Buy Roncoleukin solution 0.5 mg/ml ampoules 1 ml. 3 pcs
  • Buy Roncoleukin solution 0.5 mg/ml ampoules 1 ml. 3 pcs

Roncoleukin® [Interleukin 2]

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Clinical Pharmacology

Interleukin-2 is produced by a subpopulation of T-lymphocytes (T-helper I) in response to antigen stimulation. The synthesized IL-2 affects T-lymphocytes, increasing their proliferation and the subsequent synthesis of IL-2.

The biological effects of IL-2 are mediated by its binding to specific receptors present on various cellular targets.

IL-2 directionally affects the growth, differentiation and activation of T-and B-lymphocytes, monocytes, macrophages, oligodendroglial cells, Langerhans cells. From its presence depends on the development of cytolytic activity of natural killer cells and cytotoxic T-lymphocytes. IL-2 causes the formation of lymphokine-activated killer cells and activates tumor-infiltrating cells.

Expansion of the spectrum of the lytic effect of effector cells causes the elimination of a variety of pathogenic microorganisms, infected and malignant cells, which provides immune protection against tumor cells, as well as pathogens of viral, bacterial and fungal infections.


As part of complex therapy in adults:

  • common variable immunodeficiency;
  • combined immunodeficiency;
  • acute peritonitis;
  • acute pancreatitis;
  • osteomyelitis;
  • endometritis;
  • severe pneumonia;
  • sepsis;
  • postpartum sepsis;
  • pulmonary tuberculosis;
  • other generalized and severe localized infections;
  • infected thermal and chemical burns;
  • disseminated and locally advanced forms of renal cell cancer.

children from 0 years:

  • common variable immunodeficiency;
  • combined immunodeficiency;
  • acute peritonitis;
  • acute pancreatitis;
  • osteomyelitis;
  • severe pneumonia;
  • bacterial sepsis of newborns;
  • sepsis;
  • other generalized and severe localized infections.


active substances: human interleukin-2 recombinant 0.25 mg, 0.5 mg or 1 mg (= 250,000 IU / 500,000 IU / 1,000,000 IU);

excipients: sodium lauryl sulfate - 2.5 mg / 5 mg / 10 mg; mannitol - 12.5 mg / 25 mg / 50 mg; dithiothreitol - 0.08 mg; ammonium bicarbonate - 0.79 mg; water for injection - up to 1 ml.

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Roncoleukin® [Interleukin 2]

Dosage and Administration

Roncoleukin® administered 1 time per day subcutaneously or intravenously in the dose of 0.5–1.0 mg at intervals of 1–3 days, for a course –– 1-3 injections. For intravenous administration, the drug from the ampoule is transferred to 400 ml of isotonic sodium chloride solution for injection. Infusion of the total volume of the solution is carried out drip for 4-6 hours. The solution of the drug should be clear, colorless and free from impurities.

Roncoleukin Immunotherapy® carried out after the completion of urgent and urgent surgical interventions aimed at eliminating the life-threatening effects of the underlying disease / injury, rehabilitation and adequate drainage of the infectious focus.

In the treatment of severe sepsis, one to three courses of Roncoleukin are performed.® . The course includes 2 intravenous infusions at a dose of 0.5 mg every other day. The criteria for the appointment of the second and third courses of Roncoleukin®is lymphopenia (absolute and / or relative) remaining during treatment.

With newly diagnosed infiltrative destructive pulmonary tuberculosis - 3 IV the infusion of Roncoleukin® at a dose of 0.5 mg with an interval of 48 hours on the background of specific polychemotherapy.

For preoperative preparation with progressive fibro-cavernous tuberculosis (FCT) of the lungs on the background of specific polychemotherapy: for unilateral PCT - 3 w / w of Roncoleukin injection® on 1 mg with an interval of 48 hours; with widespread PCT of the lungs with bilateral focal dissemination - 7 intravenous infusions of Roncoleukin®: 3 administrations during the first week, 1 mg with an interval of 48 hours, then 1 mg twice a week for two weeks. The recommended course of immunotherapy should be completed 7 - 10 days before surgery.

Roncoleukin's appointment® with pulmonary tuberculosis is impractical with a body mass deficit of more than 30%.

Roncoleukin treatment course® disseminated and locally advanced forms of renal cell carcinoma include:

- a single dose or IV the introduction of the drug in a dose of 0.5 mg 24 hours before surgery;

- as part of an 8-week course of immunochemotherapy, 2.0 mg IV, every other day during the first four weeks of treatment. Repeated courses are carried out in 1 - 2 months.

Children Roncoleukin® used intravenously. Schemes of use correspond to those in adults. The drug is diluted in sodium chloride solution isotonic 0.9% for injection. A single dose of the drug and the volume of isotonic solution in children depends on age:

- from 0 to 1 month. - 0.1 mg in 30-50 ml of solution;

- from 1 month up to 1 year - 0.125 mg in 100 ml of solution;

- from 1 year to 7 years - 0.25 mg in 200 ml of solution;

- over 7 years old - 0.5 mg in 200 ml of solution;

- over 14 years old - 0.5 mg in 400 ml of solution.

