Leaflet AZACITIDINA DR REDDY'S 25mg / ml powder for suspension for injection

Product code:
W72233001
Indicated for:
myelodysplastic syndromes; acute myeloid leukemia
Route of administration:
injectable
Substance:
azacitidine (antimetabolite antineoplastic)
ATC
L01BC07 — Antineoplastic and immunomodulating agents | Antimetabolites | Pyrimidine analogues
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 AZACITIDINA DR REDDY'S 25mg / ml

Substance:
azacitidine
Product code:
W72233001
Concentration:
25mg / ml
Pharmaceutical form:
powder for suspension for injection
Product type:
Generic medicine
Prescription status:
S — Medicines dispensed with a restricted medical prescription, reserved for use in certain specialized fields.

Marketing authorisation

Manufacturer:
BETAPHARM ARZNEIMITTEL GMBH - GERMANIA
Holder:
DR. REDDY'S LABORATORIES ROMANIA S.R.L. - ROMANIA
Number:
16890/2026/01
Shelf life:
3 years-after packaging for sale;after reconstituting the solution-it is used immediately

Concentrations available for azacitidine

  • 200mg
  • 25mg/ml
  • 300mg

Precautions:

Fertility warning

This medicine may affect fertility.

Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Cytotoxic / special handling

Handle with special care.

Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hepatotoxicity

This medicine may affect the liver.

Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions

Stop taking the medicine and seek urgent medical help if a severe rash occurs.