Infibeta
Infibeta: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Infibeta
ATX code: L03AB08
Active ingredient: interferon beta-1b (Interferon beta-1b)
Manufacturer: Generium, CJSC (Russia)
Description and photo update: 28.11.2018
Prices in pharmacies: from 32,700 rubles.
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Infibeta is an interferon-based drug used to treat multiple sclerosis.
Release form and composition
Dosage form - lyophilisate for preparation of a solution for subcutaneous administration: amorphous, from slightly yellowish to white (in a cardboard box 1 or 3 blister packs of 5 vials each complete with a syringe, needles for solution preparation and for subcutaneous administration, a solvent in bottles of 1.2 ml, alcohol wipes, as well as instructions for the use of Infibeta).
Composition for 1 bottle of lyophilisate:
- active substance: interferon beta-1b - 0.3 mg (corresponds to 9.6 million IU);
- auxiliary components: mannitol - 15 mg; human albumin 15 mg
Composition for 1 bottle of solvent: sodium chloride - 5.4 mg; water for injection - up to 1 ml.
Pharmacological properties
Pharmacodynamics
The active substance of the Infibeta preparation is interferon beta-1b, has immunomodulatory and antiviral activity. Its mechanism of action in MS (multiple sclerosis) is not completely known. However, it has been established that the biological effect of a substance is mediated by its interaction with specific receptors found on the surface of human cells.
When interferon beta-1b binds to these receptors, the expression of a number of substances is induced, which are considered to be mediators of the biological effects of interferon beta-1b. The content of some of these substances is determined in the serum and fractions of blood cells of patients who received interferon beta-1b. The substance reduces the binding capacity of the interferon receptor and increases its degradation and internalization. The use of Infibeta increases the suppressor activity of peripheral blood mononuclear cells.
In relapsing and secondary progressive MS, therapy with interferon beta-1b reduces the frequency (by 30%) and severity of clinical exacerbations of the disease, the number of hospitalizations and the need for glucocorticosteroids, and the remission time is lengthened.
In case of secondary progressive MS, the use of Infibeta can delay the further progression of the disease and the onset of disability, including in a severe form (a condition when patients are forced to use a wheelchair constantly) for up to 12 months. This effect is observed in patients with / without exacerbations of the disease, as well as with any index of disability (patients with an assessment of 3–6.5 points on the extended scale for assessing the state of disability took part in clinical trials).
According to the results of magnetic resonance imaging of the brain, carried out in patients with two forms of MS, while using Infibeta, a significant positive effect of therapy on the severity of the pathological process and a significant decrease in the formation of new active foci are confirmed.
Pharmacokinetics
Serum concentrations of interferon beta-1b after subcutaneous administration at the recommended dose of 0.25 mg are low or not determined at all. Therefore, there is no information on the pharmacokinetic processes of the substance in MS patients receiving Infibeta.
When using the drug in a dose of 0.5 mg, the time to reach C max (maximum concentration) of interferon beta-1b in plasma is 1-8 hours after injection, C max is approximately 40 IU / ml. The absolute bioavailability of the substance is approximately 50%. In the case of intravenous administration of the drug, clearance and T 1/2 (half-life) of interferon beta-1b from serum averaged 30 ml / min / kg and 5 hours, respectively. When the drug is administered every other day, there is no increase in the concentration of interferon beta-1b in the blood plasma, and the pharmacokinetics of the substance remains unchanged throughout the course of treatment.
If 0.25 mg of the drug is injected subcutaneously every other day, the content of biological response markers (neopterin, β2-microglobulin and immunosuppressive cytokine, interleukin-10) significantly increases in comparison with baseline values 6–12 hours after the first dose of Infibeta. The concentration of these substances reaches maximum values after 40–124 hours and remains elevated during the seven-day (168 hours) study period.
Indications for use
- CIS (clinically isolated syndrome; the only clinical episode of demyelination that allows the presence of MS after excluding alternative diagnoses), which has a sufficient severity of the inflammatory process to prescribe corticosteroids for intravenous administration;
- RMS (relapsing-remitting multiple sclerosis): in order to reduce the severity and frequency of exacerbations in outpatients (i.e., patients who are able to walk without assistance), if there is a history of at least two exacerbations in the last 2 years, after which complete / partial restoration of neurological deficit;
- secondary progressive MS with an active course, which is characterized by exacerbations or pronounced deterioration of neurological functions over the past two years: in order 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:
- decompensated liver failure;
- suicidal thoughts and / or severe depression;
- pregnancy, breastfeeding period;
- age up to 18 years;
- individual intolerance to the components of the drug.
