Alexan (cytarabine) solution 50 mg/ml. 20 ml. (1000 mg.) vial №1

Description

Composition

active ingredient: cytarabine;

1 ml of solution contains 50 mg of cytarabine;

Excipients: sodium lactate solution, lactic acid, water for injection.

Pharmacotherapeutic group.

Antineoplastic agents. Antimetabolites. Structural analogues of pyrimidine.

ATX code L01B C01.

Indications

Achievement and maintenance of remission in acute non-lymphoblastic leukemia in adults and children. Treatment of other types of leukemia, such as acute lymphocytic leukemia, chronic myeloid leukemia (blast crisis).

Prevention or treatment of leukemic meningitis intrathecally as monotherapy or in combination with other drugs (methotrexate, hydrocortisone).

Alexan® can be used as monotherapy or in combination with other antineoplastic agents; the best results are usually achieved with complex treatment. Remissions induced by Alexan® are short-lived without further maintenance therapy.

Therapy of leukemia with a high risk of complications, refractory leukemia and relapse of acute leukemia, regardless of the concomitant use of high doses of antitumor chemotherapeutic agents.

As part of combination therapy (LSA2L2) for the treatment of non-Hodgkin’s lymphomas in children.

Drugs, the active substance of which is cytarabine, have been experimentally used to treat various types of neoplasms. In general, a small number of patients with solid tumors had a positive response to treatment.

Contraindications

Hypersensitivity to the active substance or to any excipient.
Drug suppression of bone marrow function (subject to risk assessment and expected benefits).
During pregnancy, the drug should be administered only after assessing the risks and expected benefits (see section “Use during pregnancy or lactation”).
During lactation, the drug should be discontinued (see section “Use during pregnancy or lactation”).

Dosage and Administration

Treatment with Alexan should be carried out under the supervision of an experienced oncologist or hematologist in a specialized hospital with appropriate laboratory and resuscitation support.

Alexan can be used as monotherapy, but more often it is prescribed in combination with other cytotoxic drugs.

The use of solvents containing preservatives, in particular for intrathecal administration or in high-dose therapy, is prohibited.

The solution for infusion is prepared by diluting the drug with 0.9% sodium chloride solution or 5% glucose solution.

When administered by rapid infusion, patients may tolerate higher doses of cytarabine than when administered by slow infusion. This phenomenon is associated with rapid inactivation and short exposure to high concentrations of cytarabine following rapid administration of the drug. With both modes of application, normal and neoplastic cells respond to therapy in a similar way, so far no clear clinical advantage has been demonstrated by fast or slow intravenous infusion.

Doses and treatment regimens should be selected taking into account the diagnosis and condition of the patient.

Alexan® can be administered by infusion or injection, as well as subcutaneously and intrathecally. The standard dose for subcutaneous use is 20-100 mg/m2 depending on the indication and dosing regimen.