Azacitidine

Brands

DEA Class; Rx

Common Brand Names; Vidaza, Onureg

  • Antineoplastics, DNA Methylation Inhibitor

A pyrimidine nucleoside analog chemotherapy agent
Used IV or subcutaneously in adults with certain myelodysplastic syndrome subtypes; used orally in adults with acute myelogenous leukemia
Injectable formulation contraindicated in patients with advanced malignant hepatic tumors or hypersensitivity to mannitol; oral product should not be substituted with injectable formulation

Indicated for myelodysplastic syndromes in patients with the following French-American-British (FAB) subtypes: Refractory anemia (RA) or RA with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), chronic myelomonocytic leukemia (CMMoL)

Indicated for continued treatment of adults with acute myeloid leukemia who achieved first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy

IV or SC

  • Advanced malignant hepatic tumors
  • Hypersensitivity to azacitidine or mannitol

PO

  • Hypersensitivity to azacitidine or its components
  • Nausea (48-71%)
  • Anemia (51-70%)
  • Thrombocytopenia (66-70%)
  • Neutropenia (32-66%)
  • Constipation (34-50%)
  • Vomiting (27-54%)
  • Pyrexia (30-52%)
  • Leukopenia (18-48%)
  • Injection site erythema (35-43%)
  • Diarrhea (36%)
  • Ecchymosis (31%)
  • Dyspnea (29%)
  • Injection site reaction (14-29%)
  • Petechiae (24%)
  • Fatigue (24%)
  • Injection site pain (23%)
  • Arthralgia (22%)
  • Headache (22%)
  • Anorexia (21%)
  • Dizziness (19%)
  • Injection site pain (5-19%)
  • Erythema (17%)
  • Febrile neutropenia (14-16%)
  • Chest pain (16%)
  • Myalgia (16%)
  • Nasopharyngitis (15%)
  • Rash (14%)
  • Injection site bruising (5-14%)
  • Abdominal pain (13%)
  • Upper respiratory tract infection (13%)
  • Anxiety (13%)
  • Abdominal tenderness (12%)
  • Malaise (11%)
  • Pneumonia (11%)
  • Insomnia (11%)

Do not substitute PO azacitidine for IV or SC azacitidine; intravenous treatment at the recommended dosage of oral azacitidine may result in a fatal adverse reaction; treatment of patients using oral form at doses recommended for intravenous treatment may not be effective

Fetal harm may occur when administered to pregnant females

Based on its mechanism of actions and animal studies, fetal harm may occur when administered to pregnant females

There is no information regarding presence of azacitidine in human milk, effects of therapy on breastfed infant, or effects of therapy on milk production

Adults

IV or subcutaneous dosing: 100 mg/m2 daily for 7 days per cycle.Oral dosing: 300 mg daily for 14 days per cycle.

Geriatric

IV or subcutaneous dosing: 100 mg/m2 daily for 7 days per cycle.Oral dosing: 300 mg daily for 14 days per cycle.

Adolescents

75 mg/m2 IV daily for 7 days per cycle.

Children

Less than 10 kg: 2.5 mg/kg IV daily for 7 days per cycle.10 kg or more: 75 mg/m2 IV daily for 7 days per cycle.

Infants

2.5 mg/kg IV daily for 7 days per cycle.

Neonates

Safety and efficacy not established.

Azacitidine

injection, lyophilized powder for reconstitution

  • 100mg/single-dose vial (Vidaza, generic)

tablet

  • 200mg (Onureg)
  • 300mg (Onureg)
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