Generic Name
AzaCITIDine
Brand Names
Vidaza, Onureg
FDA approval date: July 05, 2004
Classification: Nucleoside Metabolic Inhibitor
Form: Injection, Tablet
What is Vidaza (AzaCITIDine)?
Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of: · Adult patients with the following FAB myelodysplastic syndrome subtypes: Refractory anemia or refractory anemia with ringed sideroblasts , refractory anemia with excess blasts , refractory anemia with excess blasts in transformation , and chronic myelomonocytic leukemia .
Approved To Treat
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Brand Information
VIDAZA (azacitidine)
1DOSAGE FORMS AND STRENGTHS
VIDAZA (azacitidine for injection) is supplied as lyophilized powder in 100 mg single-dose vials.
2ADVERSE REACTIONS
The following adverse reactions are described in other labeling sections:
- Anemia, Neutropenia and Thrombocytopenia
- Hepatotoxicity in Patients with Severe Pre-existing Hepatic Impairment
- Renal Toxicity
- Tumor Lysis Syndrome
2.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
MDS
The data described below reflect exposure to VIDAZA in 443 patients with MDS from 4 clinical studies. Study 1 was a supportive-care controlled trial (subcutaneous administration), Studies 2 and 3 were single arm studies (one with subcutaneous administration and one with intravenous administration), and Study 4 was an international randomized trial (subcutaneous administration)
In Studies 1, 2 and 3, a total of 268 patients were exposed to VIDAZA, including 116 exposed for 6 cycles (approximately 6 months) or more and 60 exposed for greater than 12 cycles (approximately one year). VIDAZA was studied primarily in supportive-care controlled and uncontrolled trials (n=150 and n=118, respectively). The population in the subcutaneous studies (n=220) was 23 to 92 years old (mean 66.4 years), 68% male, and 94% white, and had MDS or AML. The population in the intravenous study (n=48) was 35 to 81 years old (mean 63.1 years), 65% male, and 100% white. Most patients received average daily doses between 50 and 100 mg/m
In Study 4, a total of 175 patients with higher-risk MDS (primarily RAEB and RAEB-T subtypes) were exposed to VIDAZA. Of these patients, 119 were exposed for 6 or more cycles, and 63 for at least 12 cycles. The mean age of this population was 68.1 years (ranging from 42 to 83 years), 74% were male, and 99% were white. Most patients received daily VIDAZA doses of 75 mg/m
Most Commonly Occurring Adverse Reactions (Subcutaneous or Intravenous Route) in Adult Patients with MDS: nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, injection site erythema, constipation, neutropenia, ecchymosis. The most common adverse reactions by intravenous route also included petechiae, rigors, weakness and hypokalemia.
Adverse Reactions Most Frequently (>2%) Resulting in Clinical Intervention (Subcutaneous or Intravenous Route) in Adult Patients with MDS:
Discontinuation: leukopenia, thrombocytopenia, neutropenia.
Dose Held: leukopenia, neutropenia, thrombocytopenia, pyrexia, pneumonia, febrile neutropenia.
Dose Reduced: leukopenia, neutropenia, thrombocytopenia.
Table 3 presents adverse reactions occurring in at least 5% of patients treated with VIDAZA (subcutaneous) in Studies 1 and 2. It is important to note that duration of exposure was longer for the VIDAZA-treated group than for the observation group: patients received VIDAZA for a mean of 11.4 months while mean time in the observation arm was 6.1 months.
Table 4 presents adverse reactions occurring in at least 5% of patients treated with VIDAZA in Study 4. Similar to Studies 1 and 2 described above, duration of exposure to treatment with VIDAZA was longer (mean 12.2 months) compared with best supportive care (mean 7.5 months).
In Studies 1, 2 and 4 with subcutaneous administration of VIDAZA, adverse reactions of neutropenia, thrombocytopenia, anemia, nausea, vomiting, diarrhea, constipation, and injection site erythema/reaction tended to increase in incidence with higher doses of VIDAZA. Adverse reactions that tended to be more pronounced during the first 1 to 2 cycles of subcutaneous treatment compared with later cycles included thrombocytopenia, neutropenia, anemia, nausea, vomiting, injection site erythema/pain/bruising/reaction, constipation, petechiae, dizziness, anxiety, hypokalemia, and insomnia. There did not appear to be any adverse reactions that increased in frequency over the course of treatment.
