Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 100mg/single-dose vial (Vidaza, generic)
tablet
- 200mg (Onureg)
- 300mg (Onureg)
Myelodysplastic Syndromes
Vidaza only
Indicated for myelodysplastic syndromes in patients with the following French-American-British (FAB) subtypes: Refractory anemia (RA) or RA with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), chronic myelomonocytic leukemia (CMMoL)
Each cycle is 4 weeks
75 mg/m2 IV or SC qDay for 7 days; repeat cycle every 4 weeks
May increased to 100 mg/m2 if no benefit observed after 2 treatment cycles and if no toxicity other than nausea and vomiting
Treat for minimum of 4-6 cycles
Continue treatment as long as patient continues to benefit
Acute Myeloid Leukemia
Onureg only
Indicated for continued treatment of adults with acute myeloid leukemia who achieved first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy
Each cycle is 28 days
300 mg PO qDay on Days 1-14
Continue until disease progression or unacceptable toxicity
Dosage Modifications
Hematology toxicity (SC or IV)
- If a nadir defined below occurs, administer next treatment course 28 days after the start of the preceding course as long as WBC and platelet counts are >25% above the nadir and rising
- If a >25% increase above the nadir is not seen by Day 28, reassess counts every 7 days
- If a 25% increase is not seen by Day 42, reduce scheduled dose by 50%
-
For baseline WBC ≥3 x 10^9/L, ANC ≥1.5 x 10^9/L, and platelets ≥75 x 10^9/L
- Nadir count: ANC <0.5 x 109/L or platelets <25 x 109/L: Administer 50% of dose during next treatment course
- Nadir count: ANC 0.5-1.5 x 109/L or platelets 25-50 x 109/L: Administer 67% of dose during next treatment course
- Nadir count: ANC >1.5 x 109/L or platelets >50 x 109/L: Administer 100% of dose during next treatment course
-
For baseline WBC <3 x 10^9/L, ANC <1.5 x 10^9/L, and platelets <75 x 10^9/L
- WBC or platelet nadir decreased 50-75% from baseline and bone marrow biopsy cellularity at time of nadir 30-60%: Administer 100% of dose during next treatment course
- WBC or platelet nadir decreased 50-75% from baseline and bone marrow biopsy cellularity at time of nadir 15-30%: Administer 50% of dose during next course
- WBC or platelet nadir decreased 50-75% from baseline and bone marrow biopsy cellularity at time of nadir <15%: Administer 33% of dose during next course
- WBC or platelet nadir decreased >75% from baseline and bone marrow biopsy cellularity at time of nadir 30-60%: Administer 75% of dose during next course
- WBC or platelet nadir decreased >75% from baseline and bone marrow biopsy cellularity at time of nadir 15-30%: Administer 50% of dose during next course
- WBC or platelet nadir decreased >75% from baseline and bone marrow biopsy cellularity at time of nadir <15%: Administer 33% of dose during next course
Dosage modifications based on serum electrolytes and renal toxicity (IV or SC)
- If unexplained reductions in serum bicarbonate levels <20 mEq/L occur, reduce dose by 50% for next course
- If unexplained elevations of BUN or serum creatinine occur, delay next cycle until values return to normal or baseline and reduce dose by 50% for next course
Hematology toxicity (PO)
- Neutrophils <0.5 Gi/L on Day 1 of cycle: Interrupt treatment; resume at same dose once neutrophils ≥0.5 Gi/L
-
Neutrophils <1 Gi/L with fever at any time
- First occurrence: Interrupt treatment; resume at same dose once neutrophils ≥1 Gi/L