Relative (Infibeta is prescribed under medical supervision):
- heart disease, including NYHA functional class III – IV heart failure, cardiomyopathy;
- monoclonal gammopathy;
- burdened history of seizures;
- impaired hepatic function;
- thrombocytopenia, anemia, leukopenia.
Infibeta, instructions for use: method and dosage
It is necessary to initiate therapy under the supervision of a physician experienced in the treatment of MS. The question of the duration of the use of Infibeta currently remains unresolved, so the duration of treatment is determined by the doctor.
For the preparation of the injection solution, the attached solvent in a vial (0.54% sodium chloride solution) is used. 1.2 ml of solvent is injected into the bottle with Infibeta using a syringe. The bottle should not be shaken, the powder should be completely dissolved. The prepared solution must be inspected before use. If the color of the drug changes or if there are particles in it, it cannot be used. 1 ml of the resulting solution contains 0.25 mg (8 million IU) of interferon beta-1b.
Infibeta is intended for subcutaneous administration.
A single dose - 1 ml of the finished solution (0.25 mg of the drug), is administered every other day. At the beginning of therapy, dose titration is recommended, which is carried out according to the scheme described below.
Infibeta is administered at an initial dose of 0.25 ml (0.062 5 mg), each subsequent administration (every other day) the dose is gradually increased to 1 ml (0.25 mg). The duration of the dose titration period is determined by the tolerability of the drug and is set individually.
For a single clinical episode of demyelination that suggests MS, the following titration schedule is recommended [ready-made solution in ml (lyophilisate in mg)]:
- 1-3 introduction: 0.25 ml (0.062 5 mg);
- 4-6 introduction: 0.5 ml (0.125 mg);
- 7-9 introduction: 0.75 ml (0.187 5 mg);
- further use: 1 ml (0.25 mg).
For patients with relapsing-remitting sclerosis who have had fewer than 2 exacerbations in the past two years, or with secondary progressive MS, patients who have had the disease in an inactive phase for the past two years are not recommended to prescribe Infibet.
In the absence of improvement during therapy (for example, with persistent progression of the disease on the EDSS scale for 6 months, or if three or more courses of therapy with glucocorticosteroids or corticotropin are required), the use of Infibeta should be discontinued.
The solution should be prepared just before use. The solvent bottle must be removed from the refrigerator (10-15 minutes) prior to injection.
It is recommended to use a short needle syringe to inject Infibeta. The finished solution is injected into soft tissues that are located far from the nerves and joints, namely:
- belly (except for the navel and waist);
- arms (back of the shoulder);
- the front and outer lateral surfaces of the thighs (except for the knee and groin area);
- buttocks.
The injection site must be chosen a new one every time; for convenience, it is better to fix it on the diagram after each injection.
Infibeta should not be injected into areas where swelling, bumps, hard nodules or pain are felt. Do not inject into areas of discolored skin or if there are lesions, crusts or depressions. If you find such skin changes, you should consult a doctor.
Side effects
Adverse reactions that occurred with a frequency of 2% and higher than with placebo (inactive drug) in patients treated in clinical trials of 0.25 mg (or 0.16 mg / m 2) Interferon beta-1b through to day course three years:
- genitourinary system: urge to urinate; in men - impotence, in women - acyclic uterine bleeding (metrorrhagia);
- lymphatic system and blood: lymphocytopenia (<1500 / mm 3), neutropenia (<1500 / mm 3), leukopenia (<3000 / mm 3), lymphadenopathy;
- nervous system: impaired coordination, insomnia;
- digestive system: abdominal pain;
- respiratory system: shortness of breath;
- cardiovascular system: increased blood pressure;
- musculoskeletal system: myalgia, myasthenia gravis, leg cramps;
- skin: skin lesions, rash;
- alimentary and metabolic disorders: increased activity of enzymes in the blood - aspartate aminotransferase alanine aminotransferase (5 times from the initial value);
- general reactions: reactions and necrosis at the injection site, general malaise, chills, headache, asthenia (weakness), a complex of flu-like symptoms (can be alleviated by the use of non-steroidal anti-inflammatory drugs), fever, peripheral edema, chest pain, pain of various localization.
Experience with the use of Infibeta for the treatment of MS is rather limited, therefore, disorders occurring with a low frequency may not yet be recorded.
