Aldesleykïn

When ATH:
L03AC01

Characteristic.

Interleukin-2 analogue, produced via recombinant DNA technology, chain genes using interleukin-2 E.coli; It is chemically: Des-alanyl-1, serine-125 chelovecheskiy interleukin-2. White or off-white, sterile, containing no preservatives lyophilized powder.

Pharmacological action.
Immunomodulatory.

Application.

Metastatičeskaâ počečno-kletočnaâ cancer, melanoma (complementary therapies).

Contraindications.

Hypersensitivity; status of patients with ECOG scale (шкала ECOG — см. "Cautions") ≥2; status of patients with ECOG ≥1 scale and presence of metastases to more than one body at less than 24 months from the time of diagnosis of the primary tumor; respiratory dysfunction; severe diseases of the cardiovascular system; infectious diseases, requiring antibiotic treatment; CNS metastases; convulsions.

Restrictions apply.

Autoimmune diseases, leukopenia (менее 4·10⁹/l, thrombocytopenia (менее 100·10⁹/l, pregnancy, allograft organ, reproductive age (reliable contraception), childhood (safety and effectiveness in children have not identified).

Pregnancy and breast-feeding.

When pregnancy is possible, if the effect of therapy outweighs the potential risk to the fetus (safety of use during pregnancy is not established).

Category actions result in FDA - C. (The study of reproduction in animals has revealed adverse effects on the fetus, and adequate and well-controlled studies in pregnant women have not held, However, the potential benefits, associated with drugs in pregnant, may justify its use, in spite of the possible risk.)

During the period of lactation should decide the issue of termination of breastfeeding (unknown, Do penetrates aldesleukin passes into breast milk of nursing women).

Side effects.

From the nervous system and sensory organs: change in mental status or consciousness (ažitaciâ, confusion, depression, drowsiness, unusual tiredness), dizziness, memory disorders, of view, speeches, motor dysfunction, convulsions, coma.

Cardio-vascular system and blood (hematopoiesis, hemostasis): low blood pressure, Arrhythmia, sinus tachycardia, angina, myocardial infarction, anemia, thrombocytopenia, leukopenia, leukocytosis, eozinofilija, clotting disorder.

From the respiratory system: breathlessness, cough, dyspnoea, tachypnea, pneumothorax.

From the digestive tract: nausea, vomiting, taste disturbances, diarrhea, dyspepsia, gastritis, stomatitis, increased levels of bilirubin, transaminases, Alkaline phosphatase, ascites, gepatomegaliya.

With the genitourinary system: oligurija, anurija, proteinuria, hematuria, dizurija.

On the part of the musculoskeletal system: myalgia, arthralgia, arthritis.

For the skin: эritema, itch, rash.

Other: swelling, incl. with symptoms of peripheral nerve compression or vessels (tingling in the hands and feet), fever and / or chills, gipotireoz, giperglikemiâ, hyperkalemia, hypocalcemia, weight gain, conjunctivitis.

Cooperation.

Glucocorticoids may reduce the antitumor activity Aldesleukin (however shown, Glucocorticoids, especially dexamethasone, can reduce the adverse effects of aldesleukin, incl. elevated body temperature, the severity of renal failure, giperbilirubinemiû, confusion and shortness of breath). Beta-blockers and other antihypertensive drugs may increase hypotension. Co-administration of drugs with hepatotoxic, nephrotoxic, myelotoxic cardiotoxic and may lead to increased toxicity in the corresponding organs and systems.

Overdose.

Symptoms: increased severity of side effects.

Treatment: removal of the drug, maintenance therapy, при необходимости — в/в введение дексаметазона.

Dosing and Administration.

B /, n / a. Первый индукционный цикл взрослым — непрерывная 5-дневная в/в инфузия в дозе 1 mg / m²/d, 2-6 day interval after a 5-day infusion is repeated at the same dose; второй индукционный цикл — через 3 Sun. In patients with positive dynamics possible to 4 induction loops.

Precautions.

When treating Aldesleukin patients should be under a doctor's supervision, with experience of chemotherapy. In case of side effects infusion should be stopped until the complete disappearance of toxic reactions, and then resume at half dose. Be sure to pass the patients before and after treatment the following tests: standard hematological studies with a certain amount of blood cells, biochemical analysis of blood electrolyte composition, kidney and liver function tests, X-ray of the chest. Since aldesleukin stimulates the secretory processes serous membranes, increasing the amount of effusion, necessary before the therapy and during its control functional state of lungs, to conduct treatment of opportunistic infections. Be wary appointed in the elderly (increased risk of toxicity). Patients reproductive age (both sexes) aldesleukin apply only when using reliable contraception.

Cautions.

Evaluation of physical condition on a scale ECOG (Eastern Cooperative Oncology Group):

0 - Normal physical activity of the patient;

1 - The presence of the patient's clinical symptoms, requiring outpatient care;

2 - The patient on bed rest at least 50% time;

3 - The patient on bed rest over 50% time;

4 - The patient is bedridden.

Cooperation