- Occurrence in 2 consecutive cycles: Interrupt treatment; after neutrophils ≥1 Gi/L, then resume at reduced dose of 200 mg; if febrile neutropenia continues after dose reduction, reduce treatment duration by 7 days; if febrile neutropenia reoccurs after dose and schedule reduction, discontinue treatment
-
Platelets <50 Gi/L with bleeding
- First occurrence: Interrupt dose; resume at same dose once platelets ≥50 Gi/L
- Occurrence in 2 consecutive cycles: Interrupt dose; after platelets ≥50 Gi/L, then resume at reduced dose of 200 mg; if thrombocytopenia with bleeding continues after dose reduction, reduce treatment duration by 7 days; if thrombocytopenia with bleeding reoccurs after dose and schedule reduction, discontinue treatment
Gastrointestinal toxicity (PO)
-
Grade 3 or 4 nausea, vomiting, or diarrhea
- Interrupt dose; resume at same dose once toxicity has resolved to Grade ≤1
- If toxicity reoccurs, interrupt dose until resolved to Grade ≤1, then resume at reduced dose of 200 mg
- If toxicity continues after dose reduction, reduce treatment duration by 7 days
- If toxicity continues or reoccurs after dose and schedule reduction, discontinue treatment
Other adverse reactions (PO)
- Interrupt dose and provide medical support; resume at same dose once toxicity has resolved to Grade ≤1
- If toxicity reoccurs, interrupt dose until resolved to Grade ≤1, then resume at reduced dose of 200 mg
- If toxicity continues after dose reduction, reduce treatment duration by 7 days
- If toxicity continues or reoccurs after dose and schedule reduction, discontinue treatment
Renal impairment
- Mild-severe (CrCl 15-89 mL/min): No dosage adjustment necessary
- Monitor patients with severe renal impairment (CrCl 15-29 mL/min) more frequently and modify dosage for adverse reactions
Hepatic impairment
- Mild (total bilirubin ≤ULN and AST >ULN, or total bilirubin 1-1.5x ULN and any AST): No dosage adjustment necessary
- Moderate (total bilirubin >1.5-3x ULN): Recommended dose not established
- Severe (total bilirubin >3x ULN): Not studied
Dosing Considerations
Do not substitute PO for IV/SC azacitidine
Indications and dosing regimen for PO differ from that of IV/SC azacitidine
Monitoring parameters
- Verify pregnancy status of females of reproductive potential before initiating treatment
-
PO
- Monitor CBC every other week for first 2 cycles and before start of each cycle thereafter
- Increase monitoring to every other week for 2 cycles after any dose reduction for myelosuppression
-
IV or SC
- Obtain CBC, liver chemistries and serum creatinine before first dose
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 100mg/single-dose vial (Vidaza)
Juvenile Myelomonocytic Leukemia
Vidaza only
Indicated for juvenile myelomonocytic leukemia (JMML) in children aged ≥1 month
≥1 month to <1 year OR weighs <10 kg: 2.5 mg/kg IV qDay for 7 days in a 28-day cycle
≥1 year AND weighs ≥10 kg: 75 mg/m2 IV qDay for 7 days in a 28-day cycle
Treat for at least 3 cycles; not to exceed 6 cycles
May delay dose up to 14 days for nonhematologic toxicities
May continue treatment for up to 6 cycles if patient continues to benefit
Dosage Modifications
Hematologic toxicity
- As hematological toxicity will be difficult to assess and to differentiate from underlying disorder, dose reductions are not recommended due to hematological toxicity within first 3 cycles
- However, if neutrophil count <0.5 x109/L at end of Cycle 3 or on Day 1 of Cycles 5 or 6, discontinue treatment
Dosing Considerations
Do not substitute IV for oral azacitidine
Indications and dosing regimen for IV differ from oral azacitidine
Monitoring parameters
- Monitor for hematologic response and renal toxicities, and delay or reduce dosage if necessary.
