New Pathway Identified: Splenic Tr1 Cells Drive Transplant Tolerance via Areg–EGFR Signaling
January 8, 2026
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Brand Name :
Onureg
(United States) [Available] ,Vidaza
(United States) [Available]Synonyms :
azacitidine (Rx)
Class :
Antineoplastic agents & Antimetabolite
Brand Name :
Onureg
(United States) [Available] ,Vidaza
(United States) [Available]Synonyms :
azacitidine (Rx)
Class :
Antineoplastic agents & Antimetabolite
ADULT DOSING
Dosage Forms & Strengths
Suspension, Injection:
100 mg
Tablet, Oral:
200 mg
300 mg
300
mg
Orally
once a day
14
days
for 28 days cycle
Initial:
75
mg/m^2
Intravenous (IV)
once a day
7
days
of the 28-day cycle.
If no improvement is observed, the dose can be increased to 100 mg/m^2 IV.
Off-label:
1st Treatment Cycle:
75
mg/m²
Subcutaneous (SC) or intravenously (IV)
every day
7
days
Subsequent Treatment Cycles:
Every 4 weeks, repeat the cycles
If no therapeutic impact is shown after two treatment cycles and no harm other than nausea and vomiting has occurred, the dose may be increased to 100 mg/m2
Patients should receive treatment for a minimum of 4 to 6 cycles
However, more treatment cycles might be necessary for a full or partial response
As long as the patient keeps getting well, the treatment may be continued
PEDIATRIC DOSING
Dosage Forms & Strengths
Suspension, Injection:
100 mg
Tablet, Oral:
200 mg
300 mg
Children > 2 years and adolescents:
75
mg/m^2
Subcutaneous (SC)
once a day
7
days
Or
300 mg/m^2 IV once a day for 2 days.
Children > 2 years and adolescents:
75
mg/m^2
Subcutaneous (SC)
once a day
7
days
Or
300 mg/m^2 IV once a day for 2 days.
Refer to adult dosing
it may diminish the excretion rate when combined with corifollitropin alfa resulting in an enhanced serum level
tinidazole has the potential to reduce the rate of excretion of azacitidine, potentially leading to an elevation in level of serum
The potential for bleeding risk or its seriousness may elevate when azacitidine is used together with troxerutin
When mometasone furoate is used together with azacitidine, this leads to enhanced risk or seriousness of adverse outcomes
When azacitidine is used together with capsaicin, this leads to enhanced risk or seriousness of methemoglobinemia
When azacitidine is used together with andrographolide, this leads to enhanced risk or seriousness of bleeding
azacitidine leads to a reduction in the rate of excretion of eucalyptus oil which leads to increased level of serum
cefpirome leads to a reduction in the rate of excretion of azacitidine which leads to increased level of serum
azacitidine leads to a reduction in the rate of excretion of chromous sulfate, which leads to an increased level of serum
azacitidine leads to a reduction in the rate of excretion of pentaerythritol tetranitrate, which leads to an increased level of serum
azacitidine leads to a reduction in the rate of excretion of potassium acetate, which leads to an increased level of serum
azacitidine leads to a reduction in the rate of excretion of potassium perchlorate, which leads to an increased level of serum
the risk or intensity of negative effects can be heightened when azacitidine is combined with filgotinib
azacitidine may decrease the excretion rate of almasilate, leading to higher serum levels
may increase the risk or severity of toxic effects when combined
the efficacy of the vaccine may be reduced
the risk of adverse effects can be increased
the risk of adverse effects may be increased
the risk of adverse effects may be increased
azacitidine might lead to a reduction in the rate of excretion of telavancin, potentially leading to elevated levels of serum
Action and Spectrum:
azacitidine is a nucleoside analogue that is used as a chemotherapy drug for the treatment of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). It works by causing DNA hypomethylation, leading to abnormal gene expression and inhibition of cell division, causing the death of rapidly dividing cells.
azacitidine is used to treat MDS and AML, particularly in patients who are not eligible for more intensive chemotherapy regimens. It can be administered orally or intravenously. The spectrum of activity of azacitidine includes the ability to induce differentiation and apoptosis of cancer cells, leading to a reduction in the size of the cancer cell population.
