Adverse reactions and lab abnormalities in patients with AML1,2
The safety profile of INQOVI + venetoclax in patients with newly diagnosed AML was consistent with the known safety profiles of both agents.2
Adverse reactions reported in ≥20% of patients for all grades or ≥5% for Grades 3-4 in the combined Phase 2 safety population1
ADVERSE REACTIONSa
PHASE 2 (N=159)
ALL GRADES (%)
GRADES 3-4 (%)
GASTROINTESTINAL DISORDERS
Diarrhea
38
4
Mucositisb
36
6
Constipationb
36
1
Nausea
31
0
Abdominal painb
21
3
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Fatigueb
36
8
Edemab
31
2
METABOLISM AND NUTRITION DISORDERS
Decreased appetite
31
3
BLOOD SYSTEM AND LYMPHATIC SYSTEM DISORDERS
Neutropeniab
60
58
Febrile neutropenia
52
52
Thrombocytopeniab
52
50
Anemia
41
36
White blood cell count decreased
28
28
HEPATOBILIARY DISORDERS
Transaminitisb
24
4
INFECTIONS AND INFESTATIONS
Infection (excludes fungal)b
40
13
Sepsisb
28
18
Pneumoniab
25
20
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Arthralgiab
35
6
Myalgiab
23
4
CARDIAC DISORDERS
Arrhythmiab
21
4
RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS
Dyspneab
30
12
RENAL AND URINARY DISORDERS
Renal insufficiencyb
18
5
VASCULAR DISORDERS
Hemorrhageb
42
9
Hypotension
19
6
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Rashb
25
1
aPlease see full Prescribing information for the complete list of adverse reactions (ARs) occurring during Phase 2.
bIncludes multiple AR terms.
Select laboratory abnormalities observed in >40% of patients for all grades in the combined Phase 2 safety population1
LABORATORY ABNORMALITY
PHASE 2 (N=159)
ALL GRADES (%)
GRADES 3-4 (%)
HEMATOLOGY AND COAGULATION
Lymphocytes (109/L) decreased
97
81
Leukocytes (109/L) decreased
91
91
Platelets (109/L) decreased
70
69
Hemoglobin (g/L) decreased
54
50
Neutophils (109/L) decreased
48
48
Please see full Prescribing Information for chemistry lab safety parameters.
Fatal ARs occurred in 8% of patients1
These included sepsis (5%), dyspnea (2%), myocardial infarction (1%), hemolytic anemia (1%), and tumor lysis syndrome (1%)
Permanent discontinuation due to an AR occurred in 9% of patients1
The most frequent AR resulting in permanent discontinuation in >1 patient was hemorrhage (1%)
Dosage interruptions due to an AR occurred in 55% of patients; dose reductions occurred in 6% of patients1
ARs resulting in dose interruptions in ≥5% of patients included neutropenia (40%), febrile neutropenia (11%), infection (bacterial/viral) (8%), and thrombocytopenia (8%)
The most common ARs requiring dose reductions were neutropenia (4%), thrombocytopenia (1%), and infection (1%)
Dosing guidance
Guidance on INQOVI dosing may help support treatment.
References: 1. INQOVI [package insert]. Princeton, NJ: Taiho Oncology, Inc.; 2026.
2. Data on file. Taiho Oncology Inc., Princeton, NJ.
IMPORTANT SAFETY INFORMATION
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
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