AML and MDS treatment guidelines for INQOVI¹

Dosing Guidance & Modifications

Guidance on taking, monitoring, and adjusting dosing

Indicated dosage: 1 tablet once daily
Fixed-dose combination containing 35 mg of decitabine and 100 mg of cedazuridine

Tablet shown is not actual size. Actual tablet size is 7.94 mm x 14.29 mm.²

Instruct patients to:

Take INQOVI at approximately the same time each day
Swallow INQOVI whole. Do not cut, crush, or chew the tablets
Take INQOVI on an empty stomach at least 2 hours before or 2 hours after eating

If vomiting occurs after dosing, do not take an additional dose, and continue with the next scheduled dose
Skip the dose if more than 12 hours late, take the next scheduled dose, and extend the dosing period by 1 day to ensure 5 daily doses each cycle

Instruct patients also taking venetoclax for AML to:

Take INQOVI and venetoclax at least 2 hours apart. Do not take INQOVI and venetoclax at the same time

Remind patients and their caregivers that INQOVI is a hazardous drug. Follow applicable special handling and disposal procedures. Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F).

Monitoring and dose modifications

Guidance on monitoring and dose modifications varies by indication and should be followed accordingly.

Monitoring

Obtain complete blood cell counts before initiating INQOVI, before each cycle, and as clinically indicated to monitor for response and toxicity
If patients develop cytopenias, frequently monitor blood cell counts through resolution
If a bone marrow test is needed, order it as early as Day 22

Dose delays or reductions

Hematologic ARs

If hematologic ARs occur, monitor complete blood cell counts until neutrophils and platelet counts have recovered to Grade 1 or 2 (an absolute neutrophil count [ANC] of ≥1000/μL and platelets of ≥50,000/μL).

If hematologic recovery does not occur within 2 weeks of achieving remission:

Delay INQOVI for up to 2 additional weeks
Consider reducing the number of days of INQOVI per cycle according to the table below

Nonhematologic ARs

If nonhematologic ARs occur, reduce the INQOVI dose according to the table below.

Recommended INQOVI dose reductions for ARs

INQOVI dose reduction table showing first, second, and third dose adjustment schedules across a 5-day treatment cycle for managing myelosuppression in patients with MDS.

Manage persistent severe neutropenia and febrile neutropenia with supportive treatment.

Monitoring

Obtain complete blood cell counts before initiating INQOVI, before each cycle, and as clinically indicated to monitor for response and toxicity

Dose delays or reductions

Hematologic ARs

Delay the next cycle if absolute neutrophil count (ANC) is <1000 /μL and platelets are <50,000/μL in the absence of active disease. Monitor complete blood cell counts until ANC is ≥1000/μL and platelets are ≥50,000/μL.

If hematologic recovery does not occur within 2 weeks of achieving remission:

Delay INQOVI for up to 2 additional weeks, and resume at a reduced dose by administering INQOVI on Days 1 through 4
Consider further dose reductions if myelosuppression persists after a dose reduction according to the table below
Maintain or increase the dose in subsequent cycles as clinically indicated

Nonhematologic ARs

If the following nonhematologic ARs occur, delay the next cycle, and resume INQOVI at the same dose or at a reduced dose upon resolution:

Serum creatinine ≥2 mg/dL
Serum bilirubin ≥2x upper limit of normal (ULN)
Aspartate aminotransferase or alanine aminotransferase ≥2x ULN
Active or uncontrolled infection

Recommended INQOVI dose reductions for myelosuppression

Manage persistent severe neutropenia and febrile neutropenia with supportive treatment.

Dosing schedules

INQOVI is administered on a 28-day cycle for both AML and MDS.¹ However, patients with AML may take INQOVI + venetoclax, and patients with MDS may take INQOVI alone.

See the schedules

Personalized calendar

Practices can personalize a dosing calendar based on patients’ start dates.

Create a calendar

Practice resources

Practices may find these resources helpful when prescribing INQOVI.

Explore practice resources

References: 1. INQOVI [package insert]. Princeton, NJ: Taiho Oncology, Inc.; 2026. 2. Data on file. Taiho Oncology Inc., Princeton, NJ.

INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

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.

INQOVI is indicated in combination with venetoclax for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Myelosuppression
INQOVI as Monotherapy for MDS or CMML
In patients with MDS or CMML, INQOVI can cause severe myelosuppression, including fatal adverse reactions. Based on laboratory values, new or worsening thrombocytopenia occurred in 82% of patients, with Grade 3 or 4 occurring in 76%. Neutropenia occurred in 73% of patients, with Grade 3 or 4 occurring in 71%. Anemia occurred in 71% of patients, with Grade 3 or 4 occurring in 55%. Febrile neutropenia occurred in 33% of patients, with Grade 3 or 4 occurring in 32%. Thrombocytopenia, neutropenia, anemia, and febrile neutropenia are the most frequent cause of INQOVI dose reduction or interruption, occurring in 36% of patients. Permanent discontinuation due to myelosuppression (febrile neutropenia) occurred in 1% of patients. Myelosuppression and worsening neutropenia may occur more frequently in the first or second treatment cycles and may not necessarily indicate progression of underlying MDS.

Fatal and serious infectious complications can occur with INQOVI. Pneumonia occurred in 21% of patients, with Grade 3 or 4 occurring in 15%. Sepsis occurred in 14% of patients, with Grade 3 or 4 occurring in 11%. Fatal pneumonia occurred in 1% of patients, fatal sepsis in 1%, and fatal septic shock in 1%.

Obtain complete blood cell counts prior to initiation of INQOVI, prior to each cycle, and as clinically indicated to monitor response and toxicity. Administer growth factors and anti‑infective therapies for treatment or prophylaxis as appropriate. Delay the next cycle and resume at the same or reduced dose as recommended.

INQOVI in Combination with Venetoclax for AML
In patients with AML, INQOVI can cause severe myelosuppression, including fatal adverse reactions, when given in combination with venetoclax. Based on laboratory values in Study ASTX727-07, Phase 2 new or worsening thrombocytopenia occurred in 70% of patients, with Grade 3 or 4 occurring in 69%. Neutropenia occurred in 48% of patients, with Grade 3 or 4 occurring in 48%. Anemia occurred in 54% of patients, with Grade 3 or 4 occurring in 50%. Febrile neutropenia occurred in 52% of patients, with Grade 3 or 4 occurring in 52%. Thrombocytopenia, neutropenia, anemia, and febrile neutropenia were a frequent cause of INQOVI and/or venetoclax dose reduction or interruption. Dose reductions of INQOVI due to neutropenia and thrombocytopenia occurred in 4% and 1% of patients, respectively. Dose interruptions of INQOVI due to neutropenia, febrile neutropenia, thrombocytopenia, and anemia occurred in 40%, 11%, 8%, and 2% of patients, respectively.

Fatal and serious infectious complications can occur during treatment with INQOVI and venetoclax. Pneumonia occurred in 25% of patients, with Grade 3 or 4 occurring in 20%. Sepsis occurred in 28% of patients, with Grade 3 or 4 occurring in 18%. Fatal pneumonia occurred in 2% of patients and fatal sepsis in 8%.

Obtain complete blood cell counts prior to initiation of INQOVI with venetoclax, prior to each cycle, and as clinically indicated to monitor response and toxicity. Administer growth factors and anti-infective therapies for treatment or prophylaxis as appropriate. Delay the next cycle and resume at the same or reduced dose as recommended.

Embryo-Fetal Toxicity
Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with INQOVI and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with INQOVI and for 3 months after the last dose.

ADVERSE REACTIONS

INQOVI as Monotherapy for MDS or CMML
Serious adverse reactions occurred in 68% of patients who received INQOVI. Serious adverse reactions in >5% of patients included febrile neutropenia (30%), pneumonia (14%), and sepsis (13%). Fatal adverse reactions occurred in 6% of patients. These included sepsis (1%), septic shock (1%), pneumonia (1%), respiratory failure (1%), and one case each of cerebral hemorrhage and sudden death.

