Treatment-naive

Patient Profile:
Gregory, 71

Diagnosis

Diagnosed with high-risk myelodysplastic syndromes (MDS) when a blood examination revealed pancytopenia
Bone marrow biopsy indicated 10% blasts and multilineage dysplasia

Blood Test Results

Hemoglobin: 6.0 g/dL
Red blood cells: 4.1 M/µL
White blood cells: 3.0 K/µL
ANC: 570 cells/µL*
IPSS-R Score of 5.5 points=high
Platelets: 76 x 10⁹/L
Neutrophils: 16%
Cytogenetic category: Good

About Gregory

He enjoys fishing and doing outdoor activities with his wife and 2 grandchildren
He is transfusion-dependent
His treatment team discussed hypomethylating agents due to his IPSS-R Score, but Gregory does not have to have a port placement
He would prefer a treatment option that he can take in the convenience of his home
ECOG performance status was 1 prior to taking INQOVI

*Bands: 3%

ANC=absolute neutrophil count; ECOG=Eastern Cooperative Oncology Group; IPSS-R=Revised International Prognostic Scoring System; MDS=myelodysplastic syndromes.

Treatment-switch

Patient Profile:
Diane, 74

Diagnosis

Diagnosed 6 months ago with intermediate-risk MDS
Tests revealed moderate anemia, neutropenia; there was a prior diagnosis of renal disease
11.2% blasts
Initiated MDS treatment with IV HMA therapy
Began transfusion for anemia, and monitored progress
Has since achieved transfusion independence and is stable

Blood Test Results

Hemoglobin: 6.5 g/dL
Red blood cells: 3.6 M/µL
White blood cells: 4.0 K/µL
ANC: 800 cells/µL^†
IPSS-R Score of 4.5 points=intermediate
Platelets: 103 x 10⁹/L
Neutrophils: 18%
Cytogenetic category: Very good

About Diane

She does not have a full-time caregiver or family member to help with travel; she has been unable to get to the infusion center to complete her most recent cycle
She needed a treatment option she could take at home
ECOG performance status of 2 prior to beginning INQOVI

^†Bands: 2%

HMA=hypomethylating agent; IV=intravenous.

Additional Information

Your patients that may be appropriate for INQOVI¹:

Diagnosed with de novo or secondary MDS, including CMML
Classified as intermediate- or high-risk MDS
Have been previously treated or are treatment naive

Additional Patient Considerations:

Wish to take their HMA therapy in the comfort of their own home
Unable to have, or do not wish to have, infusion port placement
Do not have regular support to manage travel to the infusion center

Reference: 1. INQOVI [package insert]. Princeton, NJ: Taiho Oncology, Inc.; 2022

Important Safety Information

Important Safety Information

Warnings and Precautions

Myelosuppression: Fatal and serious myelosuppression can occur with INQOVI. 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%. Myelosuppression (thrombocytopenia, neutropenia, anemia, and febrile neutropenia) is 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.

Embryo-Fetal Toxicity: INQOVI can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise patients to use effective contraception during treatment and for 6 months (females) or 3 months (males) after last dose.

Adverse Reactions

Serious adverse reactions in > 5% of patients included febrile neutropenia (30%), pneumonia (14%), and sepsis (13%). Fatal adverse reactions 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%).

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).

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