Cytosar lyophilisate for solution 100mg №1 bottle

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Cytosar lyophilisate for solution 100mg №1 bottle

Latin name 
Cytosar

Release form
Lyophilized powder for injection

Composition 
1 fl. contains cytarabine 500 mg

Packaging 
1 bottle

pharmachologic effect 
Cytosar is an anticancer drug from the group of antimetabolites - pyrimidine antagonists. Violates DNA synthesis by inhibiting DNA polymerase. In addition, it appears to be limitedly incorporated into RNA and DNA.

Indications 
- acute myeloblastic leukemia in children and adults (for the induction of remission and supportive treatment, including as part of combination therapy);
- acute lymphoblastic leukemia in children and adults (for the induction of remission and supportive treatment, including as part of combination therapy);
- chronic myeloid leukemia (blast crisis);
- erythroleukemia;
- Non-Hodgkin's lymphomas in children and adults (as part of combination therapy);
- Acute leukemia in children and adults (intrathecal administration).

Contraindications 
Hypersensitivity to the drug Cytosar.

Use during pregnancy and lactation
In connection with the potential for the development of anomalies as a result of cytostatic therapy, especially in the first trimester, pregnant women are warned of the potential danger to the fetus and the questionable feasibility of maintaining the pregnancy. There is a distinct, albeit less risk of conducting cytosar therapy in the second and third trimesters of pregnancy.
If necessary, the use of the drug during lactation should decide on the termination of breastfeeding.
Women of childbearing age should avoid conception during drug therapy.
In experimental studies found teratogenic effect of the drug.

Dosage and administration 
The dose of the drug requires constant modification in order to achieve the maximum clinical effect (determined by the state of peripheral blood and / or bone marrow) with the lowest possible toxic reactions. The dosage regimen is also determined by the applied basic program of cytotoxic chemotherapy, since Cytosar is used in the form of monotherapy with conventional doses or as part of high-dose chemotherapy programs, or as part of combination chemotherapy.
In acute myeloblastic leukemia, adults for induction of remission during chemotherapy with usual doses of Cytosar are prescribed 200 mg / m2 / day by continuous infusion for 5 days (120 hours), the total dose is 1000 mg / m2. This course is repeated every 2 weeks, depending on the hematological effect.
When using Cytosar in high-dose therapy programs, doses up to 3 g / m2 with 75-minute infusions every 12 hours for 1-6 days are prescribed. When used as part of a combination high-dose chemotherapy, the dose, duration and frequency of infusion are adjusted depending on the selected program. For example, when used simultaneously with L-asparginase, Cytosar is administered at 3 g / m2 with 3-hour infusions every 12 hours for 36 hours after the first injection, and asparginase is prescribed for 42 hours at a dose of 6000 IU / m2 (1-2 days The program is repeated on days 8-9 from the start of treatment.
When using combination chemotherapy programs, various combinations of drugs are used, depending on the clinical situation. Doxorubicin, thioguanine, daunorubicin, vincristine, prednisolone and other drugs can be used in conjunction with Cytosar. Dose, duration, frequency of appointment depends on the selected program. In this case, the average dose of Cytosar is 100 mg / m2 / day in the mode of continuous intravenous infusion for 7 days. After a 2–4 ​​week break with the persistence of the leukemic process, a repeated or modified course of combination chemotherapy may be required.
Maintenance therapy programs are modifications of induction programs and, in general, contain the same drug regimens. In most programs during the period of maintenance therapy, the interval between treatments is increased.
Induction of remission and maintenance therapy in children.
When using the same programs, the best response is achieved in the treatment of acute myeloblastic leukemia in children than in adults. The dose is determined based on the amount of body weight or surface area as well as in adults.
In acute lymphoblastic leukemia, the same average doses are prescribed per kg of mass or per m2 of patient's body surface.
Intrathecal use in neuroleukemia. Adults take Cytosar intrathecally at 5-75 mg / m2 with a frequency of application from 1 time / day for 4 days to 1 time in 4 days, depending on the type and severity of neurological symptoms and the effectiveness of previous therapy.The following procedure is most commonly used: 30 mg / m2 every 4 days until the composition of the cerebrospinal fluid is normalized, and then another supplementary administration.
Cytosar is administered intrathecally to children with simultaneous administration of Solute-Cortef and Methotrexate, both for prophylactic purposes in newly diagnosed acute lymphoblastic leukemia and for the treatment of neuroleukemia. The recommended doses are 30 mg / m2 Cytosar, 15 mg / m2 Tristeaf, 12 mg / m2 methotrexate.

