Azacitidine Advagen

Azacitidine Advagen

azacitidine

Manufacturer:

Advagen
Concise Prescribing Info
Contents
Azacitidine

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Indications/Uses
Adult patients not eligible for haematopoietic stem cell transplantation (HSCT) w/ intermediate-2 & high-risk myelodysplastic syndromes (MDS) according to International Prognostic Scoring System (IPSS), chronic myelomonocytic leukaemia (CMML) w/ 10-29% marrow blasts w/o myeloproliferative disorder, acute myeloid leukaemia (AML) w/ 20-30% blasts & multi-lineage dysplasia, according to World Health Organisation (WHO) classification. Adult patients aged ≥65 yr not eligible for HSCT w/ AML w/ >30% marrow blasts according to the WHO classification.
Dosage/Direction for Use
SC Recommended starting dose for 1st treatment cycle: 75 mg/m2 daily for 7 days, followed by a rest period of 21 days (28-day treatment cycle). Min: 6 cycles. Patient w/o reduced baseline blood counts (ie, WBC ≥3.0 × 109/L, ANC ≥1.5 × 109/L & platelets ≥75.0 × 109/L) prior to 1st treatment If haematological toxicity is observed following treatment, delay next therapy cycle until platelet count & ANC recovered. No dose adjustment is necessary if recovery is achieved w/in 14 days. Reduce dose if recovery is not achieved w/in 14 days. Cycle duration should return to 28 days following dose modifications. Patient w/ reduced baseline blood counts (ie, WBC <3.0 × 109/L, ANC <1.5 × 109/L or platelets <75.0 x 109/L) prior to 1st treatment Following treatment, if the decrease in WBC, ANC or platelets from that prior to treatment is ≤50% or >50% but w/ an improvement in any cell line differentiation, next cycle should not be delayed & no dose adjustment. If the decrease in WBC, ANC or platelets is >50% from that prior to treatment, w/ no improvement in cell line differentiation, delay next therapy cycle until platelet count & ANC recovered. No dose adjustment is necessary if recovery is achieved w/in 14 days. Determine bone marrow cellularity if recovery is not achieved w/in 14 days. No dose adjustment if bone marrow cellularity is >50%. Delay treatment & reduce dose if bone marrow cellularity is ≤50%. Cycle duration should return to 28 days following dose modifications. Renal impairment Reduce dose by 50% on the next cycle if unexplained reduction in serum bicarbonate levels to <20 mmol/L occur. Delay next cycle until values return to normal or baseline & reduce dose by 50% on the next treatment cycle if unexplained elevations in serum creatinine or BUN to ≥2-fold above baseline values & ULN occur.
Contraindications
Hypersensitivity. Advanced malignant hepatic tumours. Lactation.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BC07 - azacitidine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Azacitidine Advagen powd for susp for inj 100 mg
Packing/Price
1's
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