Multiple sclerosis is a severe neurological disease characterized by increasing damage to the central nervous system. In this case, the patient develops neurological and mental symptoms (see). Until recently, there was no effective treatment for this disease. However, the success of the use of interferon in multiple sclerosis allows patients to hope for an improved quality of life and a reduction in the symptoms of the disease.
General description and effect of the drug
One of the most popular interferons 1b for multiple sclerosis is Infibeta. These drugs are available in powder form complete with water for injection. The medication is mixed immediately before use.
Beta interferons 1b have both antiviral and immunomodulatory activities. However, in the case of multiple sclerosis, the overall mechanism of action of the drug in patients is still unclear. Apparently, the active substance of Infibet and other drugs interacts with receptors on immune cells and suppresses the immune response.
This effect leads to a decrease in the intensity of existing symptoms, allows partial elimination of glucocorticoids (an immunosuppressive drug widely used in multiple sclerosis) and reduces the overall number of hospitalizations for a particular patient.
At the same time, beta interferons help with various types of multiple sclerosis, allowing one to cope with exacerbations of the disease and thereby increasing the quality and standard of life of patients.
Use of drugs
The effect of interferon beta 1b in multiple sclerosis is observed in the following cases:
- The patient was diagnosed with a clinically isolated syndrome. This condition is characterized by one period of demyelination of nerve fibers in the absence of other causes. However, such patients may not take intravenous glucocorticosteroids, since interferons can prevent the progression of the disease.
- Multiple sclerosis with relapses. In this case, beta interferons are used to reduce the frequency of exacerbations and their severity, including in outpatient care.
- Multiple sclerosis with secondary progression, characterized by repeated exacerbations and remissions. Interferons can slow down the development of the disease, prolonging the life of patients.
In addition to the indications for use, there are a number of contraindications:
- hypersensitivity to the active substance or allergic reactions when using the drug in the past;
- pregnant or breastfeeding women;
- the patient's age is less than 18 years;
- severe;
- acute or chronic liver failure.
If the patient has coronary heart disease, convulsive syndromes, or liver diseases, the drug must be used with extreme caution, with constant medical supervision.
Use of interferon beta
The use of this group of drugs should begin under strict medical supervision, due to the frequent development of side effects. The recommended dosage is 8 million IU of the active substance with subcutaneous administration. It is advisable to start treatment with a lower dose, gradually increasing it to the specified dose. This allows you to prevent unwanted drug reactions from the patient’s body.
The duration of therapy is unknown. As a rule, patients are on such therapy for three to five years. In some cases, it is abandoned, but most often treatment continues due to possible relapses of the disease without drug support.
When using the drug at home, it is necessary to undergo a short training in a medical institution, since the administration of the drug has its own nuances associated with preparation for the administration of interferon 1b.
Side effects
The use of beta interferons 1b may cause the patient to experience side effects of this therapy:
- Influenza-like syndrome, manifested by symptoms of influenza without infection by its causative agent.
- Depressive states or mood lability.
- Decrease in the number of leukocytes in peripheral blood.
- There may be redness, swelling and soreness at the injection site.
- If the injection technique is not followed, subcutaneous necrosis and depletion of subcutaneous fatty tissue may develop.
- Allergic reactions such as urticaria, Quincke's edema.
If any side effect occurs, you must stop using interferon beta and seek medical help (see). The attending physician will adjust the dose and select its optimal value. No cases of drug overdose have been recorded.
Special instructions
The use of beta interferons 1b together with other drugs (see) does not affect their absorption, distribution in the body and the effect they have. In this regard, it is possible to use this group of medications in all patients. However, beta interferons reduce the ability of liver cells to neutralize toxic and medicinal substances, which must be taken into account when prescribing antidepressants and anticonvulsants with interferon.
Interferon beta 1b is a unique drug for the effective treatment of multiple sclerosis. Despite the unknown mechanism of action, the drug can reduce the frequency of disease relapses and reduce the number of hospitalizations of patients, which leads to an increase in their quality of life and improves the long-term prognosis of the disease. It is important to remember that the use of beta interferons must be under strict medical supervision.
Interferon. A drug used for multiple sclerosis
Active ingredient
Recombinant interferon beta-1b (interferon beta-1b)
Release form, composition and packaging
Solution for subcutaneous administration
Excipients: sodium acetate trihydrate - 0.408 mg, glacial acetic acid - up to pH 4.0, dextran 50-70 thousand - 15 mg, polysorbate 80 - 0.04 mg, - 50 mg, disodium edetate dihydrate - 0.0555 mg, water d/i - up to 1 ml.
0.5 ml - syringes (1) - contour cell packaging (1) (complete with alcohol wipes No. 1) - cardboard packs.
0.5 ml - syringes (1) - contour cell packaging (5) (complete with alcohol wipes No. 5) - cardboard packs.
0.5 ml - syringes (1) - contour cell packaging (15) (complete with alcohol wipes No. 15) - cardboard packs.
Solution for subcutaneous administration transparent, colorless or yellowish.
Excipients: sodium acetate trihydrate - 0.408 mg, glacial acetic acid - up to pH 4.0, dextran 50-70 thousand - 15 mg, polysorbate 80 - 0.04 mg, mannitol - 50 mg, disodium edetate dihydrate - 0.0555 mg, water d/i - up to 1 ml.
1 ml - bottles (5) - plastic contour packages (1) complete with disposable syringes (5), medical needles (5), alcohol wipes (10) - cardboard packs.
1 ml - bottles (5) - plastic contour packages (2) complete with disposable syringes (10), medical needles (10), alcohol wipes (20) - cardboard packs.
1 ml - bottles (5) - plastic contour packages (3) complete with disposable syringes (15), medical needles (15), alcohol wipes (30) - cardboard packs.
1 ml - bottles (5) - plastic contour packages (6) complete with disposable syringes (30), medical needles (30), alcohol wipes (60) - cardboard packs.
1 ml - bottles (5) - plastic contour packages (1) complete with disposable syringes (5), two types of medical injection needles (5), alcohol wipes (10) - cardboard packs.
1 ml - bottles (5) - plastic contour packages (2) complete with disposable syringes (10), two types of medical injection needles (10), alcohol wipes (20) - cardboard packs.
1 ml - bottles (5) - plastic contour packages (3) complete with disposable syringes (15), two types of medical injection needles (15), alcohol wipes (30) - cardboard packs.
1 ml - bottles (5) - plastic contour packages (6) complete with disposable syringes (30), two types of medical injection needles (30), alcohol wipes (60) - cardboard packs.
Pharmacological action
Recombinant interferon beta-1b is isolated from Escherichia coli cells, into the genome of which the human interferon beta gene is introduced, encoding the amino acid serine at position 17. Interferon beta-1b is a non-glycosylated protein with a molecular weight of 18,500 daltons, consisting of 165 amino acids.
