• Monitor for bone marrow depression. Assess for bleeding (bleeding gums, bruising, petechiae, stools, urine, emesis) and avoid IM injections and taking rectal temperatures if platelet count is low. Apply pressure to venipuncture sites for 10 min. Assess for signs of infection during neutropenia. Anemia may occur. Monitor for increased fatigue, dyspnea, and orthostatic hypotension.
• Assess patient for nausea and vomiting during therapy. Premedicate patient before each dose. For PO doses: If Grade 3 or 4 nausea or vomiting of diarrhea occurs: Hold dose until nausea and vomiting has resolved to ≤Grade 1. If symptoms reoccur, hold dose until resolved to ≤Grade 1. Resume at reduced dose of 200 mg. If a symptoms continue after dose reduction, reduce the treatment duration by 7 days. If the symptoms continue or reoccur after dose and schedule reduction, discontinue azacitidine.
• Monitor for signs of anaphylaxis (facial edema, wheezing, dizziness, fainting, tachycardia, hypotension). Discontinue medication immediately and report symptoms. Epinephrine and resuscitation equipment should be readily available.

Lab Test Considerations:

• Verify negative pregnancy status prior to starting therapy.
• Monitor CBC with differential and platelet count prior to each dosing cycle. For PO doses: If ANC <0.5 x 10⁹/L on Day 1 of a cycle, do not administer azacitidine until ANC ≥0.5 x 10⁹/L. If neutrophils <1 x 10⁹/L and 1st occurrence, hold therapy until neutrophils ≥1 x 10⁹/L. If occurs in 2 consecutive cycles, hold therapy until neutrophils ≥1 x 10⁹/L, then resume at reduced dose of 200 mg. If febrile neutropenia continues after dose reduction, reduce treatment duration by 7 days. If febrile neutropenia reoccurs after dose and schedule reduction, discontinue azacitidine. If platelets <50 x 10⁹/L and 1st occurrence, hold therapy until platelets ≥50 x 10⁹/L. If occurs in 2 consecutive cycles,hold therapy until platelets ≥50 x 10⁹/L, then resume at reduced dose of 200 mg. If thrombocytopenia with bleeding continues after dose reduction, reduce the treatment duration by 7 days. If thrombocytopenia with bleeding reoccurs after dose and schedule reduction, discontinue azacitidine. For IV or SUBQ doses:If baseline WBC ≥3 x 10⁹/L, ANC ≥1.5 x 10⁹/L, and platelets ≥75 x 10⁹/L, then dose is adjusted based on nadir counts for each cycle. If ANC <0.5 x 10⁹ and platelets <25 x 10⁹, then ↓ dose by 50%. If ANC is 0.5–1.5 x 10⁹ and platelets are 25–50 x 10⁹, then ↓ dose to 67% in next course. If ANC >1.5 x 10⁹ and platelets >50 x 10⁹, then 100% of dose can be given in subsequent cycle. If baseline WBC <3 x 10⁹/L, ANC <1.5 x 10⁹/L, or platelets <75 x 10⁹/L, adjust dose based on nadir counts and bone marrow biopsy cellularity at time of nadir for each cycle. If WBC or platelet nadir decrease 50–75% in counts from baseline and bone marrow biopsy cellularity is 30–60% at time of nadir, give 100% of dose next course. If WBC or platelet nadir decrease 50–75% in counts from baseline and bone marrow biopsy cellularity is 15–30% at time of nadir, give 50% of dose next course. If WBC or platelet nadir decrease 50–75% in counts from baseline and bone marrow biopsy cellularity is <15% at time of nadir, give 33% of dose next course. If WBC or platelet nadir decrease >75% in counts from baseline and bone marrow biopsy cellularity is 30–60% at time of nadir, give 75% of dose next course. If WBC or platelet nadir decrease >75% in counts from baseline and bone marrow biopsy cellularity is 15–30% at time of nadir, give 50% of dose next course. If WBC or platelet nadir decrease >75% in counts from baseline and bone marrow biopsy cellularity is <15% at time of nadir, give 33% of dose next course. Administer next course 28 days after start of preceding course, if both WBC and platelet counts are >25% above nadir and rising. If >25% ↑ above nadir is not seen by Day 28, reassess counts every 7 days. If a 25% increase is not seen by Day 42, reduce scheduled dose by 50%.
  • Obtain liver chemistries prior to initiation of therapy and before each cycle.
  • Monitor renal function with serum creatinine and electrolytes prior to starting therapy and before each cycle. If serum bicarbonate <20 mEq/L,↓ dose by 50% in next course. If unexplained ↑ in BUN or serum creatinine occur, delay next cycle until values return to normal or baseline and ↓ dose by 50% in next course.
  • May cause hypokalemia.