulin supply.

Use a new needle for each injection.

This reduces the risk of contamination, infection, leakage of insulin, clogged needles, and injecting the wrong dose of medication.

Never use a needle if it is bent or damaged.

2 Checking insulin delivery

— Before each injection, check your insulin supply.

This will help you ensure that the full dose of insulin has been administered.

— Dial 2 units of the drug by turning the dose selector. Make sure the dose counter shows “2”.

— Holding the pen with the needle facing up, lightly tap the top of the pen several times with your fingertip to move the air bubbles upward.

WITH

— Press the start button and hold it in this position until the dose counter

will not return to "0".

“0” should be opposite the dose indicator.

A drop of insulin should appear at the end of the needle.

There may be a small air bubble at the end of the needle, but it will not be introduced during the injection.

If a drop of insulin does not appear at the end of the needle, repeat operations 2A - 2C, but no more than 6 times.

2A - 2C again

If a drop of insulin does not appear at the end of the needle, do not use this pen. Use a new syringe pen.

Before each injection, make sure that a drop of insulin appears at the end of the needle. This ensures the supply of insulin.

If a drop of insulin does not appear, the dose will not be administered, even if the dose counter moves. This may indicate that the needle is blocked or damaged.

Before each injection, check your insulin supply. If you do not check your insulin supply, you may give insufficient or no insulin, which can cause your blood glucose levels to become too high.

3 Setting the dose

· Before starting the injection, make sure that the dose counter is set to the “0” position.

“0” should be opposite the dose indicator.

— Rotate the dose selector to set the dose you need, as prescribed by your doctor.

— The dose counter shows the accumulated dose in units. There is no need to recalculate the dose.

If you set the wrong dose, you can turn the dose selector forward or backward until you set the correct dose.

The maximum dose you can set is 160 units.

The dose selector sets the number of units. Only the dose counter and dose indicator show the number of units of insulin in the dose you have taken.

The maximum dose you can set is 160 units. If the remaining insulin in the pen is less than 160 units, the dose counter will stop at the number of insulin units remaining in the pen.

Before each injection, check how many units of insulin you have taken using the dose counter and dose indicator.

4 Insulin administration

— Insert the needle under the skin using the injection technique recommended by your doctor or nurse.

— Make sure that the dose counter is in your field of vision.

Do not touch the dose counter with your fingers. This may interrupt the injection.

— Press the start button all the way and hold it in this position until the dose counter returns to “0”.

“0” should be exactly opposite the dose indicator.

You may hear or feel a clicking sound.

- After injection, leave the needle under the skin for at least 6 seconds to ensure that the full dose of insulin has been administered.

— Remove the needle from under the skin by pulling the syringe pen up.

If blood appears at the injection site, lightly press a cotton swab onto the injection site. Do not massage the injection site.

After the injection is complete, you may see a drop of insulin at the end of the needle.

This is normal and does not affect the dose of the drug you administered.

Always check the dose counter to see how many units of insulin you have given.

5. After the injection is completed

— With the outer needle cap on a flat surface, insert the tip of the needle into the cap without touching it or the needle.

· When the needle enters the cap, carefully place the cap on the needle.

— Unscrew the needle and throw it away, taking precautions.

WITH

— After each injection, put a cap on the pen to protect the insulin it contains from exposure to light.

Throw away the needle after each injection. This reduces the risk of contamination, infection, leakage of insulin, clogged needles, and injecting the wrong dose of medication. If the needle becomes blocked, you will not be able to inject insulin. Throw away used pens with the needle removed as directed by your doctor, nurse, pharmacist, or local regulations.

Never try to put the inner cap back on the needle. You may inject yourself.

After each injection, always remove the needle and store the pen with the needle removed.

This reduces the risk of contamination, infection, insulin leakage, needle blockage, and injecting the wrong dose.

6. How much insulin is left?

The insulin remaining scale shows the approximate amount of insulin remaining in the pen.

— To find out exactly how much insulin is left in your pen, use the dose counter:

Rotate the dose selector until the dose counter stops.

If the dose counter shows 160, this means that there are at least 160 units of insulin left in your pen.

If the dose counter shows less than 160, this means that the exact number of units of insulin left in your syringe pen is that displayed on the dose counter.

— Rotate the dose selector in the opposite direction until the dose counter shows “0”.

— If the insulin remaining in the syringe pen is not enough to administer the full dose, you can administer the dose you need in two injections using two syringe pens.

Be very careful when calculating the remaining insulin dose you need.

Important information

— Always carry a syringe pen with you.

— Always carry a spare pen and new needles with you in case they are lost or damaged.

— Keep the syringe pen and needles out of the reach of everyone, and especially children.

— Never share your syringe pen and its needles with others. This may lead to cross-infection.

- Never share your pen with others. Your drug may harm their health.

— Caregivers should handle used needles with extreme care to reduce the risk of needle sticks and cross-infection.

