Theberifer - instructions for use, doses, side effects, contraindications

Excipients - lysine hydrochloride 27.4 mg, polysorbate-20 0.05 mg, sodium acetate trihydrate 0.272 mg, acetic acid ice to pH 4.2, water for injection up to 1.0 ml.

Description:

A clear, colorless solution.

Pharmacotherapeutic group:Cytokine (Interferon beta-1a)

ATX: & nbsp

L.03.A.B.07 Interferon beta-1a

Pharmacodynamics:

Interferons belong to the group of endogenous glycoproteins, which possess immunomodulatory, antiviral and antiproliferative properties. The protein structure of the drug Teberif® (interferon beta-1a recombinant human) is a natural amino acid sequence of human interferon beta obtained by genetic engineering using the culture of Chinese hamster ovary cells and is therefore glycosylated, like a natural protein.

Regardless of the mode of administration, changes in the pharmacodynamic effect are associated with therapy with Teberi ®. After a single dose, the intracellular and serum activity of the 2 ', 5'-oligoadenylate synthase (2’,5’OAS) and serum concentration of beta-2-microglobulin and neopterin increase within 24 hours and then within 2 days begin to decrease. With subcutaneous and intramuscular injection, the response to the administration of Teberi® is completely identical. After 4 consecutive subcutaneous injections, repeated every 48 hours, the biological response remains elevated without signs of addiction.

Subcutaneous administration of interferon beta-1a to healthy volunteers and patients with multiple sclerosis increases the level of biological response markers (2 ', 5'-oligoadenylate synthetase, neopterin and beta-2-microglobulin concentration in plasma). The time to reach the maximum concentration after a single subcutaneous injection of the drug Teberif® is from 24 to 48 hours for neopterin, beta-2-microglobulin and 2’,5’OAS, 12 hours for MXI and 24 hours for oligoadenylate synthetase 1 (OAS1) and oligoadenylate synthetase 2 (OAS2). Similar peak concentrations for most of these markers are observed after the first and sixth introductions. The mechanism of action of the drug TeberiF in the body of patients with multiple sclerosis is not fully understood. It is shown that the drug helps limit damage to the central nervous system (dimeilinization) underlying the disease.

Clinical Trials Data

The first episode of demyelination

In a biennial controlled clinical trial, interferon beta-1a at the recommended dosage was effective in treating patients with the first episode of demyelination, presumably as a result of multiple sclerosis. Patients included in the study had at least 2 asymptomatic foci of T2-weighted MRI images at least 3 mm in size, with at least one of the foci oval, periventricular or infratentorial. Other diseases that could better explain the patient's symptoms, than the diagnosis multiple sclerosis, were excluded. It was found that interferon beta-1a 44 mcg at admission 3 times a week delayed the progression of the disease in patients with the first episode of demyelination. The reduction in the risk of progression of the disease was 52% compared with placebo.Data on the effectiveness of interferon beta-1a when taken 44 μg 3 times a week are given below:

Options	Therapy		Comparison of interferon beta-1a therapy with 44 mcg and placebo
	Placebo (n=171)	Interferon beta-1a 44 mcg, 3 p / wk. (n=171)	Risk reduction	Propor. It relates. The risk of Coke (95% Cl)	P-value
Transition to Multiple Sclerosis by the McDonald Criterion (2005)
Number of cases	144	106	51%	0,49 (0,38; 0,64)	<0,001
Evaluation of CM	85,8%	62,5%
Transition to Clinical Reliable Multiple Sclerosis
Number of cases	60	33	52%	0,48 (0,31; 0,73)	<0,001
Evaluation of CM	37,5%	20,6%
Average by CUA (combined unique active foci) per patient during a double-blind examination
The minimum error	2,58 (0,30)	0,50 (0,06)	81%	0,19 (0,14; 0,26)	<0,001