Pharmacodynamics
Interferons are proteins in structure and belong to the cytokine family. The molecular weight of interferons ranges from 15,000 to 21,000 daltons. There are three main classes of interferons: alpha, beta and gamma. Interferons alpha, beta and gamma have a similar mechanism of action, but different biological effects. The activity of interferons is species-specific, and, therefore, it is possible to study their effects only in human cell cultures or in vivo in humans.
Special instructions
Pathology of the immune system
The use of cytokines in patients with monoclonal gammopathy was sometimes accompanied by the development of systemic increased capillary permeability syndrome with shock-like symptoms and death.
Gastrointestinal pathology
In rare cases, while using the drug interferon beta-1b, the development of pancreatitis has been observed, in most cases associated with the presence of hypertriglyceridemia.
Damage to the nervous system
Patients should be informed that side effects of interferon beta-1b may include depression and suicidal thoughts, and if they occur, they should immediately consult a doctor.
In two controlled clinical trials involving 1657 patients with secondary progressive MS, there were no significant differences in the incidence of depression and suicidal ideation when using interferon beta-1b or placebo. However, caution should be exercised when prescribing interferon beta-1b to patients with depressive disorders and a history of suicidal ideation.
If such phenomena occur during treatment, you should consider the advisability of discontinuing the drug interferon beta-1b.
Interferon beta-1b should be used with caution in patients with a history of seizures, incl. receiving therapy with antiepileptic drugs, especially if the seizures in these patients are not adequately controlled during therapy with antiepileptic drugs.
Changes in laboratory parameters
In patients with thyroid dysfunction, it is recommended that thyroid function (thyroid hormones, thyroid-stimulating hormone) be checked regularly, and otherwise as clinically indicated.
In addition to standard laboratory tests prescribed in the management of patients with multiple sclerosis, before starting therapy with interferon beta-1b. and also regularly during the treatment period, it is recommended to carry out a detailed blood test, including determination of the leukocyte formula, platelet count and biochemical blood test, as well as checking liver function (for example, AST, ALT and g-glutamyl transisferase (g-GT) activity).
When managing patients with anemia, thrombocytopenia, leukopenia (individually or in combination), more careful monitoring of a complete blood count may be required, including determination of the number of red blood cells, white blood cells, platelets and leukocyte formula.
Disorders of the liver and biliary tract
Clinical studies have shown that interferon beta-1b therapy can often lead to an asymptomatic increase in the activity of liver transaminases, which, in most cases, is mild and transient. As with other beta interferons, severe liver damage (including liver failure) is rare when using interferon beta-1b. The most severe cases have been observed in patients exposed to hepatotoxic drugs or substances, as well as in certain concomitant diseases (eg, metastatic malignancies, severe infections and sepsis, alcoholism).
When treating with interferon beta-1b, it is necessary to monitor liver function (including assessment of the clinical picture). Increased transaminase activity in the blood serum requires careful monitoring and examination. If there is a significant increase in transaminase activity in the blood serum or signs of liver damage (for example, jaundice) appear, the drug should be discontinued. In the absence of clinical signs of liver damage or after normalization of the activity of liver enzymes, it is possible to resume therapy with interferon beta-1b with monitoring of liver function.
Renal and urinary tract disorders
When prescribing the drug to patients with severe renal failure, caution should be exercised.
Diseases of the cardiovascular system
Interferon beta-1b should be used with caution in patients with heart disease, in particular with coronary artery disease, arrhythmias and heart failure. Cardiovascular function should be monitored, especially at the beginning of treatment.
There is no evidence in favor of a direct cardiotoxic effect of interferon beta-1b, however, the flu-like syndrome associated with the use of interferon beta-1b can become a significant stress factor for patients with existing significant pathology of the cardiovascular system. During post-marketing surveillance, deterioration of the cardiovascular system in patients with existing significant pathology of the cardiovascular system, which in terms of the time of occurrence was associated with the start of treatment with interferon beta-1b, very rarely occurred.
There are rare reports of the occurrence of cardiomyopathy during treatment with interferon beta-1b. With the development of cardiomyopathy. If this is suspected to be related to the use of the drug, treatment with interferon beta-1b should be discontinued.
General disorders and injection site disorders
Serious allergic reactions (rare but acute and severe, such as bronchospasm, anaphylaxis and urticaria) may occur. In patients receiving interferon beta-1b, cases of necrosis at the injection site have been observed (see section "Side effects"). Necrosis can be extensive and extend into muscle fascia as well as fatty tissue and, as a result, lead to scar formation. In some cases, removal of dead areas or, less commonly, skin grafting is necessary. The healing process can take up to 6 months.
If there are signs of damage to the integrity of the skin (for example, leakage of fluid from the injection site), the patient should consult a doctor before continuing with interferon beta-1b injections.
If multiple foci of necrosis appear, treatment with interferon beta-1b should be discontinued until the damaged areas are completely healed. In the presence of a single lesion, if the necrosis is not too extensive, the use of the drug interferon beta-1b can be continued, since in some patients the healing of the necrotic area at the injection site occurred during the use of the drug interferon beta-1b.
In order to reduce the risk of reaction and necrosis at the injection site, patients should be advised to:
Carry out injections strictly following the rules of asepsis;
Change the injection site each time;
Administer the drug strictly subcutaneously.
You should periodically monitor the correctness of self-injections, especially if local reactions occur.
Immunogenicity
As with any other protein-containing drug, there is the possibility of antibody formation when using interferon beta-1b. In a number of controlled clinical studies, serum samples were tested every 3 months to detect the formation of antibodies to interferon beta-1b. In these studies, it was shown that neutralizing antibodies to interferon beta-1b developed in 23-41% of patients, which was confirmed by at least two subsequent positive laboratory test results. In 43-55% of these patients, subsequent laboratory tests revealed a stable absence of antibodies to interferon beta-1b.
In a study of patients with clinically isolated syndrome suggestive of multiple sclerosis, neutralizing activity measured every 6 months was observed in 16.5% to 25.2% of patients receiving interferon beta-1b at appropriate visits. Neutralizing activity was detected at least once in 30% (75) of patients receiving interferon beta-1b; 23% (17) of them returned to negative antibody status before the study was completed.
During the two-year study period, development of neutralizing activity was not associated with a decrease in clinical efficacy (as measured by time to clinically definite multiple sclerosis).
The presence of neutralizing antibodies has not been shown to have any significant effect on clinical outcomes. The development of neutralizing activity was not associated with the occurrence of any adverse reactions.
The decision to continue or discontinue therapy should be based on clinical disease activity rather than neutralizing activity status.
Impact on the ability to drive vehicles and machinery
No special studies have been conducted. Adverse effects from the central nervous system may affect the ability to drive a car and operate machinery. In this regard, it is necessary to be careful when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions. If the described side effects occur, you should refrain from performing these activities.
