|The name of the preparation||Character; dose; package||Manufacturer||Price 100%||Price after refund||In which pharmacy?|
|Alexan||solution for injection; 20 mg / ml (100 mg / 5 ml); 1 fiol 5 ml||Ebewe Pharma||b / d||Check|
Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
It is an anticancer drug used in cancer Chemotherapy .
The active substance is cytarabine. It is an organic compound, nucleoside, built of cytosine and arabinose. It is an analogue of a Biol ogically active pyrimidine nucleoside, necessary for the synthesis of nucleic acids. The chemical similarity causes cytarabine to replace the biologically active metabolite in biochemical reactions. Due to this method of action belongs to a group of anti-cancer drugs called antimetabolites (it is a pyrimidine antimetabolite). Cytarabine is transformed in the cell into active metabolites that interfere with the synthesis and stability of DNA and RNA nucleic acids. This prevents cell division and leads to apoptotic cell death. Cytarabine is particularly involved in rapidly dividing cells such as cancer cells. The product limits cell division and thus the growth and development of cancer. It has a cytostatic effect. It is a chemotherapy used primarily in the treatment of various types of leukemia.
The preparation is indicated as monotherapy or in combination therapy in the initial and maintenance treatment:
• acute myeloid leukemia
• acute lymphoblastic leukemia
• leukaemic infiltrates in the central nervous system
• non-Hodgkin's lymphoma (non-Hodgkin's lymphoma).
The indications include treatment with high doses of refractory acute myeloid leukemias, refractory to treatment of acute lymphoblastic leukemias, refractory to non-Hodgkin's lymphoma, and blast crisis in chronic myeloid leukemia.
Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the preparation if you are allergic (you are hypersensitive) to any of the ingredients. Avoid using the product during pregnancy. The use of the preparation is contraindicated in women who are breast-feeding. Unless the doctor decides otherwise, the preparation should not be used in people who have already received a medicine that causes suppression of the bone marrow.
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In certain situations, it may be necessary to carry out specific check-ups. Treatment can only be carried out under the supervision of an oncologist (only hospital treatment) who has experience in the use of cancer chemotherapy.
The preparation administered as a quick intravenous injection results in fewer gastrointestinal side effects than the one given at the same dose as a slow intravenous infusion.
Caution should be exercised and the dose should be appropriately adjusted in case of liver dysfunction. Do not use the preparation in people with acute and / or severe infections. The preparation may cause eye or skin irritation. In case of accidental contact of the preparation with the skin surface, wash the contaminated area with plenty of water and soap.
During the treatment, the doctor will recommend daily hematological examinations because the treatment process is associated with the occurrence of temporary bone marrow suppression. There is a risk of severe leukopenia (reduction in the number of white blood cells [leukocytes] in blood counts) and / or thrombocytopenia (decrease in the number of platelets [thrombocytes] in blood counts). The results of hematological examinations may sometimes indicate the need for supportive treatment or placement of the patient in isolation to prevent systemic infections. The effectiveness of treatment is determined by the number of leukemic blasts in the blood and in the bone marrow.
Your doctor will regularly monitor your liver and kidneys.
The use of the preparation may lead to an increase in the concentration of uric acid in the blood due to the breakdown of neoblast cells. Your doctor will regularly monitor your uric acid levels. Depending on the results of the tests and in some clinical situations, the doctor may recommend the use of prophylaxis drugs and hyperuricemia control.
In some people, the use of the preparation may cause serious or life-threatening side effects from the central nervous, digestive or respiratory systems.
Patients with peptic ulcer disease and people after surgical procedures should be under special observation in order to exclude symptoms suggestive of hemorrhage. These patients may have an urgent need to transfuse platelets.
The use of high doses of the preparation may exacerbate its side effects and cause severe, sometimes fatal, toxic damage to the central nervous system, gastrointestinal tract and lungs. Common reversible brain or cerebellar dysfunction (personality changes, seizures, drowsiness, coma), hemorrhagic conjunctivitis or keratitis may occur (the doctor will prescribe prophylactic steroid drops during treatment with cytarabine), rash, increase in bilirubin in the blood, damage liver, perforation of the digestive tract, pancreatitis, pneumothorax, pericarditis.
Persons being treated with the preparation (both men and women) should absolutely consult a doctor about the use of effective contraception to prevent pregnancy during the treatment period and also for at least 6 months after its completion.
Does this preparation affect the ability to drive vehicles?
It is not recommended to drive or use machines because the ability to drive and use machines is limited during the treatment period. If you experience side effects such as vomiting, dizziness, blurred vision, do not drive or use machines or devices.
