Leaflet DECITABINA TEVA 50mg powder for concentrate for solution for infusion

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 TEVA 50mg

  • Substance: decitabine
  • Date of latest medicines list: 01-06-2026
  • Product code: W71851001
  • Concentration: 50mg
  • Pharmaceutical form: powder for concentrate for solution for infusion
  • 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: SINDAN-PHARMA S.R.L. - ROMANIA
  • Holder: TEVA B.V. - TARILE DE JOS
  • Number: 16565/2026/01
  • Shelf life: 30 months-after packing for marketing;after the first opening of the bottle- it is used immediately

Concentrations available for decitabine

  • 40mg
  • 50mg