Pregnancy and lactation
It is unknown whether interferon beta-1b can cause fetal harm when treated in pregnant women or affect human reproductive function. In controlled clinical studies, cases of spontaneous abortion have been reported in patients with multiple sclerosis. In studies in rhesus monkeys, human interferon beta-1b was embryotoxic and, at higher doses, caused an increase in abortion rates. Therefore, interferon beta-1b is contraindicated during pregnancy. Women of reproductive age should use adequate methods of contraception when treated with this drug. If pregnancy occurs during treatment with interferon beta-1b or pregnancy is planned, the woman should be informed of the potential risk and advised to discontinue treatment.
It is not known whether interferon beta-1b is excreted in breast milk. Given the potential for serious adverse reactions to interferon beta-1b in breastfed infants, breastfeeding should be discontinued or the drug should be discontinued.
Use in childhood
The use of the drug under the age of 18 is contraindicated (information on the effectiveness and safety of the use of interferon beta-1b in children is limited. The effectiveness of use in children has not been proven).
For liver dysfunction
The use of the drug is contraindicated for liver diseases in the stage of decompensation.
Conditions for dispensing from pharmacies
The drug is available with a prescription.
Storage conditions and periods
The drug should be stored out of the reach of children at a temperature of 2° to 8°C. Shelf life - 2 years. Within the established expiration date, it is permissible for the patient to store an unopened bottle/syringe for one month at a temperature not exceeding 25°C.
Do not use after the expiration date stated on the package.
INSTRUCTIONS for medical use GENFAXON
interferon beta-1a
Registration number: LSR-003037/10
Trade name: Genfaxon®/Genfaxon®
International nonproprietary or generic name: interferon beta-1a
Dosage form: solution for subcutaneous administration Composition: 1 syringe in 0.5 ml of solution contains 22 mcg (6 million IU) or 44 mcg (12 million IU) of interferon beta-1a and excipients: mannitol, human albumin, sodium acetate, acetic acid, water for injection. Description: transparent, colorless to slightly yellowish solution, free from foreign particles Pharmacotherapeutic group: cytokine ATC code: Pharmacological properties Genfaxon® (recombinant human interferon beta-1a) is a natural amino acid sequence of human interferon beta, obtained by genetic engineering methods using Chinese hamster ovary cell cultures. Interferon beta-1a has immunomodulatory, antiviral and antiproliferative properties. The mechanism of action of the drug interferon beta-1a in patients with multiple sclerosis has not been fully studied. It has been shown that the drug helps limit damage to the central nervous system that underlies the disease, reduces the frequency and severity of exacerbations in patients with relapsing-remitting multiple sclerosis. The effect of Genfaxon® has not been studied in primary progressive multiple sclerosis.
Pharmacokinetics
When administered subcutaneously, the concentration of interferon beta-1a in the blood serum is determined within 12-24 hours after injection. After a single injection of a dose of 60 mcg, the maximum concentration determined by immunological methods is 6-10 IU/ml 3 hours after administration. With 4 subcutaneous administration of the same dose every 48 hours, moderate accumulation of the drug occurs. After a single dose, intracellular and serum 2-5A synthetase activity and serum concentrations of beta2-microglobulin and neopterin (markers of biological response) increase within 24 hours and then decrease over 2 days. Interferon beta-1a is metabolized and eliminated by the liver and kidneys.
Indications for use
Relapsing-remitting multiple sclerosis.
Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without active disease.
Contraindications
- Hypersensitivity to natural or recombinant interferon beta-1a, human serum albumin or other components of the drug.
- Pregnancy and lactation (see "Use during pregnancy and lactation")
- Severe depressive disorders and/or suicidal thoughts.
- Epilepsy in the absence of effect from the use of appropriate therapy.
- Age up to 12 years (the effect of the drug on this age group has not been sufficiently studied).
With caution
History of depression, history of seizures, angina pectoris, heart failure, cardiac arrhythmias, severe renal or liver failure, severe myelosuppression; thyroid diseases.
Use during pregnancy and lactation
Pregnancy
Genfaxon® is not prescribed during pregnancy and lactation. Women of childbearing age should use effective methods of contraception. Considering the potential danger to the fetus, patients planning pregnancy or becoming pregnant 2 during treatment must inform their doctor about this to decide whether to continue (cancel) therapy.
Lactation
There are no data on the excretion of Genfaxon® into breast milk. Given the likelihood of serious adverse reactions in infants, a choice should be made between discontinuing Genfaxon® and stopping breastfeeding.
Directions for use and doses
Subcutaneously.
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.
During the first 2 weeks of starting therapy, Genfaxon® should be administered at a dose of 8.8 mcg (0.2 ml from a syringe containing 22 mcg or 0.1 ml from a syringe containing 44 mcg), during the 3rd and 4th week - at a dose of 22 mcg (0.5 ml from a syringe containing 22 mcg or 0.25 ml from a syringe containing 44 mcg). When prescribing the drug Genfaxon® at a dosage of 44 mcg, starting from the 5th week, a dose of 0.5 ml of 44 mcg is administered.
Adults and adolescents over 16 years of age: the maintenance dose of the drug is usually 44 mcg 3 times a week. At a dose of 22 mcg - 3 times a week, Genfaxon® is prescribed to those patients who, in the opinion of the attending physician, do not tolerate the high dose well enough.
Adolescents 12 to 16 years: 22 mcg 3 times per week.
For convenience, the syringe has corresponding divisions. The drug remaining in the syringe cannot be used for further use.
The decision on the duration of treatment should be made individually by the attending physician.
If you miss a dose, continue injections starting with the next one on the schedule. Do not give a double dose.
Side effect
Flu-like symptoms
Approximately 40% of patients during the first 6 months of therapy with Genfaxon® may experience a flu-like syndrome typical of interferons (headache, fever, chills, muscle and joint pain, nausea). These manifestations are usually moderate, observed more often at the beginning of treatment and decrease with continued treatment. The patient should be informed that if any of the listed symptoms are severe or persistent, he should inform the doctor. Your doctor may prescribe a pain reliever or change the dose temporarily.
Injection site reactions
Reactions at the injection site (redness, swelling, paleness of the skin, pain) are also possible; they are usually mild and reversible. In isolated cases, necrosis is observed at the injection site, which usually resolves on its own. In rare cases, infection of the injection site may occur. The skin in this area may become elastic, swollen, and painful.
Reactions from the digestive, nervous, cardiovascular and other body systems
Less common side effects associated with interferon beta-1a include diarrhea, loss of appetite, vomiting, sleep disturbance, dizziness, nervousness, rash, symptoms of vasodilation and palpitations, and menstrual irregularities/changes.
Hypersensitivity and allergic reactions
In exceptional cases, serious allergic reactions may occur. If immediately after the injection the patient experiences difficulty breathing, which may be accompanied by hives, a feeling of weakness or discomfort, he should immediately seek medical help.
Deviation of laboratory parameters
There may be deviations from normal laboratory parameters, manifested by leukopenia, lymphopenia, thrombocytopenia, increased activity of alanine aminotransferase (ALT), γ-glutamyltransferase and alkaline phosphatase. These changes are usually minor and reversible. Symptoms of liver disorders may occur, such as loss of appetite, nausea, vomiting, and jaundice.
