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Azacitidine: Drug information

Azacitidine: Drug information
(For additional information see "Azacitidine: Patient drug information" and see "Azacitidine: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Onureg;
  • Vidaza
Brand Names: Canada
  • NAT-AzaCITIDine;
  • Onureg;
  • REDDY-Azacitidine;
  • Vidaza
Pharmacologic Category
  • Antineoplastic Agent, Antimetabolite;
  • Antineoplastic Agent, DNA Methylation Inhibitor
Dosing: Adult

Note: Azacitidine is associated with a moderate emetic potential (ASCO [Hesketh 2020]; MASCC/ESMO [Roila 2016]); antiemetics are recommended to prevent nausea and vomiting. Do not substitute azacitidine tablets for azacitidine injection (or vice versa); indications, dosing regimens, and pharmacokinetics are different.

Acute myeloid leukemia, maintenance

Acute myeloid leukemia, maintenance (tablet): Oral: 300 mg once daily on days 1 to 14 of a 28-day treatment cycle (if complete remission following induction chemotherapy and unable to complete intensive curative therapy); continue until disease progression or unacceptable toxicity (Wei 2020). If ANC is <500/mm3 prior to the start of a cycle, delay the treatment cycle until ANC is ≥500/mm3.

Antiemetic prophylaxis : During the first 2 oral azacitidine cycles, administer an antiemetic 30 minutes prior to each dose; antiemetic prophylaxis may be omitted after 2 cycles if there has been no nausea and vomiting.

Missed dose: If an oral azacitidine dose is missed or not administered at the usual time, administer the dose as soon as possible on the same day and resume the normal schedule the following day; do not administer 2 doses on the same day. If the oral azacitidine dose is vomited, do not administer another dose on the same day; resume the normal schedule the following day.

Acute myeloid leukemia in patients requiring low-intensity therapy

Acute myeloid leukemia in patients requiring low-intensity therapy (injection; off-label use):

In combination with venetoclax: Adults ≥75 years of age and/or with comorbidities: IV, SUBQ: 75 mg/m2/day on days 1 to 7 of a 28-day treatment cycle (in combination with venetoclax); continue until disease progression or unacceptable toxicity (DiNardo 2020).

Single-agent therapy: SUBQ: 75 mg/m2/day for 7 days of a 28-day treatment cycle for at least 6 cycles; treatment may be continued as long as patient continues to benefit or until disease progression or unacceptable toxicity (Fenaux 2010). Dose reductions and/or therapy interruption may be required for hematologic toxicity; refer to protocol for details.

IDH1-mutated disease (in combination with ivosidenib): Adults ≥75 years of age and/or with comorbidities: IV, SUBQ: 75 mg/m2/day on days 1 to 7 of a 28-day treatment cycle or 75 mg/m2/day on days 1 to 5 and days 8 and 9 of a 28-day treatment cycle (in combination with ivosidenib) for a minimum of 6 cycles or until relapse, disease progression, or unacceptable toxicity (Montesinos 2022). Refer to protocol for additional details.

Myelodysplastic syndromes

Myelodysplastic syndromes (injection): IV, SUBQ: Initial cycle: 75 mg/m2/day for 7 days of a 28-day treatment cycle. Subsequent cycles: 75 mg/m2/day for 7 days every 4 weeks; dose may be increased to 100 mg/m2/day if no benefit is observed after 2 cycles and no toxicity other than nausea and vomiting have occurred. Patients should be treated for a minimum of 4 to 6 cycles; treatment may be continued as long as patient continues to benefit.

