Azacitidine tablets are an oral maintenance therapy. Correctly understanding the indicated population, contraindications, and special population medication rules is a prerequisite for ensuring efficacy and safety.
Indications of Azacitidine Tablets
Core Indications
(1) Azacitidine tablets are indicated for the continued treatment of adult patients with acute myeloid leukemia.
(2) Patients must meet the following criteria: have received intensive induction chemotherapy and achieved first complete remission or complete remission with incomplete blood count recovery; and are unable to receive intensive curative treatment (such as hematopoietic stem cell transplantation) due to age, performance status, or comorbidities.
Not for Induction Therapy
This drug is not intended for induction remission therapy in newly diagnosed AML, but rather for post-remission maintenance therapy to prolong overall survival and delay disease progression.
Not for Myelodysplastic Syndromes
(1) It is particularly important to note that the use of azacitidine tablets in patients with MDS is associated with an increased risk of early death (mainly due to sepsis), and its safety and efficacy have not been established.
(2) Use of azacitidine tablets to treat MDS outside of clinical trials is not recommended.
Contraindications and Food Restrictions of Azacitidine Tablets
Absolute Contraindications
(1) Patients with a history of severe allergic reaction to azacitidine or any of its excipients should not use this drug.
(2) Severe allergic reactions may manifest as rash, dyspnea, angioedema, or even anaphylactic shock.
Drug Substitution Contraindication
(1) Azacitidine tablets must not be substituted for intravenous or subcutaneous injectable azacitidine, and vice versa.
(2) The indications, recommended dosage, and administration schedules of the two formulations are significantly different.
(3) Using the injectable formulation at the oral tablet dose may lead to fatal adverse reactions; conversely, using the oral tablet at the injectable formulation dose may result in lack of efficacy.
Food Restrictions
(1) No specific foods are explicitly contraindicated at present.
(2) Azacitidine tablets can be taken with or without food.
(3) It should be noted that a high-fat, high-calorie meal reduces the peak drug concentration but has no significant effect on total exposure.
(4) To maintain stable plasma concentrations, take the drug at a fixed time each day and maintain a consistent dietary status.
Use of Azacitidine Tablets in Special Populations
Pregnant Women
(1) Contraindicated during pregnancy.
(2) Women of childbearing potential must have a pregnancy test before treatment, and must use effective contraception during treatment and for at least 6 months after the last dose.
Breastfeeding Women
Breastfeeding is not recommended.
Males of Reproductive Potential
Male patients with female partners of childbearing potential must use effective contraception during treatment and for at least 3 months after the last dose.
Elderly Patients
No overall differences in safety and efficacy were observed between elderly and younger patients; no dose adjustment is required based solely on age.
Patients with Renal Impairment
(1) Drug exposure is significantly increased in patients with severe renal impairment (creatinine clearance 15-29 mL/min).
(2) Such patients should be closely monitored for adverse reactions, and dose adjustment should be made based on blood counts and other parameters.
(3) No pre-dose adjustment is required for mild to moderate renal impairment.
Patients with Hepatic Impairment
(1) No dose adjustment is required for patients with mild to moderate hepatic impairment (total bilirubin ≤ ULN with AST > ULN, or total bilirubin 1-3 × ULN).
(2) No studies have been conducted in patients with severe hepatic impairment (total bilirubin > 3 × ULN), and caution should be exercised.
Pediatric Patients
The safety and efficacy of azacitidine tablets in pediatric patients have not been established; use is not recommended in individuals under 18 years of age.
