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ONUREG (azacitidine)
- acute myeloid leukemia
200 mg tablet
- 1 tablet (200 mg) by oral route once daily on days 1 through 14 of a 28-day cycle
300 mg tablet
- 1 tablet (300 mg) by oral route once daily on days 1 through 14 of a 28-day cycle
Default screening record
- 1 tablet (200 mg) by oral route once daily on days 1 through 14 of a 28-day cycle
- 1 tablet (200 mg) by oral route once daily on days 1 through 7 of a 28-day cycle
- 1 tablet (300 mg) by oral route once daily on days 1 through 14 of a 28-day cycle
- adenovirus vac live type-4 & 7
- adenovirus vaccine live type-4
- adenovirus vaccine live type-7
- BCG vaccine, live (PF)
- flu vac,qval 2013-14 (2-49yrs)
- Flumist 2013-2014
- M-m-r Ii (pf)
- measles,mumps&rubella vacc(PF)
- measles,mumps,rub,varicel(PF)
- natalizumab
- Proquad (pf)
- Rotateq Vaccine
- rotavirus vaccine live, penta
- typhoid vaccine
- Tysabri
- varicella virus vacc live (PF)
- Varivax (pf)
- Vivotif Berna Vaccine
- yellow fever vaccine live (PF)
- Yf-vax (pf)
- Zostavax (pf)
- zoster vaccine live (PF)
Contraindicated
- clozapine
- Clozaril
- deferiprone
- Fazaclo
- Ferriprox
- Versacloz
Severe
Moderate
- None
- Lactation
Contraindicated
- Pregnancy
Severe
Moderate
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Neutropenic disorder
- Thrombocytopenic disorder
ONUREG (azacitidine)
- acute myeloid leukemia
- Anaphylaxis
- Anemia
- Cellulitis
- Chest pain
- Dyspnea
- Hypokalemia
- Leukopenia
- Neutropenic disorder
- Pharyngitis
- Pneumonia
- Thrombocytopenic disorder
- Upper respiratory infection
- Urinary tract infection
- Acute abdominal pain
- Anorexia
- Arthralgia
- Bruising
- Chills
- Constipation
- Diarrhea
- Dizziness
- Dry skin
- Dyspepsia
- Ecchymosis
- Erythema
- Fatigue
- Fever
- General weakness
- Generalized abdominal tenderness
- Gingival bleeding
- Headache disorder
- Hematoma
- Injection site sequelae
- Insomnia
- Lethargy
- Loose stools
- Malaise
- Myalgia
- Nausea
- Petechiae
- Pruritus of skin
- Skin nodules
- Skin rash
- Symptoms of anxiety
- Urticaria
- Vomiting
- Weight loss
More Frequent
Severe
Less Severe
- Oral hemorrhage
- Hypotension
- Musculoskeletal pain
- Stomatitis
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Acute respiratory distress syndrome
- Agranulocytosis
- Atrial fibrillation
- Bacterial sepsis
- Black tarry stools
- Cardiomyopathy
- Cholecystitis
- Chronic heart failure
- Dermal necrosis
- Differentiation syndrome
- Diverticulitis of gastrointestinal tract
- Gastrointestinal hemorrhage
- Heart failure
- Hemoptysis
- Hepatic coma
- Injection site necrosis
- Interstitial lung disease
- Intracerebral hemorrhage
- Kidney disease with reduction in GFR
- Muscle weakness
- Necrotizing fasciitis
- Ocular hemorrhage
- Orthostatic hypotension
- Pancytopenia
- Pericardial effusion
- Pericarditis
- Pyoderma gangrenosum
- Renal failure
- Renal tubular acidosis
- Seizure disorder
- Sweet's syndrome
- Tissue necrosis
- Tumor lysis syndrome
Less Severe
- Bone pain
- Induration of skin
Contraindicated
None
Severe Precaution
Azacitidine
Safety and efficacy not established age < 1 month. Rare myelodysplastic syndrome in children often differs from adult subtypes.
- 1 Day – 29 Days
- Safety and efficacy not established age < 1 month. Rare myelodysplastic syndrome in children often differs from adult subtypes.
Management or Monitoring Precaution
None
Azacitidine
- Severity Level:
D
- Additional Notes: Based on drug pharmacology developmental toxicity is possible.
Contraindicated
Azacitidine
Avoid during tx and for 1 week after last dose
General | Excretion Potential | Effect on Infant | Notes |
Drug should not be given to breast feeding mothers | Unknown | Not known; no or inclusive data | Avoid during tx and for 1 week after last dose |
Precaution Exists
None
General | Excretion Potential | Effect on Infant | Notes |
None |
No Known Risk
None
General | Excretion Potential | Effect on Infant | Notes |
None |
Contraindicated
None
Precaution Exists
Azacitidine
Renal-Monitor renal function in elderly since they have a higher incidence of drug induced renal dysfunction.
Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
Increased Risk / Adverse Effects | Y | Y | N | N | N | N |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- None
Acute myeloid leukemia | |
C92.0 | Acute myeloblastic leukemia |
C92.00 | Acute myeloblastic leukemia, not having achieved remission |
C92.02 | Acute myeloblastic leukemia, in relapse |
C92.4 | Acute promyelocytic leukemia |
C92.40 | Acute promyelocytic leukemia, not having achieved remission |
C92.42 | Acute promyelocytic leukemia, in relapse |
C92.5 | Acute myelomonocytic leukemia |
C92.50 | Acute myelomonocytic leukemia, not having achieved remission |
C92.52 | Acute myelomonocytic leukemia, in relapse |
C92.6 | Acute myeloid leukemia with 11q23-abnormality |
C92.60 | Acute myeloid leukemia with 11q23-abnormality not having achieved remission |
C92.62 | Acute myeloid leukemia with 11q23-abnormality in relapse |
C93.0 | Acute monoblastic/monocytic leukemia |
C93.00 | Acute monoblastic/monocytic leukemia, not having achieved remission |
C93.02 | Acute monoblastic/monocytic leukemia, in relapse |
C94.4 | Acute panmyelosis with myelofibrosis |
C94.40 | Acute panmyelosis with myelofibrosis not having achieved remission |
C94.42 | Acute panmyelosis with myelofibrosis, in relapse |
0-9 | A-Z |
---|---|
C92.0 | Acute myeloblastic leukemia |
C92.00 | Acute myeloblastic leukemia, not having achieved remission |
C92.02 | Acute myeloblastic leukemia, in relapse |
C92.4 | Acute promyelocytic leukemia |
C92.40 | Acute promyelocytic leukemia, not having achieved remission |
C92.42 | Acute promyelocytic leukemia, in relapse |
C92.5 | Acute myelomonocytic leukemia |
C92.50 | Acute myelomonocytic leukemia, not having achieved remission |
C92.52 | Acute myelomonocytic leukemia, in relapse |
C92.6 | Acute myeloid leukemia with 11q23-abnormality |
C92.60 | Acute myeloid leukemia with 11q23-abnormality not having achieved remission |
C92.62 | Acute myeloid leukemia with 11q23-abnormality in relapse |
C93.0 | Acute monoblastic/monocytic leukemia |
C93.00 | Acute monoblastic/monocytic leukemia, not having achieved remission |
C93.02 | Acute monoblastic/monocytic leukemia, in relapse |
C94.4 | Acute panmyelosis with myelofibrosis |
C94.40 | Acute panmyelosis with myelofibrosis not having achieved remission |
C94.42 | Acute panmyelosis with myelofibrosis, in relapse |
Formulary Reference Tool