Note: Alternate (off-label) schedules (which have produced hematologic response) have been used for convenience in community oncology centers (Lyons 2009):

SUBQ: 75 mg/m2/day for 5 days (Monday to Friday), 2 days rest (Saturday, Sunday), then 75 mg/m2/day for 2 days (Monday, Tuesday); repeat cycle every 28 days or

SUBQ: 50 mg/m2/day for 5 days (Monday to Friday), 2 days rest (Saturday, Sunday), then 50 mg/m2/day for 5 days (Monday to Friday); repeat cycle every 28 days or

SUBQ: 75 mg/m2/day for 5 days (Monday to Friday), repeat cycle every 28 days.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Injection:

Kidney impairment at baseline:

No dosage adjustment necessary (Krens 2019). Azacitidine and its metabolites are excreted renally; monitor closely for toxicity.

Hemodialysis: No dosage adjustment necessary (Krens 2019).

Kidney toxicity during treatment: Unexplained increases in BUN or serum creatinine: Delay next cycle until values reach normal or baseline, then reduce azacitidine dose by 50% for next treatment course.

Oral: CrCl 15 to 89 mL/minute: No dosage adjustment necessary; monitor patients with CrCl 15 to 29 mL/minute more frequently and modify dosage for adverse reactions.

Dosing: Hepatic Impairment: Adult

Injection: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Advanced malignant hepatic tumors: Use is contraindicated.

The following adjustments have also been recommended:

Mild or moderate impairment: No need for dosage adjustment is expected (Krens 2019).

Albumin <30 g/L: Use is not recommended (Krens 2019).

Oral:

Mild impairment (total bilirubin ≤ ULN and AST > ULN or total bilirubin 1 to 1.5 times ULN and any AST): No dosage adjustment recommended.

Moderate impairment (total bilirubin >1.5 to 3 times ULN): A recommended dosage adjustment has not been established.

Severe impairment (total bilirubin >3 times ULN): There is no dosage adjustment provided in the manufacturer’s labeling (has not been studied).

Dosing: Pediatric

(For additional information see "Azacitidine: Pediatric drug information")

Note: Dosing and frequency may vary by protocol and/or treatment phase; refer to specific protocol. Azacitidine is associated with a moderate emetic potential (POGO [Dupuis 2011]); antiemetics are recommended to prevent nausea and vomiting. Oral (adult patients only) and injectable azacitidine dosage forms are not substitutable on a mg:mg basis due to pharmacokinetic differences and unique dosing regimens (indications). Pediatric dosing presented as mg/kg and mg/m2; use caution.

Acute myeloid leukemia

Acute myeloid leukemia (AML): Limited data available; efficacy results variable:

SUBQ:

Children ≥2 years and Adolescents: SUBQ: 75 mg/m2/dose once daily for 7 days; dosing from a patient population (n=53) that included adults up to 84 years; the minimum age of subjects in the trial was 5 years, although minimum inclusion criteria was 2 years; used in combination with tretinoin and valproic acid for refractory or relapsed cases with clinical activity observed (Soriano 2007).

IV: Reported dosing regimens variable:

Children and Adolescents: IV: 300 mg/m2/dose once daily for 2 consecutive days has been used for induction and intensive consolidation therapy in various combinations in newly diagnosed patients (Ravindranath 2005; Ribiero 2005). Note: Frequency of use of azacitidine therapy for AML (newly diagnosed) has decreased as newer therapies have replaced previous protocols.

Juvenile myelomonocytic leukemia

Juvenile myelomonocytic leukemia (JMML):

Infants: IV: 2.5 mg/kg once daily on days 1 through 7 of a 28-day cycle; treat for at least 3 cycles up to a maximum of 6 cycles.

Children weighing <10 kg: IV: 2.5 mg/kg/dose once daily on days 1 through 7 of a 28-day cycle; treat for at least 3 cycles up to a maximum of 6 cycles.

Children weighing ≥10 kg: IV: 75 mg/m2/dose once daily on days 1 through 7 of a 28-day cycle; treat for at least 3 cycles up to a maximum of 6 cycles.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing adjustment for toxicity:

Juvenile myelomonocytic leukemia (JMML): Note: A delay in dose not exceeding 14 days can be considered for nonhematologic toxicities.