Syringe pen care

Handle the pen with care. Careless or improper handling may result in incorrect dosing, which may result in glucose concentrations that are too high or too low.

— Do not leave your pen in a car or any other place where it may be exposed to extremely hot or cold temperatures.

— Protect the syringe pen from dust, dirt and all types of liquids.

— Do not wash the pen, immerse it in liquid or lubricate it. If necessary, the pen can be cleaned with a damp cloth and a mild detergent.

— Do not drop or hit the pen on a hard surface.

If you dropped the syringe pen

Side effects

The instructions for Tresiba Insulin describe in detail the side effects that this drug can cause. Unfortunately, you cannot do without them, just like when taking any pharmacological drug.

Among the most common problems are complaints of hypoglycemia. Although it occurs less frequently than in the case of taking most other insulin-containing medications.

Other side effects include:

allergic reactions (eg, anaphylaxis or urticaria);
a hypersensitivity reaction may manifest itself in the form of frequent bowel movements, numbness of the tongue, itching, fatigue);
lipodystrophy, which appears at the injection site (unpleasant consequences can be avoided if you regularly change the injection site);
local reactions and manifestations at the injection site (swelling, hematomas, connective tissue nodules, redness, compaction, itching).

The instructions for use of Tresiba Insulin recommend storing it under the same conditions as other similar medications. It is important for them to avoid freezing and overheating, otherwise they will lose almost all of their healing properties.

Indications and contraindications

The instructions for Tresiba Insulin clearly recommend the use of this drug in the treatment of diabetes mellitus in adult patients.

In this case, the drug is contraindicated in the following categories of patients:

children and adolescents under 18 years of age;
pregnant women;
nursing mothers;
patients with individual sensitivity to the main active substance of the drug or any of its auxiliary components.

Insulin degludec

Insulin degludec

or
insulin degludec
(eng.
insulin degludec
) is a new injection (for subcutaneous administration) long-acting (up to 40 hours) insulin.
Intended for the treatment of diabetes types 1 and 2 in adults. Insulin degludec is an analogue of human insulin produced using recombinant DNA technology using a strain of yeast Saccharomyces cerevisiae
.

Insulin degludec has been included in the ATC since the beginning of 2014 and is classified in the group “A10 Drugs for the treatment of diabetes mellitus”, subgroup “A10AE Long-acting insulins for injections and their analogues”. The code for insulin degludec is A10AE06. In addition, at the beginning of 2014, the code “A10AD06 Insulin degludec and insulin aspart” was added to the ATC.

Clinical and pharmacological group “Ultra-long-acting analogue of human insulin”.

A randomized controlled trial with a treat-to-target design in patients aged 1 to 17 years with type 1 diabetes mellitus showed that insulin degludec, administered once daily, in combination with bolus rapid-acting insulin (aspart) ) ensures effective achievement of glycemic control goals, demonstrates stability of the glucose-lowering effect, has a comparable high level of safety and is less likely to cause hyperglycemia with ketosis. Given its long half-life (25 hours), insulin degludec may prevent the development of the Dawn phenomenon, which is more common in adolescents. And since morning hyperglycemia in some cases may be preceded by nocturnal hypoglycemia, degludec, which has minimal variability of action and the lowest risk of hypoglycemia among registered basal insulins, will have advantages in this case (Alimova I.L.).

Publications for healthcare professionals regarding the medical use of insulin degludec

Alimova I.L. Diabetic neuropathy in children and adolescents: unresolved problems and new opportunities // Russian Bulletin of Perinatology and Pediatrics. – 2016. – No. 3. P. 114-123.

On the website in the literature catalog there is a section “Endocrinological diseases associated with gastrointestinal diseases” containing, among other things, works addressing the treatment of diabetes.

Medicines containing the active substance insulin degludec

In Russia, insulin degludec is registered under the trade name Tresiba ® (in the form of Tresiba ® FlexTouch ® and Tresiba ® Penfill ® dosage forms).
Trade name in the EU and USA is Tresiba ®. Manufacturer (applicant) - Novo Nordisk, Denmark. Insulin degludec (Tresiba) is approved for use in the European Union and Japan. In 2013, the FDA rejected Novo Nordisk's marketing authorization application for insulin degludec (Tresiba) due to potential cardiovascular safety concerns, but insulin degludec (Tresiba) received FDA approval in September 2015. In Russia, the combination of insulin degludec and insulin aspartate has the trade name Ryzodeg ® (dosage forms: Ryzodeg ® FlexTouch® and Ryzodeg ® Penfill®). A similar drug, Ryzodeg ®, has approval for use in the European Union and Japan. In 2013, the FDA rejected an application for its use in the US with insulin degludec. In September 2015, Ryzodeg 70/30 (insulin degludec + insulin aspartate) was also cleared by the FDA. The drug with the combined active ingredient insulin degludec + liraglutide, with the trade name Xultophy ® (Novo Nordisk, Denmark), received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on July 25, 2014 and on November 21, 2016 - positive decision from the US FDA. In Russia, this drug is registered under the trade name Sultofay ®.

