Interferon Beta-1b - Instructions For Use, Price, Reviews, Injections

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Interferon beta-1b

Interferon beta-1b: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Interferon beta-1b

ATX code: L03AB08

Active ingredient: interferon beta-1b (Interferon beta-1b)

Manufacturer: Biocad, CJSC (Russia)

Description and photo update: 2019-10-07

Interferon beta-1b is a drug with antiviral, antiproliferative, immunomodulatory effects, used to treat multiple sclerosis.

Release form and composition

Dosage form - solution for subcutaneous administration: transparent, yellowish or colorless (dosage 8 million IU / 1 ml: in a cardboard box 1-3 or 6 blisters containing 5 vials of 1 ml each; an additional pack with vials can be completed with 5, 10, 15 or 30 disposable injection syringes with a needle and medical injection needles with / without 10, 20, 30 and 60 alcohol wipes; dosage 8 million IU / 0.5 ml: in a cardboard box 1, 5 or 15 blisters containing three-component sterile syringe of 0.5 ml, and instructions for the use of Interferon beta-1b).

Composition of 1 ml solution:

• active substance: human recombinant interferon β-1b - 8 or 16 million IU (international units);
• auxiliary components: polysorbate-80 - 0.04 mg; sodium acetate trihydrate - 0.408 mg; dextran (average molecular weight 50–70 thousand) - 15 mg; disodium edetate dihydrate - 0.055 5 mg; mannitol - 50 mg; glacial acetic acid - up to pH 4; water for injection - up to 1 ml.

Pharmacological properties

Pharmacodynamics

The active substance of Interferon beta-1b - recombinant interferon β-1b (IFN-β-1b) - is isolated from Escherichia coli cells. The gene of human interferon beta is introduced into the genome of these cells, which codes for the amino acid of the series in the 17th position. IFN-β-1b is a non-glycosylated protein of 165 amino acids and a molecular weight of 18,500 Daltons.

By their structure, interferons are proteins and belong to the cytokine family. Their molecular weight ranges from 15,000 to 21,000 Daltons. Interferons of the three main classes (alpha, beta and gamma) have a similar mechanism of action, with different biological effects noted. The activity of interferons is species-specific; therefore, their effects can only be studied in humans or in human cell cultures.

IFN-β-1b has immunomodulatory and antiviral activity. In MS (multiple sclerosis), the mechanism of its action is not fully understood. However, it has been established that the biological effect of IFN-β-1b is based on interaction with specific receptors found on the surface of human cells. When IFN-β-1b binds to these receptors, the expression of a number of substances, which are considered to be mediators of the biological effects of IFN-β-1b, is induced. Some of these substances are detected in the serum and blood cell fractions of patients treated with IFN-β-1b. Its use helps to reduce the binding capacity of the interferon gamma receptor, thereby increasing its degradation and internalization. Also, IFN-β-1b potentiates the suppressor activity of peripheral blood mononuclear cells.

Studies aimed at studying the effect of IFN-β-1b on the function of the cardiovascular system, endocrine and respiratory systems have not been conducted.

According to the results of a controlled clinical study, in patients with relapsing-remitting MS who are able to walk independently (EDSS from 0 to 5.5), IFN-β-1b therapy reduces the frequency of exacerbations by 30%, as well as a decrease in the severity of exacerbations and number of hospitalizations due to underlying illness.

In the future, there was an increase in the interval between exacerbations and a tendency to slow down the progression of the disease.

In two controlled clinical trials of patients with secondary progressive MS who are capable of walking independently (EDSS 3 to 6.5), the main endpoint of which was time to confirmed progression, there were conflicting data.

One study found a statistically significant slowdown in the rate of progression of disability and an increase in the time interval until the moment when the ability to move independently, i.e., using a wheelchair or EDSS 7.0, was found among patients taking IFN-β-1b. The therapeutic effect of the use of Interferon beta-1b persisted throughout the subsequent observation period, regardless of the frequency of exacerbations.

In the second study, no slowing of the rate of progression of secondary progressive MS was shown. However, the patients included in this study had less disease activity than patients in other studies. A retrospective meta-analysis of data from both studies showed a statistically significant effect.

