Roncoleukin ampoules 1000000me №3

Dosage form

Solution for infusion and subcutaneous administration

Packing

3 ampoules.

Mechanism of action

Roncoleukin - a drug with antitumor and immunomodulatory activity. The active ingredient of the drug is human recombinant interleukin-2 (interleukin-2), is a complete structural and functional analogue of endogenous interleukin-2, isolated from cells of the recombinant strain of the yeast Saccharomycesrerevisiae; represented by the reduced form of the molecule.

Interleukin-2 is produced by a subpopulation of T-lymphocytes (T-helper I) in response to antigen stimulation. Synthesized Interleukin-2 acts on T-lymphocytes, enhancing their proliferation and the subsequent synthesis of Interleukin-2.
The biological effects of Interleukin-2 are mediated by its binding to specific receptors present on various cellular targets.

Interleukin-2 has a direct effect on the growth, differentiation and activation of T- and B-lymphocytes, monocytes, macrophages, oligodendroglial cells, Langerhans cells. The development of cytolytic activity of natural killer cells and cytotoxic T-lymphocytes depends on its presence. Interleukin-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.

Indications and usage

As part of complex therapy in adults:
- The usual 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.

As part of complex therapy in children from birth:
- The usual variable immunodeficiency;
- combined immunodeficiency;
- acute peritonitis;
- acute pancreatitis;
- osteomyelitis;
- severe pneumonia;
- bacterial sepsis of newborns;
- sepsis;
- other generalized and severe localized infections.

Contraindications

Hypersensitivity to interleukin-2 or to 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 care: at a chronic renal failure, a decompensated liver failure.

Dosage and administration

Roncoleukin is administered 1 time per day subcutaneously or intravenously in a 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 of impurities.

Immunotherapy with Roncoleukin is carried out after the completion of emergency and urgent surgical interventions aimed at eliminating the life-threatening consequences 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 criterion for the appointment of the second and third courses of Roncoleukin is continued lymphopenia (absolute and / or relative) during treatment.

For the first time revealed infiltrative destructive pulmonary tuberculosis - 3 in / in the infusion of Roncoleukin in 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:
with unilateral PCT - 3 in / in the introduction of Roncoleukin 1 mg with an interval of 48 hours;
in case of widespread PCT of the lungs with bilateral focal dissemination - 7 intravenous infusions of Roncoleukin: 3 injections during the first week, 1 mg at intervals 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.
Appointment of Roncoleukin with pulmonary tuberculosis is impractical with a body mass deficit of more than 30%.

The course of treatment for Roncoleukin disseminated and locally advanced forms of renal cell carcinoma includes:
- a single dose or in / in 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.

In children, Roncoleukin is administered intravenously. Schemes of use correspond to those in adults. The drug is diluted in isotonic sodium chloride solution with 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 - pain, induration, redness at the injection site.

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

Drug Interactions

Treatment with Roncoleukin can be combined with treatment with all other drugs.

With the use of Roncoleukin on the background of long-term therapy with glucocorticosteroids, the activity of the drug may be reduced.
Roncoleukin should not be mixed with other drugs in the same syringe or vial.

Overdosage

Symptoms: fever, heart rhythm disturbance, hypotension, dermatological allergic reactions. These side effects stop after the abolition of the drug, if necessary, symptomatic therapy.

Storage conditions

Store at temperatures from 2 ° C to 8 ° C out of the reach of children. Transportation is allowed at a temperature of from 9 ° C to 25 ° C for 10 days.