Frequency defined:
>10%:
Chest pain
Erythema of skin
Skin rash
Abdominal pain
Constipation
Nausea
Vomiting
Anemia
Leukopenia
Anxiety
Dizziness
Limb pain
Arthralgia
Dyspnea
Pneumonia
Fever
1%-10%
Atrial fibrillation
Hypertension
Orthostatic hypotension
Septic shock
Frequency not defined
Hepatic coma
rigors
Azacitidine does not carry a formal FDA Black Box Warning
Contraindications
Azacitidine is contraindicated in patients with advanced malignant liver tumors when given intravenously or subcutaneously. It should also not be used in individuals with known hypersensitivity to azacitidine, mannitol (for IV/SC use), or any of its ingredients (for oral use).
Cautions
Oral azacitidine must not replace IV or SC forms, as incorrect substitution can lead to fatal toxicity or ineffective treatment. It is not recommended for MDS patients outside clinical trials, and its use during pregnancy may harm the fetus. Azacitidine can cause severe bone marrow suppression, requiring regular CBC monitoring and supportive care. Tumor lysis syndrome may occur even with preventive therapy. Patients with liver disease are at increased risk of hepatic failure, especially with low albumin. Renal toxicity, including renal failure and tubular acidosis, has been reported—renal function and electrolytes must be closely monitored, especially in at-risk patients.
Pregnancy consideration: Based on animal studies, it may cause harm to patients who can become pregnant.
Lactation: excretion of azacitidine in breast milk is not known.
Pregnancy category:
Pharmacology
Azacitidine is a pyrimidine nucleoside analog of cytidine with antineoplastic and hypomethylating properties. It is primarily used in the treatment of myelodysplastic syndromes (MDS) and juvenile myelomonocytic leukemia (JMML), among other hematologic malignancies.
Pharmacokinetics
Absorption
Azacitidine is quickly absorbed after subcutaneous administration, reaching peak levels (750 ng/mL) in 0.5 hours. Its bioavailability is about 89% compared to IV, with dose-proportional exposure and no accumulation on repeated dosing.
Distribution
After IV administration, the volume of distribution is approximately 76 liters, suggesting wide tissue distribution. Protein binding data is not available
Metabolism
Azacitidine is not metabolized by cytochrome P450 enzymes. It undergoes spontaneous hydrolysis and enzymatic deamination by cytidine deaminase.
Elimination/Excretion
The drug and its metabolites are mainly excreted in urine. In patients given radioactive azacitidine IV, 85% of the dose was recovered in urine, with less than 1% excreted in feces over 3 days.
The mean half-life is about 41 minutes after SC dosing, while the elimination half-life for azacitidine and its metabolites is approximately 4 hours for both IV and SC routes.
Pharmacodynamics
Azacitidine induces DNA hypomethylation at concentrations that do not significantly inhibit DNA synthesis. This hypomethylation may help restore normal gene function involved in cell differentiation and growth. Clinical evidence in juvenile myelomonocytic leukemia shows reduced methylation in bone marrow cells after the first treatment cycle, confirming this effect.
However, azacitidine is associated with adverse effects such as anemia, neutropenia, and thrombocytopenia in both adults with myelodysplastic syndrome and children with JMML. It also carries risks of renal toxicity, tumor lysis syndrome, fetal harm, and liver toxicity, particularly in patients with severe liver impairment.
Azacitidine can be administered via intravenous (IV), subcutaneous (SC), or oral routes. The method of administration should match the prescribed formulation, as they are not interchangeable.
Patient information leaflet
Generic Name: Azacitidine
Pronounced: aza-sy-ti-din
Why do we use azacitidine?
Azacitidine is an antimetabolites chemotherapeutic drug. It is used to treat myelodysplastic syndrome and a certain type of leukemia.
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