Hematologic toxicity:

Pediatric patients: Dosage adjustment not recommended based on hematologic toxicity within the first 3 cycles because drug toxicity is difficult to differentiate from disease.

ANC <500/mm3 at end of cycle 3 or day 1 of cycles 5 or 6: Discontinue treatment.

Electrolyte disturbances: If serum bicarbonate falls to <20 mEq/L (unexplained decrease): Reduce dose by 50% for next treatment course.

Acute myeloid leukemia (AML): Refer to specific protocols.

Dosing: Kidney Impairment: Pediatric

Infants, Children, and Adolescents: Injection: There are no dosage adjustments provided in the manufacturer's labeling for pediatric patients (pediatric patients with kidney impairment were excluded from the juvenile myelomonocytic leukemia clinical trials); based on adult data, the following dose adjustments may be considered: If unexplained increases in BUN or serum creatinine occur, delay next cycle until values return to normal or baseline, then reduce azacitidine dose by 50% for next treatment course.

Dosing: Hepatic Impairment: Pediatric

Infants, Children, and Adolescents: Injection: There are no dosage adjustments provided in the manufacturer's labeling for pediatric patients (pediatric patients with hepatic impairment were excluded from the juvenile myelomonocytic leukemia clinical trials); use with caution (potentially hepatotoxic in patients with preexisting liver impairment); use is contraindicated in patients with advanced malignant hepatic tumors.

Dosing: Older Adult

Refer to adult dosing. Due to the potential for decreased kidney function, select dose carefully and closely monitor renal function.

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2 (excludes oral dosage form): Utilize patient's actual body weight for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m2; if a dose reduction is utilized due to toxicity, may consider resumption of full, weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (ASCO [Griggs 2021]).

Dosing: Adjustment for Toxicity: Adult

Azacitidine injection:

Hematologic toxicity:

For patients with baseline WBC ≥3,000/mm3, ANC ≥1,500/mm3, and platelets ≥75,000/mm3, adjust the dosage based on nadir counts for any given cycle.

Azacitidine Dosage Adjustment Based on Hematology Values

Nadir counts

% dose in the next course

ANC and platelets

<500/mm3

<25,000/mm3

50%

500 to 1,500/mm3

25,000 to 50,000/mm3

67%

>1,500/mm3

>50,000/mm3

100%

For patients whose baseline counts are WBC <3,000/mm3, ANC <1,500/mm3, or platelets <75,000/mm3, dose adjustments should be based on nadir counts and bone marrow biopsy cellularity at the time of the nadir, unless there is clear improvement in differentiation (percentage of mature granulocytes is higher and ANC is higher than at onset of that course) at the time of the next cycle, in which case the dose of the current treatment should be continued.

Azacitidine Dose Adjustments Based on Nadir Counts and Bone Marrow Biopsy Cellularity

WBC or platelet nadir % decrease in counts from baseline

Bone marrow biopsy cellularity at time of nadir

30% to 60%

15% to 30%

<15%

50% to 75%

Administer 100% of the previous dose.

Administer 50% of the previous dose.

Administer 33% of the previous dose.

>75%

Administer 75% of the previous dose.

Administer 50% of the previous dose.

Administer 33% of the previous dose.

If a nadir, as defined in the previous table, has occurred, the next course of treatment should be given 28 days after the start of the preceding course, providing that both the WBC and the platelet counts are >25% above the nadir and rising. If a >25% increase above nadir is not seen by day 28, counts should be reassessed every 7 days. If a 25% increase is not seen by day 42, then the patient should be treated with 50% of the scheduled dose.

Nonhematologic toxicity:

Dosage adjustment for electrolyte imbalance: If serum bicarbonate falls to <20 mEq/L (unexplained decrease): Reduce azacitidine dose by 50% for next treatment course.