Reactions from the endocrine system
Interferons can have an effect on thyroid function, both upward and downward. These changes may not be noticeable to the patient, but the doctor may order additional examination.
Depression
Patients with multiple sclerosis may develop depression. It is necessary to inform your doctor about any of the above side effects of the drug, including those that are not listed in these instructions. In case of severe adverse reactions or their persistence for a long time, at the discretion of the doctor, a temporary reduction in the dose of the drug or interruption of treatment is allowed. You should not stop treatment or change the dose without the advice of your doctor.
Overdose
No cases of overdose have yet been described. In case of overdose, the patient should be hospitalized for observation and symptomatic therapy if necessary.
Interaction with other drugs
Specially designed clinical studies to study the interaction of the drug Genfaxon® with other drugs have not been conducted.
However, it is known that in humans and animals interferons reduce the activity of cytochrome P450-dependent liver enzymes. Therefore, caution should be exercised when prescribing Genfaxon® concomitantly with drugs that have a narrow therapeutic index, the clearance of which is largely dependent on cytochrome P450, for example, with antiepileptic drugs and some antidepressants.
A systematic study of the interaction of Genfaxon® with glucocorticosteroids or adrenocorticotropic hormone (ACTH) has not been conducted. Data from clinical studies indicate the possibility of patients with multiple sclerosis receiving Genfaxon® and glucocorticosteroids or ACTH during exacerbations of the disease.
Special instructions
There are isolated reports of tissue necrosis at the injection site. To minimize the risk of developing necrosis, strict adherence to the rules of asepsis when performing injections and constant change of injection sites is necessary. If there is a violation of the integrity of the skin with fluid leakage at the injection site, you should consult a doctor before continuing to administer the drug. In case of multiple skin lesions, the drug should be discontinued until they heal. In case of a single lesion, it is possible to continue therapy with Genfaxon®, provided that the lesion is moderate.
Clinical trials have demonstrated an increase in the activity of liver transaminases, especially ALT. In the absence of symptoms, plasma ALT activity should be determined before starting Genfaxon® therapy and repeated after 1, 3 and 6 months and periodically while treatment is continued. It is necessary to reduce the dose of the drug if ALT activity exceeds 5 times the upper limit of normal, and gradually increase the dose after it normalizes. Caution should be exercised when prescribing interferon beta-1a to patients with a history of severe liver failure, signs of liver disease, signs of alcohol abuse, and ALT levels 2.5 times the upper limit of normal. Therapy should be discontinued if jaundice or other signs of dysfunction occur. liver.
Genfaxon®, like other beta interferons, can potentially cause serious liver problems, including acute liver failure. The mechanism of these conditions is unknown, and specific risk factors have not been identified.
In addition to laboratory tests, which are always carried out in patients with multiple sclerosis, during treatment with interferon beta-1a, it is recommended that every 1, 3 and 6 months a complete blood count with a leukocyte count and platelet count be performed, as well as a biochemical blood test, in particular , liver function tests.
Patients receiving Genfaxon® sometimes develop or worsen thyroid dysfunction. It is recommended to conduct a thyroid function test before starting treatment and, if abnormalities are detected, every 6-12 months.
Patients receiving beta interferons may develop neutralizing antibodies. Their clinical significance has not been established. If the patient does not respond well to therapy with Genfaxon® and antibodies are detected, the doctor should evaluate the advisability of continuing therapy.
Subcutaneous self-administration
Since Genfaxon® comes in the form of a pre-filled hypodermic syringe, you can safely use it at home, either on your own or with the help of family or friends. If possible, the first injection should be given under the supervision of a qualified healthcare professional.
Before using Genfaxon®, please read the following instructions carefully:
Wash your hands thoroughly with soap and water.
Select the injection site. Your doctor will advise you on possible injection sites (convenient sites are located in the upper thigh or lower abdomen). It is recommended to alternate injection sites, avoiding frequent injections into the same place.
Do not inject the drug into areas where you feel swelling, hard nodules, or pain; Tell your doctor or nurse about these areas.
Remove the syringe with Genfaxon® from the package. Clean the skin at the injection site with an alcohol wipe. Let the skin dry. If some of the alcohol remains on the skin, you may feel a burning sensation.
Gently squeeze the skin around the selected area to slightly lift it (to form a skin fold). With your wrist pressed against the skin near the area, insert the needle at a right angle into the skin with a quick, firm motion. Hold the syringe like a pencil or dart.
Inject the drug with slow and constant pressure in the dose (number of ml) prescribed by the doctor.
The drug remaining in the syringe cannot be used for further use.
Apply pressure to the injection site with a tampon. Remove the needle from the skin.
Gently massage the injection site with a dry cotton ball or gauze.
Dispose of the used syringe in a waste disposal area.
Impact on the ability to drive a car and use technical equipment
During the treatment period, you should refrain from driving a car or engaging in activities that require rapid psychomotor reactions.
Release form
Solution for subcutaneous administration 22 mcg (6 million IU) or 44 mcg (12 million IU).
0.5 ml (22 µg) or 0.5 ml (44 µg) in a colorless transparent glass syringe type I, with a stainless steel needle, closed with a butyl cap, placed in a paper-lined plastic container.
3 or 12 containers in a cardboard box with instructions for use.
Storage conditions
At a temperature of 2 to 8 ºС in a place protected from light. Do not freeze. Keep out of the reach of children.
Best before date
2 years. Do not use after the expiration date stated on the package.
Conditions for dispensing from pharmacies
According to the recipe.
Manufacturer:
Laboratory Tutor S.A.S.I.F.I.A., produced by MR Pharma S.A., Argentina
Laboratory Tuteur S.A.C.I.F.I.A., manufactured by MR Pharma S.A., Argentina.
Address: Av. Juan de Garay, 842/48, Buenos Aires, Argentina
Av. Juan de Garay, 842/48, Buenos Aires,Argentina
Consumer complaints are accepted at the address of the representative office of the company "Genfa Medica S.A." (Switzerland).
Clinically isolated syndrome (CIS) (a single clinical episode of demyelination suggestive of multiple sclerosis, subject to the exclusion of alternative diagnoses) with sufficient severity of the inflammatory process to warrant the use of intravenous corticosteroids to slow the progression to clinically definite multiple sclerosis (CDMS) in patients at high risk of developing KDRS. There is no generally accepted definition of high risk. According to the study, the high-risk group for developing CDRS includes patients with monofocal CIS (clinical manifestations of 1 lesion in the central nervous system) and >T2 lesions on MRI and/or lesions accumulating contrast agent. Patients with multifocal CIS (clinical manifestations of >1 lesion in the central nervous system) are at high risk of developing CDRS, regardless of the number of lesions on MRI. Relapsing-remitting multiple sclerosis - to reduce the frequency and severity of exacerbations of multiple sclerosis in patients who are able to walk without assistance, with a history of at least 2 exacerbations of the disease over the past 2 years, followed by complete or incomplete recovery of the neurological deficit. Secondary progressive multiple sclerosis with an active course of the disease, characterized by exacerbations or marked deterioration of neurological functions over the past two years - to reduce the frequency and severity of clinical exacerbations of the disease, as well as to slow the rate of progression of the disease. Use strictly as prescribed by your doctor.
