Description
Latin name
RONCOLEUKIN
Release form
Roncoleukin solution for infusion and sc administration is transparent, colorless or light yellow.
Packaging
3 ampoules per pack.
Pharmacological action of
Interleukin-2 is produced by a subpopulation of T-lymphocytes (T-helper cells I) in response to antigenic stimulation. The synthesized IL-2 acts on 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 directionally affects the growth, differentiation and activation of T and B lymphocytes, monocytes, macrophages, oligodendroglial cells, Langerhans cells. The development of the 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.
Extension of the lysing spectrum of effector cells leads to 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
As part of complex therapy in adults: common variable immunodeficiency
combined immunodeficiency
acute peritonitis, acute pancreatitis
osteomyelitis
endometritis
severe pneumonia
sepsis
puerperal sepsis
pulmonary tuberculosis and other severe generalized localized infections
infected thermal and chemical burns
and disseminated locally advanced RCC.
in children from 0 years: common variable immunodeficiency
combined immunodeficiency
acute peritonitis
acute pancreatitis
osteomyelitis
severe pneumonia
bacterial sepsis of newborns
sepsis localized sepsis other localized
Contraindications
Hypersensitivity to interleukin-2 or any component of the drug with a history of yeast allergy pregnancy autoimmune diseases, heart failure III stage, pulmonary heart failure III stage, metastatic brain damage, end stage renal cancer.
Precautions for chronic renal failure, decompensated liver failure.
Use during pregnancy and lactation
The drug is contraindicated in pregnancy.
Composition
active ingredients: human interleukin-2 recombinant 1 mg (1,000,000 IU)
excipients: sodium lauryl sulfate – 10 mg mannitol – 50 mg dithiothreitol – 0.08 mg ammonium bicarbonate – 0.79 mg water for injection – up to 1 ml.
Dosage and administration of
Roncoleukin ® is administered once a day subcutaneously or intravenously, in a dose of 0.5-1.0 mg at intervals of 1 to 3 days, for a course of 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 entire volume of the solution is carried out drip for 4-6 hours. The solution of the drug should be transparent, colorless and not contain impurities.
Immunotherapy with Roncoleukin ® is carried out after completion of emergency and urgent surgical interventions aimed at eliminating the life-threatening consequences of the underlying disease / injury, debridement and adequate drainage of the infectious focus.
In the treatment of severe sepsis, one to three courses of Roncoleukin ® are administered. The course includes 2 iv infusions at a dose of 0.5 mg every other day. The criterion for prescribing the second and third courses of Roncoleukin ® is the lymphopenia (absolute and / or relative) that persists during treatment.
With the first detected infiltrative destructive pulmonary tuberculosis – 3 on / in infusion of Roncoleukin ® at a dose of 0.5 mg with an interval of 48 hours on the background of specific chemotherapy.
For preoperative preparation for progressive pulmonary fibro-cavernous tuberculosis (FCT) with specific polychemotherapy: with unilateral FCT – 3 iv intravenous administration of Roncoleukin ® 1 mg every 48 hours with widespread pulmonary FCT with bilateral focal dissemination – 7 iv Roncoleukin ® 3 injections during the first week of 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 to 10 days before surgery.
Prescribing Roncoleukin ® for pulmonary tuberculosis is not practical with a body mass deficit of more than 30%.
The course of treatment with Roncoleukin ® disseminated and locally advanced forms of renal cell carcinoma includes:
– a single sc or intramuscular injection 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 during the first four weeks of treatment. Repeated courses are carried out after 1 – 2 months.
In children, Roncoleukin ® is administered intravenously. Dosage regimens correspond to those in adults. The drug is diluted in sodium chloride with an isotonic 0.9% solution 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.
Side effects
In some cases, during the administration of Roncoleukin ®, short-term chills and fever may occur, which stops with conventional therapeutic agents and is not a reason to interrupt the administration of the drug, as well as the course of treatment. With subcutaneous administration of the drug, local reactions were noted – pain, tightness, redness at the injection site.
Drug Interaction
Treatment with Roncoleukin ® can be combined with treatment with all other medicines. When using Roncoleukin ® against the background of long-term therapy with glucocorticosteroid drugs, the activity of the drug may be reduced. Roncoleukin ® should not be mixed with other medicines in a single syringe or vial.
Overdose
Overdose has been reported with a single dose of Roncoleukin ® above 7 mg in the form of fever, heart rhythm disorder, hypotension, dermatological allergic reactions. These side effects are stopped after the withdrawal of the drug, if necessary, symptomatic therapy.
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.
Expiration
2 years.
Active substance
Interleukin 2
pharmacy leave terms for
Biotech NPK, Russia