Remittent Multiple Sclerosis

The safety and efficacy of interferon beta-1a were evaluated in patients with remitting multiple sclerosis at doses in the range of 11-44 μg (2-12 million) ME), administered subcutaneously three times a week. It has been shown that, at a dose of 44 μg, interferon beta-1a reduces the incidence (30% for 2 years) and the severity of exacerbations in patients with two or more exacerbations over the past 2 years and an estimate of 0 to 5 in the extended scale of disability assessment (EDSS) before starting treatment. The proportion of patients with confirmed disability progression decreased from 39% (placebo) to 30% and 27% (interferon beta-1a 22 μg and interferon beta-1a 44 μg, respectively).After 4 years, the average reduction in the number of exacerbations was 22% and 29% in patients receiving 22 μg of interferon beta-1a and 44 μg of interferon beta-1a, respectively, compared with the group of patients who received placebo for 2 years and then interferon beta -1a 22 mcg and interferon beta-1a 44 mcg.

In a three-year study in patients with secondary-progressive multiple sclerosis (3-6.5 points on a scale EDSS) with reliable progression of disability during the previous 2 years and absence of exacerbations during the previous 8 weeks, interferon beta-1a did not have a significant effect on disability, however, the frequency of exacerbations decreased by 30%. In the two groups of patients (who had or had not had an exacerbation of the disease in the last 2 years), the effect of the drug on the progression of disability was not found in the "without exacerbations" group, whereas in the "exacerbated" group the proportion of patients with progression at the end of the study decreased from 70 % (placebo) to 57% (interferon beta-1a 22 μg and interferon beta-1a 44 μg).

Primary-progressive multiple sclerosis

The effect of the drug in primary-progressive multiple sclerosis has not been studied.

Pharmacokinetics:

Suction:

After intravenous administration to healthy volunteers, the concentration of interferon beta-la undergoes a sharp exponential decrease, with serum levels of the drug being proportional to the dose.

Distribution:

After repeated subcutaneous injections of the drug Teberif® at a dose of 22 μg and 44 μg, the maximum concentrations of interferon beta-1a are observed after 8 hours, but the values vary greatly.

Metabolism:

Interferon beta-1a is metabolized and excreted by the liver and kidneys.

Excretion:

After repeated subcutaneous injections of Teberif® to healthy volunteers, the main pharmacokinetic parameters (area under the pharmacokinetic curve (AUC) and maximum concentration (C_max)) increase in proportion to the increase in dose from 22 mcg to 44 mcg. The half-life is between 50 and 60 hours, which correlates with the cumulation process observed after repeated administration.

Indications:

- Treatment of patients with the first episode of demyelination, which is based on an acute inflammatory process, if other diagnoses have been excluded, and if there is a high risk of developing clinically significant multiple sclerosis;

- Treatment of patients with relapsing multiple sclerosis, in whom the disease is characterized by two or more exacerbations in the previous two years.

Efficacy was not demonstrated in patients with secondary-progressive multiple sclerosis in the absence of exacerbations.

Contraindications:

- Hypersensitivity to natural or recombinant interferon beta, to other components of the drug.

- Initiation of therapy during pregnancy.

- Severe depressive disorders and / or suicidal ideation.

- Age before 12 years.

Pregnancy and lactation:

Women with childbearing potential

Women of childbearing age should use effective means of contraception. Given the potential danger to the fetus, patients planning pregnancy or becoming pregnant while on treatment should inform the doctor in charge of the decision to discontinue the drug. For patients with a high relapse rate, the risk of a severe relapse should be compared before the start of treatment in the event of discontinuation of the drug because of the onset of pregnancy, with the possible increase in the likelihood of spontaneous abortion.

Pregnancy

Begin the treatment with Teberif ® during pregnancy is contraindicated. The available data indicate a possible increase in the risk of spontaneous abortion.

Breastfeeding period

There is no data on the excretion of the drug Teberi ® into breast milk. Given the likelihood of developing serious adverse reactions in newborns, a choice should be made between the cancellation of the drug TeberiF and the cessation of breastfeeding.