Side effects 
Expected reactions from the hematopoietic system: anemia, leukopenia, thrombocytopenia, megaloblastosis, reduction in the number of reticulocytes, cellular changes in the morphology of bone marrow smears and peripheral blood.
On the part of the gastrointestinal tract: anorexia, abnormal liver function of varying severity, nausea, vomiting, diarrhea, inflammation or ulceration of the oral mucosa or anal area; rarely - abdominal pain, hyperbilirubinemia, jaundice, esophageal ulceration, esophagitis, liver abscess, small bowel necrosis, necrotic colitis; in some cases, peritonitis and acute pancreatitis.
On the part of the central nervous system: dizziness, headache, neuritis, neurotoxicity; with the use of high doses - dysfunction of the brain and cerebellum, personality changes, coma, peripheral neuropathy; in isolated cases - delayed ascending progressive paralysis.
On the part of the respiratory system: pneumonia; rarely - pulmonary edema, diffuse interstitial pneumonitis; in some cases, acute respiratory distress syndrome.
Allergic reactions: rash, fever; rarely - conjunctivitis, anaphylactic reactions, allergic edema, itching, urticaria, skin desquamation.
On the part of the urinary system: urinary retention, increased levels of uric acid in the blood plasma, impaired renal function.
Local reactions: pain and inflammation at the site of s / c injection, thrombophlebitis.
Other: skin pigmentation, alopecia, chest pain, feeling of lack of air, hemorrhagic conjunctivitis.
The development of Cytosar syndrome, characterized by fever, myalgia, bone pain, sometimes chest pain, maculo-papular rash, conjunctivitis and malaise, has been described.
After intrathecal administration of Cytosar, the development of paraplegia, leukoencephalopathy, and blindness is also described.

special instructions
Cytosar is used only by physicians with experience in antitumor therapy. During the period of induction of remission, patients should only be in a specialized hospital with appropriate laboratory and resuscitation services, as well as with the possibility of adequate replacement therapy.
The drug is prescribed only by pre-assessing the ratio of the potential benefits of using the drug for the patient and the risk of toxic effects.
Since the drug has a pronounced myelodepressive effect, the patients receiving it should be under careful medical supervision, and during the period of the induction of remission they need daily studies of the number of white blood cells and platelets. After the disappearance of blast cells from the peripheral blood, frequent bone marrow studies are performed.
When monitoring the effectiveness and safety of the drug should be borne in mind that reducing the number of leukocytes after five days of therapy at a dose of 50-600 mg / m2 is biphasic. Regardless of the initial leukocyte level, dose, or pattern of use, the initial 24 hours show an initial decrease, and the necessary blood formation depression is reached by days 7–9. This is followed by a short-term ascent with a maximum of about 12 days, with a second and deeper decrease, the necessary blood formation depression is noted in 15-24 days, then in the next 10 days the number of leukocytes quickly increases above the initial level. The decrease in the number of platelets becomes noticeable by 5 days, and the minimum occurs between 12-15 days, in the next 10 days their number quickly increases to a level higher than the initial one.
In the case when the number of platelets is reduced to 50,000 / μl or granulocytes to 1000 / μl, the question is raised about the termination or modification of therapy. The number of formed elements in the peripheral blood can continue to decrease after discontinuation of the drug and reach minimum values ​​in 12-24 days. Therapy is resumed in cases of clear signs of recovery of the bone marrow and the presence of evidence, without waiting for the normalization of peripheral blood, otherwise the process may get out of control.
Cytosar is used with caution in patients with previous drug myelodepression.
In patients with impaired liver and / or kidney function, the drug should be used with caution and in reduced doses.
In all patients receiving Cytosar, periodic monitoring of liver and kidney function is necessary.
In order to reduce nausea and vomiting, occurring against the background of rapid on / in the introduction of high doses of the drug and continuing for several hours after injection, it is recommended to inject the drug by continuous infusion.
When conducting high-dose therapy is not recommended to use a solvent containing benzyl alcohol.
In case of accidental contact with the skin, this area should be washed with running water and soap.

Drug interaction
With simultaneous use of Cytosar and digoxin, a decrease in the equilibrium plasma concentration of digoxin and its renal excretion is observed, which requires careful monitoring of the level of digoxin. The equilibrium plasma concentration of digitoxin does not change.
There is antagonism between gentamicin and cytosarum regarding the sensitivity of K. pneumoniae strains.
There is a possibility of reducing the effectiveness of fluorocytosine in its use with Cytosar.
The combined use of Cytosar and other anticancer drugs may mutually enhance the toxicity and immunosuppressive effects.
Pharmaceutical interaction.
Cytosar is physically incompatible with heparin, insulin, methotrexate, 5-fluorouracil, nafcillin, oxacillin, penicillin, sol-medrol.

Overdose 
There is no antidote that is applicable in overdose.

Storage conditions 
In the dark place at a temperature of no higher than 25 °.

Shelf life 
3 years.

It is a drug. Consultation with a doctor is required.