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Azacitidine Dosage

Applies to the following strength(s): 100 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Myelodysplastic Syndrome

-First Treatment Cycle: 75 mg/m2/day via subcutaneous injection or IV infusion for 7 days; repeat cycles every 4 weeks.
-Subsequent Cycles: After 2 treatment cycles, may increase dose to 100 mg/m2 if no beneficial effect is seen and if no toxicity other than nausea and vomiting has occurred.
-Duration of Therapy: Minimum of 4 to 6 cycles; may continue treatment as long as the patient continues to benefit.

Comments: Premedicate patients for nausea and vomiting.

Use: Treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome (MDS) subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) if accompanied by neutropenia or thrombocytopenia or requiring transfusions; refractory anemia with excess blasts (RAEB); refractory anemia with excess blasts in transformation (RAEB-T); and chronic myelomonocytic leukemia (CMMoL).

Renal Dose Adjustments

-All Levels of Renal Impairment: Administer drug without initial dose adjustment; monitor for toxicity.
-Unexplained Reductions in Serum Bicarbonate Levels to Less Than 20 mEq/L: 50% dose in the next course.
-Unexplained Elevations of BUN or Serum Creatinine: Delay the cycle until values return to normal or baseline, and use 50% dose in the next course.

Liver Dose Adjustments

-Hepatic Impairment: Data not available.
-Advanced Malignant Hepatic Tumors: Contraindicated.

Dose Adjustments

Baseline WBC 3 x 10(9)/L or Greater, Absolute Neutrophil Count (ANC) 1.5 x 10(9)/L or Greater, AND Platelets 75 x 10(9)/L or Greater:
-ANC Less Than 0.5 x 10(9)/L and Platelets Less Than 25 x 10(9)/L: 50% dose in the next course.
-ANC 0.5 to 1.5 x 10(9)/L and Platelets 25 to 50 x 10(9)/L: 67% dose in the next course.
-ANC Greater Than 1.5 x 10(9)/L and Platelets Greater Than 50 x 10(9)/L: 100% dose in the next course.

Baseline WBC Less Than 3 x 10(9)/L, ANC Less Than 1.5 x 10(9)/L, OR Platelets Less Than 75 x 10(9)/L AND WBC or Platelet Nadir 50% to 75% Decrease in Counts from Baseline:
-Bone Marrow Biopsy Cellularity (BMBC) of 30% to 60% at Nadir time: 100% dose in the next course.
-BMBC of 15% to 30% at Nadir time: 50% dose in the next course.
-BMBC Less Than 15% at Nadir time: 33% dose in the next course.

Baseline WBC Less Than 3 x 10(9)/L, ANC Less Than 1.5 x 10(9)/L, OR Platelets Less Than 75 x 10(9)/L AND WBC or Platelet Nadir Greater Than 75% Decrease in Counts from Baseline:
-BMBC of 30% to 60% at Nadir time: 75% dose in the next course.
-BMBC of 15% to 30% at Nadir time: 50% dose in the next course.
-BMBC Less Than 15% at Nadir time: 33% dose in the next course.
-Give the next course 28 days after the start of the preceding course provided that both the WBC and platelet counts are greater than 25% above the nadir and rising.
-At the time of the next cycle, continue the current dose if there is clear improvement in differentiation (i.e., percentage of mature granulocytes is higher and ANC is higher than at onset of that course).
-If Greater Than 25% Increase Above the Nadir is Not Seen by Day 28: Reassess counts every 7 days.
-If 25% Increase is Not Seen by Day 42: Reduce the scheduled dose by 50%.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available.

Other Comments

Administration Advice:
-Subcutaneous administration: Divide doses greater than 4 mL equally into 2 syringes and inject into 2 separate sites. Rotate sites (thigh, abdomen, upper arm) for each injection; give new injections at least 1 inch/2.5 cm from the previous site and avoid areas that are tender, bruised, red, or hardened.
-IV administration: Administer the total dose over a period of 10 to 40 minutes; complete the administration within 45 to 60 minutes of reconstitution.

Storage Requirements:
-Consult the manufacturer product information.

Reconstitution/Preparation Techniques:
-Consult the manufacturer product information.

IV Compatibility:
-Consult the manufacturer product information.

General:
-Overdosage: There is no known specific antidote.

Monitoring:
-Hematologic: Complete blood counts (prior to treatment initiation and with each cycle); signs and symptoms of bleeding (during treatment)
-Hepatic: Liver chemistries (prior to treatment initiation and with each cycle)
-Metabolic: Signs and symptoms of tumor lysis syndrome (during treatment)
-Renal: Serum creatinine, serum bicarbonate, and electrolytes (prior to treatment initiation and with each cycle)

Patient Advice:
-Avoid potentially dangerous activities such as driving and operating machinery until you know how this drug affects you.

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