According to the results of a retrospective analysis, a more pronounced effect on the rate of MS progression was observed in the group of patients with high disease activity prior to initiation of therapy. After analyzing the available data, it can be concluded that considering the frequency of relapse and the rapid progression of EDSS can facilitate the identification of patients with an active course of the disease. Also in these studies, a decrease in the frequency of exacerbations was recorded (30%). The effect of IFN-β-1b on the duration of the exacerbation period has not been shown.

In patients with CIS (Clinically Isolated Syndrome), one controlled clinical trial of IFN-β-1b was carried out, suggesting the presence of a single clinical episode of demyelination and / or at least two lesions clinically not manifesting themselves on T2-weighted MRI images (magnetic resonance imaging).), which are not enough for the diagnosis of clinically reliable MS. It was found that in the future, CIS is likely to lead to the development of MS. The study included patients with one or two or more clinical foci on MRI. In this case, all alternative diseases that could be the most likely cause of the existing symptoms, except for MS, should be excluded.

The study consisted of two phases: a placebo-controlled phase and a follow-up phase. The first phase lasted for two years or until the patient's transition to KDRS (clinically significant multiple sclerosis). He was then transferred to the follow-up phase with IFN-β-1b therapy. To assess the early / delayed effect of prescribing the drug, the groups of patients initially randomized to IFN-β-1b and placebo were compared (group of immediate and delayed treatment, respectively).

In the placebo-controlled phase of the study, it was statistically reliably confirmed that IFN-β-1b prevents the transition of CIS to EDMS. In the group of patients who received IFN-β-1b, there was a delay in transformation into significant MS according to MacDonald's criteria.

Depending on baseline factors, subgroup analyzes demonstrated the efficacy of IFN-β-1b in preventing transformation to MDRS in all subgroups. The likelihood of transformation into KDRS for two years was higher in the group of patients with monofocal CIS with foci on T2-weighted images in the amount of 9 or more, or with foci that accumulate contrast, according to MRI data at the beginning of the study. In the group of patients with multifocal clinical manifestations, the efficacy of IFN-β-1b did not depend on baseline MRI parameters. This is evidence that patients in this group have a high risk of transformation of CIS into CDRS.

There is currently no generally accepted definition of high risk, however, patients with monofocal CIS (with a clinical manifestation of one lesion in the central nervous system) and with at least 9 lesions on MRI in T2 mode and / or accumulating contrast agent. Patients with multifocal CIS, with clinical manifestations of one or more foci in the central nervous system, are considered to be at high risk of developing KDRS, regardless of the number of foci on MRI. In any case, the decision to prescribe IFN-β-1b is made on the basis of the conclusion that the patient is at high risk of developing CDRS.

IFN-β-1b therapy is generally well tolerated by patients, as evidenced by the low dropout rate (93% of patients completed the study).

In order to improve the tolerability of the treatment, the dose of Interferon beta-1b was titrated; at the beginning of therapy, non-steroidal anti-inflammatory drugs were used. Also, the majority of patients used an autoinjector throughout the study.

Subsequently, after 3 and 5 years of follow-up, IFN-β-1b remained highly effective in its ability to prevent the development of EDMS, despite the fact that the majority of patients who received placebo began therapy with IFN-β-1b two years after the start of the study. Confirmed progression of EDSS was lower in the immediate group. In most cases, there was no progression of disability in both groups over a five-year period. There is no convincing evidence to support this outcome with immediate IFN-β-1b. The effect of immediate therapy with IFN-β-1b on the quality of life of patients has not been shown.

The efficacy of IFN-β-1b was presented in all clinical trials for the ability to reduce the activity of remitting, secondary progressive MS and CIS, assessed by MRI. Currently, the relationship between the clinical activity of MS and the activity of the disease by MRI parameters has not been fully established.

Pharmacokinetics

After subcutaneous administration of the recommended dose (8 million IU), IFN-β-1b is detected in low serum concentrations or the substance is not detected at all. Therefore, there are no data on the pharmacokinetic processes of the drug in MS patients receiving IFN-β-1b at the recommended dose. The maximum plasma levels of the drug after administration of 16 million IU 1–8 hours after injection are approximately 40 IU / ml.

