Roncoleukin^® (Solution) Instructions for Use

Marketing Authorization Holder

Strategy, LLC (Russia)

Manufactured By

Biotech, LLC (Russia)

Contact Information

NPK BIOTEKH, LLC (Russia)

ATC Code

L03AC (Interleukins)

Dosage Forms

	Roncoleukin®	Solution for infusion and subcutaneous administration 1 mg/1 ml: amp. 3 or 5 pcs.
		Solution for infusion and subcutaneous administration 250 mcg/1 ml: amp. 3 or 5 pcs.
		Solution for infusion and subcutaneous administration 500 mcg/1 ml: amp. 3 or 5 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion and subcutaneous administration transparent, colorless or light yellow in color.

Excipients: sodium lauryl sulfate – 2.5 mg, mannitol – 12.5 mg, dithiothreitol – 0.08 mg, ammonium bicarbonate – 0.79 mg, water for injection – up to 1 ml.

1 ml – ampoules (3) – carton packs.
1 ml – ampoules (5) – carton packs.

Solution for infusion and subcutaneous administration transparent, colorless or light yellow in color.

Excipients: sodium lauryl sulfate – 5 mg, mannitol – 25 mg, dithiothreitol – 0.08 mg, ammonium bicarbonate – 0.79 mg, water for injection – up to 1 ml.

1 ml – ampoules (3) – carton packs.
1 ml – ampoules (5) – carton packs.

Solution for infusion and subcutaneous administration transparent, colorless or light yellow in color.

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.

1 ml – ampoules (3) – carton packs.
1 ml – ampoules (5) – carton packs.

Clinical-Pharmacological Group

Interleukin. A drug with antitumor and immunomodulatory activity

Pharmacotherapeutic Group

Cytokine

Pharmacological Action

Recombinant interleukin-2 (rIL-2), a structural and functional analog of endogenous interleukin-2 (IL-2).

IL-2 is produced by a subpopulation of T-lymphocytes (T-helper 1) 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 target cells.

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

The expansion of the lytic action spectrum of effector cells leads to the elimination of various pathogenic microorganisms, infected and malignant cells, providing immune defense directed against tumor cells, as well as pathogens of viral, bacterial, and fungal infections.

Pharmacokinetics

Pharmacokinetic data for the drug Roncoleukin^® are not provided.

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;
• Other generalized and severe localized infections;
• Infected thermal and chemical burns;
• Disseminated and locally advanced forms of renal cell carcinoma.

As part of complex therapy in children from 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.

ICD codes

Dosage Regimen

Roncoleukin^® is administered once daily subcutaneously or intravenously by drip at a dose of 0.5-1.0 mg with intervals of 1-3 days, for a course – 1-3 administrations. For intravenous administration, the drug is transferred from the ampoule into 400 ml of isotonic sodium chloride solution for injection. The entire volume of the solution is infused by drip over 4-6 hours.

The drug solution must be transparent, colorless, and free from foreign particles.

Immunotherapy with the drug Roncoleukin^® is carried out after the completion of emergency and urgent surgical interventions aimed at eliminating life-threatening consequences of the underlying disease/trauma, and after sanitation and adequate drainage of the infectious focus.

In the treatment of severe sepsis, from 1 to 3 courses of treatment with the drug Roncoleukin^® are conducted. 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 treatment with the drug Roncoleukin^® is persistent lymphopenia (absolute and/or relative) during treatment.

For newly diagnosed infiltrative destructive pulmonary tuberculosis – 3 intravenous infusions of the drug Roncoleukin^® at a dose of 0.5 mg with an interval of 48 hours against the background of specific polychemotherapy.

For preoperative preparation in progressive fibrocavernous tuberculosis (FCT) of the lungs against the background of specific polychemotherapy: for unilateral FCT – 3 intravenous administrations of the drug Roncoleukin^® at 1 mg with an interval of 48 hours; for widespread FCT of the lungs with bilateral focal dissemination – 7 intravenous administrations of the drug Roncoleukin^®: 3 administrations during the first week at 1 mg with an interval of 48 hours, then 1 mg 2 times a week for 2 weeks. The recommended course of immunotherapy should be completed 7-10 days before the surgical intervention.

Prescribing the drug Roncoleukin^® for pulmonary tuberculosis is not advisable with a body weight deficit of more than 30%.

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

• A single subcutaneous or intravenous administration 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 intravenously every other day during the first 4 weeks of treatment. Repeat courses are conducted after 1-2 months.

In children, Roncoleukin^® is used intravenously by drip. The administration schemes correspond to those in adults. The drug is diluted in isotonic (0.9%) sodium chloride solution. The single dose of the drug and the volume of isotonic solution in children depend on age

• From 0 to 1 month – 0.1 mg in 30-50 ml of solution;
• From 1 month 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 – 0.5 mg in 200 ml of solution;
• Over 14 years – 0.5 mg in 400 ml of solution.

Adverse Reactions

Systemic reactions in some cases, the appearance of short-term chills and an increase in body temperature during the administration of the drug Roncoleukin^® is possible, which is relieved by conventional therapeutic means and is not a basis for interrupting the administration of the drug or canceling the course of therapy.

Local reactions with subcutaneous administration of the drug, pain, induration, and redness at the injection site were noted.

Contraindications

• Autoimmune diseases;
• Stage III heart failure;
• Stage III cardiopulmonary failure;
• Metastatic brain lesion;
• Terminal stage of renal cell carcinoma;
• Pregnancy;
• Hypersensitivity to yeast;
• History of hypersensitivity to interleukin-2 or any component of the drug.

With caution in chronic renal failure, decompensated hepatic failure.

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy.

Use in Hepatic Impairment

With caution in decompensated hepatic failure.

Use in Renal Impairment

With caution in chronic renal failure.

Pediatric Use

Used according to indications

Special Precautions

Effect on ability to drive vehicles and mechanisms

No special studies on the effect of the drug on the ability to drive vehicles and use complex equipment have been conducted. In case of adverse reactions from the organ of vision and/or decreased ability to concentrate and speed of reaction, patients are recommended to refrain from driving vehicles or working with complex equipment until these adverse reactions resolve.

Overdose

Symptoms of overdose were observed when taking the drug Roncoleukin^® in a single dose above 7 mg in the form of fever, heart rhythm disturbances, hypotension, dermatological allergic reactions.

Treatment these symptoms are relieved after discontinuation of the drug administration; if necessary, symptomatic therapy is carried out.

Drug Interactions

Treatment with the drug Roncoleukin^® can be combined with treatment with all other medicines.

When using the drug Roncoleukin^® against the background of long-term therapy with glucocorticosteroids, the activity of the drug may decrease.

Roncoleukin^® should not be mixed with other medicines in the same syringe or vial.

Storage Conditions

The drug should be stored out of the reach of children at a temperature of 2°C (35.6°F) to 8°C (46.4°F).

Shelf Life

Shelf life – 2 years.

Transportation is allowed at a temperature from 9°C (48.2°F) to 25°C (77°F) for 10 days.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.