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VIDAZA is a brand name for Azacitidine, supplied as a powder for suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VIDAZA® (azacitidine for injection) is indicated for the treatment of adult patients who are not eligible for hematopoietic stem cell transplantation with: • Intermediate-2 and High-risk Myelodysplastic Syndrome (MDS) according to the International Prognostic Scoring System (IPSS), • Acute Myeloid Leukemia (AML) with…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations 06/2022 7 WARNINGS AND PRECAUTIONS 06/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..............................................................................
2 TABLE OF CONTENTS .................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................... 4 1 INDICATIONS .........................................................................................................
1 Pediatrics ................................................................................................................ 2 Geriatrics ................................................................................................................
4 2 CONTRAINDICATIONS ......................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................. 4 4 DOSAGE AND ADMINISTRATION .......................................................................
1 Dosing Considerations ......................................................................................... 2 Recommended Dose and Dosage Adjustment ................................................ 3 Reconstitution ........................................................................................................
4 Administration ........................................................................................................ 5 Missed Dose ..........................................................................................................
8 5 OVERDOSAGE....................................................................................................... 9
1 Adverse Reaction Overview Adverse reactions considered to be possibly or probably related to the administration of VIDAZA® (azacitidine for injection) have occurred in 97 % of patients. The most commonly reported adverse reactions with VIDAZA® treatment were hematological reactions including thrombocytopenia, neutropenia and leukopenia (usually Grade 3-4), gastrointestinal events including nausea, vomiting (usually Grade 1 2) or injection site reactions (usually Grade 1-2).
3 %). , cerebral hemorrhage). Adverse reactions most frequently resulting in discontinuation or dose reduction were leukopenia, thrombocytopenia, and neutropenia. Adverse reactions most frequently resulting in the dose being held were leukopenia, neutropenia, thrombocytopenia, pyrexia, pneumonia, and febrile neutropenia.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. VIDAZA® (Azacitidine for injection) Page 13 of 44 Phase 3 Pivotal International Open-Label Randomized Survival Study in Higher Risk MDS (AZA-001) The pivotal clinical study (AZA-001) was an international, multicenter, open-label, randomized trial in MDS patients with refractory anemia with excessive blasts (RAEB), RAEB in transformation (RAEB-T) or modified chronic myelomonocytic leukemia (CMMoL) according to the French American British (FAB) classification and Intermediate-2 and High risk according to IPSS classification.
Of the 358 patients enrolled in the study, 179 were randomized to receive VIDAZA® plus best supportive care (BSC) and 179 were randomized to receive conventional care regimens (CCR) plus BSC (105 to BSC alone, 49 to low dose cytarabine and 25 to chemotherapy with cytarabine and anthracycline).
06/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................. 2 TABLE OF CONTENTS ....................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................... 4 1 INDICATIONS ......................................................................................................... 1 Pediatrics ................................................................................................................
2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS .........................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................. 4 4 DOSAGE AND ADMINISTRATION ....................................................................... 1 Dosing Considerations .........................................................................................
2 Recommended Dose and Dosage Adjustment ................................................ 3 Reconstitution ........................................................................................................ 4 Administration ........................................................................................................
5 Missed Dose .......................................................................................................... 8 5 OVERDOSAGE.......................................................................................................
9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............. 9 7 WARNINGS AND PRECAUTIONS........................................................................ 1 Special Populations ............................................................................................
• Patients who are hypersensitive to azacitidine or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGHTS, COMPOSITION AND PACKAGING. • Advanced malignant hepatic tumors.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Azacitidine in Canada.
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VIDAZA® was administered subcutaneously (SC) at a dose of 75 mg/m2 daily for 7 consecutive days every 28 days (which constituted one cycle of therapy). 0 days, suggesting that investigators were delaying the start of the next treatment cycle consistent with protocol- specified dosing recommendations based on hematological toxicities.
The median number of treatment cycles was 9. 16 months). 7% each). 1 % of patients) were also considered medically important. 4%, respectively. 9% of patients. 9%. The percentage for all other TEAEs that led to interruption was < 2%. 0% of VIDAZA® patients (Study AZA- 001).
6% (19/102) in the BSC group. 7%). Note that some of these patients experienced more than 1 treatment emergent adverse event resulting in death. Of the 21 on-treatment deaths in the VIDAZA® group, 7 were assessed as possibly related to VIDAZA® (of which 1 was considered to be possibly related to underlying disease as well).
3) 0 0 0 Injection […]
1 Pregnant Women .......................................................................................... 2 Breast-feeding................................................................................................ 3 Pediatrics ........................................................................................................
4 Geriatrics ........................................................................................................ 12 8 ADVERSE REACTIONS ...................................................................................... 1 Adverse Reaction Overview ..............................................................................
2 Clinical Trial Adverse Reactions ....................................................................... 3 Less Common Clinical Trial Adverse Reactions ............................................ 5 Post-Market Adverse Reactions .......................................................................
19 9 DRUG INTERACTIONS ....................................................................................... 2 Drug Interactions Overview ............................................................................... 3 Drug-Behavioural Interactions...........................................................................
4 Drug-Drug Interactions ....................................................................................... 5 Drug-Food Interactions....................................................................................... 6 Drug-Herb Interactions .......................................................................................
7 Drug-Laboratory Test Interactions .................................................................... 21 10 CLINICAL PHARMACOLOGY............................................................................. 1 Mechanism of Action ....................................................................................
2 Pharmacodynamics ...................................................................................... 3 Pharmacokinetics .......................................................................................... 22 11 STORAGE, STABILITY AND DISPOSAL ...........................................................
24 12 SPECIAL HANDLING INSTRUCTIONS .............................................................. 24 PART II: SCIENTIFIC INFORMATION ........................................................................... 26 13 PHARMACEUTICAL INFORMATION .................................................................
26 14 CLINICAL TRIALS ............................................................................................... 1 Clinical Trials by Indication .......................................................................... 27 16 NON-CLINICAL TOXICOLOGY ...........................................................................
33 PATIENT MEDICATION INFORMATION ....................................................................... 1 Pediatrics The safety and effectiveness of VIDAZA® in children and adolescents (<18 yrs) have not been established. 2 Geriatrics No overall differences in safety or […]