Safety profile similar to IV decitabine^1,2

MDS Safety

Adverse reactions and lab abnormalities in patients with MDS and CMML

Incidence of cytopenias was slightly higher in patients taking INQOVI during Cycle 1 compared with those receiving IV decitabine^1,3
In the pooled safety population of Phases 2 and 3, 61% of patients receiving INQOVI were exposed for ≥6 months and 24% were exposed for >1 year¹
In the long-term follow-up, the adverse event (AE) profile was similar to what was observed in the pooled safety population^1,2
- The incidence of serious adverse reactions (ARs) in Cycles 1 and 2 was 31% (40/130) with oral decitabine-cedazuridine and 18% (24/132) with IV decitabine²

Adverse reactions reported in ≥10% of patients in the pooled Phase 2 and Phase 3 safety population¹

ADVERSE REACTIONS^a	INQOVI CYCLE 1 (N=107)		IV DECITABINE CYCLE 1 (N=106)		INQOVI ALL CYCLES (N=208^c)
	ALL GRADES (%)	GRADE 3 OR 4 (%)	ALL GRADES (%)	GRADE 3 OR 4 (%)	ALL GRADES (%)	GRADE 3 OR 4 (%)
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Fatigue^b	29	2	25	0	55	5
Hemorrhage^b	24	2	17	0	43	3
Edema^b	10	0	11	0	30	0.5
Pyrexia	7	0	7	0	19	1
GASTROINTESTINAL DISORDERS
Constipation^b	20	0	23	0	44	0
Mucositis^b	18	1	24	2	41	4
Nausea	25	0	16	0	40	0.5
Diarrhea^b	16	0	11	0	37	1
Transaminase increased^b	12	1	3	0	21	3
Abdominal pain^b	9	0	7	0	19	1
Vomiting	5	0	5	0	15	0
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Myalgia^b	9	2	16	1	42	3
Arthralgia^b	9	1	13	1	40	3
RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS
Dyspnea^b	17	3	9	3	38	6
Cough^b	7	0	8	0	28	0
BLOOD AND LYMPHATIC SYSTEM DISORDERS
Febrile neutropenia	10	10	13	13	33	32
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Rash^b	12	1	11	1	33	0.5
NERVOUS SYSTEM DISORDERS
Dizziness^b	16	1	11	0	33	2
Headache^b	22	0	13	0	30	0
Neuropathy^b	4	0	8	0	13	0
METABOLISM AND NUTRITIONAL DISORDERS
Decreased appetite	10	1	6	0	24	2
INFECTIONS AND INFESTATIONS
Upper respiratory tract infection^b	6	0	3	0	23	1
Pneumonia^b	7	7	7	5	21	15
Sepsis^b	6	6	2	1	14	11
Cellulitis^b	4	1	3	2	12	5
INVESTIGATIONS
Renal impairment^b	9	0	8	1	18	0
Weight decreased	5	0	3	0	10	1
INJURY, POISONING, AND PROCEDURAL COMPLICATIONS
Fall	4	0	1	0	12	1
PSYCHIATRIC DISORDERS
Insomnia	6	0	2	0	12	0.5
VASCULAR DISORDERS
Hypotension^b	4	0	6	1	11	2
CARDIAC DISORDERS
Arrhythmia^b	3	0	2	0	11	1

^aPlease see full Prescribing Information for complete list of ARs occurring during all cycles.

^bIncludes multiple AR terms.

^cIncludes ARs that occurred during all cycles, including during treatment with 1 cycle of IV decitabine.

Select hematologic lab abnormalities (>20%) worsening from baseline in the pooled safety population¹

LAB PARAMETER^a	INQOVI CYCLE 1^b		IV DECITABINE CYCLE 1^b		INQOVI ALL CYCLES^b
	ALL GRADES (%)	GRADE 3 OR 4 (%)	ALL GRADES (%)	GRADE 3 OR 4 (%)	ALL GRADES (%)	GRADE 3 OR 4 (%)
HEMATOLOGY
Leukocytes decreased	79	65	77	59	87	81
Platelet count decreased	79	65	77	67	82	76
Neutrophil count decreased	70	65	62	59	73	71
Hemoglobin decreased	58	41	59	36	71	55

^aIncludes any lab abnormalities that worsened by ≥1 grades. Grades 3 to 4 include any lab abnormalities that worsened to Grade 3 or Grade 4.

^bThe denominator used to calculate the rate varied from 103 to 107 for INQOVI Cycle 1, from 102 to 106 for the IV decitabine Cycle 1, and from 203 to 208 for INQOVI (all cycles) based on the number of patients with a baseline value and ≥1 post-treatment value.

Please see full Prescribing Information for chemistry lab safety parameters.

Fatal ARs occurred in 6% of patients¹

These included sepsis (1%), pneumonia (1%), respiratory failure (1%), septic shock (1%), and 1 case each of cerebral hemorrhage and sudden death¹
Also in the long-term follow-up, 11 (8%) of 133 participants had fatal treatment-emergent serious ARs during the study. 5 of these deaths were deemed treatment related; 2 to oral therapy (sepsis and pneumonia) and 3 to IV treatment (septic shock [n=2] and pneumonia [n=1])²

Permanent discontinuation due to an AR occurred in 5% of patients¹

1 participant in each group discontinued treatment during the first 2 cycles due to an AR²
Overall treatment discontinuations due to an AR included 1 (out of 132) receiving IV decitabine and 2 (out of 130) receiving oral decitabine-cedazuridine²
The most frequent ARs resulting in permanent discontinuation were febrile neutropenia (1%) and pneumonia (1%)¹
The most common reason for treatment discontinuation was undergoing allogeneic hematopoietic stem-cell transplantation (HSCT) (27 [20%])²

Dose interruptions due to an AR occurred in 41% of patients¹

ARs requiring dose interruptions in ≥5% of INQOVI patients included neutropenia (18%), febrile neutropenia (8%), thrombocytopenia (6%), and anemia (5%)

Dose reductions due to an AR occurred in 19% of patients¹

ARs requiring dose reductions in >2% of patients included neutropenia (12%), anemia (3%), and thrombocytopenia (3%)

Additional safety profile information¹

Clinically relevant ARs in <10% of patients who received INQOVI tablets included acute febrile neutrophilic dermatosis (Sweet's syndrome) (1%) and tumor lysis syndrome (0.5%)
Serious ARs occurred in 68% of patients who received INQOVI. Serious ARs in >5% of patients included febrile neutropenia (30%), pneumonia (14%), and sepsis (13%)

Dosing guidance

Guidance on INQOVI dosing may help support treatment.

Understand dosing

How to start patients

Patients can be started on INQOVI in both inpatient and outpatient settings.¹

Start patients on INQOVI

References: 1. INQOVI [package insert]. Princeton, NJ: Taiho Oncology, Inc.; 2026. 2. Garcia-Manero G, McCloskey J, Griffiths EA, et al. Oral decitabine-cedazuridine versus intravenous decitabine for myelodysplastic syndromes and chronic myelomonocytic leukaemia (ASCERTAIN): a registrational, randomised, crossover, pharmacokinetics, phase 3 study. Lancet Haematol. 2024;11(1):e15-e26. 3. Kim N, Norsworthy KJ, Subramaniam S, et al. FDA approval summary: decitabine and cedazuridine tablets for myelodysplastic syndromes. Clin Cancer Res. 2022;28(16):3411-3416.

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.

Safety profile similar to IV decitabine^1,2

Adverse reactions and lab abnormalities in patients with MDS and CMML

Adverse reactions reported in ≥10% of patients in the pooled Phase 2 and Phase 3 safety population¹