Adverse reactions registered during post-marketing observations [> 10% - very often; (> 1% and 0.1% and 0.01% and <0.1%) - rarely; <0.01% - very rare]:
- cardiovascular system: infrequently - increased blood pressure; rarely - tachycardia, cardiomyopathy, palpitations; very rarely - vasodilation;
- endocrine disorders: rarely - thyroid dysfunction, including hypo- and hyperthyroidism;
- lymphatic system and blood: infrequently - leukopenia, thrombocytopenia, anemia; rarely, lymphadenopathy;
- nervous system: infrequently - depression, muscle hypertonia; rarely - dizziness, agitation, anorexia, emotional lability, convulsions, confusion, suicidal attempts;
- digestive system: infrequently - vomiting, nausea; rarely - diarrhea, pancreatitis;
- metabolism: rarely - an increase in the concentration of triglycerides;
- skeletal musculature: infrequently - myalgia; rarely - arthralgia;
- subcutaneous tissue and skin: infrequently - itching of the skin, urticaria, alopecia, skin rashes; rarely - discoloration of the skin;
- respiratory organs: rarely - bronchospasm, shortness of breath;
- biliary tract, liver: infrequently - increased activity of aspartate aminotransferase, alanine aminotransferase in the blood; rarely - hepatitis, an increase in the concentration of bilirubin in the blood, the activity of γ-glutamyltransferase;
- female reproductive system: rarely - menstrual irregularities; very rarely - prolonged menstrual bleeding (menorrhagia);
- allergic reactions: rarely - anaphylactic reactions;
- local reactions: very often - reactions at the injection site (in the form of hyperemia, local edema), pain, inflammation; often - necrosis at the injection site of Infibeta;
- general reactions: very often - flu-like symptoms (in the form of fever, chills, myalgia, headache or excessive sweating) over time, the frequency of these symptoms decreases; rarely - weight loss / gain, general malaise, chest pain.
Overdose
When administered intravenously to adult patients with oncological diseases, 5.5 mg (176 million IU) of Infibeta three times a week, serious adverse events were not identified.
Glucocorticosteroids and corticotropin, prescribed for up to 28 days in the treatment of exacerbations, are well tolerated during the use of Infibeta.
special instructions
Against the background of monoclonal gammopathy, the use of Infibeta may be accompanied by a systemic increase in capillary permeability with the subsequent development of shock and death.
In rare cases, during the period of therapy, the occurrence of pancreatitis was noted, mainly associated with hypertriglyceridemia.
It should be borne in mind that side effects of Infibeta can be suicidal thoughts and depression, if these disorders appear, you should immediately consult a doctor. In the course of two controlled clinical trials, no significant differences were found in the incidence of depression and suicidal thoughts due to the use of Infibeta and placebo. Nevertheless, if such violations appear, it is necessary to consider the feasibility of discontinuing therapy.
With a history of seizures, the drug should be used with caution.
Infibeta contains human albumin, so there is very little risk of transmission of viral diseases. The theoretical risk of transmission of Creutzfeldt-Jakob disease is also considered extremely unlikely.
In addition to standard laboratory tests, which are prescribed in the management of patients with MS, it is recommended to monitor a detailed blood test before starting therapy, as well as regularly during the period of therapy, including determining the leukocyte count, biochemical blood test and platelet count. In addition, liver function must be monitored. When managing patients with thrombocytopenia, anemia, leukopenia (in combination or separately), more careful monitoring of a detailed blood test may be required, including determining the number of platelets, leukocytes, erythrocytes and leukocyte formula.
During clinical trials, it was found that the use of Infibeta often leads to an asymptomatic increase in the activity of hepatic transaminases. Usually this violation is transient and insignificant.
During the period of therapy, in rare cases, the development of severe liver damage (including liver failure) is observed. The most severe course is observed in patients who used hepatotoxic drugs / substances, in addition to having some concomitant diseases, including malignant neoplasms with metastasis, sepsis, severe infections, alcoholism.
During treatment, monitoring of hepatic function is necessary, including an assessment of the clinical picture. With an increase in the activity of transaminases in the blood serum, careful observation and examination are required. With significant deviations in this indicator or when signs of liver damage (in particular, jaundice) appear, Infibeta is canceled. Resumption of therapy under the control of hepatic function is possible after normalization of the activity of hepatic enzymes and in the absence of clinical signs of liver damage.
In patients with severe renal impairment, the drug should be administered with caution.
In case of dysfunction of the thyroid gland, it is recommended to regularly check its function (thyroid-stimulating hormone, thyroid hormones), in other cases the study is carried out according to clinical indications.
Against the background of heart disease, in particular with heart failure III – IV functional class according to NYHA, Infibeta is prescribed with caution. In case of development of cardiomyopathy, presumably associated with therapy, the drug is canceled.