Azacitidine and its metabolites undergo substantial renal excretion; renal impairment may increase risk of toxicity
Select dose carefully and monitor renal function in geriatric patients; owing to increased risk of decreased renal function
Adverse Effects
>10% (SC or IV)
All grades
- Nausea (48-71%)
- Anemia (51-70%)
- Thrombocytopenia (66-70%)
- Neutropenia (32-66%)
- Constipation (34-50%)
- Vomiting (27-54%)
- Pyrexia (30-52%)
- Leukopenia (18-48%)
- Injection site erythema (35-43%)
- Diarrhea (36%)
- Ecchymosis (31%)
- Dyspnea (29%)
- Injection site reaction (14-29%)
- Petechiae (24%)
- Fatigue (24%)
- Injection site pain (23%)
- Arthralgia (22%)
- Headache (22%)
- Anorexia (21%)
- Dizziness (19%)
- Injection site pain (5-19%)
- Erythema (17%)
- Febrile neutropenia (14-16%)
- Chest pain (16%)
- Myalgia (16%)
- Nasopharyngitis (15%)
- Rash (14%)
- Injection site bruising (5-14%)
- Abdominal pain (13%)
- Upper respiratory tract infection (13%)
- Anxiety (13%)
- Abdominal tenderness (12%)
- Malaise (11%)
- Pneumonia (11%)
- Insomnia (11%)
Grade 3-4
- Anemia (44%)
- Thrombocytopenia (34%)
- Neutropenia (28%)
- Pyrexia (18%)
- Fatigue (12%)
- Nausea (12%)
>10% (PO)
All grades
- Nausea (65%)
- Vomiting (60%)
- Diarrhea (50%)
- Fatigue /asthenia (44%)
- Constipation (39%)
- Pneumonia (27%)
- Abdominal pain (22%)
- Arthralgia (14%)
- Decreased appetite (13%)
- Febrile neutropenia (12%)
- Pain in extremity (11%)
- Dizziness (11%)
Grade 3-4
- Neutropenia (49%)
- Thrombocytopenia (21%)
- Febrile neutropenia (11%)
1-10% (SC or IV)
All grades
- Gingival bleeding (10%)
- Hematoma (6-9%)
- Hypertension (9%)
- Lethargy (8%)
- Stomatitis (8%)
- Injection site pruritus (7%)
- Hypotension (7%)
- Anemia aggravated (6%)
- Loose stools (6%)
- Urticaria (6%)
- Postprocedural hemorrhage (6%)
- Dyspepsia (6%)
- Injection site rash (6%)
- Injection site swelling (5%)
- Injection site pigmentation changes (5%)
- Injection site induration (6%)
- Skin nodule (5%)
- Injection site granuloma (5%)
- Chest wall pain (5%)
- Dry skin (5%)
- Mouth hemorrhage (5%)
-
<5%
- Blood and lymphatic system disorders: Agranulocytosis, bone marrow failure, pancytopenia splenomegaly
- Cardiac disorders: Atrial fibrillation, cardiac failure, cardiac failure congestive, cardiorespiratory arrest, congestive cardiomyopathy
- Eye disorders: Eye hemorrhage
- Gastrointestinal disorders: Diverticulitis, gastrointestinal hemorrhage, melena, perirectal abscess
- General disorders and administration site conditions: Catheter site hemorrhage, general physical health deterioration, systemic inflammatory response syndrome
- Hepatobiliary disorders: cholecystitis. Immune system disorders: anaphylactic shock, hypersensitivity
- Infections and infestations: Abscess limb, bacterial infection, cellulitis, blastomycosis, injection site infection, Klebsiella sepsis, neutropenic sepsis, pharyngitis streptococcal, pneumonia Klebsiella, sepsis, septic shock, Staphylococcal bacteremia, Staphylococcal infection, toxoplasmosis
- Metabolism and nutrition disorders: Dehydration
- Musculoskeletal and connective tissue disorders: Bone pain aggravated, muscle weakness, neck pain
- Neoplasms benign, malignant and unspecified: Leukemia cutis
- Nervous system disorders: Cerebral hemorrhage, convulsions, intracranial hemorrhage
- Renal and urinary disorders: Loin pain, renal failure
- Respiratory, thoracic and mediastinal disorders: Hemoptysis, lung infiltration, pneumonitis, respiratory distress
- Skin and subcutaneous tissue disorders: Pyoderma gangrenosum, rash pruritic, skin induration. Surgical and medical procedures: cholecystectomy
- Vascular disorders: Orthostatic hypotension
Grade 3-4
- Febrile neutropenia (10%)
- Constipation (8%)
- Abdominal pain (7%)
- Vomiting (7%)
- Dyspnea (5%)
- Hypertension (4%)
- Petechiae (4%)
- Upper respiratory tract infection (4%)
- Erythema (3%)
- Pharyngolaryngeal pain (3%)
- Insomnia (3%)
- Hypokalemia (3%)
- Urinary tract infection (3%)
- Leukopenia (2%)
- Dyspepsia (2%)
- Hematuria (2%)
- Pruritus (2%)
- Lethargy (2%)
- Rash (1%)
- Dyspnea exertional (1%)
- Rash (1%)
- Anxiety (1%)
- Rhinitis (1%)
1-10% (PO)
Grade 3-4
- Pneumonia (9%)
- Diarrhea (5%)
- Fatigue/asthenia (4%)
- Anemia (4%)
- Nausea (3%)
- Vomiting (3%)
- Abdominal pain (2%)
- Constipation (1%)
- Decreased appetite (1%)
- Arthralgia (1%)
<1% (PO)