The clearance of IFN-β-1b and its T _1/2 (half-life) from serum, according to the results of numerous clinical studies, averages 30 ml / min / kg and 5 hours, respectively. The absolute bioavailability is about 50%.

With the introduction of IFN-β-1b every other day, an increase in its plasma level in the blood does not occur; during the course of therapy, the pharmacokinetics, most likely, does not change.

When administered subcutaneously every other day, IFN-β-1b 0.25, the levels of biological response markers (neopterin, immunosuppressive cytokine interleukin-10 and β2-microglobulin) significantly increased compared to baseline values 6–12 hours after the first dose. They peaked at 40-124 hours and remained enlarged over the seven-day (168 hours) study period. The relationship between the plasma level of IFN-β-1b or the level of markers induced by it and the mechanism of action of IFN-β-1b in MS has not been established.

Indications for use

• CIS (the presence of a single clinical episode of demyelination, which suggests MS in cases where alternative diagnoses are excluded) with a sufficiently pronounced inflammatory process for the administration of intravenous corticosteroids: Interferon beta-1b is prescribed to slow down the transition to EDRS in patients at high risk of its development;
• remitting MS: interferon beta-1b is used to reduce the severity and frequency of exacerbations of the disease in patients who are able to walk without assistance, in cases where there is a history of at least two exacerbations of the disease in the last 2 years, followed by complete / partial recovery of neurological deficit;
• Secondary progressive MS in an active course, characterized by exacerbations or severe deterioration of neurological functions over the past two years: therapy is carried out to reduce the severity and frequency of clinical exacerbations of the disease, as well as to slow down the rate of disease progression.

Contraindications

Absolute:

• liver disease in the stage of decompensation;
• epilepsy (in the absence of adequate control of the condition);
• burdened history of severe depressive illness and / or suicidal thoughts;
• pregnancy and lactation;
• age up to 18 years;
• individual intolerance to the components of the drug.

Relative (Interferon beta-1b is prescribed under medical supervision):

• burdened history of depression or seizures;
• severe renal failure;
• heart failure stage III – IV according to the NYHA classification;
• cardiomyopathy;
• dysfunction of the bone marrow;
• thrombocytopenia;
• anemia;
• combined use with anticonvulsants.

Interferon beta-1b, instructions for use: method and dosage

Interferon beta-1b treatment should be initiated under the supervision of a physician experienced in MS treatment. The drug is injected subcutaneously.

The recommended adult dose of IFN-β-1b is 8 million IU every other day.

Dose titration is usually recommended at the start of treatment. Therapy begins with 2 million IU of IFN-β-1b every other day, gradually increasing the dose to 8 million IU, also administered every other day (by 2 million IU every 3 injections). The titration period, depending on the individual tolerance of the drug, may vary.

The recommended course duration has not been established at this time. There are results of clinical studies in which the duration of the use of interferon beta-1b in patients with secondary progressive and remitting MS reached 3 and 5 years, respectively. In the group of patients with recurrent MS, high efficacy was recorded during the first two years. Further observation over the course of 3 years revealed the preservation of efficacy indicators during the entire period of drug use. In patients with CIS, there was a significant delay in the transformation into significant MS over a period longer than five years.

The use of IFN-β-1b in patients with relapsing-remitting multiple sclerosis (RRMS) who have had fewer than two exacerbations in the past two years, or patients with secondary progressive MS who have not progressed over the past two years is not indicated …

Patients who do not have stabilization of the course of the disease (for example, with persistent progression of the disease on the EDSS scale for six months, or if it is necessary to undergo 3 or more courses of treatment with glucocorticosteroids or corticotropin) within 12 months, the use of Interferon beta-1b is canceled.

It is advisable to inject in the evening before bedtime. Before the procedure, you must thoroughly wash your hands with soap and water.

A blister strip with a filled syringe / bottle from a cardboard box must be taken out of the refrigerator and kept at room temperature for some time. This will allow the temperature of the preparation to equal the ambient temperature. If condensation appears on the surface of the syringe / vial, wait a few more minutes until it evaporates.