Azacitidine tablets:

Recommended Azacitidine Tablet Dosage Modifications

Adverse reaction

Severity

Recommended azacitidine dosage modification

Hematologic toxicity

Neutrophils <500/mm3 on day 1 of cycle

Interrupt azacitidine treatment; resume at the same dose after neutrophils return to ≥500/mm3. May require WBC growth factor support.

Neutrophils <1,000/mm3 with fever at any time

First occurrence: Interrupt azacitidine treatment; resume at the same dose after neutrophils return to ≥1,000/mm3.

Occurrence on 2 consecutive cycles: Interrupt azacitidine treatment; resume at a reduced dose of 200 mg after neutrophils return to ≥1,000/mm3. If a patient continues to experience neutropenic fever following dose reduction, reduce the treatment duration by 7 days. If neutropenic fever recurs after dose and schedule reduction, discontinue oral azacitidine.

May require WBC growth factor support.

Platelets <50,000/mm3 with bleeding

First occurrence: Interrupt azacitidine treatment; resume at the same dose after platelets return to ≥50,000/mm3.

Occurrence on 2 consecutive cycles: Interrupt azacitidine treatment; resume at a reduced dose of 200 mg after platelets return to ≥50,000/mm3. If thrombocytopenia with bleeding continues following dose reduction, reduce the treatment duration by 7 days. If thrombocytopenia with bleeding recurs after dose and schedule reduction, discontinue oral azacitidine.

GI toxicity

Grade 3 or 4 nausea and vomiting

Interrupt azacitidine treatment; once toxicity has resolved to ≤ grade 1, resume azacitidine at the same dose. If toxicity recurs, interrupt azacitidine treatment until resolved to ≤ grade 1 and resume azacitidine at reduced dose of 200 mg. If nausea/vomiting continue after dose reduction, reduce the treatment duration by 7 days. If nausea/vomiting continue or recur after dose and schedule reduction, discontinue oral azacitidine.

Grade 3 or 4 diarrhea

Interrupt azacitidine treatment; once toxicity has resolved to ≤ grade 1, resume azacitidine at the same dose. If toxicity recurs, interrupt azacitidine treatment until resolved to ≤ grade 1 and resume azacitidine at reduced dose of 200 mg. If diarrhea continues after dose reduction, reduce the treatment duration by 7 days. If diarrhea continues or recurs after dose and schedule reduction, discontinue oral azacitidine.

Other adverse reactions

Grade 3 or 4

Interrupt azacitidine treatment and provide supportive care; once toxicity has resolved to ≤ grade 1, resume azacitidine at the same dose. If toxicity recurs, interrupt azacitidine treatment until resolved to ≤ grade 1 and resume azacitidine at reduced dose of 200 mg. If the toxicity continues after dose reduction, reduce the treatment duration by 7 days. If the toxicity continues or recurs after dose and schedule reduction, discontinue oral azacitidine.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension Reconstituted, Injection:

Generic: 100 mg (1 ea)

Suspension Reconstituted, Injection [preservative free]:

Vidaza: 100 mg (1 ea)

Generic: 100 mg (1 ea)

Tablet, Oral:

Onureg: 200 mg, 300 mg

Generic Equivalent Available: US

May be product dependent

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension Reconstituted, Injection:

Vidaza: 100 mg (1 ea)

Generic: 100 mg (1 ea)

Tablet, Oral:

Onureg: 200 mg, 300 mg

Administration: Adult

Azacitidine is associated with a moderate emetic potential (ASCO [Hesketh 2020]; MASCC/ESMO [Roila 2016]); antiemetics are recommended to prevent nausea and vomiting.

Oral: Swallow whole; do not split, crush, or chew tablets. Administer at approximately the same time each day, with or without food. During the first 2 cycles, administer an antiemetic 30 minutes prior to each dose; antiemetic prophylaxis may be omitted after 2 cycles if there has been no nausea and vomiting.

IV: Infuse over 10 to 40 minutes; infusion must be completed within 1 hour of (vial) reconstitution.

