Leaflet DECITABINA EVER PHARMA 50mg powder for concentrate for solution for infusion

Product code:
W71944001
Indicated for:
hematologic malignancies
Route of administration:
infusion
Substance:
decitabine (antimetabolite antineoplastic)
ATC
L01BC08 — 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.

Decitabine is a hypomethylating agent used for the treatment of myelodysplastic syndromes and acute myeloid leukemia. It works by inhibiting DNA methyltransferase, leading to the reactivation of tumor suppressor genes and inhibition of cancer cell growth.

The medication is administered via intravenous infusion, usually in treatment cycles, with the dose adjusted based on the patient's condition and response to therapy. Common side effects include nausea, anemia, neutropenia, and thrombocytopenia.

Decitabine is contraindicated in patients with hypersensitivity to the active substance or any of its excipients. Its use also requires careful monitoring to prevent severe hematological complications.

This medication is an important option for patients with malignant hematological disorders, helping to improve their prognosis.

General data about DECITABINA EVER PHARMA 50mg

Substance:
decitabine
Product code:
W71944001
Concentration:
50mg
Pharmaceutical form:
powder for concentrate for solution for infusion
Product type:
Generic medicine
Prescription status:
S — Medicines dispensed with a restricted medical prescription, reserved for use in certain specialized fields.

Marketing authorisation

Manufacturer:
EVER PHARMA JENA GMBH - GERMANIA
Holder:
EVER VALINJECT GMBH - AUSTRIA
Number:
16628/2026/01
Shelf life:
2 years-after packaging for sale;after reconstituting the solution-it is used immediately

Concentrations available for decitabine

  • 40mg
  • 50mg