Grade 3-4
- Pain in extremity (<1%)
Frequency Not Defined
IV or SC
- Nausea
- Anemia
- Thrombocytopenia
- Vomiting
- Pyrexia
- Leukopenia
- Diarrhea
- Injection site erythema, constipation
- Neutropenia
- Ecchymosis
- Petechiae
- Rigors
- Weakness
- Hypokalemia
- Postmarketing Reports H3
- Interstitial lung disease
- Tumor lysis syndrome
- Injection site necrosis
- Sweet’s syndrome (acute febrile neutrophilic dermatosis)
- Necrotizing fasciitis
- Differentiation syndrome
Postmarketing Reports
Pericardial effusion
Pericarditis
Warnings
Contraindications
IV or SC
- Advanced malignant hepatic tumors
- Hypersensitivity to azacitidine or mannitol
PO
- Hypersensitivity to azacitidine or its components
Cautions
Do not substitute PO azacitidine for IV or SC azacitidine; intravenous treatment at the recommended dosage of oral azacitidine may result in a fatal adverse reaction; treatment of patients using oral form at doses recommended for intravenous treatment may not be effective
Fetal harm may occur when administered to pregnant females
PO azacitidine
Safety and effectiveness for MDS have not been established
Not recommended for MDS patients outside of controlled trials
Anemia, neutropenia, and thrombocytopenia
- May cause anemia, neutropenia, and thrombocytopenia in adult patients with MDS and in pediatric patients with JMML; monitor CBC frequently for response and/or toxicity, at a minimum, before each dosing cycle; provide standard supportive care, including hematopoietic growth factors, if myelosuppression occurs
- In adult patients with MDS, after administration of the recommended dosage for first cycle, adjust dosage for subsequent cycles based on nadir counts and hematologic response
- In pediatric patients with JMML, dose reductions due to hematological toxicity are not recommended within first 3 cycles as hematological toxicity will be difficult to assess and differentiate from natural course of underlying disorder
IV or SC azacitidine
- Fatal or serious tumor lysis syndrome may occur despite concomitant use of allopurinol; assess baseline risk and monitor and treat appropriately
-
Hepatic toxicity
- Exercise caution in patients with liver disease due to the increased risk of hepatotoxicity in patients with severe pre-existing hepatic impairment
- Patients with extensive tumor burden due to metastatic disease reported to experience progressive hepatic coma and death during treatment, especially in such patients with baseline albumin <30 g/L; monitor liver chemistries prior to initiation of therapy and with each cycle
- Safety and effectiveness in patients with MDS or in pediatric patients with JMML and hepatic impairment not studied
-
Renal toxicity
- Renal toxicity ranging from elevated serum creatinine to renal failure and death reported in patients treated with intravenous azacitidine in combination with other chemotherapeutic agents for nonMDS conditions
- Renal tubular acidosis, defined as a fall in serum bicarbonate to <20 mEq/L in association with alkaline urine and hypokalemia (serum potassium <3 mEq/L) reported in patients with CML treated with azacitidine and etoposide; monitor serum creatinine and electrolytes prior to initiation of therapy and with each cycle
- Patients with renal impairment may be at increased risk of renal toxicity; closely monitor if treated
- If unexplained reductions in serum bicarbonate <20 mEq/L or elevations of BUN or serum creatinine occurs, reduce, or hold the dose
Pregnancy & Lactation
Pregnancy
Based on its mechanism of actions and animal studies, fetal harm may occur when administered to pregnant females
No data available on use in pregnant females to evaluate for drug-associated risks
Verify pregnancy status of females of reproductive potential before initiating treatment
Animal data
- Teratogenic and caused embryofetal lethality in animals at doses less than the recommended human dose of azacitidine
- Advise pregnant females of the potential risk to fetus
Contraception
-
IV or SC
- Use effective contraception during treatment and for 6 months after last dose
- Advise males with female partners of reproductive potential to use effective contraception during treatment with this medication and for 3 months after last dose
-
PO
- Females of reproductive potential: Use effective contraception during treatment and for at least 6 months after last dose