SUBQ: The manufacturer recommends equally dividing doses requiring more than one vial into 2 syringes and injecting into 2 separate sites. Rotate sites for each injection (thigh, abdomen, or upper arm). Administer subsequent injections at least 1 inch from previous injection sites; do not inject into tender, bruised, red, or hard areas. Allow refrigerated suspensions to come to room temperature (for up to 30 minutes) prior to administration. Resuspend by vigorously rolling the syringe between the palms until a cloudy suspension is achieved.

If azacitidine suspension (injection) comes in contact with the skin, immediately wash with soap and water. If it comes into contact with mucous membranes, flush thoroughly with water.

Administration: Pediatric

If azacitidine suspension comes in contact with the skin, immediately wash with soap and water; if it comes into contact with mucous membranes, flush thoroughly with water. Azacitidine is associated with a moderate emetic potential (POGO [Dupuis 2011]); antiemetics are recommended to prevent nausea and vomiting.

SubQ: The manufacturer recommends equally dividing volumes >4 mL into two syringes and injecting into two separate sites; however, policies for maximum SubQ administration volume may vary by institution; interpatient variations may also apply. Rotate sites for each injection (thigh, abdomen, or upper arm). Administer subsequent injections at least 1 inch from previous injection sites and never into areas where the site is tender, bruised, red, or hardened. Allow refrigerated suspensions to come to room temperature up to 30 minutes prior to administration; suspension stored at room temperature must be administered within 1 hour after reconstitution. Resuspend by inverting the syringe 2 to 3 times and then rolling the syringe between the palms for 30 seconds.

IV: Infuse over 10 to 40 minutes; infusion must be completed within 1 hour of vial reconstitution.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 1]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).

Use: Labeled Indications

Acute myeloid leukemia, maintenance (tablet): Treatment (maintenance) of acute myeloid leukemia in adults who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.

Juvenile myelomonocytic leukemia, newly diagnosed (injection): Treatment of newly diagnosed juvenile myelomonocytic leukemia in pediatric patients ≥1 month of age.

Myelodysplastic syndromes (injection): Treatment of myelodysplastic syndromes (MDS) in adults with the following French-American-British (FAB) classification subtypes: Refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia.

Use: Off-Label: Adult

Acute myeloid leukemia in patients requiring low-intensity therapy (injection)

Medication Safety Issues
Sound-alike/look-alike issues:

AzaCITIDine may be confused with azaTHIOprine, decitabine

High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

>10%:

Cardiovascular: Chest pain (16%)

Dermatologic: Ecchymoses (31%), erythema of skin (7% to 17%), pruritus (12%), skin rash (10% to 14%)

Gastrointestinal: Abdominal pain (13% to 22%), abdominal tenderness (12%), anorexia (21%), constipation (34% to 50%), decreased appetite (13%), diarrhea (36% to 50%; grades 3/4: 5%), nausea (48% to 71%; grades 3/4: 2% to 3%), vomiting (27% to 60%; grades 3/4: 3%)

Hematologic & oncologic: Anemia (25% to 70%; grades 3/4: 4% to 14%), febrile neutropenia (7% to 16%; grades 3/4: 11% to 13%), leukopenia (18% to 48%; grades 3/4: 15%), neutropenia (32% to 74%; grades 3/4: 49% to 61%), petechia (11% to 24%; more common with IV administration), thrombocytopenia (65% to 70%; grades 3/4: 21% to 58%)

Local: Bruising at injection site (5% to 14%), erythema at injection site (35% to 43%), injection-site reaction (14% to 29%), pain at injection site (19% to 23%)

Nervous system: Anxiety (5% to 13%), asthenia (≤44%), dizziness (11% to 19%), fatigue (≤44%), headache (22%), insomnia (9% to 11%), malaise (11%)

Neuromuscular & skeletal: Arthralgia (14% to 22%), limb pain (11%), myalgia (16%)

