Betabioferon

Betabioferon is an immunostimulant from the category of cytokines, interferons and immunomodulators.

Indications Betabioferon

It is used to eliminate multiple sclerosis, occurring in a relapsing-remitting form, and characterized by at least 2 exacerbations over the previous 3 years. Also, there should be no symptoms of continuous progression of the disease in the intervals between the development of relapses.

Release form

It is produced in the form of a solution used for injections, as well as in the form of a lyophilisate, which is used in the manufacture of solutions.

Betabioferon-1b

Betabioferon-1b is a lyophilisate produced in ampoules of 0.3 mg (or 9600000 IU), 10 pieces per package. The kit also includes a solvent (0.54% sodium chloride solution) in ampoules of 2 ml, in the amount of 10 pieces inside the box.

Betabioferon-1a

Betabioferon-1a is a solution in ampoules/vials with a capacity of 3,000,000 and 6,000,000 IU or 12,000,000 IU. The box contains 5 or 10 vials/ampoules.

Pharmacodynamics

Interferons are endogenous glycoproteins and have antiviral, immunomodulatory, and antiproliferative effects. The active element of the drug is a native amino acid sequence similar to natural human interferon-β. Its production involves the use of cells from certain mammals.

The effectiveness of the effect and safety of the substance were assessed in individuals with multiple sclerosis using the drug in doses of 6,000,000 IU, as well as 12,000,000 IU, three times a week. The dosage of the drug, amounting to 12,000,000 IU, reduced the frequency (by approximately 30% over 2 years) and the severity of relapses of the pathology.

Over a 4-year period, the reduction in average exacerbation rates was 22% in people taking Betabioferon compared to people who were given a placebo for 2 years. In the subsequent 2 years, the substance was used in the amount of 6,000,000 IU or 12,000,000 MO.

Pharmacokinetics

The effect of the drug in the treatment of multiple sclerosis has not been fully studied. There is evidence that the drug helps to limit the area of lesions that are the basis of the pathology in the CNS area. The drug's indicators for intramuscular or subcutaneous injection are the same.

With a single injection of 60 mcg, the peak level of the drug during its determination by the immunological method is approximately 6-10 IU / ml. On average, it takes 3 hours to reach this value.

Four times a day, the drug was administered subcutaneously in the above-mentioned dose at intervals of 48 hours, resulting in moderate accumulation of the element (the AUC value increased by approximately 2.5 times).

With a single administration of the substance, the activity of the element 2-5A synthetase in serum and cells increases over a 24-hour period, and in addition, the serum values of neopterin and β-2 microglobulin gradually decrease over the next 2 days.

Subcutaneous and intramuscular injections of the drug cause similar reactions. With four times the drug is administered subcutaneously with an interval of 48 hours, the described biological effect is preserved, and symptoms of tolerance to the substance do not develop.

Interferon undergoes metabolic processes within the body, after which it is excreted in the urine and bile.

Dosing and administration

Betabioferon-1α is prescribed in a portion of 12,000,000 IU with subcutaneous administration, three times a week. For people who have intolerance to this dosage, portions of 6,000,000 IU are used (or 2 ampoules of 3,000,000 IU) - the same injection method and the same frequency of administration. Therapy should be carried out under the supervision of a doctor with experience in treating this disease. The solution must be administered at the same time and on the same day of the week.

At the initial stage of therapy using Betabioferon-1a, in order to reduce the risk of negative effects, it is necessary to use the drug in a dosage of 2,400,000 IU - during the first 14 days. Then, during the 3-4th week, a solution is used in a portion of 6,000,000 IU. Starting from the 5th week of therapy, the patient is administered 12,000,000 IU.

There is no information on how long the drug should be used. The patient's condition must be assessed at least once every 24 months for 4 years from the start of the course. The decision to extend the therapy is made by the doctor, for each patient individually.

Betabioferon-1β in a portion of 8,000,000 IU of the prepared solution must be administered subcutaneously, at intervals of 24 hours. To obtain this solution, add 1.2 ml of solvent (0.54% sodium chloride solution) to the ampoule with the powder. Wait until the powder is completely dissolved, without shaking the ampoule. Carefully inspect the solution before use. If there are any particles in the solution or it has changed color, it cannot be used.

Regarding the duration of the therapeutic course, during a controlled clinical test it was revealed that the drug continued to maintain its medicinal effectiveness during the entire 3-year period during which observations were conducted.

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Use Betabioferon during pregnancy

It is prohibited to use Betabioferon during pregnancy.

Contraindications

Main contraindications:

• intolerance to natural or recombinant interferon-β, as well as albumin contained in the serum or other elements of the drug;
• during the period of breastfeeding;
• severe depression, as well as suicidal tendencies;
• epilepsy, if treatment is not provided or does not bring the desired effect.

Side effects Betabioferon

Most often, patients experience flu-like syndrome, arthralgia with myalgia, chills, nausea, fever, headaches, and a feeling of general weakness. In addition, manifestations are recorded at the injection site: swelling, pain, redness or pallor of the skin. Occasionally, necrosis develops in the area of drug administration.

Other side effects include:

• vomiting, anorexia, loss of appetite, diarrhea;
• dizziness, insomnia, as well as feelings of anxiety and depersonalization;
• seizures, arrhythmia or tachycardia;
• skin hyperemia and manifestations of intolerance;
• changes in laboratory test values – development of leukopenia or thrombocytopenia and lymphopenia, and in addition, an increase in the level of γ-GT, ALT, AST, and alkaline phosphatase.

Interactions with other drugs

Betabioferon-1α.

The drug should be combined with caution with medications that have a narrow drug index and clearance that is significantly dependent on hemoprotein P450, such as antidepressants and anticonvulsants.

Not compatible with myelosuppressants.

Betabioferon-1β.

Interferons weaken the activity of liver hemoprotein P450-dependent enzymes (animal and human).

It is necessary to combine any agents that have an effect on hematopoietic function with the drug with the utmost caution.

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Storage conditions

Betabioferon should be kept in a dark, dry place, out of the reach of small children. Temperature conditions – within 2-8°C.

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Shelf life

Betabioferon can be used for 2 years from the date of release of the drug. The shelf life of the ready solution is a maximum of 3 hours at a temperature of 2-8 ° C.