Leaflet VIDACULEM 25mg / ml powder and solvent for injection suspension

Product code:
W68486001
Quantity:
1
Indicated for:
myelodysplastic syndromes; acute myeloid leukemia
Route of administration:
injectable
Substance:
azacitidine (antimetabolite antineoplastic)
ATC
L01BC07 — Antineoplastic and immunomodulating agents | Antimetabolites | Pyrimidine analogues

Precautions:

Fertility warning

Fertility warning

This medicine may affect fertility.

Dose adjustment in hepatic impairment

Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Cytotoxic / special handling

Cytotoxic / special handling

Handle with special care.

Contraception required

Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding

Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy

Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hepatotoxicity

Hepatotoxicity

This medicine may affect the liver.

Major drug interactions

Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis

Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring

Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests

Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions

Severe skin reactions

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.

Marketing authorisation

Manufacturer:
SEACROSS PHARMA (EUROPE) LIMITED - IRLANDA
Holder:
BIO EEL S.R.L. - ROMANIA
Number:
14151/2021/01
Shelf life:
3 years-after packing for marketing; after the first opening of the bottle-it is used immediately

Concentrations available for azacitidine

  • 200mg
  • 25mg/ml
  • 300mg