Respiratory: Dyspnea (5% to 29%), nasopharyngitis (15%), pneumonia (8% to 27%), upper respiratory infection (9% to 13%)

Miscellaneous: Fever (30% to 52%)

1% to 10%:

Cardiovascular: Atrial fibrillation (<5%), chest wall pain (5%), congestive cardiomyopathy (<5%), heart failure (<5%), hypertension (9%), hypotension (7%), orthostatic hypotension (<5%), septic shock (<5%)

Dermatologic: Cellulitis (<5%), cutaneous nodule (5%), pruritic rash (<5%), pyoderma gangrenosum (<5%), skin sclerosis (<5%), urticaria (6%), xeroderma (5%)

Endocrine & metabolic: Dehydration (<5%), hypokalemia (6%; more common with IV administration), weight loss (4% to 8%)

Gastrointestinal: Abscess of rectum and/or peri-rectal area (<5%), cholecystectomy (<5%), cholecystitis (<5%), diverticulitis of the gastrointestinal tract (<5%), dyspepsia (6%), gastrointestinal hemorrhage (<5%), gingival hemorrhage (10%), loose stools (6%), melena (<5%), oral hemorrhage (5%), stomatitis (8%)

Genitourinary: Hematuria (6%), urinary tract infection (9%)

Hematologic & oncologic: Agranulocytosis (<5%), bone marrow failure (<5%), hematoma (9%), leukemia cutis (<5%), pancytopenia (<5%), postprocedural hemorrhage (6%), splenomegaly (<5%)

Hypersensitivity: Anaphylactic shock (<5%), hypersensitivity reaction (<5%)

Infection: Bacterial infection (<5%), blastomycosis (<5%), Klebsiella pneumoniae infection (<5%), limb abscess (<5%), neutropenic sepsis (<5%), sepsis (<5%, including Klebsiella sepsis), staphylococcal bacteremia (<5%), staphylococcal infection (<5%), systemic inflammatory response syndrome (<5%), toxoplasmosis (<5%)

Local: Hematoma at injection site (6%), induration at injection site (5%), injection-site granuloma (5%), injection-site infection (<5%), injection-site pruritus (7%), rash at injection site (6%), skin discoloration at injection site (5%), swelling at injection site (5%)

Nervous system: Cerebral hemorrhage (<5%), debility (<5%), intracranial hemorrhage (<5%), lethargy (7% to 8%), myasthenia (<5%), seizure (<5%)

Neuromuscular & skeletal: Aggravated bone pain (<5%), neck pain (<5%)

Ophthalmic: Subconjunctival hemorrhage (<5%)

Renal: Flank pain (<5%), renal failure syndrome (<5%)

Respiratory: Hemoptysis (<5%), pharyngolaryngeal pain (6%), pneumonitis (<5%), pulmonary infiltrates (<5%), respiratory distress (<5%), rhinitis (6%), streptococcal pharyngitis (<5%)

Frequency not defined:

Hepatic: Hepatic coma

Nervous system: Rigors (more common with IV administration)

Postmarketing:

Cardiovascular: Pericardial effusion, pericarditis

Dermatologic: Sweet syndrome

Hematologic & oncologic: Differentiation syndrome, tumor lysis syndrome

Infection: Necrotizing fasciitis

Local: Tissue necrosis at injection site

Respiratory: Interstitial pulmonary disease

Contraindications

Hypersensitivity to azacitidine or any component of the formulation; hypersensitivity to mannitol (injection only); advanced malignant hepatic tumors (injection only).

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Neutropenia, thrombocytopenia, and anemia commonly occur; neutropenic fever has been reported.

• Hepatotoxicity: May cause hepatotoxicity in patients with preexisting hepatic impairment. Progressive hepatic coma leading to death has been reported in patients with extensive tumor burden due to metastatic disease, especially those with a baseline albumin <30 g/L. Patients with hepatic impairment were excluded from clinical studies for myelodysplastic syndrome (MDS) and juvenile myelomonocytic leukemia (JMML).

