Adult Dosing
Myelodysplastic syndromes
- 75 mg/m2 SC/IV qd x 7 days
- Repeat cycles every 4 weeks. Dose may be increased to 100 mg/m2 SC/IV qd if no beneficial effect is seen after 2 treatment cycles or if no toxicity other than nausea/vomiting
- Adjust dose amount/timing according to lab results. Refer PI
- Continue therapy for a minimum of 4-6 cycles. May continue therapy as long as the patient continues to benefit
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
- Therapy with azacitidine is associated with with anemia, neutropenia and thrombocytopenia. Monitor CBC with differential count and platelets prior to each cycle, then periodically. After administration of the recommended dosage for the first cycle, dosage for subsequent cycles should be reduced or delayed based on nadir counts and hematologic response
- Evaluate renal function prior to starting therapy and before each cycle. If unexplained elevations in BUN or creatinine occur, delay next cycle until values return to normal, and reduce the dose 50% on the next treatment course. Monitor for hematologic response. Monitor for signs of toxicity because azacitidine and its metabolites are primarily excreted by the kidneys
- Safety and effectiveness of azacitidine in patients with MDS and renal impairment have not been established
- Monitor LFTs prior to each cycle
- Azacitine may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be warned of the potential risks of therapy during pregnancy
- Advise women to use reliable contraception during therapy of childbearing potential
- Advise men with partners of childbearing potential to use reliable contraception
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Elderly patients
- Women of child bearing potential
Pregnancy Category:D
Note: Embryotoxicity, fetal death, and fetal abnormalities demonstrated in animal studies. Women of childbearing age should be advised to avoid pregnancy during treatment. Males on azacitidine therapy should avoid fathering a child
Breastfeeding: Unsafe. Discontinue drug or nursing taking into consideration importance of drug to the mother