Dosing and Administration:

The drug is administered subcutaneously. Treatment should be started under the supervision of a specialist doctor who has experience in the treatment of this disease. Treatment with the drug Teberif ® to prevent the development of tachyphylaxis and reduce unwanted reactions is recommended to begin with a dose of 8.8 mcg and then for 4 weeks the dose should be increased to the recommended dosage according to the scheme below:

Terms of introduction	Recommended titration (% final dosage)	Titration of a dose of the drug Teuber® 44 μg 3 times a week
Weeks 1 and 2	20%	8,8 mkg 3 r / week.
Weeks 3 and 4	50%	22 mcg 3 p / wk.
Week 5 and onwards	100%	44 mcg 3 p / wk.

With the appointment of the drug Teberif® at a dose of 44 mcg, starting from the 5th week, 0.5 ml of the drug is administered at this dosage.To reduce influenza-like symptoms associated with the appointment of the drug Teberif® before administration and within 24 hours after each injection, it is recommended to prescribe an antipyretic agent (antipyretic).

The first episode of demyelination

The dosage of interferon beta-1a for patients with the first episode of demyelination is 44 μg 3 times a week subcutaneously.

Remittent Multiple Sclerosis

Adults and adolescents over 16 years of age usually receive a recommended dose of 44 μg 3 times a week. At a dose of 22 μg 3 times a week, the drug Teberi® is prescribed to those patients who, according to the attending physician, do not tolerate the high dose well enough.

The safety and effectiveness of the use of interferon beta-1a for subcutaneous use in adolescents aged 12-16 years has not yet been fully established. The safety data given in the "Side effect" section does not give an opportunity to give recommendations on the dosing regimen for this group of patients. Nevertheless, published data suggest that the safety profile of interferon beta-1a in adolescents aged 12 to 16 years receiving subcutaneous injections of the drug at a dose of 22 μg 3 times a week is similar to that in adults.The safety and efficacy of interferon beta-1a in children under 12 years of age have not been established, only limited information is available, so Teberif® should not be used in this age group. The drug should be used at the same time (preferably in the evening), on certain days of the week, with an interval of at least 48 hours. The drug Teberif ® can be used only if the solution of the drug is clear or slightly opalescent and, if it is not contained foreign particles. There are currently no clear recommendations on how long the treatment should be carried out. It is recommended that patients be evaluated at least every two years for the first 4 yearstreatment with Teberi ®, the decision on longer-term therapy should be taken by the attending physician individually for each patient.

The doctor should bring the following information to the patient:

To use the drug TeberiF® was effective and safe, you need:

- Use Teberif ® only under the supervision of an experienced doctor.

- Read the instructions carefully and follow the instructions to prevent necrosis. If a reaction occurs at the injection site, consult a physician.

- Do not change the dose without consulting the doctor.

- Do not discontinue treatment without consulting a doctor.

- Warn doctor if you have intolerance to any medications.

- In the course of treatment, inform the doctor of any violations of health. Independent subcutaneous administration

Since the drug TeberiF is available as a pre-filled syringe for subcutaneous administration, you can safely use it at home, either alone or with the help of relatives and friends. If possible, the first injection should be done under the supervision of a qualified health professional.

Before using Teberif®, please read the following instructions carefully:

1. Choose the time of your injection that is convenient for you. Injections should be done in the evening before bedtime.

2. Before using the product, wash your hands thoroughly with soap and water.

3. Take one out-of-the-box package with a filled syringe from the carton that should be stored in the refrigerator and let it sit at room temperature for a few minutes so that the temperature of the drug is equal to that of the ambient air.In case of occurrence of condensate on the surface of the syringe, wait a few minutes until the condensation evaporates. In case of failure of the syringe unopened storage in the refrigerator, it is acceptable once stored in the dark place not more than 30 days at a temperature not higher than 25 ° C. The date of storage at room temperature should be marked on the package.

4. Before use, inspect the solution in a syringe. In the presence of suspended particles or a discoloration of the solution or damage to the syringe, the drug should not be used. If there was a foam, that is, when the syringe is shaken or strongly shake, wait until the foam settles.

5. Select the area of the body for injection. Preparation Teberif® injected into the subcutaneous adipose tissue (fat layer between skin and muscle tissue), so use with loose-fiber seats away from areas of skin stretching, nerves, joints and blood vessels (Figure 1 and 2 are recommended area for injection.):

- Hips (anterior thighs other than groin and knee);

- The abdomen (except the midline and the near-pustular region);

- The outer surface of the shoulders;

- Buttocks (upper outer quadrant).