Before injecting the solution, it should be inspected for discoloration or the presence of suspended particles. You also need to make sure the integrity of the syringe / vial. If foam appears (possibly by shaking or shaking the syringe / bottle), you must wait until it settles.

IFN-β-1b should be injected into the subcutaneous adipose tissue; for injection, use places with loose fiber away from areas of skin stretching, the location of blood vessels, joints and nerves. Interferon beta-1b can be injected into the anterior thighs (excluding the knee and groin), abdomen (excluding the midline and umbilical region), the outer surface of the shoulders, and the upper outer quadrant of the buttocks.

It is not recommended to use sore spots, reddened, discolored areas of the skin or areas with nodules and lumps for injections. For an injection, each time it is necessary to choose a new place, which will reduce pain and discomfort on the skin area at the injection site. Within a specific area, the injection points should be constantly changed.

The amount of Interferon beta-1b solution that needs to be administered is determined by the dose recommended by the doctor. You cannot store the drug left in the syringe / vial after injection for reuse.

Before each dose is administered, it is necessary to disinfect the area of the skin where Interferon beta-1b will be injected. After the skin is dry, you need to lightly collect it into a fold with your thumb and forefinger. The syringe is positioned perpendicular to the injection site. The recommended depth of needle insertion from the skin surface is 6 mm. Depth can vary depending on the body type and the thickness of the subcutaneous fat.

If a dose is missed, it must be administered as soon as possible. The interval until the next injection of Interferon beta-1b should be 48 hours. The introduction of a double dose of the drug is unacceptable.

You should not interrupt the course of treatment without medical advice.

Side effects

Side effects are often observed at the initial stages of the use of Interferon beta-1b, however, with further use of the drug, their intensity and frequency decrease.

Most often, the development of a flu-like symptom complex (in the form of fever, chills, sweating, malaise, headache, joint or muscle pain) and reactions at the injection site was noted, which is largely due to the pharmacological properties of IFN-β-1b.

The most common reactions at the injection site: edema, redness, decoloration, necrosis, inflammation, hypersensitivity, pain, nonspecific reactions.

In order to improve tolerance, it is recommended to start therapy with dose titration. Influenza-like syndrome can be corrected with non-steroidal anti-inflammatory drugs. The prevalence of injection site reactions can be reduced by using an autoinjector.

Experience with IFN-β-1b in MS is limited, so side effects, which develop in very rare cases, may not yet be identified.

Adverse reactions occurring with a frequency of> 10% compared to the frequency of the corresponding event with placebo, as well as significant side effects associated with therapy <10% (CIS; secondary progressive MS according to the European / North American studies; relapsing MS):