The most common adverse reactions (≥20%) were fatigue (55%), constipation (44%), hemorrhage (43%), myalgia (42%), mucositis (41%), arthralgia (40%), nausea (40%), dyspnea (38%), diarrhea (37%), rash (33%), dizziness (33%), febrile neutropenia (33%), edema (30%), headache (30%), cough (28%), decreased appetite (24%), upper respiratory tract infection (23%), pneumonia (21%), and transaminase increased (21%). The most common Grade 3 or 4 laboratory abnormalities (≥50%) were leukocytes decreased (81%), platelet count decreased (76%), neutrophil count decreased (71%), and hemoglobin decreased (55%).

INQOVI in Combination with Venetoclax for AML
Serious adverse reactions occurred in 82% of patients who received INQOVI+VEN. Serious adverse reactions in >5% of patients included febrile neutropenia (31%), sepsis (22%), pneumonia (15%), infection (bacterial/viral) (10%), hemorrhage (9%), and dyspnea (6%). Fatal adverse reactions occurred in 8% of patients who received INQOVI+VEN. These included sepsis (5%), dyspnea (2%), myocardial infarction (1%), hemolytic anemia (1%), and tumor lysis syndrome (1%).

The most common adverse reactions (≥20%) were neutropenia (60%), febrile neutropenia (52%), thrombocytopenia (52%), hemorrhage (42%), anemia (41%), infection (bacterial/viral) (40%), diarrhea (38%), fatigue (36%), mucositis (36%), constipation (36%), arthralgia (35%), decreased appetite (31%), edema (31%), nausea (31%), dyspnea (30%), white blood cell count decreased (28%), sepsis (28%), pneumonia (25%), rash (25%), transaminitis (24%), myalgia (23%), arrhythmia (21%), and abdominal pain (21%). The most common Grade 3 or 4 laboratory abnormalities (≥20%) were decreased leukocytes (91%), decreased lymphocytes (81%), decreased platelets (69%), decreased hemoglobin (50%), and decreased neutrophils (48%).

USE IN SPECIFIC POPULATIONS

Lactation
Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with INQOVI and for 2 weeks after the last dose.

Renal Impairment
No dosage modification of INQOVI is recommended for patients with mild or moderate renal impairment (creatinine clearance [CLcr] of 30 to 89 mL/min based on Cockcroft-Gault). Due to the potential for increased adverse reactions, monitor patients with moderate renal impairment (CLcr 30 to 59 mL/min) frequently for adverse reactions. INQOVI has not been studied in patients with severe renal impairment (CLcr 15 to 29 mL/min) or end-stage renal disease (ESRD: CLcr <15 mL/min).

Please see full Prescribing Information.

AML and MDS treatment guidelines for INQOVI¹

Guidance on taking, monitoring, and adjusting dosing

Instruct patients to:

Instruct patients also taking venetoclax for AML to:

Monitoring and dose modifications

Monitoring

Dose delays or reductions

Hematologic ARs

Nonhematologic ARs

Monitoring

Dose delays or reductions

Hematologic ARs

Nonhematologic ARs

Dosing schedules

Personalized calendar

Practice resources

INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

USE IN SPECIFIC POPULATIONS

Choose when your patient will start INQOVI + venetoclax for AML

Print the calendar to help your patient get started

Choose when your patient will start INQOVI for MDS

Print the calendar to help your patient get started

AML and MDS treatment guidelines for INQOVI1

Guidance on taking, monitoring, and adjusting dosing

Instruct patients to:

Instruct patients also taking venetoclax for AML to:

Monitoring and dose modifications

Monitoring

Dose delays or reductions

Hematologic ARs

Nonhematologic ARs

Monitoring

Dose delays or reductions

Hematologic ARs

Nonhematologic ARs

Dosing schedules

Personalized calendar

Practice resources

INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

USE IN SPECIFIC POPULATIONS

Choose when your patient will start INQOVI + venetoclax for AML

Print the calendar to help your patient get started

Choose when your patient will start INQOVI for MDS

Print the calendar to help your patient get started

AML and MDS treatment guidelines for INQOVI¹