Adverse reactions

In some cases, during the administration of Roncoleukin® a short-term chill and an increase in body temperature may occur, which is stopped by conventional therapeutic agents and is not a reason to interrupt the administration of the drug, as well as the course of treatment. With the subcutaneous administration of the drug, local reactions were noted - soreness, induration, redness at the injection site.


Hypersensitivity to interleukin-2 or any component of the drug in history; yeast allergy; pregnancy; autoimmune diseases, cardiac insufficiency, stage III, pulmonary heart disease, stage III, metastatic brain damage, end-stage renal cell carcinoma.

With caution in chronic renal failure, decompensated liver failure.

Drug interactions

Roncoleukin drug treatment® can be combined with treatment with all other drugs. When using Roncoleukin® against the background of long-term therapy with glucocorticosteroids, the activity of the drug may decrease. Roncoleukin® can not be mixed with other drugs in one syringe or vial.

Pregnancy and Lactation

The drug is contraindicated in pregnancy.

Special instructions

When stored at a temperature of from 2 to 8 ° C, sodium lauryl sulfate crystals may precipitate, which should dissolve at room temperature for 30 minutes. To speed up the dissolution, you can tilt the ampoule, avoiding rapid mixing of the liquid and foaming.


Overdose manifestations were observed with a single dose of Roncoleukin® above 7 mg in the form of fever, heart rhythm disturbances, hypotension, dermatological allergic reactions. These side effects stop after the abolition of the drug, if necessary, symptomatic therapy.

  • Brand name: Roncoleukin
  • Active ingredient: Interleukin 2
  • Dosage form: Solution for infusion and subcutaneous administration.
  • Manufacturer: BIOTECH NPK
  • Country of Origin: Russia

Studies and clinical trials of Interleukin 2 (Click to expand)

  1. Incidence and clinical significance of neutralizing antibodies in patients receiving recombinant interferon alfa-2a by intramuscular injection
  2. Recombinant alfa-2B-interferon therapy in untreated, stages A and B chronic lymphocytic leukemia. A preliminary report
  3. Treatment of carcinoma of the esophagus with 5-fluorouracil and recombinant alfa-2a-interferon
  4. A phase I study of subcutaneous recombinant interleukin-2 and interferon alfa-2a
  5. Reversible hepatic steatosis in patients treated with interferon alfa-2A and 5-fluorouracil
  6. Acute rhabdomyolysis after concurrent administration of interleukin-2, interferon-alfa, and chemotherapy for metastatic melanoma
  7. Relief of intractable pruritus in polycythemia vera with recombinant interferon alfa
  8. Phase II trial of recombinant interferon alfa-2 in the treatment of primary systemic amyloidosis
  9. Effect of interferon alfa-2b and ribavirin treatment on hepatitis C–associated cryoglobulinemia and rheumatoid factor: Comment on the article by Vassilopoulos and Calabrese
  10. Treatment of primary sjögren's syndrome with low-dose human interferon alfa administered by the oromucosal route: Combined phase III results
  11. PEGylated interferon alfa-2b and ribavirin treatment in patients with hepatitis C virus–related systemic vasculitis
  12. Efficacy and tolerability of rituximab with or without PEGylated interferon alfa-2b plus ribavirin in severe hepatitis C virus–related vasculitis: A long-term followup study of thirty-two patients
  13. Results of a Phase II trial of oral bexarotene (Targretin) combined with interferon alfa-2b (Intron-A) for patients with cutaneous T-cell lymphoma
  14. Genes for interleukin-2 receptor β chain, interleukin-1 β, and schizophrenia: No evidence for the association or linkage
  15. Interleukin-6 and cancer-related hypoaldosteronism
  16. Serum interleukin-10 in plasma-cell dyscrasias
  17. Plasma soluble interleukin-2 receptor levels in patients with idiopathic thrombocytopenic purpura
  18. Eosinophilia associated with adult t-cell leukemia: Role of interleukin 5 and granulocyte-macrophage colony-stimulating factor
  19. Hematopoietic differentiation activity of a recombinant human interleukin-6 (IL-6) isoform resulting from alternatively spliced deletion of the second exon
  20. Multiple myeloma presenting high fever and high serum levels of lactic dehydrogenase, CRP, and interleukin-6
  21. Human hepatitis B virus enhancer 1 is responsive to human interleukin-6
  22. Contribution of tumor necrosis factor α and interleukin-1 α on the production of macrophage inflammatory protein-2 in response to respiratory syncytial virus infection in a murine macrophage cell line, RAW264.7
  23. Double-blind, randomized controlled trial of interleukin-2 treatment of chronic hepatitis B
  24. Interleukin 12 enhances deficient HCV-antigen-induced Th1-type immune response of peripheral blood mononuclear cells

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