Do not use painful points, discolored, reddened areas of the skin or areas with seals and nodules for injection.

Each time choose a new site for the injection, so you can reduce discomfort and pain on the skin area at the injection site. Within each injection area, there are many points for the injection. Constantly change injection points within a specific area.

6. Preparation for injection.

Take the prepared syringe in the hand that you are writing. Remove the protective cap from the needle.

7. The amount of solution of the drug Teberif®, which must be administered during the injection, depends on the dose recommended by your doctor. Do not store leftovers in the syringe for reuse.

Depending on the dose your doctor prescribes, you may need to remove excess volume of the drug solution from the syringe. If necessary, slowly and gently press the plunger of the syringe to remove excess solution. Press the piston until the piston reaches the required mark on the syringe label.

8.Pre-disinfect the area of skin where the drug Teberif® will be injected. When the skin dries, slightly gather the skin into the fold with the thumb and forefinger (Fig. 3).

9. With the syringe perpendicular to the injection site, insert the needle into the skin at an angle of 90 ° (Figure 4). The recommended insertion depth is 6 mm from the skin surface. Depth is selected depending on the type of physique and thickness of subcutaneous fat. Introduce the drug, evenly pressing the syringe piston down to the end (until it is completely emptied).

10. Remove the syringe with the needle moving vertically upward, keeping the previous angle.

11. A dry sterile cotton ball can be applied to the injection site. If necessary, you can glue it with a band-aid. It is not recommended to rub or massage the injection site after injection.

12. Dispose of used syringes only in a designated place out of the reach of children.

13. If you forget to inject the drug, inject immediately as soon as you remember it. The next injection is given after 48 hours. Do not administer a double dose of the drug.

Do not stop using TeberiF without consulting your doctor.

What to do in case of an overdose of Teberi ®

No cases of overdose have been described to date. However, in case of a dose increase (increase in single-dose volume and frequency of administration per week), immediately inform your doctor.

What to do if you missed a dose

If you miss a dose, continue the injection, starting with the next on schedule. Do not administer a double dose.

Correction of the dosing regimen

If the upper limit of the ALT content level is increased, the dose of the drug Teberi® should be reduced and gradually increased after normalizing the ALT level. A temporary reduction in the dose of the drug may also be required if the flu-like symptoms are significant.

Use in special patient groups

Caution should be exercised when prescribing Teberi® to patients with severe hepatic insufficiency in history, with signs of liver disease, signs of alcohol abuse, ALT level 2.5 times higher than the upper limit of the norm. Therapy should be discontinued with jaundice or other symptoms of liver dysfunction.

Care should be taken when prescribing the drug to patients with severe renal failure and myelosuppression.

Side effects:

The most frequent adverse reactions observed in the treatment with interferon beta- la, associated with the emergence of influenza-like syndrome. Grippopodobnye symptoms are particularly pronounced at the beginning of treatment and weaken in frequency as the treatment continues. Approximately 70% of patients taking interferon beta-1a, you can expect the appearance of a typical flu-like syndrome in the first six months after the start of treatment. Approximately 30% of patients develop reactions at the injection site, mostly mild irritation or erythema.

Asymptomatic increase in laboratory parameters of hepatic function and decrease in the number of leukocytes are also frequent. Below are the undesirable reactions that were observed in both clinical trials and post-registration periods (marked *) in patients with multiple sclerosis. Undesirable reactions are listed according to their frequency and system-organ class. To denote the frequency of adverse reactions, a common classification is used: very often (≥ 1/10 cases), often (≥ 1/100, <1/10), infrequently (≥ 1 / 1,000, <1/100), rarely (≥ 1 / 10,000, <1 / 1,000), very rarely (<1 / 10,000), the frequency is unknown (can not be established based on the received data)

Violations from the blood and lymphatic system:

Very often: neutropenia, lymphopenia, leukopenia, thrombocytopenia, anemia.

