Alexan Ebewe 50 mg/mL solution for injection/infusion (cytarabine) – chemotherapy for leukaemia and non-Hodgkin lymphoma

Alexan Ebewe contains cytarabine, a cytotoxic medicine from the antimetabolite group (pyrimidine analogue) used to treat malignant blood diseases. It is usually given together with other anticancer medicines, following a protocol set for the specific disease.

The form currently authorised in Serbia is Alexan Ebewe 50 mg/mL solution for injection/infusion in a 10 mL vial (500 mg cytarabine). It is prescribed only by haematologists or oncologists experienced in chemotherapy and is given only in specialised clinics.

When is Alexan Ebewe (cytarabine) used and what should patients know during chemotherapy?

Key facts about the medicine

What is Alexan Ebewe used for?

According to the patient leaflet, cytarabine is used alone or with other chemotherapy medicines in adults and children to treat:

• acute myeloid leukaemia (AML)
• acute lymphoblastic leukaemia (ALL)
• chronic myeloid leukaemia (CML)
• intermediate and high-grade non-Hodgkin lymphomas (e.g. lymphoblastic and Burkitt lymphoma)
• prevention and treatment of leukaemia in the central nervous system (intrathecally, alone or with methotrexate and corticosteroids)

How is it used and dosed?

The medicine is given only by medical staff, and the dose and schedule depend on the protocol, the disease and the patient’s body surface area. Cytarabine is not active when taken by mouth. It is given as an intravenous infusion or injection, subcutaneously or intrathecally; for infusion it is diluted with 0.9% sodium chloride or 5% glucose solution. Indicative doses from the information for healthcare professionals:

• remission induction: 100–200 mg/m² daily, as a continuous or rapid infusion, for 5–10 days
• maintenance: usually 70–200 mg/m² daily as a rapid IV or subcutaneous injection for 5 days at 4-week intervals, or once a week
• high-dose therapy: 1–3 g/m² as an IV infusion over 1–3 hours every 12 hours for 4–6 days
• intrathecal: 5–75 mg/m², most commonly 30 mg/m² every 4 days until the cerebrospinal fluid is clear (preservative-free diluent)

Treatment is stopped or modified if the platelet count falls below 50,000/mm³ or the polymorphonuclear count below 1,000/mm³.

Special patient groups

• Children: the medicine is also used in children within appropriate protocols (e.g. BFM); serious neurological events have been reported in children and young people when cytarabine was given IV with intrathecal methotrexate.
• Older people (>55 years): with high doses, neurological side effects may be more frequent.
• Liver impairment: use with caution and at a reduced dose.
• Kidney impairment: according to the Summary of Product Characteristics, dose reduction does not appear to be necessary, but kidney function is monitored regularly.

Contraindications – when the medicine must not be used

The medicine must not be used:

• if you are allergic to cytarabine or any of the excipients
• in anaemia, leukopenia or thrombocytopenia of non-malignant origin (e.g. bone marrow aplasia), unless the benefit outweighs the risk
• in degenerative and toxic encephalopathies, especially after methotrexate or radiation
• during breastfeeding

Precautions and warnings

• Great caution is needed in patients who have recently received radiotherapy or other cytotoxic medicines.
• Hyperuricaemia may occur due to breakdown of tumour cells – uric acid is monitored and prophylaxis given.
• Simultaneous granulocyte transfusion should be avoided because of the risk of severe respiratory failure.
• With intrathecal use, radiotherapy is not given at the same time.
• The medicine contains 2.7 mg sodium per mL – relevant for people on a salt-restricted diet.
• Cytarabine is mutagenic and carcinogenic in animals, which is taken into account in long-term treatment.

Interactions with other medicines, alcohol and food

Tell your doctor if you use: 5-flucytosine (antifungal – cytarabine may reduce its effect), digoxin or beta-acetyldigoxin (levels may fall), gentamicin, or medicines containing cyclophosphamide, vincristine and prednisone. Live and attenuated vaccines are not given during treatment. The medicine is physically incompatible with heparin, insulin, methotrexate, 5-fluorouracil and some antibiotics in the same solution.