Contraindications Interferon beta-1b injection solution 8 million IU/0.5 ml
Hypersensitivity to recombinant interferon-beta or other components of the drug. Liver diseases in the stage of decompensation. History of severe depressive illness and/or suicidal ideation. Epilepsy (not adequately controlled). Pregnancy. Children under 18 years of age (Information on the effectiveness and safety of the use of interferon beta-lb in children is limited. The effectiveness of use in children has not been proven). With caution. Interferon beta-lb should be used with caution in patients with a history of depression or seizures or in patients receiving anticonvulsants. The drug should be used with caution in patients with heart failure stage III-IV according to the NYHA classification and in patients with cardiomyopathy. Caution must be exercised when treating patients with bone marrow dysfunction, anemia, or thrombocytopenia with interferon beta-1b. Use during pregnancy and breastfeeding. It is unknown whether interferon beta-1b can cause fetal harm when treated in pregnant women or affect human reproductive function. In controlled clinical studies, cases of spontaneous abortion have been reported in patients with multiple sclerosis. In studies in rhesus monkeys, human interferon beta-1b was embryotoxic and, at higher doses, caused an increase in abortion rates. Therefore, interferon beta-lb is contraindicated during pregnancy. Women of reproductive age should use adequate methods of contraception when treated with this drug. If pregnancy occurs during treatment with interferon beta-lb or pregnancy is planned, the woman should be informed of the potential risk and advised to discontinue treatment. It is not known whether interferon beta-lb is excreted in breast milk. Given the potential for serious adverse reactions to interferon beta-1b in breastfed infants, breastfeeding should be discontinued or the drug should be discontinued.
Method of administration and dosage Interferon beta-1b injection solution 8 million IU/0.5 ml
Treatment with interferon beta-1b should be initiated under the supervision of a physician experienced in the treatment of multiple sclerosis. Adults: The recommended dose of interferon beta-1b is 8 million IU, administered subcutaneously every other day. Children: No formal clinical and pharmacokinetic studies have been conducted in pediatric and adolescent populations. Limited published data indicate a comparable safety profile for interferon beta-1b at a dose of 8 million IU subcutaneously every other day in patients 12 to 16 years of age compared with the adult population. There is no information on the use of interferon beta-1b in persons under 12 years of age; the drug cannot be used in this group of patients. At the beginning of treatment, it is usually recommended to titrate the dose. Treatment should begin with the administration of 2 million IU subcutaneously every other day, gradually increasing the dose to 8 million IU, also administered every other day. The dose titration period may vary depending on individual tolerability of the drug. The titration period may be extended if adverse reactions develop. The duration of treatment has not been established at this time. There are results of clinical studies in which the duration of treatment in patients with relapsing-remitting and secondary progressive multiple sclerosis reached 5 and 3 years, respectively. In the group of patients with relapsing multiple sclerosis, high effectiveness is shown during the first two years. A further three-year follow-up showed continued effectiveness throughout the entire treatment period. In patients with clinically isolated syndrome, there was a significant delay in transformation to definite multiple sclerosis over more than five years. Interferon beta-1b therapy is not indicated for patients with relapsing-remitting multiple sclerosis who have had fewer than two exacerbations in the past 2 years, or for patients with secondary progressive multiple sclerosis who have not progressed in the past two years. For patients who do not experience disease stabilization (e.g., persistent disease progression on the EDSS scale within 6 months or the need for three or more courses of corticotropin or glucocorticosteroid therapy) within 1 year, treatment with interferon beta-1b is recommended to be discontinued. Recommendations for use for patients: It is advisable to do injections in the evening before bedtime. Before administering the drug, wash your hands thoroughly with soap and water. Take one blister pack with a filled syringe/vial from a cardboard box, which should be stored in the refrigerator, and keep it at room temperature for several minutes so that the temperature of the drug is equal to the ambient temperature. If condensation appears on the surface of the syringe/vial, wait a few more minutes until the condensation evaporates. Before use, you should inspect the solution in the syringe/vial. If there are suspended particles or a change in the color of the solution or damage to the syringe/vial, the drug should not be used. If foam appears, which happens when the syringe/vial is shaken or shaken vigorously, wait until the foam settles. Select the area of the body to be injected. Interferon beta-lb is injected into the subcutaneous fat (the fatty layer between the skin and muscle tissue), so use areas with loose fiber away from areas of stretching of the skin, nerves, joints and blood vessels: thighs (front surface of the thighs except the groin and knee); abdomen (except for the midline and umbilical region); outer surface of the shoulders; buttocks (upper outer quadrant). Do not inject into painful spots, discolored or red areas of the skin, or areas with lumps or lumps. Choose a new injection site each time, this way you can reduce discomfort and pain in the area of skin at the injection site. There are many injection points within each injection area. Constantly change injection points within a specific area. Preparing for injection. If the patient is using interferon beta-1 b syringes: Place the prepared syringe in the hand you are writing with. Remove the protective cap from the needle. If the patient is using interferon beta-1 b vials. Take a bottle of interferon beta-1b and carefully place the bottle on a flat surface (table). Use tweezers (or another convenient device) to remove the cap of the bottle. Disinfect the top of the bottle. Take a sterile syringe in the hand you are writing with, remove the protective cap from the needle and, without violating sterility, carefully insert the needle through the rubber cap of the bottle so that the end of the needle (3-4 mm) is visible through the glass of the bottle. Turn the bottle over so its neck is facing down. The amount of interferon beta-lb solution that must be administered during the injection depends on the dose recommended by the doctor. Do not store any remaining drug left in the syringe/vial for reuse. If a patient is using interferon beta-lb syringes, depending on the dose your doctor has prescribed, you may need to remove excess drug solution from the syringe. If necessary, slowly and gently press the syringe plunger to remove excess solution. Press down on the plunger until the plunger reaches the desired mark on the syringe label. If the patient uses the drug interferon beta-1 b in vials. Slowly pull the plunger back and draw the required volume of solution into the syringe from the bottle, corresponding to the dose of interferon beta-1b prescribed by your doctor. Then, without compromising sterility, remove the vial from the needle, holding the needle at the base (make sure that the needle does not come off the syringe). Turning the syringe upside down with the needle and moving the piston, remove any air bubbles by gently tapping the syringe and pressing on the piston. Replace the needle on the syringe and remove the cap. Pre-disinfect the area of skin where interferon beta-1b will be injected. When the skin is dry, lightly gather the skin into a fold with your thumb and forefinger.) With the syringe perpendicular to the injection site, insert the needle into the skin at a 90° angle. The recommended depth of needle insertion is 6 mm from the skin surface. The depth is selected depending on the body type and the thickness of the subcutaneous fat. Inject the drug by evenly pressing the syringe plunger down to the end (until it is completely empty). Dispose of used syringes/vials only in a specially designated place, out of the reach of children. If you forget to inject interferon beta-1b, give the injection as soon as you remember. The next injection is given after 48 hours. A double dose of the drug is not allowed. Do not stop using Interferon beta-1b without consulting your doctor.