The preparation may be administered intravenously (in the form of an injection or infusion) or subcutaneously. Some forms of cancer require intrathecal applications. The preparation may only be administered by qualified medical personnel. If you have any doubts regarding the use of the preparation, consult a physician. The doctor will select the dosage schedule individually depending on the indication, the expected result, the clinical situation, and whether the preparation will be used as a monotherapy or as part of a multi-drug chemotherapy. During the treatment, the doctor will adjust the dosage depending on the results of hematology (white blood cell count, platelet count) and also depending on the severity of side effects (symptoms of toxic effects).
Remission induction (initial treatment):
100-200 mg / m2 body surface area per day, continuous or rapid infusion for 5-10 days. The duration of treatment and the number of treatment cycles depends on the results of haematological tests and bone marrow tests.
Remedy to maintain remission: usually 70-200 mg / m2 of body surface area per day, by rapid intravenous or subcutaneous injection for 5 days every 4 weeks (or once a week).
Treatment of non-Hodgkin's lymphoma (non-Hodgkin's lymphoma):
Adults: the dose depends on the treatment schedule chosen by the doctor; for example, it can be 300 mg / m2 of body surface area per day on the 8th day of the treatment cycle.
children: the dose depends on the severity of the disease and its type; your doctor may choose one of many effective dosing regimens and appropriate combination therapies.
Treatment with high doses: 1-3 g / m2 of body surface area in a 1-3-hour infusion, every 12 hours, for 4-6 days.
Treatment of leukemas localized within the central nervous system: usually 5-30 mg / m2 of the body surface, intrathecally, every 2-7 days.
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or plan to become pregnant, please inform the doctor prescribing the prescription for this medicine. Also, see the warnings in the "Take special care with the preparation" section.
In each case, an individual doctor will consider the expected benefits with respect to the potential risk to the fetus.
The preparation is contraindicated during breast-feeding.
Tell your doctor about all medicines you have recently taken, including those that are over the counter.
The preparation may reduce the effectiveness of other anticancer medicines, drugs that inhibit bone marrow function and radiotherapy (parallel or previous irradiation). Adequate dosage adjustment is necessary.
The preparation may reduce the absorption of Digoxin . The concentration of digoxin in the blood should be monitored.
The preparation may reduce the effect of Gentamicin againstKlebsiella pneumoniae.
In the case of combination therapy with other anticancer drugs (doxorubicin, Cisplatin , Methotrexate , vincristine, cyclophosphamide and others), toxic effects, in particular bone marrow toxicity, may be exacerbated.
Parallel use with fluorocytosine may reduce the efficacy of fluorocytosine.
Like all medicines, Alexan can also cause side effects, although they will not occur in all patients who use this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects. The severity of the side effects of the preparation may be greater if it is given in combination with other chemotherapeutics.
The most common side effects include gastrointestinal disorders: mucositis, inflammation and sores in the mouth, loss of appetite, abdominal pain, nausea, vomiting, diarrhea, inflammation and ulceration of the anus. It is also possible: inflammation and ulceration of the esophagus, intestinal pneumothorax, distressing colitis, perforation of the gastrointestinal tract, increase in liver enzymes, jaundice. Very often, a cytarabic syndrome may occur, with fever, muscle pain, bone pain, chest pain, rash, conjunctivitis, and nausea occurring within 6-12 hours of starting treatment. Frequently possible hematological disorders: leukopenia (reduction in the number of white blood cells [leukocytes] in blood counts), granulocytopenia (decrease in the number of granulocytes in blood counts), anemia, thrombocytopenia, megaloblastosis, bleeding. Possible sepsis. Possible hypersensitivity reactions (rash, pruritus, redness) as well as possible dangerous life-threatening Anaphylactic reactions . There may be: pruritus and skin changes, erythema, alopecia, freckles, pain in the hands and soles of the feet, inflammation of the connective tissue and tissue at the injection site, thrombophlebitis, fever, muscle and joint pain, kidney problems, urinary retention, arrhythmias heart, chest pain, pericarditis, pneumonia, shortness of breath, interstitial pneumonia, respiratory disorders, pneumothorax, hemorrhagic conjunctivitis, keratitis. In the case of treatment with high doses, frequent toxic effects on the brain or cerebellum with a decrease in consciousness, nystagmus, convulsions (after intrathecal administration), headaches and dizziness, neuritis. Occasionally, complete intra-ocular blindness, leukoencephalopathy leading to necrosis, paraplegia (bipolar paralysis) or quadriplegia may occur with intrathecal administration.
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