• Injection-site reactions: Injection site reactions commonly occurred with SUBQ azacitidine administration.

• Nephrotoxicity: Kidney toxicities, including serum creatinine elevations, renal tubular acidosis (serum bicarbonate decrease to <20 mEq/L associated with alkaline urine and serum potassium <3 mEq/L), and kidney failure (some fatal), have been reported with IV azacitidine when used in combination with other chemotherapy agents. Patients with kidney impairment may be at increased risk for kidney toxicity. Patients with kidney impairment were excluded from clinical studies for MDS and JMML.

• Tumor lysis syndrome: May cause serious or fatal tumor lysis syndrome (TLS). TLS has occurred despite receiving antihyperuricemic therapy (eg, allopurinol).

Disease-related concerns:

• Myelodysplastic syndromes: In a clinical trial of patients with RBC transfusion-dependent anemia and thrombocytopenia due to MDS, patients were randomized to receive oral azacitidine (300 mg once daily for 21 days every 28 days) versus placebo; patients received oral azacitidine for a median of 5 cycles. Enrollment was discontinued early in the trial due to a higher incidence of early fatal and/or serious adverse reactions in the azacitidine arm; sepsis was the most frequent fatal adverse reaction. Safety and efficacy of oral azacitidine for treatment of MDS have not been established, and treatment of MDS with oral azacitidine outside of a clinical trial is not recommended.

Dosage form specific issues:

• Do not substitute: Do not substitute azacitidine tablets for azacitidine injection (or vice versa); indications, dosages, and pharmacokinetics are different. Treatment of patients using IV or SUBQ azacitidine at the recommended tablet dosage may result in a fatal adverse reaction; treatment of patients using azacitidine tablets at the doses recommended for IV or SUBQ azacitidine may not be effective.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination

Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Cedazuridine: May increase the serum concentration of Cytidine Deaminase Substrates. Risk X: Avoid combination

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination

Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing cytotoxic chemotherapy several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification

COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy

COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and cytotoxic chemotherapy. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification

Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination

Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification

Leflunomide: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as cytotoxic chemotherapy. Risk D: Consider therapy modification

Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider therapy modification

Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider therapy modification

Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy

Palifermin: May enhance the adverse/toxic effect of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Risk D: Consider therapy modification

Pidotimod: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination

Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification

Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Ruxolitinib (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants, such as cytotoxic chemotherapy, prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification

Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor therapy

Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination

Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination

Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination

Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification

Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination

Reproductive Considerations

Verify pregnancy status prior to therapy in patients who could become pregnant. Patients who could become pregnant should use effective contraception during therapy and for at least 6 months after the last azacitidine dose. Patients with partners who could become pregnant should use effective contraception during therapy and for at least 3 months after the last azacitidine dose.

Pregnancy Considerations

Based on its mechanism of action and data from animal reproduction studies, in utero exposure to azacitidine may cause fetal harm. Information related to the use of azacitidine for the treatment of acute myeloid leukemia (AML) in pregnancy is limited (Alrajhi 2019; Mahdi 2018).

The European Society for Medical Oncology has published guidelines for diagnosis, treatment, and follow-up of cancer during pregnancy (ESMO [Peccatori 2013]). Guidelines are also available for the treatment of AML in pregnancy (BCSH [Ali 2015]). The guidelines recommend referral to a facility with expertise in cancer during pregnancy and encourage a multidisciplinary team (obstetrician, neonatologist, oncology team). If chemotherapy is indicated, it should not be administered in the first trimester but may begin in the second trimester. There should be a 3-week time period between the last chemotherapy dose and anticipated delivery, and chemotherapy should not be administered beyond week 33 of gestation (Ali 2015; ESMO [Peccatori 2013]).

