Interleukin-2 human recombinant - instructions for use, dose, side effects, contraindications

Clinical and pharmacological group: & nbsp

Interleukins

Included in the formulation

Roncoleukin®

solution d / infusion PC

STRATEGY, LLC Russia

АТХ:

L.03.A.C Interleukins

Pharmacodynamics:

The drug is a functional and structural analogue of endogenous human interleukin-2. Interleukin-2 binds and activates receptors to interleukin-2, leading to increased differentiation and proliferation of T lymphocytes and dependent on interleukin-2 cell populations (macrophages, monocytes, Langerhans cells, oligodendroglial cells). The drug stimulates the activity of cytotoxic Tlymphocytes and natural killers, enhances the immune response, promotes the activation of tumor-infiltrating cells and the formation of lymphokine-activated killers,the production of interferon-γ, tumor necrosis factor, interleukin-1.

Expansion of the spectrum of the lysis effect of effector cells causes the elimination of a variety of pathogenic microorganisms, infected and malignant cells, which provides immune protection directed against tumor cells, as well as pathogens of viral, bacterial and fungal infections.

Pharmacokinetics:

The drug is metabolized similarly to endogenous human interleukin-2.

Indications:

As part of complex therapy, u of adults:

- 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 carcinoma.

As part of complex therapy, u children from 0 years:

- usual variable immunodeficiency;

- combined immunodeficiency;

acute peritonitis;

acute pancreatitis;

- osteomyelitis;

- severe pneumonia;

- bacterial sepsis of newborns;

- sepsis;

- other generalized and severe localized infections.

ICD-10

I.A15-A19.A15 Tuberculosis of respiratory organs, confirmed bacteriologically and histologically

I.A30-A49.A40 Streptococcal septicemia

I.A30-A49.A41 Other septicemia

I.A30-A49.A41.9 Septicemia, unspecified

II.C64-C68.C64 Malignant neoplasm of kidney, except for renal pelvis

III.D80-D89.D81 Combined immunodeficiencies

III.D80-D89.D83 Common variable immunodeficiency

III.D80-D89.D84.9 Immunodeficiency, unspecified

X.J10-J18.J12 Viral pneumonia, not elsewhere classified

X.J10-J18.J15 Bacterial pneumonia, not elsewhere classified

X.J10-J18.J16 Pneumonia caused by other infectious agents, not elsewhere classified

X.J10-J18.J18 Pneumonia without clarification of the pathogen

XI.K65-K67.K65.0 Acute peritonitis

XI.K80-K87.K85 Acute pancreatitis

XIII.M86-M90.M86 Osteomyelitis

XIV.N70-N77.N71 Inflammatory diseases of the uterus, except the cervix

XV.O85-O92.O85 Postpartum sepsis

XVI.P35-P39.P36 Bacterial sepsis of newborn

XIX.T79.T79.3 Post-traumatic wound infection, not elsewhere classified

Contraindications:

- autoimmune diseases;

heart failure of grade III;

- pulmonary heart failure of III degree;

- metastatic brain damage;

- terminal stage of renal cell carcinoma;

- Pregnancy;

- hypersensitivity to yeast;

- Hypersensitivity to interleukin-2 or any component of the drug in anamnesis.

Carefully:

In chronic renal failure, decompensated hepatic insufficiency.

Pregnancy and lactation:

FDA recommendation category C. The drug is contraindicated in pregnancy and lactation. There is no information on the penetration into breast milk.In view of the potential risk of undesirable effects on the child during interleukin-2 treatment, breastfeeding is recommended to be discontinued.

Dosing and Administration:

Interleukin-2 is administered 1 time per day subcutaneously or intravenously by 0.5-1.0 mg at intervals of 1-3 days, on the course - 1-3 administration. 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 dropwise for 4-6 hours.

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

When treatment of severe sepsis spend from one to three courses of treatment with the drug. 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 is the lymphopenia persisting during treatment (absolute and / or relative).

When the first time detected infiltrative destructive pulmonary tuberculosis - 3 intravenous infusions of the drug at a dose of 0.5 mg at an interval of 48 h against a background of specific polychemotherapy.

