Betaleukin^® (Lyophilisate) Instructions for Use

Marketing Authorization Holder

State Research Institute of Occupational Health FMBA, FSUE (Russia)

ATC Code

L03AC (Interleukins)

Dosage Forms

	Betaleukin®	Lyophilisate for preparation of solution for intravenous and subcutaneous administration 0.05 mcg: amp. 5 pcs.
		Lyophilisate for preparation of solution for intravenous and subcutaneous administration 0.5 mcg: amp. 5 pcs.
		Lyophilisate for preparation of solution for intravenous and subcutaneous administration 1 mcg: amp. 5 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intravenous and subcutaneous administration in the form of a powder or porous mass of white color.

Excipients: low molecular weight medical polyvinylpyrrolidone.

0.05 mcg – ampoules (5) – contour cell packaging (1) cassette – cardboard packs.

Clinical-Pharmacological Group

Immunostimulant drug. Leukopoiesis stimulator

Pharmacotherapeutic Group

MIBP-cytokine

Pharmacological Action

Betaleukin^® stimulates hematopoiesis and early post-radiation recovery, has an immunostimulating effect and antiviral activity. The drug accelerates the recovery of stem potential and bone marrow hematopoiesis, especially granulopoiesis, after the damaging effects of cytostatics and ionizing radiation.

This is due to its ability to initiate the entry of stem cells into the mitotic cycle and their mobilization into the blood, enhance the production of hematopoietic growth factors, and activate mechanisms of general and local nonspecific resistance.

The immunostimulating effect of the drug is realized by increasing the functional activity of neutrophilic granulocytes, inducing the differentiation of precursors of immunocompetent cells, enhancing lymphocyte proliferation, activating cytokine production, and increasing antibody formation.

The drug has antiviral activity against the hepatitis C virus due to a direct, interferon-alpha-independent action using unique systems for activating innate antiviral immunity, induces the synthesis of endogenous interferon-alpha, and also helps to cancel the blocking effect of the hepatitis C virus on the biological activity of interferon-alpha.

Systemic use of interleukin-1 beta is completely identical to the action of the main endogenous inducer of the local inflammatory response and systemic acute-phase response.

At the same time, due to the high purity of the drug Betaleukin^®, the formation of autoantibodies is not observed. The half-life of interleukin-1 beta in blood plasma after intravenous administration is 7.5 min. It is excreted unchanged through the kidneys and is evenly distributed in organs and tissues with the bloodstream.

Indications

Betaleukin^® is used as a leukopoiesis stimulator

• For toxic leukopenia of grade II-IV, complicating chemotherapy and radiotherapy of malignant tumors, and as a leukopoiesis protector when it is necessary to conduct chemotherapy against a leukopenic background (peripheral blood leukocyte count not less than 3×10⁹/l).

As an immunostimulant

• Secondary immunodeficiency states developing after severe injuries, extensive surgical interventions;
• Purulent-septic and purulent-destructive processes;
• Infectious diseases;
• Chronic septic conditions.

As a means of emergency anti-radiation therapy

• For acute emergency total and subtotal exposures to ionizing radiation, not complicated by additional thermal exposure. Betaleukin^® is used if the radiation dose is estimated to exceed 1 Gy.

An indication for the use of Betaleukin^® is also newly diagnosed pulmonary tuberculosis of limited extent with a predominance of the productive type of tissue reaction (with or without destruction) and pulmonary tuberculosis, in which medium-sized productive foci in the lung tissue and “residual cavities” persist at 4-5 months of treatment, regardless of the initial form of tuberculosis.

The drug Betaleukin^® is used to treat patients with chronic viral hepatitis C, genotype 1, in the absence of a virological response to primary antiviral therapy with pegylated or standard interferons and ribavirin.

ICD codes

Dosage Regimen

1. As a leukopoiesis stimulator, the drug is used at a dose of 0.015-0.020 mcg/kg of body weight, for immunostimulation at a dose of 0.005-0.008 mcg/kg of body weight. Treatment is carried out as a course of 5 daily drip intravenous infusions or subcutaneous injections.

To obtain an infusion solution for intravenous administration, the contents of the ampoule with the drug are dissolved immediately before administration in 1 ml of 0.9 % sodium chloride solution or water for injections and the total volume of the solution is adjusted to 100 ml with 0.9% sodium chloride solution. To achieve the calculated dose for infusions, this solution is diluted in the required amount (depending on the initial dose of the drug in the ampoule, and accordingly, its concentration in the resulting solution) in 500 ml of 0.9% sodium chloride solution or 5% dextrose solution.

The duration of infusions can vary from 120 to 180 minutes.

To obtain an injection solution for subcutaneous administration, the contents of the ampoule with the drug are dissolved in 0.5-1 ml of 0.9% sodium chloride solution or water for injections.

If necessary, similar repeated courses of treatment can be carried out with an interval of two weeks.

2. Betaleukin^® as a means of emergency anti-radiation therapy is administered subcutaneously, within 2 hours after radiation exposure, at a dose of 1 mcg (the contents of a 1 mcg ampoule are dissolved in 1 ml of 0.9% sodium chloride solution).

3. For the treatment of tuberculosis, Betaleukin^® is administered at a dose of 0.005 mcg/kg of body weight. The drug is administered intravenously by drip over 3 hours or subcutaneously. Solutions for infusions or injections are prepared as described in paragraph 1 of this section. Treatment is carried out as a course of 5 daily procedures.

Betaleukin^® is prescribed against the background of the use of anti-tuberculosis drugs; specific polychemotherapy is carried out with 4 drugs selected in accordance with the drug sensitivity of Mycobacterium tuberculosis.

4. Complex antiviral therapy for patients with chronic viral hepatitis C, genotype 1, who have not achieved a virological response to therapy with pegylated or standard interferons and ribavirin, is supplemented with the drug Betaleukin^® at a dose of 0.5 mcg (0.25 mcg if the patient’s body weight is less than 70 kg) subcutaneously 3 times a week (Monday, Wednesday, Friday), in courses of 3 weeks, for a total of 6 courses with intervals of 6 weeks; the total duration of antiviral therapy is 48 weeks.

Contraindications

• Individual intolerance;
• In patients in the stage of septic shock and with severe fever;
• Pregnancy, breastfeeding period;
• Children under 18 years of age.

Contraindications for the appointment of Betaleukin^® as a means of emergency anti-radiation therapy

• Combined radiation-thermal injuries (CRTI);
• Febrile conditions;
• Severe hypotension;
• Shock.

Contraindications for the appointment of Betaleukin^® in the treatment of tuberculosis

• Lesion volume of more than 3 segments (including dissemination foci),
• Presence of destruction cavities larger than 3 cm;
• Predominance of exudative tissue reaction in the lung tissue;
• Severe symptoms of intoxication, including hyperthermia.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated in children under 18 years of age.

Storage Conditions

Store at 2°C (36°F) to 15°C (59°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.