Betaferon - Instructions For Use Of The Drug, Price, Reviews, Analogues

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

Betaferon

Betaferon: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacodynamics and pharmacokinetics
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. Application for violations of liver function
12. 12. Application for impaired renal function
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Reviews
16. 16. Price in pharmacies

Latin name: Betaferon

ATX code: L03AB08

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

Producer: Boehringer Ingelheim Pharma (Germany)

Description and photo update: 2019-06-08

Betaferon is an immunomodulatory drug used in the treatment of multiple sclerosis.

Release form and composition

Dosage form - lyophilizate for preparation of a solution for subcutaneous administration: lyophilized white mass (in glass vials complete with a solvent (in a syringe), in plastic trays, 5 or 15 trays in a cardboard box).

In 1 bottle:

• Active substance: recombinant interferon beta-1b - 9.6 million IU (0.3 mg);
• Excipients: human albumin, mannitol.

Solvent: sodium chloride solution 0.54% (sterile).

Pharmacodynamics and pharmacokinetics

Interferon beta-lb, which is part of the drug, has immunomodulatory and antiviral activity.

The mechanism of action of this substance in multiple sclerosis has not been finally established, however, it is known that the use of Betaferon in relapsing and secondary progressive multiple sclerosis can reduce the frequency (by 30%) and severity of clinical exacerbations of the disease, the need for treatment with glucocorticosteroids, as well as reduce the number of hospitalizations and lengthen the duration of remission.

During the treatment with Betaferon in patients with secondary progressive multiple sclerosis, a delay in the further progression of the disease and the onset of disability (including severe disability in which patients have to use a wheelchair constantly) for up to 12 months was observed. A similar effect takes place in patients with exacerbations of the disease or without them, as well as with any index of disability (the study was conducted with the participation of patients with an assessment of 3–6.5 points).

The results of MRI of the brain of patients with secondary progressive and remitting multiple sclerosis confirm the fact that drug treatment has a positive effect on the severity of the pathological process and significantly reduces the risk of the formation of new active foci.

Acute toxicity studies of the drug have not been conducted. Toxicity studies at repeated doses in rhesus monkeys indicate the possibility of developing transient hyperthermia, which is accompanied by a pronounced transient decrease in the number of segmented neutrophils and platelets and a transient increase in the concentration of lymphocytes.

Reproductive toxicity studies carried out on rhesus monkeys have shown that Betaferon is not only toxic to the mother, but also increases the frequency of spontaneous abortions. At the same time, no malformations were observed in living offspring.

Studies of the effect of the drug on fertility have not been carried out, no effect on the estrous cycle of monkeys has been recorded.

One separate study of genotoxicity (the Ames test) failed to reveal any mutagenic effects.

Carcinogenicity studies have also not been conducted and the results of the in vitro cell transformation test did not show any carcinogenic potential.

With the subcutaneous administration of the recommended doses of Betaferon (0.25 mg), the concentrations of interferon beta-lb in the blood serum are low or not determined at all. That is why there is no data on the pharmacokinetics of the drug in patients with multiple sclerosis receiving the recommended doses of the drug.

When a 0.5 mg dose is administered subcutaneously, the maximum plasma concentration is observed 1–8 hours after injection and is approximately 40 IU / ml. The indicator of the absolute bioavailability of the drug when administered subcutaneously is approximately 50%.

When administered intravenously, the clearance and half-life of Betaferon from serum are 30 ml / min / kg and 5 hours, respectively.

Betaferon injections every other day do not cause an increase in the concentration of interferon beta-lb in the blood plasma, and the pharmacokinetics of the drug does not change during the entire course of therapy.

Subcutaneous administration of the drug every other day at a dose of 0.25 mg leads to a significant increase in the content of biological response markers (interleukin-10, neopterin, immunosuppressive cytokine, beta2-microglobulin) compared with the initial values 6–12 hours after the first dose of the drug. This indicator reached its peak after 40–124 hours and remained elevated throughout the entire study period (7 days, or 168 hours).