Insulin degludec has contraindications, side effects and application features; consultation with a specialist is necessary.

Back to section

Compound

The drug is available in the form of a solution for subcutaneous administration. The main active ingredient is insulin degludec.

Phenol, glycerol, zinc, hydrochloric acid, as well as water required for injection are used as excipients in this drug.

One package contains five syringes of 3 ml of substance each.

Insulin degludec is able to specifically bind to the human endogenous insulin receptor. By directly interacting with it, it realizes its pharmacological effect, which is almost similar to the action of human insulin.

It is worth noting that the hypoglycemic property of this drug is due to the ability to significantly increase glucose utilization. This occurs due to the binding of insulin itself to the receptors of fat and muscle cells. It is important that in parallel this significantly reduces the rate of glucose production by the liver.

Mode of application

Once again, we note that this drug is intended exclusively for subcutaneous administration. It should not be administered intravenously, as this can lead to the development of severe hypoglycemia. It is also prohibited to administer intramuscularly, since in this case there is a risk that the absorption of the main active substances will change. In this case, it is almost impossible to predict how this remedy will act in the future. Among the caveats, there is one more thing to remember: Tresiba Insulin cannot be used in pumps.

The drug is injected subcutaneously into the area of the anterior abdominal wall, thigh or shoulder area. Remember to regularly change the injection site within the same anatomical area to minimize the risk of developing lipodystrophy.

Externally, the drug is an already filled syringe pen, which is designed for use with disposable injection needles.

It is important that the medicine itself and the needles are intended exclusively for individual use. Refilling the pen cartridge is prohibited.

Monitor the condition and appearance of the solution. You cannot take it if the solution is no longer colorless and transparent. It also loses all its beneficial properties after it has been frozen. Be sure to throw away the needle after each injection.

Carefully follow local regulations that apply to the disposal of used medical supplies in the region where you live. The syringe pen is used by the patient independently after he has mastered its use under the supervision of a doctor or nurse.

There are several main stages into which injection procedures can be divided. First, the syringe pen should be prepared for use. To do this, start by carefully checking the dosage and name on the label of the pen. Make sure it contains the medicine you need. It is especially important to pay attention to this stage if you simultaneously or alternately take several insulins of different types. In this case, you need not to get confused so as not to harm yourself, and the effect of using the medicine is maximum. Only then remove the cap from the syringe pen.

Make sure that the drug contained in the syringe is colorless and transparent. To do this, pay attention to the insulin remaining scale window. If the product becomes cloudy, it should not be used.

Remove the protective sticker from the disposable needle. Place the needle on the pen, and then twist it so that the needle is held as tightly as possible. Once you remove the outer cap, do not throw it away. You will need it after the injection is complete to safely remove the needle. But you can immediately throw away the inner needle cap. Never try to put it back on as there is a high risk of getting pricked.

Make sure a drop of insulin appears at the very tip of the needle. This should be done to check the flow of the medicine in the syringe.

Use a new needle for each injection to avoid the risk of blockage, infection, and the risk of injecting the wrong dose. Do not use the needle if you find it is damaged or bent.

Tresiba FlexTouch, 100 U/ml, solution for subcutaneous administration, 3 ml, 5 pcs.

PC,

Once a day at any time of the day, but it is preferable to administer the drug at the same time every day.

Tresiba® FlexTouch® is an ultra-long-acting insulin analogue.

In patients with type 2 diabetes mellitus, Tresiba® FlexTouch® can be used either as monotherapy or in combination with PGGP, GLP-1 receptor agonists, or bolus insulin (see “Pharmacodynamics”). Patients with type 1 diabetes mellitus are prescribed Tresiba® FlexTouch® in combination with short-acting/ultra-short-acting insulin to cover the need for prandial insulin.

The dose of Tresiba® FlexTouch® should be determined individually according to the needs of the patient. To optimize glycemic control, it is recommended to adjust the dose of the drug based on fasting plasma glucose levels.

As with any insulin preparation, dose adjustment of Tresiba® FlexTouch® may also be necessary if the patient increases physical activity, changes his usual diet, or has a concomitant disease.

Tresiba® FlexTouch® starting dose

Patients with type 2 diabetes mellitus.

The recommended initial daily dose of Tresiba® FlexTouch® is 10 units, followed by selection of an individual dose of the drug.

Patients with type 1 diabetes mellitus.

Tresiba® FlexTouch® is prescribed once a day in combination with prandial insulin, which is administered with meals, followed by selection of an individual dose of the drug.

Transfer from other insulin preparations

Careful monitoring of blood glucose concentrations is recommended during transfer and in the first weeks of prescribing a new drug. It may be necessary to adjust concomitant hypoglycemic therapy (dose and time of administration of short-acting and ultra-short-acting insulin or other simultaneously used hypoglycemic drugs).