During the administration of Infibeta's solution, in rare cases, serious allergic reactions may develop, and they can proceed in a severe and acute form (such as anaphylaxis, bronchospasm, and urticaria).
If signs of damage to the integrity of the skin appear (in particular, when fluid flows out from the injection site), the patient should consult a doctor before continuing with the injection.
During the use of Infibeta, there were cases of necrosis at the injection site. The process can take place over a wide area and spread to adipose tissue and muscle fascia, leading to scarring. Sometimes it is necessary to remove dead areas, in more rare cases - a skin graft. In this case, the healing process can take up to six months.
If multiple foci of necrosis appear, Infibeta is canceled until the damaged areas are completely healed. In the presence of one, not too extensive focus, therapy can be continued, since there is information about the healing of the dead area against the background of continuing treatment.
Recommendations to reduce the risk of developing a reaction and necrosis at the injection site:
- Carrying out injections with strict adherence to the rules of asepsis.
- The introduction of the drug in different places and strictly subcutaneously.
The correctness of self-injections should be periodically monitored, especially in cases of local reactions.
During the period of therapy, there is a risk of antibodies. In a number of controlled clinical trials, blood serum was analyzed every 3 months in order to detect the formation of antibodies to interferon beta-1b. It was found that neutralizing antibodies to Infibeta developed in 23–41% of cases. In subsequent laboratory studies, 43–55% of patients in this group showed a stable absence of antibodies to interferon beta-1b.
In the course of two-year studies, the development of neutralizing activity did not correlate with a decrease in clinical efficacy.
There is no evidence that the presence of neutralizing antibodies has a significant effect on clinical outcomes. The appearance of any side reactions was not associated with the development of neutralizing activity. The decision to continue / discontinue treatment should be based not on the status of neutralizing activity, but on indicators of clinical disease activity.
Influence on the ability to drive vehicles and complex mechanisms
When driving motor vehicles, patients should consider the likelihood of developing unwanted side effects from the central nervous system.
Application during pregnancy and lactation
Infibeta is not prescribed during pregnancy / lactation.
It has not been established whether interferon beta-1b can cause fetal abnormalities when treating pregnant women or affect human reproductive function. In controlled clinical trials, spontaneous abortions have been reported in patients with MS.
Women of reproductive age should use reliable methods of contraception during therapy. When planning / starting pregnancy, it is necessary to take into account the existing risk, therefore, it is recommended to cancel Infibet.
There is no information confirming / refuting the fact that interferon beta-1b is excreted in breast milk. It is necessary to take into account the theoretical possibility of developing adverse reactions to Infibeta in breastfed babies.
Pediatric use
Since the efficacy and safety of Infibeta in patients under 18 years of age has not been studied, prescribing the drug to patients of this age group is contraindicated.
With impaired renal function
Patients with severe renal impairment should be prescribed Infibeta with caution.
For violations of liver function
- decompensated liver failure: therapy is contraindicated;
- liver dysfunction: Infibeta is prescribed with caution.
Drug interactions
The combined use of Infibeta with other immunomodulators, in addition to corticotropin or glucocorticosteroids, has not been studied.
When combined with other drugs, the metabolism of which occurs by certain cytochrome P 450 isoenzymes, caution is required. This group of drugs includes anticonvulsants, analgesics and antipyretics, antidepressants. Also, caution should be exercised when used simultaneously with any drugs that affect the hematopoietic system.
If you need to additionally take any medications for a long period, you need to consult your doctor.
There is no information on the compatibility of Infibeta with other drugs, so it cannot be mixed with other solutions.
Analogs
Infibeta's analogues are Interferon beta-1b, Betaferon, Extavia, Ronbetal, etc.
Terms and conditions of storage
Store at 2–8 ° C, do not freeze. Keep out of the reach of children.
Immediately before use, it is allowed to store the drug in its original packaging: up to 15 days - at a temperature not higher than 15 ° С, up to 7 days - not higher than 25 ° С.
Shelf life: lyophilisate - 2 years; solvent - 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Infibet
Reviews about Infibet are few. In general, the high efficiency of the drug is noted. Some users indicate good tolerance, but in other cases they report the development of side effects of varying severity. At the same time, the patient's response to the drug may change over time.
Infibeta price in pharmacies
The approximate price for Infibeta (15 bottles) is 11,700-29,542 rubles.
Infibeta: prices in online pharmacies
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Drug name Price Pharmacy |
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Infibeta 9.6 million IU lyophilisate for the preparation of a solution for subcutaneous administration 15 pcs. 32700 RUB Buy |
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!
