Adult: Initial cycle: 75 mg/m2 daily via SC inj or slow IV infusion over 10-40 minutes for 7 days, followed by a 21-day rest period of each 28-day cycle. For myelodysplastic syndromes, dose may be increased to 100 mg/m2 daily if no benefit after 2 cycles. Treatment duration: 4-6 cycles; treatment may be continued as long as the patient benefits or until disease progression. Premedicate with antiemetic prior to each dose. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety and tolerability (refer to detailed product guidelines).
Intravenous Juvenile myelomonocytic leukaemia
Child: 1 month to <1 year or patient weighing <10 kg: 2.5 mg/kg daily; ≥1 year and patient weighing ≥10 kg: 75 mg/m2 daily. All doses are given via slow IV infusion over 20-40 minutes for 7 days followed by a 21-day rest period of each 28-day cycle. Treatment duration: Minimum of 3 cycles up to a Max of 6 cycles; treatment may be continued as long as the patient benefits or until disease progression. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety and tolerability. Dosage recommendation may vary between countries (refer to specific country guidelines).
Oral Acute myeloid leukaemia
Adult: As maintenance therapy in patients who achieved complete remission or complete remission with incomplete blood count recovery following induction therapy with or without consolidation treatment and those who are not candidates for (including those who choose not to proceed to) haematopoietic stem cell transplantation: 300 mg once daily for 14 days, followed by a 14-day rest period (28-day cycle). Administer an antiemetic prior to each dose for the 1st 2 cycles, then as needed for subsequent cycles. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety and tolerability (refer to detailed product guidelines).
What are the brands available for Azacitidine in Philippines?
Oral:
Moderate to severe: Dose adjustment may be necessary.
Administration
Azacitidine May be taken with or without food.
Reconstitution
SC: Add 4 mL of sterile water for inj to a vial containing 100 mg of azacitidine to obtain a final concentration of 25 mg/mL. Vigorously shake vial until a cloudy suspension is formed. IV: Add 10 mL of sterile water for inj to a vial labelled as containing 100 mg to obtain a final concentration of 10 mg/mL. Vigorously shake the vial until all solids are dissolved and a clear solution is achieved. Further dilute with 50-100 mL of NaCl 0.9% or Lactated Ringer's inj for IV infusion.
Contraindications
Advanced malignant hepatic tumour. Lactation.
Special Precautions
Patient with cardiac disease, pulmonary disease; high tumour burden associated with metastatic disease. Due to the differences in exposure, dose and schedule of treatment, the oral preparation of azacitidine should not be used interchangeably with parenteral azacitidine preparations. Renal and hepatic impairment. Children. Pregnancy.
This drug may cause fatigue, if affected, do not drive or operate machinery. Women of childbearing potential must use effective contraception during therapy and for at least 6 months after stopping the treatment. Men with female partners of childbearing potential should not father a child during therapy and for at least 3 months after stopping the treatment.
Monitoring Parameters
Monitor renal function at baseline, prior to each cycle and as clinically indicated. Monitor for toxicities. Assess risk for TLS prior to treatment and monitor for signs of TLS during therapy. Oral: Monitor CBC prior to initiation of therapy, every other week for the 1st 2 cycles, every other week for the next 2 cycles after dose adjustment, then monthly thereafter, prior to start of subsequent cycles, and as clinically indicated. Parenteral: Monitor CBC with differential and platelets at baseline then before each cycle and as necessary thereafter; LFTs, serum creatinine, serum bicarbonate, electrolytes prior to initiation of treatment, prior to each cycle, and as clinically indicated. Perform cardiopulmonary assessment before and during treatment. Assess for haematologic response, nausea and vomiting, and for inj site reactions.
Description: Mechanism of Action: Azacitidine, a pyrimidine nucleoside analogue of cytidine, is an antineoplastic agent. It exerts its cytotoxic effect through multiple mechanisms, such as incorporation into the DNA and RNA and inhibition of DNA and RNA methyltransferases, it decreases DNA and RNA methylation, it alters DNA gene expression which includes the re-expression of genes that regulate tumour suppression and cell differentiation, and it decreases RNA stability and decreases protein synthesis. Pharmacokinetics: Absorption: Rapidly and completely absorbed after SC inj. Bioavailability: Approx 89% (SC); approx 11% (oral). Time to peak plasma concentration: 30 minutes (SC); 1 hour (oral). Distribution: Volume of distribution: 76 ± 26 L (IV). Plasma protein binding: 6-12% (oral). Metabolism: Metabolised in the liver via spontaneous hydrolysis and deamination by cytidine deaminase into several metabolites. Excretion: Mainly via urine (50-85% [SC/IV]; <2% as unchanged drug [oral]); faeces (<1% [SC/IV]). Elimination half-life: Approx 4 hours (SC/IV); approx 0.5 hours (oral).
Chemical Structure
Azacitidine Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 9444, Azacitidine. https://pubchem.ncbi.nlm.nih.gov/compound/Azacitidine. Accessed Oct. 25, 2024.
Storage
Tab: Store below 30°C. Solution for IV inj or suspension for SC inj: Store below 25°C. This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal.
L01BC07 - azacitidine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
References
Anon. Azacitidine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 06/09/2024.Azacitidine 300 mg Film-coated Tablets (MSN Laboratories Europe Ltd). MHRA. https://products.mhra.gov.uk. Accessed 11/10/2024.Azacitidine. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 06/09/2024.Azadine Powder for Suspension for Injection (Accord Healthcare Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 11/10/2024.Brayfield A, Cadart C (eds). Azacitidine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/09/2024.Onureg 200 mg, 300 mg Film-coated Tablets (DKSH Malaysia Sdn Bhd). Website Name: National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/09/2024.Onureg Tablet, Film Coated (Celgene Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 12/09/2024.Pharmacy Retailing (NZ) Limited Trading as Healthcare Logistics. Azacitidine Accord 100 mg Powder for Injection data sheet 18 March 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 06/09/2024.Vidaza 25 mg/mL Powder for Suspension for Injection (Bristol-Myers Squibb Pharma EEIG). MHRA. https://products.mhra.gov.uk. Accessed 06/09/2024.Vidaza Injection, Powder, Lyophilized, for Solution (Celgene Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 12/09/2024.
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