Patients with type 2 diabetes mellitus.

When switching to Tresiba® FlexTouch® in patients with type 2 diabetes mellitus who are on a basal or basal-bolus insulin regimen, or a regimen of ready-mixed insulin/self-mixed insulin, the dose of Tresiba® FlexTouch® should be calculated based on the dose of basal insulin, that the patient received before switching to a new type of insulin, on a unit-by-unit basis, and then adjusted according to the individual needs of the patient.

Patients with type 1 diabetes mellitus.

For most patients with type 1 diabetes, when switching from any basal insulin to Tresiba® FlexTouch®, a unit-for-unit approach is used based on the dose of basal insulin the patient was receiving before switching, then the dose is adjusted to meet individual needs. In patients with type 1 diabetes mellitus who, at the time of transfer to therapy with Tresiba® FlexTouch®, were on insulin therapy with basal insulin administered twice daily, or in patients with an HbA1c <8%, the dose of Tresiba® FlexTouch® should be set on an individual basis. basis. It may be necessary to reduce the dose followed by individual selection based on glycemic parameters.

Use of Tresiba® in combination with GLP-1 receptor agonists in patients with type 2 diabetes mellitus.

When adding Tresiba® to treatment with GLP-1 receptor agonists, the recommended initial daily dose is 10 units, followed by individual dose adjustment.

When adding GLP-1 receptor agonists to treatment with Tresiba, it is recommended to reduce the dose of Tresiba by 20% to minimize the risk of hypoglycemia. Subsequently, the dose should be adjusted.

Flexible dosing regimen

Based on the needs of the patient, Tresiba® FlexTouch® allows you to change the time of its administration (see “Pharmacodynamics”). In this case, the interval between injections should be at least 8 hours. For those patients who forget to administer a dose of insulin on time, it is recommended to administer the dose as soon as they discover this, and then return to their usual time of daily single administration of the drug.

Tresiba® FlexTouch® 100 and 200 U/ml. Tresiba® FlexTouch® is available in two dosages. For both dosages, the required dose of the drug is set in units. However, the dose increments differ between the two dosages of Tresiba® FlexTouch®.

Tresiba® FlexTouch®, 100 U/ml allows you to administer doses from 1 to 80 U in 1-U increments in a single injection. Tresiba® FlexTouch®, 200 U/ml allows you to administer doses from 2 to 160 U in 2-U increments in a single injection. The dose of insulin is contained in half the volume of solution compared to basal insulin preparations of 100 U/ml.

The dose counter shows the number of units regardless of the dosage; there is no need to recalculate the dose when transferring patients to a new dosage.

Special patient groups

Elderly patients (over 65 years old).

Tresiba® FlexTouch® can be used in elderly patients. Blood glucose concentrations should be carefully monitored and the insulin dose adjusted individually (see Pharmacokinetics).

Failure of kidney and liver function.

Tresiba® FlexTouch® can be used in patients with impaired renal and hepatic function. Blood glucose concentrations should be carefully monitored and the insulin dose adjusted individually (see Pharmacokinetics).

Children and teenagers.

Tresiba® can be used to treat adolescents and children over 1 year of age (see Pharmacodynamics). When switching from basal insulin to Tresiba®, the need to reduce the dose of basal and bolus insulin should be considered in each individual case to minimize the risk of hypoglycemia (see “Special Instructions”).

Mode of application

Tresiba® FlexTouch® is intended for subcutaneous administration only. Tresiba® FlexTouch® cannot be administered intravenously, because this may lead to the development of severe hypoglycemia. Tresiba® FlexTouch® cannot be administered intramuscularly, because in this case, the absorption of the drug changes. Tresiba® FlexTouch® cannot be used in insulin pumps.

Tresiba® FlexTouch® is injected subcutaneously into the thigh, anterior abdominal wall or shoulder area. Injection sites within the same anatomical area should be rotated regularly to reduce the risk of developing lipodystrophy. Tresiba® FlexTouch® is a pre-filled pen designed for use with NovoFine® or NovoTwist® disposable injection needles.

Directions for use of the drug

FlexTouch® is a pre-filled pen designed for use with NovoFine® or NovoTwist® needles up to 8 mm in length.

Tresiba® FlexTouch®, 100 U/ml allows you to administer doses from 1 to 80 U in 1-U increments.

Tresiba® FlexTouch® 200 U/ml allows you to administer doses from 2 to 160 U in 2-U increments. It is necessary to strictly follow the instructions contained in the attached Instructions for use of the FlexTach® syringe pen.

Tresiba® FlexTouch® and needles are for individual use only. The pen cartridge must not be refilled. Do not use the drug if the solution is no longer transparent and colorless. Do not use the drug if it has been frozen. The needle should be thrown away after each injection.

Follow local regulations for disposal of used medical supplies.

