Leaflet VIDACULEM 25mg / ml powder and solvent for injection suspension
Indicated for: myelodysplastic syndromes; acute myeloid leukemia
Route of administration: injectable
Substance: azacitidine (antimetabolite antineoplastic)
ATC: L01BC07 (Antineoplastic and immunomodulating agents | Antimetabolites | Pyrimidine analogues)
This medicine may affect fertility.
Dose adjustment may be needed in liver disease.
Handle with special care.
Effective contraception is required during treatment.
Do not use this medicine while breastfeeding.
Do not use this medicine during pregnancy.
This medicine may affect the liver.
This medicine may have important interactions with other medicines.
This medicine may lower blood cell counts.
This medicine is subject to additional monitoring.
Periodic laboratory tests may be required during treatment.
Stop taking the medicine and seek urgent medical help if a severe rash occurs.
Azacitidine is a hypomethylating agent used in the treatment of myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML) in patients who are not eligible for intensive chemotherapy. It works by inhibiting DNA methyltransferases, reducing DNA methylation, and reactivating tumor suppressor genes.
Azacitidine is administered as subcutaneous or intravenous injections, usually for 7 consecutive days in a 28-day cycle. The treatment aims to improve blood cell production, reduce the need for transfusions, and prolong survival.
Common side effects include nausea, vomiting, diarrhea, fatigue, and bone marrow suppression, which can lead to anemia, neutropenia, and thrombocytopenia. In rare cases, severe allergic reactions or serious infections may occur. Regular monitoring of hematological parameters is essential during treatment.
Azacitidine represents an important therapeutic option for patients with hematologic malignancies, contributing to improved quality of life and prognosis.
General data about VIDACULEM 25mg / ml
- Substance: azacitidine
- Date of latest medicines list: 01-04-2022
- Product code: W68486001
- Concentration: 25mg / ml
- Pharmaceutical form: powder and solvent for injection suspension
- Quantity: 1
- Product type: Generic medicine
- Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.
Pharmaceutical forms available for azacitidine
Concentrations available for azacitidine
- 200mg
- 25mg/ml
- 300mg