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AZACITIDINE FOR 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: AZACITIDINE FOR INJECTION (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…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 06/2025 TABLE OF CONTENTS Certain sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph 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 ..................................................................................................................................
8
1 Adverse Reaction Overview Adverse reactions considered to be possibly or probably related to the administration of azacitidine for injection have occurred in 97% of patients. The most commonly reported adverse reactions with azacitidine for injection 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. 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 Azacitidine for injection Page 13 of 39 Protected B / Protégé B 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 azacitidine for injection 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).
1 Dosing Considerations • Patients should be premedicated with anti-emetics for nausea and vomiting. • AZACITIDINE FOR INJECTION is for subcutaneous use only. • Azacitidine for injection has not been studied in patients with impaired hepatic function.
• Dosage given should be adjusted according to tolerability as described below. • Injectable azacitidine should not be used interchangeably with oral azacitidine. Due to Azacitidine for injection Page 5 of 39 Protected B / Protégé B differences in exposure, the dose and schedule recommendations for oral azacitidine are different from those for injectable azacitidine.
Verify drug name, dose, and administration route. 2 Recommended Dose and Dosage Adjustment Recommended dose The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 of body surface area, injected subcutaneously, daily for 7 consecutive days, followed by a rest period of 21 days (28 -day treatment cycle).
It is recommended that patients be treated for a minimum of 6 cycles unless unacceptable toxicities occur after dose delays / adjustments or standard supportive care such as transfusions, growth factors or antibiotics have proved to be unsuccessful.
Treatment should be continued as long as the patient continues to benefit or until disease progression. Patients should be monitored for hematologic response/toxicity and renal toxicities (see 7 WARNINGS and PRECAUTIONS); a delay in starting the next cycle or a dose reduction as described below may be necessary.
• Renal impairment: AZACITIDINE FOR INJECTION can be administered to patients with renal impairment without initial dose adjustment. If unexplained reductions in serum bicarbonate levels to less than 20 mmol/L occur, the dose should be reduced by 50 % on the next cycle.
If unexplained elevations in serum creatinine or BUN to ≥ 2 fold above baseline values and above ULN occur, the next cycle should be delayed until values return to normal or baseline. The dose should be reduced by 50 % on the next treatment cycle (see 7 WARNINGS AND PRECAUTIONS).
• 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, STRENGTHS, COMPOSITION AND PACKAGING. • Advanced malignant hepatic tumors.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Azacitidine for injection 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 azacitidine for injection 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 azacitidine for injection group, 7 were assessed as possibly related to azacitidine for injection (of which 1 was considered to be possibly related to underlying disease as well).
0) 0 Dyspepsia 10 […]
Patients with renal impairment should be closely monitored for toxicity since AZACITIDINE FOR INJECTION and/or its metabolites are primarily excreted through the kidney. • Hepatic impairment: Patients with impaired liver function were excluded from the pivotal clinical trial.
These patients should be treated with caution. AZACITIDINE FOR INJECTION is contraindicated in patients with advanced malignant hepatic tumors (see 7 WARNINGS AND PRECAUTIONS and 2 CONTRAINDICATIONS). 0 x 109/L and/or absolute neutrophil count (ANC) below 1 x 109/L.
5 x [Baseline count – Nadir count]). e. 0 x 109/L) prior to the first treatment. If hematological toxicity is observed following AZACITIDINE FOR INJECTION treatment, the next cycle of AZACITIDINE FOR INJECTION therapy should be delayed until the platelet count and the ANC have recovered.
If recovery is achieved within 14 days, no dose adjustment is necessary. However, if recovery has not been achieved within 14 days, the dose should be reduced according to Table 1. Following dose modifications, the cycle duration should return to 28 days.
e. 0 x 109/L) prior to the first treatment. Following AZACITIDINE FOR INJECTION treatment, if the decrease in WBC or ANC or platelets from that prior to treatment is less than 50%, or greater than 50% but with an improvement in any cell line differentiation, the next cycle should not be delayed and no dose adjustment made.
If the decrease in WBC or ANC or platelets is greater than 50 % from that prior to treatment, with no improvement in cell line differentiation, the next cycle of AZACITIDINE FOR INJECTION therapy should be delayed until the platelet count and the ANC have recovered.
If recovery is achieved within 14 days, no dose adjustment is necessary. However, if recovery has not been achieved within 14 days, bone marrow cellularity should be determined. If the bone marrow cellularity is >50%, no dose adjustments should be made.
5 x [Baseline count - Nadir count]) Following dose modifications, the cycle duration should return to 28 days. 3 Reconstitution Table 3 - Reconstitution Vial Size Volume of […]