Instructions for patients on the use of Tresiba® FlexTouch®, solution for subcutaneous administration 100 or 200 U/ml

You must read these instructions carefully before using the Tresiba® FlexTouch® Pre-Filled Pen. If the patient does not follow the instructions, he may inject too little or too much insulin, which could result in blood glucose levels that are too high or too low.

A pen should only be used after the patient has learned how to use it under the guidance of a doctor or nurse.

Check the label on your pen to make sure it contains Tresiba® FlexTouch®, and then carefully look at the illustrations below that show the parts of the pen and needle.

If the patient is visually impaired or has severe vision problems and cannot distinguish the numbers on the dose counter, the pen should not be used without assistance. This patient can be assisted by a person without visual impairments who has been trained in the proper use of the FlexTouch® pre-filled syringe pen.

Tresiba® FlexTouch® 100 units/ml is a pre-filled pen containing 300 units of insulin degludec. The maximum dose you can set is 80 units in 1 unit increments.

Tresiba® FlexTouch® 200 U/ml allows you to administer doses from 2 to 160 U in 2-U increments.

The Tresiba® FlexTouch® pen is designed for use with NovoFine® or NovoTwist® disposable needles up to 8 mm in length. Needles are not included in the package.

Important information

. Pay attention to the information marked with such icons, this is very important for the safe use of the pen.

Tresiba® FlexTouch® 100 U/ml and needle (example).

Figure 1. Tresiba® FlexTouch®, 100 U/ml.

Figure 2. Tresiba® FlexTouch®, 200 U/ml

I. Preparing the syringe pen for use

Check the name and dosage on the pen label to ensure it contains Tresiba® FlexTouch® 100 IU/mL/Tresiba® FlexTouch® 200 IU/mL. This is especially important if the patient uses different types of insulin. If he injects another type of insulin by mistake, the blood glucose concentration may be too high or low.

A. Remove the cap from the syringe pen

Figure A.

B. Make sure that the insulin preparation in the syringe pen is transparent and colorless. Look at the insulin balance scale window. If the drug is cloudy, the pen syringe cannot be used.

Figure B

C. Take a new disposable needle and remove the protective sticker

Figure C.

D. Place the needle on the pen and turn it so that the needle fits tightly onto the pen.

Figure D

E. Remove the outer needle cap, but do not throw it away. You will need it after the injection is complete to safely remove the needle.

Figure E.

F. Remove and discard the inner needle cap. If the patient tries to put the inner cap back on the needle, they may stick themselves.

A drop of insulin may appear at the end of the needle. This is normal, but the patient should still check their insulin supply.

Figure F.

Important information.

Use a new needle for each injection to avoid contamination, infection, insulin leakage, needle blockage, and injecting the wrong dose of medication. Never use a needle if it is bent or damaged.

II. Checking insulin delivery

G. Before each injection, check the insulin supply. This way the patient can be sure that the full dose of insulin has been administered. Dial 2 units of the drug by turning the dose selector. Make sure the dose counter shows “2”.

Figure G.

H. Holding the pen with the needle pointing up, lightly tap the top of the pen several times with your fingertip to force air bubbles upward.

Figure H.

I. Press the start button and hold it in this position until the dose counter returns to zero. “0” should be opposite the dose indicator. A drop of insulin should appear at the end of the needle. Sometimes a small air bubble may remain at the end of the needle, but it will not be introduced when injecting. If a drop of insulin does not appear at the end of the needle, repeat operations IIG–II I, but no more than 6 times. If a drop of insulin does not appear, change the needle and repeat operations IIG–II I again.

Figure I.

If a drop of insulin does not appear at the end of the needle, do not use this syringe pen, use a new syringe pen.

Important information.

Before each injection, make sure that a drop of insulin appears at the end of the needle. This ensures the supply of insulin. If no insulin drop appears, no dose will be given even if the dosage counter moves. This may indicate that the needle is blocked or damaged.

Before each injection, check the insulin supply. If a patient does not check their insulin supply, they may inject insufficient or no insulin, which can result in blood glucose levels that are too high.

III. Setting the dose

J. Before starting the injection, make sure that the dose counter is set to the “0” position. “0” should be opposite the dosage indicator. Rotate the dose selector to set the dose prescribed by the doctor. The dose selector sets the number of units. Only the dose counter and dose indicator show the number of units of insulin in the selected dose. If the wrong dose is set, the patient can turn the dose selector forward or backward until the correct dose is set. The maximum dose he can set is 80/160 units. If the remaining insulin in the pen is less than 80/160 units, the dose counter will stop at the number of insulin units remaining in the pen. Each time you turn the dose selector, clicks are heard; the sound of the clicks depends on which direction the dose selector is rotated (forward, backward, or if the dialed dose exceeds the number of units of insulin remaining in the pen). Don't count these clicks.

Figure J.

Important information.

Before each injection, check how many units of insulin the patient has collected using the dose counter and dose indicator. Do not set the dose by the number of clicks. If the patient sets and administers the incorrect dose, the blood glucose concentration may become too high or low.