- Males with female sexual partners of reproductive potential: Use effective contraception during treatment and for at least 3 months after last dose
Infertility
-
PO
- Based on animal data, male and female fertility may be impaired
Lactation
There is no information regarding presence of azacitidine in human milk, effects of therapy on breastfed infant, or effects of therapy on milk production
IV or SC: Because many drugs are excreted in human milk and because of potential for tumorigenicity shown for azacitidine in animal studies and potential for serious adverse reactions in nursing infants, advise patients not to breastfeed during treatment and for 1 week after the last dose
PO: Advise patients not to breastfeed during therapy and for 1 week after last dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Pyrimidine analog of cytidine that inhibits DNA/RNA methyltransferases
Azacitidine is incorporated into RNA and DNA following cellular uptake and enzymatic biotransformation to nucleotide triphosphates
Hypomethylation of DNA and direct cytotoxic effect on abnormal hematopoietic cells in bone marrow
Absorption
Peak plasma concentration: 750 ng/mL (SC)
Peak plasma time
- SC: 0.5 hr
- PO: 1 hr
Bioavailability
- SC: ~89% relative to IV
- PO: ~11% relative to SC
Effect of food
- High-fat, high-calorie meal (~800-1000 calories, 50% fat) with PO azacitidine did not affect AUC and decreased peak plasma concentration by 21%
Distribution
Protein bound: ~6-12% (PO)
Blood-to-plasma ratio: ~0.3 (PO)
Vd
- IV: 76 L
- PO: 881 L
Metabolism
Undergoes spontaneous hydrolysis and deamination mediated by cytidine deaminase
Elimination
Clearance: 167 L/hr (SC)
Half-life
- PO: ~0.5 hr
- SC or IV: 4 hr
Excretion
- PO: <2% unchanged (urine)
- IV: 85% (urine); <1% (feces)
- SC: 50% (urine)
Administration
IV Incompatibilities
Dextrose 5%
IV Compatibilities
Lactated ringer
0.9% NaCl
IV Preparation
Reconstitute each vial with 10 mL sterile water for injection
Vigorously shake or roll vial until all solids are dissolved; resulting concentration is 10 mg/mL; solution should appear clear
Visually inspect parenteral drug product for particulate matter and discoloration before administration, whenever solution and container permit
Adults: Withdraw required amount and inject into a 50 -100 mL infusion bag of either 0.9% NaCl or Lactated Ringer
Pediatric patients: Withdraw required amount of drug solution and inject into an infusion bag (volume up to 100 mL) of either 0.9% NaCl or Lactated Ringer to achieve a final concentration of 0.9-4 mg/mL
IV Administration
IV administration only when reconstituted with 10 mL of sterile water
Administer total dose over a period of 10 - 40 min; complete administration within 1 hr of reconstitution
SC Preparation
Reconstitute with 4 mL room temperature sterile water for injection for immediate use and refrigerated sterile water (2-8C, 36-46F) for delayed use; inject diluent slowly into vial
Vigorously shake or roll the vial until a uniform suspension is achieved; suspension will be cloudy; resulting concentration is 25 mg/mL
Do not filter suspension after reconstitution; filtering could remove the active substance
For doses requiring >1 vial, divide dose equally between the syringes (eg, dose 150 mg = 6 mL, 2 syringes with 3 mL in each syringe) and inject into 2 separate sites
Due to retention in vial and needle, it may not be feasible to withdraw all of the suspension from vial
SC Administration
SC administration only when reconstituted with 4 mL of sterile water
Resuspend the contents of syringe to provide a homogeneous suspension immediately before administration
To resuspend, vigorously roll syringe between the palms until a uniform, cloudy suspension is achieved
Rotate sites for each injection (thigh, abdomen, or upper arm)
Administer new injections at least 1 inch from an old site and never into areas where the site is tender, bruised, red, or hard
Oral Administration
Hazardous drug; follow applicable special handling and disposal procedure
Do not split, crush, or chew tablets
Take a dose about the same time each day
Do not substitute IV or SC azacitidine
Indications and dosing regimen differ from that of IV or SC azacitidine
Premedication
- Administer an antiemetic 30 min before each dose for the first 2 cycles