• lymphatic system and blood: leukopenia (11%; 13% / 13%; 16%); lymphopenia (79%; 53% / 88%; 82%); neutropenia (11%; 18% / 4%; 18%); lymphadenopathy (1%; 3% / 11%; 14%);
• infectious lesions: infections (6%; 13% / 11%; 14%); abscess (0%; 4% / 4%; 1%);
• psyche: anxiety (3%; 6% / 10%; 15%); depression (10%; 24% / 44%; 25%);
• metabolism: hypoglycemia (3%; 27% / 5%; 15%);
• sense organ: conjunctivitis (1%; 2% / 6%; 12%); ear pain (0%; <1% / 6%; 16%); visual impairment (3%; 11% / 11% 7%);
• nervous system: paresthesias (16%; 35% / 40%; 19%); headache (27%; 47% / 55%; 84%); migraine (2%; 4% / 5%; 12%); dizziness (3%; 14% / 28%; 35%); insomnia (8%; 12% / 26%; 31%;);
• respiratory organs: cough (2%; 5% / 11%; 31%); upper respiratory tract infections (18%; 3% / 0%; 0%); sinusitis (4%; 6% / 16%; 36%); shortness of breath (0%; 3% / 8%; 8%);
• cardiovascular system: palpitations (1%; 2% / 5%; 8%); vasodilation (0%; 6% / 13%; 18%); arterial hypertension (2%; 4% / 9%; 7%);
• reproductive system: dysmenorrhea (2%; <1% / 6%; 18%); violation of the menstrual cycle (1%; 9% / 10%; 17%); impotence (1%; 7% / 10%; 2%); metrorrhagia (2%; 12% / 10%; 15%);
• digestive system: diarrhea (4%; 7% / 21%; 35%); vomiting (5%; 4% / 10%; 21%); constipation (1%; 12% / 22%; 24%); nausea (3%; 13% / 32%; 48%); abdominal pain (5%; 11% / 18%; 32%);
• skin and subcutaneous fat: rash (11%; 20% / 26%; 27%); skin reactions (1%; 4% / 19%; 6%);
• liver and biliary tract: increased aspartate aminotransferase (6%; 4% / 2%; 4%); increased alanine aminotransferase (18%; 14% / 4%; 19%);
• urinary system: urinary retention (1%; 4% / 15%; 0%); increased urination (1%; 6% / 12%; 3%); urinary incontinence (1%; 8% / 20%; 2%); proteinuria (25%; 14% / 5%; 5%); imperative urge (1%; 8% / 21%; 4%);
• musculoskeletal system: hypertonicity (2%; 41% / 57%; 26%); myasthenia gravis (2%; 39% / 57%; 13%); back pain (10%; 26% / 31%; 36%); myalgia (8%; 23% / 19%; 44%); limb pain (6%; 14% / 0%; 0%);
• reactions at the injection site and general reactions: asthenia (22%; 63% / 64%; 49%); malaise (0%; 8% / 6%; 15%); chills (5%; 23% / 22%; 46%); sweating (2%; 6% / 10%; 23%); chest pain (1%; 5% / 15%; 15%); peripheral edema (0%; 7% / 21%; 7%); reactions at the injection site of various types (52%; 78% / 89%; 85%); necrosis at the injection site (1%; 55% / 6%; 5%); flu-like syndrome (44%; 61% / 43%; 52%); fever (13%; 40% / 29%; 59%); pain (4%; 31% / 59%; 52%).

Possible adverse reactions (> 10% - very common;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare):

• immune system: rarely - anaphylactic reactions; very rarely - syndrome of increased capillary permeability in the presence of monoclonal gammopathy;
• blood and lymphatic system: often - anemia; infrequently - thrombocytopenia; rarely - bleeding;
• metabolism: often - weight gain / loss; infrequently - increased blood triglyceride levels; rarely - anorexia;
• endocrine system: often - hypothyroidism; rarely - hyperthyroidism, thyroid disease;
• cardiovascular system: often - tachycardia; infrequently - hypertension; rarely - lowering blood pressure, cardiomyopathy;
• nervous system: infrequently - convulsions;
• digestive system: rarely - pancreatitis;
• reproductive system: often - menorrhagia;
• musculoskeletal system: very often - arthralgia;
• hepatobiliary system: often - increased blood bilirubin levels; infrequently - hepatitis, increased levels of gamma-glutamyl transpeptidase; rarely - liver failure, liver disorders (including hepatitis);
• skin and subcutaneous fat: often - itching, urticaria, alopecia; infrequently - discoloration of the skin;
• respiratory system: infrequently - bronchospasm;
• psyche: often - confused consciousness; infrequently - suicidal attempts, emotional lability.

Overdose

IFN-β-1b in adult patients with malignant tumors, when administered intravenously at doses up to 176 million IU three times a week, did not lead to the development of serious adverse events.

special instructions

The use of cytokines in patients with monoclonal gammopathy in some cases was accompanied by the emergence of a syndrome of systemic increase in capillary permeability in combination with shock-like symptoms and death.

Against the background of the use of Interferon beta-1b, in rare cases, the development of pancreatitis was noted, most often associated with the presence of hypertriglyceridemia.

Patients should be informed that suicidal thoughts and depression can be a side effect of IFN-β-1b. If they appear, you should immediately consult a doctor.