Rarely: Thrombotic microangiopathy, including thrombotic thrombocytopenic purpura / hemolytic-uremic syndrome * (is an interferon-class effect class, see section "Special instructions"), pancytopenia *.

Immune system disorders:

Rarely: anaphylactic reactions *.

Disorders from the endocrine system:

Infrequent: a dysfunction of the thyroid gland, most often manifested in the form of hypo- or hyperthyroidism (see section "Special instructions").

Disorders from the liver and bile ducts:

Very often: an asymptomatic increase in transaminase activity in the blood.

Often: a significant increase in transaminase activity in the blood.

Infrequently: hepatitis (with or without jaundice) *.

Rarely: hepatic insufficiency *, autoimmune hepatitis *.

Mental disorders:

Often: depression, insomnia.

Rarely: suicidal attempts (cf.section "Special instructions").

Impaired nervous system:

Very often: headache.

Infrequently: convulsions * (see section "Special instructions").

The frequency is unknown: transient neurological symptoms (hypoesthesia, muscle spasms, paresthesia, difficulty walking, rigidity of the muscles), which can mimic the aggravation of multiple sclerosis *.

Disturbances on the part of the organ of sight:

Infrequent: retinal vascular lesions (ie, retinopathy, "cotton spots" on the retina, arterial obstruction or retinal veins) *.

Disorders from the vascular system:

Infrequently: thromboembolism *.

Disturbances from respiratory system, chest and mediastinum: Infrequently: shortness of breath.

The frequency is unknown: arterial pulmonary hypertension (class-effect, see below "Arterial pulmonary hypertension")

Disorders from the gastrointestinal tract:

Often: diarrhea, vomiting, nausea.

Disturbances from the skin and subcutaneous tissues:

Often: itching, rash, erythematous rash, maculopapular rash, alopecia *.

Infrequently: urticaria *.

Rarely: Quincke's edema *, erythema multiforme *, skin reaction, resembling multiforme erythema *, Stevens-Johnson syndrome *.

Disturbances from the musculoskeletal and connective tissue:

Often: myalgia, arthralgia.

Rarely: drug lupus erythematosus *.

Disorders from the kidneys and urinary system:

Rarely: nephrotic syndrome *, glomerulosclerosis * (see section "Special instructions").

General disorders and disorders at the site of administration:

Very often: inflammation at the injection site, reactions at the injection site, for example, bruising, swelling at the injection site, swelling, redness), flu-like symptoms.

Often: pain at the injection site, fatigue, chills, fever.

Infrequent: necrosis at the injection site, swelling at the injection site, abscess at the injection site, infection of the injection site *, increased sweating *.

Rarely: phlegmon at injection site *.

Children

No separate clinical or pharmacokinetic studies have been conducted for children and adolescents. However, published data on the use of interferon beta-1a in adolescents aged 12 to 16 years who received interferon beta-1a at a dose of 22 μg 3 times per week subcutaneously suggest that the safety profile of the drug TeberiF in this group is similar to that in adult patients.

Class Effects

The use of interferons is associated with loss of appetite, dizziness, anxiety, arrhythmia, enlargement of blood vessels and rapid heart rate, menorrhagia and metrorrhagia.

In the course of treatment with interferon beta, enhanced antibody formation may occur.

Arterial pulmonary hypertension

Against the background of the use of interferon beta preparations, cases of arterial pulmonary hypertension were registered. These cases were recorded at different stages of treatment, including several years after initiation of interferon beta therapy.

It is necessary to inform the doctor about any of the above undesirable reactions, as well as those that are not specified in this manual. If unwanted reactions persist for a long time or in case of development of severe unwanted reactions at the discretion of the doctor, a temporary reduction in the dose of the drug or interruption of treatment is allowed.

Do not discontinue treatment or change the dose without the indication of the attending physician.

Overdose:

If a patient injects more than prescribed doses, immediately inform the attending physician.If necessary, in case of an overdose, the patient should be hospitalized for follow-up and maintenance therapy.