The insulin remaining scale shows the approximate amount of insulin remaining in the pen, so it cannot be used to measure insulin doses

IV. Insulin administration

K. Insert the needle under the skin using the injection technique recommended by your doctor. Make sure the dose counter is within the patient's field of vision. Do not touch the dose counter with your fingers as this may interrupt the injection. Press the start button all the way and hold it in this position until the dose counter shows “0”. “0” should be exactly opposite the dose indicator, and the patient may hear or feel a click.

After injection, leave the needle under the skin for at least 6 seconds. This will ensure that the full dose of insulin is administered.

Drawing K.

L. Remove the needle from under the skin by pulling the syringe pen upward.

If blood appears at the injection site, lightly press a cotton swab onto the injection site. Do not massage the injection site.

Figure L

After the injection is completed, the patient may see a drop of insulin at the end of the needle. This is normal and does not affect the dose of the drug that is administered.

Important information.

Always check the dose counter to ensure you know how many units of insulin have been administered. The dose counter will show the exact number of units. Don't count the number of clicks. Hold the start button until the dose counter shows “0”. If the dose counter stops before showing 0, the full dose of insulin has not been delivered, which may result in the blood glucose concentration being too high.

V. After completing the injection

M. Place the outer needle cap on a flat surface and insert the tip of the needle into the cap without touching it or the needle.

Drawing M.

N. When the needle enters the cap, carefully place the cap on the needle. Unscrew the needle and discard it, taking precautions.

Figure N.

A. After each injection, put a cap on the pen to protect the insulin it contains from exposure to light. Throw away the needle after each injection to avoid contamination, infection, insulin leakage, needle blockage, and injecting the wrong dose of medication. If the needle becomes blocked, the patient will not be able to inject insulin. Discard used pens with the needle removed as directed by your doctor, nurse, pharmacist, or local regulations.

Drawing O.

Important information.

To avoid accidental needle sticks, never attempt to put the inner cap back on the needle. Remove the needle from the pen after each injection and store the pen with the needle disconnected. This will avoid contamination, infection, insulin leakage, needle blockage, and incorrect dosage administration.

VI. How much insulin is left?

P. The insulin remaining scale shows the approximate amount of insulin remaining in the pen.

Figure P

R. To find out how much insulin is left in your pen, you need to use a dose counter. Rotate the dosage selector until the dose counter stops. If the dose counter shows 80/160, this means that there is at least 80/160 units of insulin left in the pen. If the dose counter shows less than 80/160, this means that the exact number of units of insulin left in the pen is the one displayed on the dose counter.

Rotate the dose selector in the opposite direction until the dose counter shows “0”. If the insulin remaining in the pen is not enough to administer the full dose, you can administer the required dose in two injections using two pens.

Figure R.

Important information.

You must be very careful when calculating the remaining required insulin dose. If the patient has doubts, it is better to inject himself with a full dose of insulin using a new syringe pen. If the patient makes a mistake in the calculations, he may enter an insufficient dose or too much insulin. This can cause your blood glucose concentration to become too high or low.

You should always carry a pen with you. You should always carry a spare pen and new needles with you in case they are lost or damaged. Keep the syringe pen and needles out of the reach of everyone, and especially children. Never share your syringe pen and its needles with others. This may lead to cross-infection. Caregivers should handle used needles with extreme care to avoid accidental sticking and infection.

Syringe pen care

Handle the syringe pen carefully. Careless or improper handling may result in incorrect dosing, which may result in glucose concentrations that are too high or too low.

Do not leave your pen in a car or any other place where it may be exposed to extremely hot or cold temperatures.

Protect the syringe pen from dust, dirt and all types of liquids.

Do not wash the pen, immerse it in liquid or lubricate it. If necessary, the pen can be cleaned with a damp cloth and a mild detergent. Do not drop or hit the pen on a hard surface. If the patient drops the pen or doubts its functionality, attach a new needle and check the flow of insulin before injecting.

Refilling the syringe pen is not allowed. An empty syringe pen should be thrown away immediately. Do not try to repair the syringe pen yourself or take it apart.

Overdose

In some cases, there is a possibility of overdose when using this drug. It is worth noting that a specific dose that leads to a similar effect has not been established. Hypoglycemia, which most diabetics fear, usually develops gradually.

The patient is able to cope with mild hypoglycemia on his own by taking sugar-containing foods or glucose. Patients with diabetes are advised to carry sugar-containing products with them at all times.

In cases of severe hypoglycemia, when the patient is unconscious, glucagon or dextrose solution should be administered. Dextrose should also be administered if the patient does not regain consciousness a quarter of an hour after the administration of glucagon. When consciousness is restored, it is recommended to take a carbohydrate-rich meal as quickly as possible to prevent relapse.

Patient reviews

Reviews from diabetics about Tresiba Insulin can often be found simply enthusiastic. The injection is usually given at night. This allows a person to wake up in the morning with normal sugar levels and in a normal state.

