Roncoleukin - Instructions For Use, Price, Reviews, Analogs, Dosage

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Roncoleukin

Roncoleukin: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Roncoleukin

ATX code: L03AC

Active ingredient: interleukin-2 human recombinant (Interleukin-2 human recombinant)

Manufacturer: BIOTECH, NPK (Russia)

Description and photo updated: 2019-27-08

Prices in pharmacies: from 1880 rubles.

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Roncoleukin is a drug used to provide the body's immune defense against tumor cells and pathogens of bacterial, fungal, viral infections.

Release form and composition

The drug is produced in the form of a solution for intravenous (i / v) infusion and subcutaneous (s / c) administration: colorless or light yellow transparent liquid, at a storage temperature of 2 to 8 ° C (in the refrigerator), precipitation of sodium lauryl sulfate crystals, dissolving, is allowed within ½ hour at room temperature; to accelerate the dissolution of the sediment, it is allowed to gently tilt the ampoule without stirring its contents in order to avoid foaming (1 ml in ampoules, in a cardboard box of 3 or 5 ampoules and instructions for using Roncoleukin).

Composition of 1 ml solution (IU - international units):

• Active substance (active substance): recombinant human interleukin-2 (rIL-2) - 0.25, 0.5 or 1 mg (250,000, 500,000 or 1,000,000 ME, respectively);
• Auxiliary components: mannitol, sodium lauryl sulfate, ammonium bicarbonate, dithiothreitol, water for injection.

Pharmacological properties

Pharmacodynamics

Recombinant interleukin-2 (rIL-2) is a structural and functional analogue of endogenous interleukin-2 (IL-2).

IL-2 is produced by a subpopulation of T-lymphocytes (T-helpers I) in response to antigenic stimulation. The synthesized IL-2 has an effect on T-lymphocytes, which leads to an increase in their proliferation and the subsequent synthesis of IL-2.

The biological effects of IL-2 are based on its binding to specific receptors, which are presented on various cellular targets.

IL-2 has a directed effect on the growth, differentiation and activation of macrophages, monocytes, T- and B-lymphocytes, oligodendroglial cells, Langerhans cells. Its presence determines the development of cytolytic activity of natural killer cells and cytotoxic T-lymphocytes. IL-2 leads to the formation of lymphokine-activated killers and the activation of cells infiltrating the tumor.

Expansion of the spectrum of the lyzing action of effector cells contributes to the elimination of various pathogenic microorganisms, malignant and infected cells, this provides immune protection, which is directed against tumor cells, as well as pathogens of bacterial, viral and fungal infections.

Indications for use

Roncoleukin is used concurrently with other drugs.

In adults, the drug is prescribed for the following diseases / conditions:

• Infected burns (thermal and chemical);
• Combined immunodeficiency;
• Common variable immunodeficiency;
• Osteomyelitis;
• Pancreatitis in acute course;
• Peritonitis in acute course;
• Renal cell carcinoma (in locally advanced and disseminated forms);
• Sepsis (including sepsis after childbirth);
• Pulmonary tuberculosis;
• Severe pneumonia;
• Endometritis;
• Other generalized and severe localized infections.

From the moment of birth, the drug is prescribed to children for the treatment of such conditions / diseases:

• Sepsis, including bacterial sepsis of the newborn;
• Combined immunodeficiency;
• Common variable immunodeficiency;
• Osteomyelitis;
• Pancreatitis in acute course;
• Peritonitis in acute course;
• Severe pneumonia;
• Other generalized and severe localized infections.

Contraindications

• Yeast allergy;
• Autoimmune diseases;
• Pulmonary heart failure III degree;
• Heart failure III degree;
• Metastatic brain damage;
• End-stage renal cell carcinoma;
• Pregnancy period;
• Hypersensitivity to the components of the drug, including a history of data.

With decompensated liver failure and chronic renal failure, Roncoleukin is prescribed with caution.

Roncoleukin, instructions for use: method and dosage

Roncoleukin's solution is administered intravenously or subcutaneously.

For intravenous administration, the drug is transferred from the ampoule into isotonic sodium chloride solution for injection (400 ml). The infusion of the entire volume is carried out by drip slowly, over 4-6 hours.

For subcutaneous administration of the solution, the contents of 1 ampoule are diluted in 1.5-2 ml of isotonic sodium chloride solution or water for injection.

The solution should be inspected before use: it should be colorless, transparent and free of impurities.

The recommended dosage of Roncoleukin: 1 time per day, 0.5-1 mg with an interval of 1 to 3 days, 1-3 injections per course.

Immunotherapy with Roncoleukin should be carried out after the completion of urgent and urgent surgical interventions aimed at eliminating the life-threatening consequences of the underlying disease / injury, as well as sanitation and adequate drainage of the infectious focus.