When prescribing Interferon beta-1b, patients with a history of depressive disorders and suicidal thoughts should be careful (despite the absence of a reliably confirmed relationship between drug therapy and the development of these disorders). In case of occurrence of such phenomena during the period of use of Interferon beta-1b, the question of discontinuation of the drug should be considered.

Against the background of thyroid dysfunction, it is recommended to regularly check its condition (control of thyroid-stimulating hormone, thyroid hormones), and in other cases - according to clinical indications.

In addition to standard laboratory tests, which are prescribed in the management of patients with MS, a detailed blood test (including determination of the number of platelets, leukocyte count) and a biochemical blood test should be performed before the use of Interferon beta-1b, and also regularly during the period of therapy. and monitor liver function (including alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase activity).

In the case of managing patients with anemia, leukopenia, thrombocytopenia (individually or in combination), it may be necessary to conduct more careful monitoring of a detailed blood test, including the determination of the number of erythrocytes, platelets, leukocytes and leukocyte formula.

According to the conducted clinical studies, against the background of IFN-β-1b therapy, an asymptomatic increase in the activity of hepatic transaminases is often observed, which is most often of a transient unexpressed character. As with therapy with other interferons-β, with the use of Interferon beta-1b, severe liver damage (including liver failure) is rare. The most severe cases were observed in patients who were exposed to hepatotoxic substances / drugs, as well as in some concomitant diseases (including alcoholism, malignant neoplasms with metastasis, sepsis, severe infections).

When using Interferon beta-1b, monitoring of hepatic function (including assessment of the clinical picture) is required. With an increase in the serum activity of transaminases in the blood, careful observation and examination is required. In cases of a significant increase in these indicators or when signs of liver damage (in particular jaundice) appear, the drug is canceled. Resumption of therapy, under the supervision of hepatic function, is possible in the absence of clinical signs of liver dysfunction or after the activity of liver enzymes is resumed.

Patients with heart disease (coronary heart disease, arrhythmias, heart failure) are prescribed Interferon beta-1b with caution under monitoring of the function of the cardiovascular system, especially at the beginning of therapy.

There is no evidence in favor of a direct cardiotoxic effect of IFN-β-1b, while the influenza-like syndrome associated with the use of the drug can be a significant stress factor for patients with existing significant cardiovascular disease. During post-marketing observation, in very rare cases, a deterioration in the state of the cardiovascular system was recorded in patients with an existing significant disease, which, in terms of development time, was associated with the initiation of IFN-β-1b use.

There are rare reports of the appearance of cardiomyopathy against the background of the use of Interferon beta-1b. If there is a suspicion of a connection between this condition and therapy, the drug is canceled.

During the period of treatment with IFN-β-1b, serious allergic reactions may develop (rarely, but in a severe and acute form, disorders such as bronchospasm, urticaria and anaphylaxis may occur). There is also information about cases of necrosis at the injection site of Interferon beta-1b. It can cover large areas and spread to muscle fascia as well as adipose tissue, leading to scarring. Some patients may require the removal of dead areas or, more rarely, a skin graft. In this case, the healing process can last up to 6 months.

If there are signs of damage to the integrity of the skin (including leakage from the injection site), the patient should see a doctor before continuing with the injection.

If multiple foci of necrosis are detected, Interferon beta-1b is canceled until the damaged areas are completely healed. In the presence of one non-extensive focus, therapy can be continued, since there is evidence of the healing of the necrotic area at the injection site with the use of IFN-β-1b. To reduce the likelihood of developing this disorder, it is recommended to give injections of Interferon beta-1b with strict adherence to the rules of asepsis, each time injecting the solution into a new place and strictly subcutaneously.

Periodically, especially when local reactions appear, the correctness of performing self-injections should be monitored.

As in the case of treatment with any other drugs with a protein content, when using Interferon beta-1b, there is a possibility of antibody formation. In some controlled clinical trials, serum analysis was performed every 3 months to detect the formation of antibodies to IFN-β-1b. It was shown that neutralizing antibodies to IFN-β-1b occurred in 23–41% of patients, which was confirmed by at least two subsequent positive laboratory test results. In subsequent laboratory studies, 43–55% of these patients showed a stable absence of antibodies to IFN-β-1b.

