Human recombinant interleukin-2 (Roncoleukin) infusions + subcutaneous 250000 IU 1 ml – [3 vials]

The active ingredient of the drug is recombinant human interleukin-2 (pIL-2), which is a full structural and functional analogue of endogenous interleukin-2, isolated from cells of recombinant strain of Saccharomyces cerevisiae yeast; represented by reduced form of molecule.

Pharmacotherapeutic group Cytokine

Pharmacological (immunobiological) properties

Interleukin-2 is produced by a subpopulation of T-lymphocytes (T-helper I) in response to antigenic stimulation. The synthesized IL-2 affects T-lymphocytes, enhancing their proliferation and 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 directly affects the growth, differentiation and activation of T- and B-lymphocytes, monocytes, macrophages, oligodendroglial cells, and Langerhans cells. The development of cytolytic activity of natural killer cells and cytotoxic T-lymphocytes depends on its presence. IL-2 induces the formation of lymphokinactivated killer cells and activates tumor-infiltrating cells.

Expansion of the spectrum of the effector cells’ lysing action causes elimination of a variety of pathogens, infected and malignized cells, which provides immune protection directed against tumor cells and 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 disseminated forms of renal cell cancer.

In children from the age of 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.

Hypersensitivity to interleukin-2 or any drug component in anamnesis; allergy to yeast; pregnancy; autoimmune diseases, Stage III heart failure, Stage III pulmonary and heart failure, metastatic brain injury, terminal stage of renal cell cancer.

Caution with chronic renal failure, decompensated liver failure.

 

• Roncoleukin® is administered once daily subcutaneously or intravenously by drop of 0.5 – 1.0 mg at 1 – 3 day intervals, for one to 3 injections. For intravenous administration the drug from the ampoule is transferred into 400 ml of isotonic sodium chloride solution for injection. Infusion of the entire solution volume is carried out by drip for 4-6 hours. The drug solution should be clear, colorless and free of foreign substances.
• Roncoleukin® immunotherapy is carried out after completion of emergency and urgent surgical interventions aimed at elimination of life-threatening consequences of the underlying disease/trauma, sanation and adequate drainage of the infectious focus.
• In treatment of severe sepsis one to three courses of Roncoleukin® are carried out. The course includes 2 intravenous infusions at a dose of 0.5 mg every other day. The criterion for prescribing the second and third courses of Roncoleukin is lymphopenia (absolute and/or relative) that persists during treatment.
• In newly diagnosed infiltrative destructive pulmonary tuberculosis – 3 intravenous infusions of Roncoleukin® at a dose of 0.5 mg with an interval of 48 hours against a background of specific polychemotherapy.
• For preoperative preparation in progressive pulmonary fibrosis-cavernous tuberculosis (FCT) against the background of specific polychemotherapy: in unilateral FCT – 3 Roncoleukin® infusions by 1 mg at 48-hour intervals; in generalized FCT with bilateral focal dissemination – 7 Roncoleukin® infusions: 3 injections during the first week by 1 mg at 48-hour intervals, then by 1 mg twice a week during two weeks. The recommended course of immunotherapy should be completed 7 to 10 days before surgical intervention.
• Roncoleukin® prescription for pulmonary tuberculosis is inexpedient in case of body weight deficit of more than 30%.
• The course of Roncoleukin® treatment of disseminated and locally advanced forms of renal cell cancer includes:
• – A single p/c or intravenous injection of the drug at a dose of 0.5 mg 24 hours prior to surgery;
• – as part of an 8-week course of immunochemotherapy at 2.0 mg v/v every other day during the first four weeks of treatment. Repeated courses are carried out after 1 to 2 months.
• In children Roncoleukin® is administered intravenously by IV drip. The regimen of administration corresponds to that for adults. The drug is diluted in sodium chloride 0.9% isotonic solution for injection. The single dose of the drug and volume of isotonic solution in children depend on their age:
• – 0 to 1 month. – 0.1 mg in 30-50 ml of solution;
• – 1 month to 1 year – 0.125 mg in 100 ml of solution;
• – 1 month to 7 years – 0.25 mg in 200 ml of solution;
• – over 7 years of age – 0.5 mg in 200 ml of solution;
• – over 14 years of age – 0.5 mg in 400 ml of solution.