A pregnancy registry is available for all cancers diagnosed during pregnancy at Cooper Health (1-877-635-4499).

Breastfeeding Considerations

It is not known if azacitidine is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends discontinuing breastfeeding during treatment and for 1 week after the last azacitidine dose.

Monitoring Parameters

Monitor LFTs, electrolytes, CBC with differential and platelets at baseline and prior to each cycle (at a minimum) and as clinically indicated (injection). For oral azacitidine, monitor blood counts every other week for 2 cycles, then prior to each cycle; increase to every other week for 2 cycles after any myelosuppression-related dose reduction. Monitor renal function (BUN and serum creatinine) at baseline, prior to each cycle, and more frequently if indicated; monitor closely for toxicities, particularly in patients with severe renal impairment (azacitidine and metabolites are excreted renally). Assess risk for tumor lysis syndrome (TLS) prior to treatment and monitor for signs/symptoms of TLS. Also monitor for hematologic response, nausea/vomiting, and for injection-site reactions. Monitor adherence (tablets).

The American Society of Clinical Oncology hepatitis B screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends hepatitis B virus (HBV) screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Azacitidine (a hypomethylating agent) is a pyrimidine nucleoside analog of cytidine that inhibits DNA/RNA methyltransferases; it is incorporated into DNA and RNA and inhibits DNA and RNA methyltransferases, reduces DNA and RNA methylation, alters DNA gene expression (including re-expression of genes that regulate tumor suppression and cell differentiation), and decreases RNA stability and decreases protein synthesis.

Pharmacokinetics

Absorption: SUBQ: Rapid and complete.

Distribution: Vd: IV: 76 ± 26 L; does not cross blood-brain barrier; Oral: Vz/F: 881 L.

Protein binding: Oral: 6% to 12%.

Metabolism: Hepatic; spontaneous hydrolysis and deamination (mediated by cytidine deaminase) to several metabolites.

Bioavailability: SUBQ: ~89%; Oral: ~11% (compared to SUBQ).

Half-life elimination:

Infants and children <7 years: IV: Geometric mean: 0.3 hours (azacytidine) (Niemeyer 2021).

Adults: IV, SUBQ: 41 ± 8 minutes (azacitidine); ~4 hours (azacitidine and metabolites); ~4 hours; Oral: ~0.5 hours (azacitidine).

Time to peak, plasma: SUBQ: 30 minutes; Oral: 1 hour.

Excretion: IV, SUBQ: Urine (50% to 85%); feces (<1%); Oral: Urine (<2% as unchanged drug).

Pharmacokinetics: Additional Considerations

Altered kidney function: The AUC was increased by ~70% after a single SUBQ dose and by 41% after multiple SUBQ doses in patients with severe renal impairment (CrCl <30 mL/minute) compared to patients with normal renal function. This increase in exposure did not correlate with increased adverse effects.

Pricing: US

Suspension (reconstituted) (azaCITIDine Injection)

100 mg (per each): $46.80 - $617.62

Suspension (reconstituted) (Vidaza Injection)

100 mg (per each): $702.29

Tablets (Onureg Oral)

200 mg (per each): $1,895.16

300 mg (per each): $1,895.16

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Andason (TW);
  • Azadine (AU);
  • Azitech (AR);
  • Celazadine (AU);
  • Clandra (CR, DO, GT, HN, NI, PA, SV);
  • Maturus (AR);
  • Remitiva (AR);
  • Tazidir (AR);
  • Vidaza (AR, AT, AU, BB, BE, BH, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, IE, IL, IS, IT, JO, JP, KR, KW, LB, LT, LU, MT, MX, MY, NI, NL, NO, NZ, PA, PE, PH, PL, PT, RO, RU, SA, SE, SG, SI, SK, SV, TH, TR, TW, VE, ZA);
  • Xpreza 100 (HK)


For country code abbreviations (show table)
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