Pregnancy and breastfeeding

Cytarabine may harm the unborn baby. Pregnancy should be avoided while the woman or her partner is receiving the medicine; men and women use effective contraception during treatment and for at least 6 months afterwards. Breastfeeding must be stopped before treatment begins.

Driving and using machines

Cytarabine does not affect intellectual or psychomotor function, but patients receiving chemotherapy may have a reduced ability to drive. If you feel unwell, do not drive or use machines.

Possible side effects

• Very common: low red and white blood cell and platelet counts, liver damage, jaundice, rash, bleeding of the skin and mucous membranes, gastrointestinal bleeding, chest pain, irritation or sepsis at the injection site.
• Common: anaemia, decreased appetite, increased uric acid, disturbances of consciousness and speech, dizziness, haemorrhagic conjunctivitis, keratitis, difficulty swallowing, nausea, vomiting, diarrhoea, abdominal pain, inflammation and sores in the mouth or around the anus, raised liver enzymes, hives, vasculitis, kidney impairment, fever.
• Uncommon: sepsis, pneumonia, headache, peripheral neuropathy, paraplegia with intrathecal use, pericarditis, breathing difficulty, oesophagitis, peritonitis, skin ulcers, joint and muscle pain.
• Very rare: severe spinal cord toxicity, arrhythmia, anaphylaxis, pancreatitis.
• With high doses: very common eye infection, irritation, pain and blurred vision; common hair loss; uncommon blistering of the hands and feet.

Suspected side effects can be reported to the doctor or to the Medicines and Medical Devices Agency of Serbia (ALIMS).

Overdose, missed dose and stopping treatment

• Overdose: there is no specific antidote; treatment is stopped and bone marrow depression is managed with transfusions and antibiotics as needed; the doctor may use haemodialysis.
• Missed dose: the medicine is given in hospital, so a missed dose is unlikely; if you think a dose was not given, talk to your doctor.
• Stopping treatment: the doctor decides when to stop; if you wish to stop earlier, discuss it with them first.

Composition, packaging and manufacturer

• Active substance: cytarabine – 1 mL solution contains 50 mg cytarabine; a 10 mL vial contains 500 mg cytarabine.
• Excipients: sodium lactate solution 60%, lactic acid, water for injections.
• Appearance and pack: clear, colourless solution; 20 mL glass vial containing 10 mL solution, 1 vial per carton.
• Marketing authorisation holder: Representative office of Sandoz Pharmaceuticals d.d. Belgrade. Manufacturer: Fareva Unterach GmbH, Austria.
• ALIMS authorisation: 515-01-03326-21-001 of 31.05.2022.

Storage

• Store below 25 °C in the original package to protect from light.
• Shelf life: 2 years. From a microbiological point of view the diluted solution is used immediately, and for no longer than 24 hours at 2–8 °C if dilution was not performed under validated aseptic conditions.
• Handling and disposal are carried out by the healthcare institution according to the rules for cytotoxic medicines.

Frequently asked questions

Can Alexan Ebewe be obtained at a pharmacy?

No. The medicine may be used only in inpatient healthcare institutions and is given by medical staff as part of a chemotherapy protocol.

Why are blood tests taken so often during cytarabine treatment?

Cytarabine strongly suppresses the bone marrow. Regular blood counts show when treatment needs to be adjusted or paused; values may keep falling for another 5–7 days after stopping.

Which vaccines can be given during treatment?

Live or attenuated vaccines can cause serious infections in immunocompromised patients. Any vaccination during and after chemotherapy is decided by the treating doctor.

How long is contraception needed?

According to the Summary of Product Characteristics, men and women should use effective contraception during treatment and for 6 months after it ends.

Sources

• ALIMS – Patient leaflet Alexan® Ebewe, 50 mg/mL, solution for injection/infusion (May 2022)
• ALIMS – Summary of Product Characteristics Alexan® Ebewe, 50 mg/mL (authorisation 515-01-03326-21-001)
• ALIMS – New authorisations and renewals 01.04.–30.06.2022 (Alexan® Ebewe 50 mg/mL, 1 × 10 mL, 31.05.2022)

Sources checked on: 23 October 2026.