cedazuridine and decitabine
cedazuridine and decitabine is listed in the FDA National Drug Code directory with 1 NDC code. Available dosage form: tablet, film coated.
Drug Details
- Generic Name
- cedazuridine and decitabine
- Brand Names
- N/A
- Application Number
- Sponsor
- BSP Pharmaceuticals S.p.A.
- NDC Codes
- 1
- Dosage Forms
- TABLET, FILM COATED
- Routes
- N/A
- Active Ingredients
- CEDAZURIDINE
Indications and Usage
1 INDICATIONS AND USAGE INQOVI is a combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor, indicated: For treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. ( 1.1 ) In combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. ( 1.2 ) 1.1 Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia INQOVI is indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. 1.2 Acute Myeloid Leukemia INQOVI is indicated in combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.