Overall, adverse reactions were qualitatively similar between the intravenous and subcutaneous studies. Adverse reactions that appeared to be specifically associated with the intravenous route of administration included infusion site reactions (e.g. erythema or pain) and catheter site reactions (e.g. infection, erythema, or hemorrhage).
In clinical studies of either subcutaneous or intravenous VIDAZA, the following serious adverse reactions occurring at a rate of <5% (and not described in Tables 2 or 3) were reported:
Blood and lymphatic system disorders: agranulocytosis, bone marrow failure, pancytopenia splenomegaly.
Cardiac disorders: atrial fibrillation, cardiac failure, cardiac failure congestive, cardio-respiratory 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.
Juvenile Myelomonocytic Leukemia (JMML)
The safety of VIDAZA was evaluated in pediatric patients with JMML (N=18; 0.2-6.9 years old) in Study AZA-JMML-001
Sixteen patients completed 3 cycles of therapy and 5 of the 16 patients completed 6 cycles. The median treatment duration was 12.3 weeks (range: 4.0 to 30.6 weeks) and the median total number of treatment cycles completed was 3 cycles (range: 1 to 6 cycles).
Serious adverse reactions occurred in 67% of patients who received VIDAZA for JMML.
Permanent discontinuation of VIDAZA due to an adverse reaction occurred in a single patient who had abdominal pain and acute respiratory distress syndrome.
The most common (≥30%) adverse reactions were pyrexia, rash, upper respiratory tract infection, and anemia.
Table 5 summarizes the adverse reactions in pediatric JMML.
a Grouped term includes: face edema, generalized edema, edema peripheral.
b Grouped term includes: rash, rash macular, dermatitis bullous, rash maculo-papular, rash papular, rash pruritic.
c Grouped term includes: pruritis, pruritis generalized.
d Grouped term includes: influenza, nasopharyngitis, Parainfluenzae virus infection, respiratory tract infection, rhinitis, upper respiratory tract infection, and viral upper respiratory tract infection
e Grouped term includes: anal candidiasis, Candida infection, oral candidiasis.
f Grouped term includes: lung infection, pneumonia respiratory syncytial viral.
g Grouped term includes: abdominal pain, abdominal pain upper.
h Grouped term includes: mouth hemorrhage, rectal hemorrhage.
i Grouped term includes: back pain, musculoskeletal pain, non-cardiac chest pain, pain in extremity.
2.2Postmarketing Experience
The following adverse reactions have been identified during postmarketing use of VIDAZA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Interstitial lung disease
- Tumor lysis syndrome
- Injection site necrosis
- Sweet’s syndrome (acute febrile neutrophilic dermatosis)
- Necrotizing fasciitis (including fatal cases)
- Differentiation syndrome
- Pericardial effusion
- Pericarditis
- Cutaneous vasculitis
3OVERDOSAGE
One case of overdose with VIDAZA was reported during clinical trials. A patient experienced diarrhea, nausea, and vomiting after receiving a single intravenous dose of approximately 290 mg/m
4DESCRIPTION
VIDAZA (azacitidine for injection) contains azacitidine, which is a nucleoside metabolic inhibitor. Azacitidine is
4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one. The structural formula is as follows:
The empirical formula is C
The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of VIDAZA contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder.
5REFERENCES
- “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
6PATIENT COUNSELING INFORMATION
Hepatotoxicity in Patients with Severe Pre-Existing Hepatic Impairment
Instruct patients to inform their physician about any underlying liver disease [see Warnings and Precautions (5.3)].
Instruct patients to inform their physician about any underlying liver disease [see Warnings and Precautions (5.3)].
Renal Toxicity
Instruct patients to inform their physician about any underlying renal disease [see Warnings and Precautions (5.4)].
Instruct patients to inform their physician about any underlying renal disease [see Warnings and Precautions (5.4)].
Embryo-Fetal Toxicity
Advise pregnant women of the potential risk to a fetus [see Warnings and Precautions (5.6) and Use in Specific Populations (
Advise pregnant women of the potential risk to a fetus [see Warnings and Precautions (5.6) and Use in Specific Populations (
Advise females of reproductive potential to use effective contraception during treatment with VIDAZA and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with VIDAZA and for 3 months after the last dose. Advise patients to report known or suspected pregnancy to their physicians immediately
Lactation
Advise patients to avoid breastfeeding while receiving VIDAZA and for 1 week after the last dose [see Use in Specific Populations (
Advise patients to avoid breastfeeding while receiving VIDAZA and for 1 week after the last dose [see Use in Specific Populations (
Infertility
Advise males and females that VIDAZA may impair fertility
VIDAZA
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