Indications for use

• Clinically isolated syndrome (the only clinical episode of demyelination, allowing, subject to the exclusion of alternative diagnoses, to suggest multiple sclerosis);
• Secondary progressive multiple sclerosis with an active course of the disease, including exacerbations or severe deterioration of neurological functions over the past few years (the use of Betaferon allows to reduce the frequency and severity of such exacerbations, as well as slow down the rate of progression of the disease);
• Remitting multiple sclerosis. The drug is effective for reducing the frequency and severity of exacerbations of the disease in outpatients (able to move without assistance) with a history of at least two exacerbations of the disease in the last two years, followed by recovery (complete or incomplete) of neurological symptoms.

Contraindications

The use of the drug is contraindicated in pregnancy, breastfeeding, hypersensitivity to the components of the drug.

Caution requires the appointment of a drug to patients with heart disease, as well as thrombocytopenia, anemia, liver dysfunction, depression and a history of suicidal thoughts.

The experience of using Betaferon in children is limited.

Instructions for the use of Betaferon: method and dosage

Treatment should be started under the supervision of an experienced physician.

The recommended dose of the drug is 250 μg (1 ml of the prepared solution). The solution is administered subcutaneously every other day. The duration of therapy is determined by the doctor individually.

Side effects

When using Betaferon, various side effects may occur. On the part of the body as a whole, they usually manifest as asthenia, general malaise, reaction at the injection site, headache, chest pain, fever, chills, abdominal pain, pains of various localization, necrosis at the injection site, a complex of flu-like symptoms, with the development of which the doctor can prescribe non-steroidal anti-inflammatory drugs.

The drug can cause some dermatological reactions, usually manifested as a rash and skin lesions.

In addition, during treatment with Betaferon, disorders of the cardiovascular, musculoskeletal, nervous, digestive, urinary, respiratory and reproductive systems of the body may occur with varying frequency.

Overdose

With the introduction of Betaferon at a dose of 5.5 mg 3 times a week, severe adverse reactions were not observed in adult patients with oncological diseases.

special instructions

Betaferon contains human albumin, so there is very little risk of transmission of viral diseases.

Patients during the treatment, in addition to standard laboratory tests, are advised to regularly conduct a detailed blood test. Patients with anemia, leukopenia, and thrombocytopenia may also require more careful monitoring of a detailed blood test, including determining the number of leukocytes, erythrocytes, platelets and leukocyte count.

Application during pregnancy and lactation

According to the instructions, Betaferon is forbidden to use during pregnancy and lactation.

Women of childbearing age should use reliable methods of contraception during treatment. When planning pregnancy or its occurrence during drug therapy, the course of therapy must be interrupted.

There are no data on the excretion of interferon beta-1b in breast milk, however, due to the theoretical possibility of serious side effects in breastfed infants with the appointment of Betaferon during lactation, breastfeeding should be interrupted.

Pediatric use

When treating children and adolescents under 18 years of age, the drug is used with caution.

Application for violations of liver function

In liver failure, the drug is used with caution.

Application for impaired renal function

In renal failure, the drug is used with caution.

Analogs

Betaferon analogs are:

• By active substance: Ronbetal, Infibeta, Extavia, Interferon beta-1b;
• By the mechanism of action: Grippferon, Lokferon, Layfferon, Infagel, Alfaferon, Interferal, Diaferon, Reaferon, Avonex, Altevir, Rebif, Pegasis, Inferon, Leikinferon, Sveferon, Genfaxon, Viferon, Ingaron, Algeron.

Terms and conditions of storage

The drug is dispensed by prescription. Store at temperatures up to 25 ° C.

The shelf life of the lyophilisate is 2 years, the solvent retains its properties for 3 years.

Reviews about Betaferon

Reviews of Betaferon indicate the effectiveness of the drug, however, many users note the development of side effects of varying severity.

The price of Betaferon in pharmacies

The price of Betaferon is approximately 27,900–32,000 rubles per package of 15 bottles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, 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!