Latin name
INTERFERON BETA-1B
Active ingredient
Release form
solution for subcutaneous administration
Owner/Registrar
BIOCAD, JSC
International Classification of Diseases (ICD-10)
G35 Multiple sclerosisPharmacological group
Interferon. A drug used for multiple sclerosis
Clinically isolated syndrome (CIS) (a single clinical episode of demyelination suggestive of multiple sclerosis, subject to the exclusion of alternative diagnoses) with sufficient severity of the inflammatory process to prescribe intravenous corticosteroids to slow the transition to CDRS in patients at high risk of developing CDRS.
There is no generally accepted definition of high risk. According to the study, patients with monofocal CIS (clinical manifestations of 1 lesion in the central nervous system) and ≥T2 lesions on MRI and/or lesions accumulating contrast agent are considered to be at high risk of developing CDRS. Patients with multifocal CIS (clinical manifestations of >1 lesion in the central nervous system) are at high risk of developing CDRS, regardless of the number of lesions on MRI;
Relapsing-remitting multiple sclerosis - to reduce the frequency and severity of exacerbations of multiple sclerosis in patients who are able to walk without assistance, with a history of at least 2 exacerbations of the disease over the past 2 years, followed by complete or incomplete recovery of the neurological deficit;
Secondary progressive multiple sclerosis with an active course of the disease, characterized by exacerbations or marked deterioration of neurological functions over the past 2 years - to reduce the frequency and severity of clinical exacerbations of the disease, as well as to slow down the rate of progression of the disease.
Use strictly as prescribed by your doctor.
Hypersensitivity to recombinant ipterferon-beta or other components of the drug;
Liver diseases in the stage of decompensation;
History of severe depressive illness and/or suicidal thoughts;
Epilepsy (not adequately controlled);
Pregnancy;
Children under 18 years of age (information on the effectiveness and safety of the use of interferon beta-1b in children is limited. The effectiveness of use in children has not been proven).
Interferon beta-1b should be used with caution in patients with a history of depression or seizures, or in patients receiving anticonvulsants. The drug should be used with caution in patients with heart failure stage III-IV according to the NYHA classification and in patients with cardiomyopathy. Caution must be exercised when treating patients with bone marrow dysfunction, anemia or thrombocytopenia with interferon beta-lb.
Adverse reactions often occur in the initial stages of treatment, however, during subsequent treatment their frequency and intensity decrease. The most common reactions are flu-like symptoms (fever, chills, joint pain, malaise, sweating, headache or muscle pain) and injection site reactions, which are largely due to the pharmacological properties of interferon beta-1b. Reactions at the injection site are common after the use of interferon beta-1b: redness, swelling, discoloration, inflammation, pain, hypersensitivity, necrosis, and unspecific reactions. To improve tolerability, it is recommended to begin therapy with interferon beta-1b with titration (see dose titration scheme in the "Dosage Regimen" section); flu-like syndrome can also be corrected by prescribing NSAIDs. The incidence of injection site reactions may be reduced with the use of an auto-injector.
Below are lists of adverse events identified in clinical studies (Table 3. Adverse events and laboratory abnormalities) and according to post-registration data on the use of interferon bega-1b (Table 4, frequencies calculated based on pooled data from clinical studies (very common (> 10%), often (<10% - >1%), uncommon (<1% - >0.1%), rarely (<0.1% - >0.01%) and very rarely (<0.01%)). Опыт применения интерферона бета-1b у пациентов с рассеянным склерозом ограничен, нежелательные реакции, возникающие очень редко, могут быть еще не выявлены.
Table 3. Adverse events and laboratory abnormalities with an incidence >10% compared with the incidence of the corresponding event on placebo; significant drug-related side effects<10%.
| Organ system Adverse events and laboratory abnormalities and laboratory abnormalities |
Clinically isolated syndrome (BENEFIT) |
Secondary progressive multiple sclerosis (European study) |
Secondary progressive multiple sclerosis (North American study) |
Relapsing multiple sclerosis |
| Interferon beta-1b 250 mcg (placebo) n=292 (n=176) |
Interferon beta-1b 250 mcg (placebo) n=360 (n=358) |
Interferon beta-1b 250 mcg (placebo) n=317 (n=308) |
Interferon beta-1b 250 mcg (placebo) n=124 (n=123) |
|
| Infections | ||||
| Infections | 6% (3%) | 13% (11%) | 11% (10%) | 14% (13%) |
| Abscess | 0% (1%) | 4% (2%) | 4% (5%) | 1% (6%) |
| Lymphopenia (<1500/мм 3) 1,2,4 | 79% (45%) | 53% (28%) | 88% (68%) | 82% (67%) |
| Neutropenia (<1500/мм 3) 1,2,3,4 | 11% (2%) | 18% (5%) | 4% (10%) | 18% (5%) |
| Leukopenia (<3500/мм 3) 1,2,3,4 | 11% (2%) | 13% (4%) | 13% (4%) | 16% (4%) |
| Lymphadenopathy | 1% (1%) | 3% (1%) | 11% (5%) | 14% (11%) |
| Metabolic disorders | ||||
| Hypoglycemia (<55 мг/дл) | 3% (5%) | 27% (27%) | 5% (3%) | 15% (13%) |
| Mental disorders | ||||
| Depression | 10% (11%) | 24% (31%) | 44% (41%) | 25% (24%) |
| Anxiety | 3% (5%) | 6% (5%) | 10% (11%) | 15% (13%) |
| Nervous system | ||||
| Headache 2 | 27% (17%) | 47% (41%) | 55% (46%) | 84% (77%) |
| Dizziness | 3% (4%) | 14% (14%) | 28% (26%) | 35% (28%) |
| Insomnia | 8% (5%) | 12% (8%) | 26% (25%) | 31% (33%) |
| Migraine | 2% (2%) | 4% (3%) | 5% (4%) | 12% (7%) |
| Paresthesia | 16% (17%) | 35% (39%) | 40% (43%) | 19% (21%) |
| Organs of vision | ||||
| Conjunctivitis | 1% (1%) | 2% (3%) | 6% (6%) | 12% (10%) |
