Combined anticancer treatment of acute lymphoblastic leukemia in children and adults, and non-Hodgkin's lymphoma in children.
Composition:
1 vial contains 5,000 IU or 10,000 IU asparaginase.
Action:
Enzyme catalyzing the cleavage of L-asparagine to aspartic acid and ammonia. The maximum activity in the inhibition of proliferation is observed in the post-G1 phase of the cell cycle. Asparaginase is believed to work by reducing the concentration of L-asparagine in leukemic cells. Treatment with L-asparaginase induces the cleavage of the amino acid L-asparagine, which leads to the inhibition of protein synthesis. Repeated daily administration of the preparation leads to a cumulative increase in the concentration of the drug in the blood and persisting for over one week at the level that can be determined. L-asparaginase is a protein that is virtually unabsorbed after oral administration. After intravenous administration of T0,5 is 14-22 h. The drug penetrates into the reticuloendothelial system and as a protein it is broken down into peptides and amino acids.
Contraindications:
Hypersensitivity to the components of the preparation, including a history of allergic reactions to asparaginase obtained from the strainE. coli. Pancreatitis (currently or in an interview).
Precautions:
Before starting treatment and before resuming treatment, a skin sensitization or intradermal injection should be performed; It is also recommended to conduct an intravenous allergic test in the case of intravenous administration of the drug. During treatment should monitor the level of Glucose in the urine and blood and blood amylase levels; in case of pancreatitis, asparaginase should be discontinued. Due to the possibility of pancreatic pancreatic cysts, the patient should be monitored at this angle for up to 4 months after the last administration of the drug.
Pregnancy and lactation:
Do not use during pregnancy unless clearly necessary. Use effective contraception during and at least 3 months after completing asparaginase therapy. Do not use during breast-feeding.
Side effects:
Common: increase in body temperature. Uncommon: allergic reactions (rash, urticaria), blood coagulation disorders and fibrinolysis, nausea, vomiting, lack of appetite. Rare: breathing difficulties (in individual cases leading to an anaphylactic shock), life-threatening hyperpyrexia, pancreatic function disorders, acute pancreatitis, decreased glucose tolerance, decreased insulin levels, liver dysfunction, increased transaminases, alkaline phosphatase, LDH and bilirubin in the blood, thromboembolism, thrombosis, increased urea nitrogen, prerenal metabolic imbalances, hyperuricemia, lethargy, pathological drowsiness, confusion. Very rare: hemorrhagic pancreatitis, ketoacidosis, decreased albumin in the blood, thrombus in blood vessels (thrombus with emboli), bleeding (haemorrhage with stroke and loss of consciousness), cramps. Isolated cases: toxic epidermal necrolysis, pseudocyst cysts, cholestasis, jaundice, hepatic cell necrosis, haemolytic anemia, transient hypothyroidism, thyroxine-binding globulin.
Dosage:
Intramuscularly or intravenously. The drug should only be administered by a doctor with experience in antitumor therapy using cytostatics. Monotherapy is used only in exceptional situations, usually intravenously at a dose of 200 IU / kg. daily for adults and children. In combined treatment in the stages of induction, reinduction and consolidation, different doses of asparaginase are administered at different rates - from 3,000 IU / m22 pc. daily up to 45,000 IU / day2 pc. per day. Large doses can only be administered intravenously. The average dose for intramuscular injections is 100-400 IU / kg, respectively. daily and 3,000-3,000 IU / day2 per day. Do not give more than 5,000 IU. in 2 ml to one injection site; using more than 5,000 IU. in one dose, the drug should be given in several injections into different places. In case of continuous intravenous infusion after preparing the solution according to the instructions, the calculated amount of asparaginase should be dissolved in 250-500 ml of 0.9% NaCl solution or in a 5% glucose solution and infused over several hours. To prepare the solution, inject 2 ml (4 ml) of water for injections into the vial of powder, respectively; inject carefully, not on the substance, but on the inside wall of the vial. The solution thus prepared can be used without further dissolution for intramuscular injections.
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