For preoperative preparation with progressive fibrous-cavernous pulmonary tuberculosis against the background of specific polychemotherapy: with unilateral fibro-cavernous tuberculosis - 3 intravenous injections of 1 mg every 48 hours; with disseminated fibrous-cavernous pulmonary tuberculosis with bilateral focal dissemination - 7 intravenous injections of the drug: 3 injections during the first week for 1 mg at intervals of 48 hours, then 1 mg twice a week for 2 weeks. The recommended course of immunotherapy should be completed 7-10 days before surgery.

Appointment of the drug for pulmonary tuberculosis is inappropriate with a body weight deficit of more than 30%.

Course of drug treatment Disseminated and locally advanced forms of renal cell carcinoma includes:

- a single subcutaneous or intravenous injection of the drug at a dose of 0.5 mg for 24 hours before the operation;

- as part of an 8-week course of immunochemotherapy, 2.0 mg intravenously every other day for the first 4 weeks of treatment. Repeated courses take place after 1-2 months.

Have children the drug is used intravenously drip. Schemes of application correspond to those of adults. The drug is diluted in isotonic (0.9%) sodium chloride solution. A single dose of the drug and the volume of isotonic solution in children depends on the 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.

Side effects:

From the side of the blood: anemia, leukopenia, thrombocytopenia.

From the cardiovascular system: increased capillary permeability and reduced vascular resistance, leading to hypotension, decreased organ perfusion and edema (occurs more often with intravenous than with subcutaneous injection, may require infusion therapy and pressor administration) and accompanied by cardiac disorders (tachycardia, coronary heart disease, heart attack myocardium), kidney function (uremia, oligo- and anuria), CNS (irritability, depression, confusion, drowsiness) and respiratory disorders (dyspnea, swelling lungs, respiratory failure).

From the digestive tract: gastrointestinal disorders (antiemetic and anti-diarrheal drugs may be required).

From the nervous system: confusion, drowsiness, progressing to coma (in severe cases, cancellation of treatment).

Dermatological: reactions and necrosis of tissues at the injection site, hypersensitivity, skin itch and skin rashes (possibly using antihistamines).

Other: increased activity of hepatic enzymes, flu-like syndrome (chills, fever, arthralgia, myalgia, possible use of paracetamol, but not other non-steroidal anti-inflammatory drugs, bacteremia (when interleukin-2 is administered through venous catheters and possibly subcutaneously), hypothyroidism, goiter.

Overdose:

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

Treatment: these symptoms stop after the withdrawal of the drug, if necessary, symptomatic therapy.

Interaction:

The drug is compatible with other medicines.

When using interleukin-2 drug against the background of long-term therapy with glucocorticosteroids, the activity of the drug may decrease.

Iodixanol - patients who took less than 2 weeks before the study of interleukin-2, are prone to an increased incidence of delayed adverse reactions (flu-like conditions or skin reactions).

It should be taken into account that the risk of developing a reaction to the introduction of yoxagolic acid and yoxythalamic acid (skin rash or, more rarely, hypotension, oliguria and kidney failure) increases if the patient has previously received intravenous therapy with interleukin-2.

The drug should not be mixed with other medicinal products in one syringe or vial.

Special instructions:

Fast intravenous the introduction may be accompanied by the development of cardiovascular failure.

When stored at a temperature of 2 to 8 ° C, sodium lauryl sulfate crystals may precipitate, which must dissolve at room temperature for 30 minutes. To accelerate the dissolution, it is possible to tilt the ampoule, avoiding a sharp mixing of the liquid and foaming.

Impact on the ability to manage motor transport and other technical devices

Special studies of the effect of the drug on the ability to drive vehicles and use complex equipment were not conducted. In the case of unwanted reactions on the part of the visual organ and / or a decrease in the ability to concentrate and respond quickly, patients are advised to refrain from driving vehicles or working with complex equipment until such unwanted reactions are resolved.

Instructions

Interleukin-2 human recombinant (Interleukinum-2 humanum recombinans)