The main thing is that the dose is selected correctly. In the reviews of experienced diabetics about Tresiba Insulin, it was noted that before the advent of this version of this drug, all previous variations acted for a significantly shorter time, which caused a lot of trouble. Controlling fasting glucose levels was quite problematic.

At the same time, in reviews and “Insulin Tresibe”, many emphasize that an important advantage of the drug is that with its help it is possible to more gradually reduce blood sugar compared to many other similar drugs. For example, with Lantus or Levemir. In addition, the risk of developing hypoglycemia is significantly reduced, although it still remains in case of overdose. This is noted both in reviews and in the instructions for use of Insulin Tresiba.

UZ "Mogilev City Emergency Hospital"

Your doctor may prescribe one or two injections of extended-release insulin per day (morning and evening).

How many injections (1 or 2) will be prescribed depends on the duration of action of the particular insulin preparation (it lasts a day or less) and on the insulin that is administered with food.

Often during the day, the background is provided by the “tails” of food insulin, and long-acting insulin is administered only at night.

In a scheme in which the daily background is maintained by dietary insulin, you should remember that if you skip meals and do not administer short-term insulin, then you will not have enough background insulin during the day.

The need for basal insulin may change throughout the day. But in general, the correctly selected dose of basal insulin as usual (without acute illnesses, etc.) rarely changes. There is no need to change your basal insulin dose every day for no reason. It is necessary to regulate fluctuations in blood glucose as a result of food intake with short-acting insulin.

The dose of basal insulin is adequate if blood glucose is within the target level in the morning fasting, at night and during periods of skipping meals.

Basal night insulin should “maintain” the glucose level that was before bedtime. Those. If the dose of basal insulin is selected correctly, then what sugar you go to bed with is what you should wake up with.

What are the requirements for basal insulin?

The main requirement is the absence of an action peak. Insulin should act as smoothly as possible. Otherwise, hypoglycemia is possible at the peak of action. All genetically engineered basal insulins (protamine, humulin N, basal, gensulin N, protaphan, etc.) are peak (have a peak of action) and this is their significant drawback. The action profile of these insulins is as follows: onset - 1-2 hours after subcutaneous administration; “peak” - 5-8 hours; the total duration of action is 16-18 hours (initially 24 hours were stated).

Ultra-long-acting analogues (Lantus, glargine, levemir, Toujeo, Tresiba) are peakless insulins (flat-acting insulins) and this is their huge advantage.

How to choose the right background insulin?

In type 2 diabetes, insulin therapy often begins with an insulin injection at night (“prick”). In type 1 diabetes, basal insulin is also often given once in the evening.

The dose of evening basal insulin should be assessed based on blood glucose levels at night and in the morning.

At night and in the morning, the blood glucose level is within the target level, which means that the insulin dose is selected correctly.

Often in practice, increasing the dose of nightly basal insulin is based on fasting glucose levels. If blood glucose in the morning is above target values, the dose of night insulin is simply increased. This is not entirely the right approach. You must first understand why glucose levels are high in the morning.

Morning hyperglycemia is one of the most difficult problems in the treatment of diabetes mellitus.

High blood glucose levels in the morning can be caused by:

High blood glucose levels before bedtime.
“Late dinner”: (“slow” food in the evening, which “comes out” at night and “hangs” all night).
Lack of insulin.
Insufficient duration of action of insulin.
Nocturnal hypoglycemia.
The "dawn" phenomenon.
“Early dinner” for type 2 diabetes.
An increase in glucose levels after waking up (“stress of awakening”, the “feet on the floor” phenomenon).

This list does not include such technical reasons as a faulty syringe pen, a bent cannula, spoiled insulin, injection into areas of lipodystrophy, etc.

To check your basal night insulin dose, you need to have a proper dinner. Dinner should be no later than 4 hours before bedtime. Also, dinner should be light and light. When checking the base for dinner, you cannot eat pasta, buckwheat, barley, complex foods (dumplings, pancakes, pilaf, etc.), cottage cheese and products made from it (cheese cakes, casserole, etc.), fatty foods. You can: millet porridge, rolled oats, boiled potatoes, boiled and fresh vegetables, boiled meat, boiled fish, bread. The meaning of an early dinner: if you have a late dinner and, accordingly, introduce short-term insulin late, then the effect of short-term insulin will be layered on the effect of basal insulin and it will be impossible to correctly assess the dose of basal insulin. The meaning of a “light” dinner: food must be absorbed by the body before a person goes to bed, i.e. food should be “quick”. If you have a “slow” meal for dinner, it will “come out” at night and will increase your blood glucose levels all night long.