- Omit antiemetics after 2 cycles if no nausea and vomiting has occurred
Missed dose
- Take dose as soon as possible on the same day, and resume the normal schedule the following day; do not take 2 doses on the same day
Vomited dose
- If dose is vomited, do not take another dose on the same day
- Resume normal schedule the following day
Storage
Cytotoxic drug; follow applicable special handling and disposal procedures
Unused vials
Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)
Reconstituted vial or diluted IV infusion bag
- Store for up to 1 hr at 25ºC (77ºF)
Reconstituted suspension or prepared SC syringes
- Reconstituted with non-refrigerated water for injection: Store for up to 1 hr at 25ºC (77ºF) or for up to 8 hr between 2-8ºC (36-46ºF)
- Reconstituted with refrigerated (2-8ºC, 36-46ºF) water for injection: Store for 22 hr at 2-8ºC (36-46ºF)
Tablets
- Store bottles at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
- Keep bottle tightly closed
- Store and dispense in the original bottle (with 2 desiccant canisters)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| azacitidine injection - | 100 mg vial |  | |
| azacitidine injection - | 100 mg vial |  | |
| azacitidine injection - | 100 mg vial |  | |
| azacitidine injection - | 100 mg vial |  | |
| azacitidine injection - | 100 mg vial |  | |
| azacitidine injection - | 100 mg vial |  | |
| azacitidine injection - | 100 mg vial |  | |
| azacitidine injection - | 100 mg vial |  | |
| azacitidine injection - | 100 mg vial |  | |
| azacitidine injection - | 100 mg vial |  | |
| azacitidine injection - | 100 mg vial |  | |
| azacitidine injection - | 100 mg vial |  | |
| Vidaza injection - | 100 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
azacitidine injection
AZACITIDINE - INJECTION
(ay-za-SYE-ti-deen)
COMMON BRAND NAME(S): Vidaza
USES: This medication is used to treat certain types of cancers (such as acute myeloid leukemia-AML, myelodysplastic syndromes-MDS, Juvenile Myelomonocytic Leukemia-JMML) in which the bone marrow does not produce enough healthy blood cells. People with these disorders usually have problems such as infections, anemia, and easy bleeding/bruising. Azacitidine works by helping your bone marrow make healthy blood cells. It also kills abnormal blood cells that have grown too fast and do not work properly.This form of azacitidine should not be used in place of the form taken by mouth.
HOW TO USE: This medication is given by injection under the skin or into a vein by a health care professional.If you are receiving the injection under the skin, your health care professional will change the injection site each time to lessen injury under the skin.This medication is injected as directed by your doctor, usually once a day for 7 days in a row. A 7-day course of this medication is called a cycle. This cycle is repeated every 4 weeks depending on your response and blood tests.The dosage is based on your medical condition, body size, lab tests, and response to treatment. Keep all medical/lab appointments.
SIDE EFFECTS: Redness/pain/bruising at the injection site, tiredness, diarrhea, dizziness, trouble sleeping, constipation, nausea, vomiting, mouth sores, dry skin, headache, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects last or worsen, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, chest pain, muscle/joint pain, muscle cramps, irregular heartbeat, mental/mood changes (such as anxiety), dark urine, yellowing eyes/skin.This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).Azacitidine sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using azacitidine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as mannitol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease (including cancer).Azacitidine can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using azacitidine before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using azacitidine. Azacitidine may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for some time after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 1 week after the last dose is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Lab and/or medical tests (such as complete blood counts, kidney/liver function, blood chemistry) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised February 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
