Myelodysplastic syndromes, chronic myelomonocytic leukaemia, acute myeloid leukaemia

Indication for Azacitidine

Population group: Suitable for both men and women, only adults (18 years old or older)

Azacitidine is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:

  • intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),
  • chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder,
  • acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification,
  • AML with >30% marrow blasts according to the WHO classification.

For this indication, competent medicine agencies globally authorize below treatments:

75 mg/m² once daily

Route of admnistration


Defined daily dose

75 - 75 mg per m² of body surface area (BSA)

Dosage regimen

From 75 To 75 mg per m² of body surface area (BSA) once every day for 7 day(s)

Detailed description

The recommended starting dose for the first treatment cycle, for all patients regardless of baseline haematology laboratory values, is 75 mg/m² of body surface area, injected subcutaneously, daily for 7 days, followed by a rest period of 21 days (28-day treatment cycle).

It is recommended that patients be treated for a minimum of 6 cycles. Treatment should be continued as long as the patient continues to benefit or until disease progression.

Dosage considerations

Azacitidine should be injected subcutaneously into the upper arm, thigh or abdomen. Injection sites should be rotated. New injections should be given at least 2.5 cm from the previous site and never into areas where the site is tender, bruised, red, or hardened.

Active ingredient

Azacitidine is believed to exert its antineoplastic effects by multiple mechanisms including cytotoxicity on abnormal haematopoietic cells in the bone marrow and hypomethylation of DNA. The cytotoxic effects of azacitidine may result from multiple mechanisms, including inhibition of DNA, RNA and protein synthesis, incorporation into RNA and DNA, and activation of DNA damage pathways.

Read more about Azacitidine

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