| Visual impairment 2 | 3% (1%) | 11% (15%) | 11% (11%) | 7% (4%) |
| Hearing organs | ||||
| Ear pain | 0% (1%) | <1% (1%) | 6% (8%) | 16% (15%) |
| Heart diseases | ||||
| Heartbeat sensation 3 | 1% (1%) | 2% (3%) | 5% (2%) | 8% (2%) |
| Vascular system | ||||
| Vasodilation | 0% (0%) | 6% (4%) | 13% (8%) | 18% (17%) |
| Arterial hypertension 4 | 2% (0%) | 4% (2%) | 9% (8%) | 7% (2%) |
| Respiratory organs | ||||
| Upper respiratory tract infections | 18% (19%) | 3% (2%) | ||
| Sinusitis | 4% (6%) | 6% (6%) | 16% (18%) | 36% (26%) |
| Cough | 2% (2%) | 5% (10%) | 11% (15%) | 31% (23%) |
| Shortness of breath 3 | 0% (0%) | 3% (2%) | 8% (6%) | 8% (2%) |
| Gastrointestinal tract | ||||
| Diarrhea | 4% (2%) | 7% (10%) | 21% (19%) | 35% (29%) |
| Constipation | 1% (1%) | 12% (12%) | 22% (24%) | 24% (18%) |
| Nausea | 3% (4%) | 13% (13%) | 32% (30%) | 48% (49%) |
| Vomit 2 | 5% (1%) | 4% (6%) | 10% (12%) | 21% (19%) |
| Abdominal pain 4 | 5% (3%) | 11% (6%) | 18% (16%) | 32% (24%) |
| Liver and yellow tract | ||||
| Increased ALT (> | 18% (5%) | 14% (5%) | 4% (2%) | 19% (6%) |
| Increased AST (>5 times compared to baseline) 1,2,3,4 | 6% (1%) | 4% (1%) | 2% (1%) | 4% (0%) |
| Skin and subcutaneous fat tissue | ||||
| Skin reactions | 1% (0%) | 4% (4%) | 19% (17%) | 6% (8%) |
| Rash 2.4 | 11% (3%) | 20% (12%) | 26% (20%) | 27% (32%) |
| Musculoskeletal system disorders | ||||
| Hypertonicity 4 | 2% (1%) | 41% (31%) | 57% (57%) | 26% (24%) |
| Myalgia 3.4 | 8% (8%) | 23% (9%) | 19% (29%) | 44% (28%) |
| Myasthenia gravis | 2% (2%) | 39% (40%) | 57% (60%) | 13% (10%) |
| Back pain | 10% (7%) | 24% (26%) | 31% (32%) | 36% (37%) |
| Pain in limbs | 6% (3%) | 14% (12%) | 0% (0%) | |
| Urinary system | ||||
| Urinary retention | 1% (1%) | 4% (6%) | 15% (13%) | |
| Proteinuria (>1) 1 | 25% (26%) | 14% (11%) | 5% (5%) | 5% (3%) |
| Frequent urination | 1% (1%) | 6% (5%) | 12% (11%) | 3% (5%) |
| Urinary incontinence | 1% (1%) | 8% (15%) | 20% (19%) | 2% (1%) |
| Imperative urges | 1% (1%) | 8% (7%) | 21% (17%) | 4% (2%) |
| Reproductive system | ||||
| Dysmenorrhea | 2% (0%) | <1% (1%) | 6% (5%) | 18% (11%) |
| Menstrual irregularities 3 | 1% (2%) | 9% (13%) | 10% (8%) | 17% (8%) |
| Metrorargy | 2% (0%) | 12% (6%) | 10% (10%) | 15% (8%) |
| Impotence | 1% (0%) | 7% (4%) | 10% (11%) | 2% (1%) |
| General reactions and reactions at the injection site | ||||
| Reactions at the injection site (various types) 2,3,4,5 | 52% (11%) | 78% (20%) | 89% (37%) | 85% (37%) |
| Necrosis at the injection site 3 | 1% (0%) | 5% (0%) | 6% (0%) | 5% (0%) |
| Flu-like syndrome 3.4 | 44% (18%) | 61% (40%) | 43% (33%) | 52% (48%) |
| Fever 2,3,4 | 13% (5%) | 40% (13%) | 29% (24%) | 59% (41%) |
| Pain | 4% (4%) | 31% (25%) | 59% (59%) | 52% (48%) |
| Chest pain 4 | 1% (0%) | 5% (4%) | 15% (8%) | 15% (15%) |
| Peripheral edema | 0% (0%) | 7% (7%) | 21% (18%) | 7% (8%) |
| Asthenia 3 | 22% (17%) | 63% (58%) | 64% (59%) | 49% (35%) |
| Chills 2,3,4 | 5% (1%) | 23% (7%) | 22% (12%) | 46% (19%) |
| Sweating 3 | 2% (1%) | 6% (6%) | 10% (10%) | 23% (11%) |
| Malaise 3 | 0% (1%) | 8% (5%) | 6% (2%) | 15% (3%) |
1 Deviation of laboratory value
2 Significantly associated with interferon beta-1b therapy in patients with CIS, p<0.05
3 Significantly associated with interferon-1b therapy in patients with RRMS. r<0.05
4 Significantly associated with interferon beta-1b therapy in patients with SPMS, p<0.05
5 Injection site reactions may include any adverse event occurring at the injection site, such as: injection site bleeding, hypersensitivity, injection site inflammation, injection site swelling, injection site necrosis, injection site pain. swelling at the injection site, and atrophy at the injection site; "Growth-like syndrome" refers to a combination of at least two of the following symptoms: fever, chills, myalgia, malaise, sweating.
Table 4. (Frequency is indicated in accordance with the given classification: very often (> 10%). often (<10% - >1%). infrequently (<1% - >0.1%), rarely (<0.1% - >0.01%) and very rarely (<0.01%)). Опыт применения интерферонов бета-1b у пациентов с рассеянным склерозом ограничен, нежелательные реакции, возникающие очень редко, могут быть еще не выявлены (данные основаны на зарегистрированных спонтанных сообщениях).
| Organ system class | Very common ≥1/10 | Often ≥1/100 to<1/10 | Uncommon ≥1/1000 to<1/100 | Rarely ≥1/10000 to<1/1000 | Very rarely<0.01% |
| Blood and lymphatic system | Anemia | Thrombocytopenia | Bleeding** | ||
| Immune system disorders | Anaphylactic reactions | Capillary hyperpermeability syndrome in the presence of monoclonal gammopathy | |||
| Endocrine disorders | Hypothyroidism | Hyperthyroidism Pathology of the thyroid gland |
|||
| Metabolic disorders | Weight gain Weight loss |
Increased blood triglyceride levels | Anorexia | ||
| Mental disorders | Confusion | Emotional lability Suicide attempts |
|||
| Nervous system disorders | Convulsions | ||||
| Heart disorders | Tachycardia | Cardiomyopathy | |||
| Vascular disorders | Hypertension | Decreased blood pressure** | |||
| Respiratory, thoracic and mediastinal disorders | Bronchospasm | ||||
| Gastrointestinal disorders | Pancreatitis | ||||
| Hepatobiliary tract disorders | Increased blood bilirubin levels | Increased levels of gamma-glutamine transpeptidase Hepatitis |
Liver disorders, including hepatitis Liver failure |
||
| Skin and subcutaneous fat | Hives Itching Alopecia |
Change in skin color | |||
| Musculoskeletal and connective tissue disorders | Arthralgia | ||||
| Reproductive system and breast disorders | Menorrhagia |
*frequency established in clinical studies
** data from JSC "Biocard"
Treatment with interferon beta-1b should be initiated under the supervision of a physician experienced in the treatment of multiple sclerosis.
