INQOVI (Decitabine 35 mg/Cedazuridine 100 mg) FilmCoated Tablets

Manufacturer
BSP Pharmaceuticals S.p.A.(ITALY)

Registraction Number
MAL24106011ACZ


Content:
INQOVI (Decitabine 35 mg/Cedazuridine 100 mg) Film-Coated Tablets contain 35 mg of decitabine and 100 mg of cedazuridine. Decitabine is a hypomethylating agent, and cedazuridine is a cytidine deaminase inhibitor that helps decitabine work more effectively by preventing its breakdown in the body.
Indication:
INQOVI is indicated for the 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. It is also indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for standard induction chemotherapy.
Instructions:

1. Dosage: Take INQOVI exactly as prescribed by your doctor. The recommended dosage is one tablet once daily on days 1 through 5 of each 28-day cycle.
2. Administration: Take INQOVI on an empty stomach, at least 2 hours before or 2 hours after a meal. Swallow the tablets whole; do not cut, crush, or chew them.
3. Monitoring: Your doctor will monitor your blood counts and liver/renal function regularly while you are taking this medication. Dose adjustments may be necessary based on your response and any side effects.
4. Storage: Store INQOVI at room temperature, away from moisture and heat.
5. Precautions: Do not use INQOVI if you have an active infection. Inform your doctor if you have any history of heart disease, liver disease, or other medical conditions.