Betabioferon

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

Indications of the betabiferon

It is used to eliminate multiple sclerosis, which occurs in a relapse remitting form, and is characterized by a minimum of 2 exacerbations during 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

The release is made in the form of a solution used for injection, as well as in the form of lyophilizate, which is used in the manufacture of solutions.

Betabiferon-1b

Betabiferon-1b is a lyophilizate, produced in ampoules with a volume of 0.3 mg (or 9600000 MO), 10 pieces per pack. The kit also includes a solvent (0.54% solution of sodium chloride) in ampoules with a capacity of 2 ml, in an amount of 10 pieces inside the box.

Betabioferon-1a

Betabioferon-1a - solution in ampoules / vials with a capacity of 3,000,000 and 6,000,000 IU or 1,200,000 IU. Inside the box contains 5 or 10 bottles / ampoules.

Pharmacodynamics

Interferons enter the category of glycoproteins of endogenous nature and have antiviral, immunomodulating, and also antiproliferative effect. The active element of the drug is the native sequence of amino acids, analogous to the natural human interferon-β. Its reception is associated with the use of cells of certain mammals.

The efficacy and safety of the substance were evaluated in persons with disseminated sclerosis when using drugs in portions of 600,000 IU, and 1,200,000 IU, three times per week. The dosage of the preparation, making 12000000 МО, reduced frequency (for 2 years approximately on 30%) and intensity of relapses of a pathology.

In the period of 4 years, the decrease in the average indicators of the frequency of exacerbations was equal to 22% in patients taking Betabioferon, compared to people who were given placebo for 2 years. In the following 2 years, a substance of 6,000,000 IU or 1,200,000 IU was used.

Pharmacokinetics

Effects of the drug in the treatment of disseminated sclerosis have not been fully studied. There is evidence that the drug helps to limit the area of lesions, which are the basis of pathology, in the central nervous system. Indicators of the substance with a / m or s / c injection - the same.

With a single injection of 60 μg, the peak level of the drug at the time of its determination by immunological means is approximately 6-10 IU / ml. To achieve this value you need an average of 3 hours.

Four-time administration of the drug by the SC method in the above portion at intervals of 48 hours resulted in a moderate accumulation of the element (the AUC index increased approximately 2.5-fold).

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

Injections of LS subcutaneously and intramuscularly cause similar reactions. With a four-time administration of the drug n / k method with an interval equal to 48 hours, the described biological effect is preserved, and the symptoms of tolerance to the substance do not develop.

Interferon passes the metabolic processes inside the body, after which it is excreted in the urine, as well as bile.

Dosing and administration

Betabiferon-1α is administered in a dose of 1,200,000 IU with administration under the skin, three times a week. For people who are intolerant of this dosage, portions of 6000000 IU (or 2 ampules with a volume of 3,000,000 IU) are used - the same method of injection and the same frequency of administration. Therapy should be conducted under the supervision of a doctor with experience in the treatment of 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 with the use of Betabioferon-1a, in order to reduce the risk of the appearance of negative manifestations, it is required to use medicines at a dosage of 2,400,000 IU - during the first 14 days. Further, in the period of 3-4 weeks, apply a solution in a dose of 6000000 IU. Starting with the 5th week of therapy, the patient is injected to 1,200,000 IU.

There is no information as to what the duration of the drug should be. Assessment of the patient's condition is required to be done at least once in 24 months for 4 years from the start of the course. The doctor decides to extend the therapy, for each patient separately.

Betabiferon-1β in a dose of 8,000,000 IU of the finished solution must be administered by the method, in intervals every other day. To obtain this solution, a solvent of 1.2 ml (0.54% solution of sodium chloride) should be added to the ampoule with powder. It is necessary to wait for complete dissolution of the powder, without shaking the ampoule. It is necessary to thoroughly inspect the solution before use. If any particles are present in the solution, or it has changed its color, it can not be used.

Regarding the duration of the therapeutic course - during the controlled clinical trial, it was found that the drug continued to maintain drug efficacy during all 3 years during which observations were made.

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Use of the betabiferon during pregnancy

To use Betabioferon during pregnancy is prohibited.

Contraindications

The main contraindications:

• intolerance with respect to natural or recombinant interferon-β, and also contained albumin or other elements of the drug inside the serum;
• during the period of breastfeeding;
• a severe form of depression, as well as a tendency to commit suicide;
• epilepsy, if the treatment is not or does not bring the desired effect.

Side effects of the betabiferon

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

Among other side effects:

• vomiting, anorexia, loss of appetite, diarrhea;
• dizziness, insomnia, as well as feelings of anxiety and depersonalization;
• seizures, arrhythmia or tachycardia;
• cutaneous hyperemia and manifestations of intolerance;
• changes in the values of laboratory tests - the development of leukemia or thrombocytopenia and lymphopenia, and in addition, an increase in the level of γ-HT, ALAT, ASAT, as well as AF.

Interactions with other drugs

Betabiferon-1α.

It is necessary to carefully combine the drug with medications that have a narrow drug index, as well as clearance, which is highly dependent on the hemoprotein P450 - such as antidepressants and anticonvulsants.

Does not have compatibility with myelosuppressors.

Betabiferon-1β.

Interferons impair the activity of hepatic hemoprotein P450-dependent enzymes (animals and human).

It is necessary to combine with the medicine as carefully as possible any means that have an effect on the hematopoietic function.

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Storage conditions

Betabiferon should be kept in a dark, dry place and closed from small children. The temperature conditions are within the limits of 2-8 ° С.

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Shelf life

Betabiferon can be used for 2 years since the release of the drug. The shelf life of the ready-made solution is a maximum of 3 hours at temperature marks of 2-8 ° C.