Roncoleukin solution for infusion and subcutaneous injection 0.5mg/ml ampoules 1ml, 3pcs

Composition

Active ingredients:  

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;

dithiotreitol-0.08 mg;

ammonium bicarbonate-0.79 mg;

water for injection-up to 1 ml

Pharmacological action

Pharmacotherapy group

Cytokine

ATX

code

L03AC Pharmacological (immunobiological) properties

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

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

IL-2 specifically 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 killers and cytotoxic T-lymphocytes depends on its presence. IL-2 causes the formation of lymphokine-activated killers and activates tumor-infiltrating cells.

The expansion of the spectrum of lysing action of effector cells leads to the elimination of various pathogenic microorganisms, infected and malignated cells, which provides immune protection directed against tumor cells, as well as pathogens of viral, bacterial and fungal infections.

Indications

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 carcinoma. for children from 0 years of age: common 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 any component of the drug in the anamnesis; allergy to yeast; pregnancy; autoimmune diseases, stage III heart failure, stage III pulmonary heart failure, metastatic brain damage, end-stage renal cell carcinoma. Use caution in patients with chronic renal failure, decompensated hepatic insufficiency.

Side effects

In some cases, during the use of Roncoleukin®, short-term chills and an increase in body temperature may occur, which is stopped by conventional therapeutic means and is not a reason for interrupting the use of the drug, as well as the course of treatment. Local reactions were observed with subcutaneous use of the drug-soreness, compaction, redness at the injection site.

Interaction

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

How to take, course of use and dosage

Ronkoleukin® is administered 1 time a day subcutaneously or intravenously in drops of 0.5-1.0 mg at intervals of 1-3 days, for a course of 1-3 injections. For intravenous use, the drug is transferred from the ampoule to 400 ml of an isotonic sodium chloride solution for injection. Infusion of the entire volume of the solution is carried out dropwise for 4-6 hours. The solution of the drug should be transparent, colorless and free of foreign inclusions.

Roncoleukinomide immunotherapy is performed after the completion of urgent 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 2 are performed. 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 B is the lymphopenia that persists during treatment (absolute and/or relative).

If infiltrative destructive pulmonary tuberculosis is detected for the first time,3 intravenous infusions of Roncoleukin® at a dose of 0.5 mg with an interval of 48 hours against the background of specific chemotherapy.

For preoperative preparation for progressive fibrocavvernous tuberculosis (FCT) of the lungs against the background of specific polychemotherapy:

in unilateral Fkt – 3 in/in the introduction of Roncoleukin® 1 mg every 48 hours;in advanced Fkt lungs with bilateral focal dissemination – 7 in/in introductions Roncoleukin®: 3 introduction during the first week of 1 mg every 48 hours, then 1 mg twice a week for two weeks. The recommended course of immunotherapy should be completed 7-10 days before surgery.

The use of Roncoleukin® in pulmonary tuberculosis is impractical if the body weight is more than 30% deficient.

The course of treatment with Roncoleukin®for disseminated and locally advanced forms of renal cell carcinoma includes:

– single subcutaneous or intravenous use of the drug at 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 for the first four weeks of treatment. Repeated courses are carried out in 1-2 months.

For children Roncoleukin is administered intravenously by drip. The application regimens correspond to those for adults. The drug is diluted in an isotonic 0.9% sodium chloride solution for injection. The single dose of the drug and the volume of isotonic solution in children depends on age:

– from 0 to 1 months. – 0.1 mg 30-50 ml;

– from 1 month. up to 1 year – 0.125 mg in 100 ml;

– from 1 year to 7 years – 0.25 mg in 200 ml;

– 7 years and older – 0.5 mg in 200 ml;

– 14 years and older – 0.5 mg in 400 ml of solution.

Overdose

Overdose manifestations were observed with a single dose of Roncoleukin® above 7 mg in the form of fever, cardiac arrhythmia, hypotension, dermatological allergic reactions. These side effects are stopped after discontinuation of the drug, if necessary, symptomatic therapy is performed.

Special instructions

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

Form of production

Roncoleukin solution for infusion and subcutaneous use is clear, colorless or light yellow in color.

Storage conditions

The drug is stored at a temperature of 2°C to 8°C. Transportation is allowed at temperatures from 9°C to 25°C for 10 days.

Shelf life

2 years

Active ingredient

Interleukin 2

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection and infusion