Roncoleukin dosage depending on the condition / disease:

• Severe sepsis (surgical, post-traumatic, obstetric-gynecological, wound burns, etc.): from one to three courses, including 2 intravenous infusions at a dose of 0.5 mg with an interval of 1 day. The basis for the appointment of subsequent courses (second and third) is the relative and / or absolute lymphopenia that persists during therapy;
• Infiltrative destructive pulmonary tuberculosis, first identified: 3 intravenous infusions at a dose of 0.5 mg with an interval of 2 days (against the background of specific polychemotherapy);
• Progressive fibrous-cavernous tuberculosis (FCT) of the lungs against the background of specific polychemotherapy (preoperative preparation): unilateral FCT - 3 intravenous infusions of 1 mg with an interval of 2 days; common pulmonary fibrosis with bilateral focal dissemination - 7 intravenous infusions (3 injections during the first week, 1 mg with an interval of 2 days, then 1 mg 2 times a week for 2 weeks). The recommended course of immunotherapy should be completed 7-10 days before elective surgery;
• Renal cell carcinoma (disseminated and locally advanced forms): the course of therapy includes: a single administration of Roncoleukin (IV or SC) at a dose of 0.5 mg 1 day before the operation, as well as IV administration of the drug as part of an 8-week course immunochemotherapy, 2 mg every other day during the first 4 weeks of treatment (repeated courses of therapy are prescribed in 1-2 months).

With a body weight deficit of ≥30%, the appointment of a drug for the treatment of pulmonary tuberculosis is inappropriate.

Children are recommended to use the drug intravenously by drip according to the schemes similar to those for adults. For dilution, sodium chloride solution for injection isotonic 0.9% is used.

A single dose of the drug for the volume of the required isotonic solution for children (depending on age):

• Neonatal period (up to 1 month): 0.1 mg per 30-50 ml;
• 1-12 months: 0.125 mg per 100 ml;
• 1-7 years: 0.25 mg per 200 ml;
• 7-14 years old: 0.5 mg per 200 ml;
• From 14 years old: 0.5 mg per 400 ml.

Side effects

During the administration of Roncoleukin, a short-term chill and fever may appear. This condition of the patient is stopped by ordinary therapeutic drugs and cannot be a reason for stopping the administration of the solution, as well as interrupting the course of therapy. Subcutaneous administration of the drug may be accompanied by the following reactions at the injection site: soreness, redness, induration.

Overdose

Overdose is possible with the introduction of a single dose of Roncoleukin more than 7 mg, it is expressed in the form of hypotension, heart rhythm disturbances, fever, dermatological allergic reactions. After discontinuation of the drug, these side effects stop. If necessary, symptomatic therapy is recommended.

special instructions

Influence on the ability to drive vehicles and complex mechanisms

There have been no special studies on the effect of the drug on the ability to control complex mechanisms and drive vehicles. In this regard, patients should refrain from these types of activities with the development of undesirable effects on the part of the organ of vision and / or a decrease in the speed of psychomotor reactions and the ability to concentrate (until they are resolved).

Application during pregnancy and lactation

Roncoleukin is not prescribed during pregnancy.

There is no information on the use of the drug during lactation.

Pediatric use

The drug is used in children according to indications.

With impaired renal function

In chronic renal failure, Roncoleukin is prescribed under medical supervision.

For violations of liver function

In case of decompensated liver failure, Roncoleukin is prescribed under medical supervision.

Drug interactions

Roncoleukin therapy can be combined with treatment with any other drugs, but the solution cannot be mixed with them in the same bottle or syringe.

Against the background of prolonged use of glucocorticosteroids, the activity of Roncoleukin may decrease.

Analogs

Roncoleukin's analogues are: Betaleukin, Proleukin.

Terms and conditions of storage

Store out of the reach of children at a temperature of 2-8 ° C.

Shelf life is 2 years.

It can be transported no more than 10 days at a temperature of 9-25 ° С.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews of Roncoleukin

According to reviews, Roncoleukin is an effective drug. It is often prescribed as part of a comprehensive treatment. There are also reports of the development of severe side effects, sometimes requiring a long recovery period. The cost of the funds is assessed as high.

The price of Roncoleukin in pharmacies

Approximate prices for Roncoleukin are 1599-1966 rubles. (3 ampoules of 0.25 mg / ml) or 2999-3400 rubles. (3 ampoules of 0.5 mg / ml).

Roncoleukin: prices in online pharmacies

Drug name Price Pharmacy

Roncoleukin 250,000 IU solution for infusion and subcutaneous administration 1 ml 3 pcs. 1880 RUB Buy

Roncoleukin 0.5 mg / ml solution for infusion and subcutaneous administration 1 ml 3 pcs. 2176 RUB Buy

Roncoleukin 1,000,000 IU solution for infusion and subcutaneous administration 1 ml 3 pcs. RUB 6147 Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!