In studies involving patients with CIS, suggesting MS, neutralizing activity, measured once every six months during the respective visits, was observed in 16.5–25.2% of patients receiving IFN-β-1b.

The development of neutralizing activity during the two-year study period was not associated with a decrease in clinical efficacy.

It has not been proven that the presence of neutralizing antibodies has any effect on clinical results. The relationship between the appearance of any side effects and the development of neutralizing activity has not been established.

The decision to continue therapy or discontinue therapy should be based not on the status of neutralizing activity, but on the indicators of the clinical activity of the disease.

Influence on the ability to drive vehicles and complex mechanisms

When driving vehicles during therapy, it is necessary to take into account the likelihood of side effects from the central nervous system.

Application during pregnancy and lactation

Interferon beta-1b is not prescribed during pregnancy / lactation.

Whether IFN-β-1b can cause fetal damage when treating pregnant women or affect human reproductive function is unknown.

In controlled clinical trials, spontaneous abortions have been reported in patients with MS. In studies in rhesus monkeys, human IFN-β-1b was embryotoxic and, when used at higher doses, led to an increase in abortion rates.

During the period of therapy, women of reproductive age must use adequate methods of contraception. When planning / getting pregnant, a woman should take the potential risk into account. She is advised to stop using Interferon beta-1b.

There is no evidence to support or deny that IFN-β-1b is excreted in milk during lactation, so the potential risk of serious adverse reactions to IFN-β-1b in breastfed infants should be considered.

Pediatric use

No formal clinical and pharmacokinetic studies have been conducted in the pediatric and adolescent population. Based on the limited published data, it can be assumed that the safety profile of IFN-β-1b at a dose of 8 million IU, administered every other day, in a group of patients 12-16 years old, compared with therapy in adults, can be assumed. There are no data on the use of Interferon beta-1b in patients under 12 years of age.

Due to the limited (lack) of information on the safety of the use of IFN-β-1b in pediatric patients and unproven efficacy, Interferon beta-1b is not prescribed for patients under 18 years of age.

With impaired renal function

Caution is required when prescribing Interferon beta-1b in patients with severe renal impairment.

For violations of liver function

Interferon beta-1b is contraindicated for patients with liver disease in the stage of decompensation.

Drug interactions

Special studies aimed at studying the interaction of IFN-β-1b with other drugs / substances have not been conducted.

The effect of using Interferon beta-1b every other day at a dose of 8 million IU on drug metabolism in MS patients is unknown. ACTH (adrenocorticotropic hormone) and glucocorticosteroids prescribed for up to 28 days in the treatment of exacerbations are well tolerated against the background of therapy with Interferon beta-1b. The use of IFN-β-1b in combination with other immunomodulators (except ACTH or glucocorticosteroids) has not been studied.

Interferons reduce the activity of microsomal liver enzymes of the cytochrome P _{450 system} in animals and humans.

When prescribing IFN-β-1b in combination with drugs that have a narrow therapeutic index, the clearance of which significantly depends on the activity of these enzymes (including antidepressants, antiepileptic drugs), care must be taken. Also, medical supervision is required when used simultaneously with any drugs / substances that affect the hematopoietic system.

Studies that determine the compatibility of IFN-β-1b and drugs with antiepileptic action have not been conducted.

Analogs

Interferon beta-1b analogs are Betaferon, Extavia, Ronbetal, Infibeta.

Terms and conditions of storage

Store at 2-8 ° C. Keep out of the reach of children.

Shelf life is 2 years.

Within the specified shelf life, it is allowed to store an unopened vial / syringe at a temperature not exceeding 25 ° C for one month.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews of Interferon beta-1b

Reviews of Interferon beta-1b from patients indicate its effectiveness. However, many point to the development of pronounced side effects, doctors and patients note that among analogues, it has the worst tolerance. The main advantage is that the drug can be obtained free of charge after confirming the diagnosis of MS.

Price for Interferon beta-1b in pharmacies

The approximate price for Interferon beta-1b (5 syringes of 8 million IU / 0.5 ml) is 7,000-15,950 rubles.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!