Children
No formal clinical and pharmacokinetic studies have been conducted in pediatric and adolescent populations. Limited published data indicate a comparable safety profile of interferon beta-1b at a dose of 8 million IU subcutaneously every other day in a group of patients from 12 to 16 years of age, compared with the adult population. There is no information on the use of interferon beta-1b in persons under 12 years of age; the drug cannot be used in this group of patients.
At the beginning of treatment, it is usually recommended to titrate the dose. Treatment should begin with the administration of 2 million IU subcutaneously every other day, gradually increasing the dose to 8 million IU, also administered every other day. The dose titration period may vary depending on individual tolerability of the drug.
Table 2. Dose titration scheme*
* The titration period may be extended if adverse reactions develop
The duration of treatment has not been established at this time. There are results of clinical studies in which the duration of treatment in patients with relapsing-remitting and secondary progressive multiple sclerosis reached 5 and 3 years, respectively. In the group of patients with relapsing multiple sclerosis, high effectiveness is shown during the first 2 years. A further three-year follow-up showed continued effectiveness throughout the entire treatment period. In patients with clinically isolated syndrome, there was a significant delay in transformation to definite multiple sclerosis for more than 5 years.
Interferon beta-1b therapy is not indicated for patients with relapsing-remitting multiple sclerosis who have had fewer than 2 exacerbations in the past 2 years, or for patients with secondary progressive multiple sclerosis who have not progressed in the past 2 years.
For patients who do not experience disease stabilization (e.g., persistent disease progression on the EDSS scale within 6 months or the need for 3 or more courses of corticotropin or corticosteroid therapy) within 1 year, treatment with interferon beta-1b is recommended to be discontinued.
1. Choose a time for the injection that is convenient for you. It is advisable to do injections in the evening before bedtime.
2. Before administering the drug, wash your hands thoroughly with soap and water.
3. Take one blister pack with a filled syringe/vial from a cardboard box, which should be stored in the refrigerator, and keep it at room temperature for several minutes so that the temperature of the drug is equal to the ambient temperature. If condensation appears on the surface of the syringe/vial, wait a few more minutes until the condensation evaporates.
4. Before use, you should inspect the solution in the syringe/vial. If there are suspended particles or a change in the color of the solution or damage to the syringe/vial, the drug should not be used. If foam appears, which happens when the syringe/vial is shaken or shaken vigorously, wait until the foam settles.
5. Select the area of the body to be injected. Interferon beta-1b is injected into the subcutaneous fat (the fatty layer between the skin and muscle tissue), so use areas with loose fiber away from areas of stretching of the skin, nerves, joints and blood vessels:
Hips (front surface of thighs except groin and knee);
Abdomen (except for the midline and peri-umbilical region);
Outer surface of the shoulders;
Buttocks (upper outer quadrant).
Do not inject into painful spots, discolored or red areas of the skin, or areas with lumps or lumps.
Choose a different injection site each time, so you can reduce discomfort and pain in the area of skin at the injection site. There are many injection points within each injection area. Constantly change injection points within a specific area.
6. Preparation for injection.
If the patient is using interferon beta-1b syringes
Take the prepared syringe into the hand you are writing with. Remove the protective cap from the needle.
If the patient is using interferon beta-1b vials
Take a bottle of interferon beta-1b and carefully place the bottle on a flat surface (table). Use tweezers (or another convenient device) to remove the cap of the bottle. Disinfect the top of the bottle. Take a sterile syringe in the hand you are writing with, remove the protective cap from the needle and, without violating sterility, carefully insert the needle through the rubber cap of the bottle so that the end of the needle (3-4 mm) is visible through the glass of the bottle. Turn the bottle over so its neck is facing down.
7. The amount of interferon beta-1b solution that must be administered during the injection depends on the dose recommended by your doctor. Do not store the remaining drug remaining in the syringe/vial for repeated use.
use.
If the patient uses the drug interferon beta-1b in syringes
Depending on the dose prescribed by your doctor. You may need to remove excess drug solution from the syringe. If necessary, slowly and gently press the syringe plunger to remove excess solution. Press down on the plunger until the plunger reaches the desired mark on the syringe label.
If the patient is using the drug interferon beta-1b in vials
Slowly pull the plunger back and draw the required volume of solution into the syringe from the bottle, corresponding to the dose of interferon beta-lb prescribed by your doctor. Then, without compromising sterility, remove the vial from the needle, holding the needle at the base (make sure that the needle does not come off the syringe). Turning the syringe upside down with the needle and moving the piston, remove any air bubbles by gently tapping the syringe and pressing on the piston. Replace the needle on the syringe and remove the cap.
8. Pre-disinfect the area of skin where interferon beta-1b will be injected. When the skin is dry, lightly gather the skin into a fold with your thumb and forefinger.
9. Positioning the syringe perpendicular to the injection site, insert the needle into the skin at an angle of 90°. The recommended depth of needle insertion is 6 mm from the skin surface. The depth is selected depending on the body type and the thickness of the subcutaneous fat. Inject the drug by evenly pressing the syringe plunger down to the end (until it is completely empty).
10. Remove the syringe with the needle by moving vertically upward.
11. Dispose of used syringes/vias only in a specially designated place, out of the reach of children.
12. If you forget to inject interferon beta-1b, inject it immediately as soon as you remember. The next injection is given after 48 hours. A double dose of the drug is not allowed. Do not stop using Interferon beta-1b without consulting your doctor.
Release from pharmacies
The drug is available with a prescription.
Interferon Beta-1B: indications and instructions for use
- Interferon Beta 1-B is a solution in a syringe, which is actively used for the treatment of multiple sclerosis. Prescribed for relapsing-remitting sclerosis, when the patient can move without assistance, the disease progresses secondary. Relieves symptoms of exacerbation, restores neurological functionality, and slows down the development of the disorder.
- The composition of Interferon is characterized by the presence of a chemical substance that inhibits the patient’s transition to CDRS.
- How to take Interferon? The expert will determine the form and duration of the disease and select the exact dosage of the chemical.
- It is not advisable to use Interferon during pregnancy, children, epilepsy, depression, after suicide attempts, and liver dysfunction. It is prescribed with special care to patients consuming anticonvulsants when anemia develops.
Side effects, overdose of Interferon Beta-1B
- Incident symptoms when administering the drug Interferon Beta-1B are necrosis, body soreness, development of fever, redness of the dermis, decoloration. The substance is immediately discontinued.
- Taking the drug Interferon Beta-1B in excess of norms did not lead to dysfunctional disorders. In case of overdose, go to the clinic.