The next point is glucose measurements. If there is no monitoring, measurements should be taken at least 5 times: before bedtime; at 00.00; at 03.00; at 06.00 and before breakfast. To do this, an alarm clock is set (or another person measures the sleeping patient). It's even better to measure every 2 hours. It is advisable (many believe that it is mandatory) to carry out such a check not one night, but three nights, in order to exclude random fluctuations. If a problem area is clearly visible, measurements should be taken on it every hour.

What are the possible options?

1) Glucose at night and in the morning within the target level - the optimal dose of basal insulin.

2) Linear growth - lack of basal insulin (little insulin).

On monitoring, we see that blood glucose has been continuously increasing since 01.00, which means we need to increase the dose of basal insulin. But, if you ate “heavy” food for dinner (dumplings, pasta, a lot of meat, etc.), then this food may “come out”!

3) The increase in blood glucose begins closer to the morning and increases gradually - insufficient duration of action of insulin (insulin “does not last” until the morning).

What can you do in this case:

a) shift the injection time to a later time;

b) try to increase the dose of insulin - if there is no tendency to low glucose levels;

c) inject insulin into a “slower” place (leg);

d) replace insulin with an analogue.

4) Low glucose levels at night and high in the morning. This situation indicates an excess of basal insulin.

If the dose of basal insulin is excessive, then at night there may be low blood glucose levels, to which the body responds by releasing glycogen from the liver and the blood glucose level increases (the so-called “rollback”). Hypoglycemia most often occurs at the peak of action of long-acting insulin (if “peak” insulin is administered). A person may not feel hypoglycemia. There may simply be an attack of sweating (the person wakes up all wet), the person may have nightmares, and other nonspecific symptoms may also occur. Hypoglycemia can last several minutes and may not be “caught” when measuring glucose (sometimes even during monitoring). Instead of hypoglycemia, high glucose levels are recorded and the insulin dose is increased. But instead of reducing blood glucose, we get an even greater increase. This situation often occurs when administering “peak” insulins. This is Somogyi syndrome - insulin overdose syndrome.

5) A sharp increase in glucose in the morning - “morning dawn”.

In such a situation, we see that at night glucose is in the target range, but from 4-5 in the morning a sharp increase begins. The fight against the “dawn” is not easy. If a person is on a pump, a large dose of insulin is set for this time. If not, the “dawn” needs to be “chopped off” with short-term insulin. And often it is necessary to “chip” as a warning (i.e., by monitoring or frequent measurements, it is clearly determined at what time the dawn begins, and short-term insulin is administered before this time, because when the “dawn” has unfolded, it is not easy to “chip” it ).

6) Increase in glucose level after waking up (“stress of awakening”, “feet on the floor” phenomenon).

The situation is similar to the “dawn”, but occurs after the person has woken up. Those. The person wakes up with normal blood glucose levels, takes daily basal insulin, does not eat breakfast, and does not inject short-acting insulin. It would seem that blood glucose should not increase (there is no food, there is basal insulin). However, often, the longer a person does not eat, the more glucose increases and is poorly “cracked” with short-term insulin. It is the liver that begins to “feed” you, since you don’t want to eat yourself. In such a situation, you need to introduce the habit of having breakfast soon after waking up.

In general, situations with morning dawn, overdose or lack of insulin can be very difficult to differentiate.

Checking basal insulin during the day is done by skipping meals. To assess the base from morning to lunch, do not inject short-term insulin in the morning, do not eat anything until lunch, and measure glucose every hour. To evaluate the area from lunch to dinner, at least 4 hours must pass between breakfast and dinner, short-term insulin is not administered at lunch, lunch is skipped, and glucose is measured every hour. The same applies to the section from dinner to bed. During the entire period under test, there should be no snacks or additional doses of insulin.

The method of checking the base by skipping meals is not suitable if the daily background is provided by the “tails” of short-acting insulin (i.e., long-acting insulin with a duration of action of less than 12 hours is administered once a day at night). The database should be checked in the absence of physical activity, acute illnesses, and stress. You cannot check the database after suffering from hypoglycemia.

Negative

Despite all the positive aspects, it is worth noting that negative opinions about this drug still exist. True, negative reviews about Tresiba Insulin are not related to its effectiveness, but to its high cost.

It should be noted that only very wealthy patients can afford it, since this drug is an order of magnitude more expensive than many other analogues. If you have such free money, switching to a new insulin should be discussed with your doctor. We emphasize that for diabetes mellitus, many drugs are prescribed individually depending on the patient’s condition. In addition, it is important to determine the dosage based on the health status of the individual patient.

It currently costs about three times more than Levemir and Lantus, which are also actively used for diabetes by many patients.

Experts who are close to the pharmaceutical business note that in the coming years we can count on the appearance of analogues, the properties of which will be no less impressive than those of Insulin Tresiba. You have yet to carefully read the reviews and instructions for these medications, but you cannot expect that these medications will cost less. This is mainly due to the fact that in the world there are currently only a few reputable companies that produce modern and high-quality insulin. At the same time, there is an opinion that there is a corporate agreement between them that allows them to maintain prices at a consistently high level.