Interaction:

Specially planned clinical studies to study the interaction of interferon beta-1a with other drugs have not been conducted. However, it is known that in humans and animals, interferons decrease the activity of cytochrome-P450-dependent liver enzymes. Therefore, care should be taken when prescribing TeberiF® concomitantly with drugs that have a narrow therapeutic index, the clearance of which depends to a large extent on the cytochrome P450 of the liver system, for example, with antiepileptic drugs and some antidepressants.

A systematic study of the interaction of interferon beta-1a with corticosteroids or adrenocorticotropic hormone (ACTH) has not been carried out. Data from clinical trials indicate the possibility of receiving interferons beta-1a and corticosteroids or ACTH during the exacerbation of patients with multiple sclerosis.

Special instructions:

Patients should be informed of the most common side effects associated with taking interferon run, including influenza-like symptoms (see "Side effect"), which are especially pronounced at the beginning of treatment and decrease in frequency and severity as treatment continues.

Thrombotic microangiopathy (TMA)

There is information about cases of thrombotic microangiopathy, which manifested itself as thrombotic thrombocytopenic purpura or hemolytic-uremic syndrome, including fatal cases. Such cases were recorded at different time periods, from several weeks to several years after initiation of treatment with interferon beta-1a. It is recommended to monitor early symptoms such as thrombocytopenia, newly occurring cases of hypertension, fever, central nervous system disorders (eg confused consciousness, paresis) and decreased renal function. Laboratory data for a presumptive diagnosis of TMA include a decrease in platelet count, an increase in serum lactate dehydrogenase (LDH) activity caused by hemolysis and schizocytes (fragments of erythrocytes) in the blood smear.If clinical signs of TMA are observed, a determination of the platelet count is recommended; serum LDH, take a blood smear and evaluate the kidney function. If the diagnosis of TMA is confirmed, immediate treatment is required (plasma transfusion may be required) and discontinuation of interferon beta-1a treatment.

Depression and suicidal ideation

The drug Teberif® should be administered with caution to patients who are or have been depressed. Depressive and suicidal conditions with increased frequency are observed in the group of patients with multiple sclerosis and taking interferon.

Patients should be warned that they should immediately report any symptoms of depression and / or suicidal ideation to the treating physician. The treatment of patients with depression with the drug Teberi ® should take place under close monitoring and providing them with the necessary care. In a number of cases, the issue of discontinuing drug treatment may arise.

Convulsive Syndrome

Caution should be exercised when prescribing Tuberif® to patients with epileptic seizures in history,especially if the course of this disease is not completely controlled by antiepileptic drugs.

Cardiovascular diseases

At the initial stages of treatment with Teberi ®, strict surveillance of patients suffering from cardiovascular diseases such as angina pectoris, congestive heart failure and rhythm disturbances is necessary. This observation should be aimed at timely detection of possible deterioration of the condition. In heart diseases, influenza-like symptoms associated with interferon beta-1a therapy can be a serious burden for patients.

Necrosis at the injection site

There are isolated reports of necrosis at the injection site. To minimize the risk of developing necrosis, strict adherence to the rules of asepsis during the injection and changing the injection site after each injection is necessary. It is necessary to regularly evaluate the technique of self-administration of the drug by patients, especially when reactions occur at the injection site. If there is damage to the skin with swelling and discharge of fluid at the injection site, you should consult a doctor before proceeding with the drug.For multiple skin lesions, the drug should be discarded before healing. With a single lesion, it is possible to continue therapy with Teberi ®, provided that the lesion is moderately expressed.

Dysfunction of the liver

Clinical trials demonstrated an asymptomatic increase in hepatic transaminase activity, especially alanine aminotransferase (ALT), and in 1-3% of patients, the hepatic transaminase content exceeded the upper limits of the norm (IVF) by more than 5 times. In the absence of clinical symptoms, it is necessary to monitor the activity of ALT in plasma prior to the initiation of interferon beta-1a, in the 1 st, 3 rd and 6 th months from its onset, and periodically during further treatment. It is necessary to lower the dose of the drug if ALT activity exceeds the upper limit by 5 times, and gradually increase the dose after its normalization. Caution should be exercised when prescribing Teberi® to patients with severe hepatic insufficiency in history, with signs of liver disease, signs of alcohol abuse, ALT activity 2.5 times higher than the upper limit of the norm.Therapy with Teberi ® should be discontinued if jaundice or other clinical signs of liver dysfunction occur.

Teberif ®, like other interferons beta, can potentially cause severe liver damage, including acute liver failure. Severe dysfunction of the liver mainly occurs in the first 6 months of therapy. The mechanism of these conditions is unknown, specific risk factors have not been identified.

Impaired renal and urinary system

Nephrotic syndrome

During the treatment with interferon beta-1a and other beta interferons, there may be cases of nephrotic syndrome with various nephropathies, including focal segmental glomerulosclerosis (OSGS), membranoproliferative glomerulonephritis and membrane glomerulopathy. Cases have occurred both in the process of treatment, and a few years after its completion. It is recommended that periodic monitoring of early signs or symptoms (eg, swelling, proteinuria, or renal dysfunction) be monitored in particular in patients at high risk of developing kidney disease.Nephrotic syndrome requires immediate treatment and discontinuation of the drug TeberiF.

Violation of laboratory indicators

In addition to laboratory tests that are always performed for patients with multiple sclerosis, it is recommended in the 1 st, 3 rd and 6 th months after initiation of therapy with Teberi ®, and also periodically, in the absence of clinical symptoms, during further treatment determine the general clinical analysis of blood with the leukocyte formula, the content of platelets, as well as conduct a biochemical blood test, including functional tests of the liver.

Thyroid gland diseases

In patients receiving interferon beta-1a, sometimes existing pathological changes in the thyroid gland can develop or worsen. It is recommended to carry out thyroid function tests immediately before treatment and, if violations are detected, every 6-12 months. from the moment of its beginning. If the function of the thyroid gland is normal before the start of treatment, then periodic studies of its function are not required, but their conduct is necessary when there are clinical signs of thyroid dysfunction.

Severe renal and hepatic impairment and expressed myelosuppression

Care should be taken when prescribing the drug to patients with severe renal failure and myelosuppression.

Neutralizing antibodies

In patients receiving interferons beta, the formation of neutralizing antibodies is possible. Clinical data suggest that after 24-48 months of treatment with interferon beta-1a, 44 μg, approximately 13-14% (24% for 22 μg) of patients in the serum of the blood appear neutralizing antibodies to interferon beta-1a. The presence of antibodies is associated with a decrease in the effectiveness of treatment, which is confirmed by MRI study and clinical indicators. The overall clinical significance of the production of neutralizing antibodies has not been sufficiently studied.

The formation of neutralizing antibodies is associated with the response to the presence of various forms of interferon beta. If the patient does not have an adequate response to therapy with TeberiF, and this is due to the persistent presence of neutralizing antibodies, the physician should evaluate the feasibility of continuing interferon therapy. The use of various methods for detecting antibodies in serum and determining their characteristics limitsthe possibility of comparing the immunogenicity of various drugs.

Other forms of multiple sclerosis

For non-ambulatory patients with multiple sclerosis, only some data on the safety and efficacy of the drug are available. The use of interferon beta-1a in patients with primary progressive multiple sclerosis has not been studied to date, so the drug should not be used in this disease.

Precautions for use

Does not require special precautions for use.

Effect on the ability to drive transp. cf. and fur:

Adverse reactions from the central nervous system to interferon therapy (see "Possible side effects when used") may affect the ability to drive and technique.

Form release / dosage:

The solution for subcutaneous administration is 22 μg / 0.5 ml, 44 μg / 0.5 ml.

Packaging:

For 0.5 ml in syringes from colorless glass I hydrolytic class. 1 syringe per contour pack. For 3 or 12 contour mesh packages, along with instructions for medical use, they are placed in a pack of cardboard.The pack with syringes is additionally completed with alcoholic napkins in quantity of 3 or 12 pcs.

Storage conditions:

Store at a temperature of 2 to 8 ° C in a dark place.

Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-004137

Date of registration:13.02.2017

Expiration Date:13.02.2022

The owner of the registration certificate:BIOCAD, CJSC BIOCAD, CJSC Russia

Manufacturer: & nbsp