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%
Additional Information
Your patients who may be appropriate for INQOVI1
Diagnosed with de novo or secondary MDS, including CMML
Classified as intermediate- or high-risk MDS
Are treatment naive
Have previously been treated, and may be ready to switch from current treatment
Additional Patient Considerations1,2:
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
References:1. INQOVI [package insert]. Princeton, NJ: Taiho Oncology, Inc.; 2022. 2. Savona MR, Odenike O, Amrein PC, et al. An oral fixed‑dose combination of decitabine and cedazuridine in myelodysplastic syndromes: a multicentre, open‑label, dose‑escalation, phase 1 study. Lancet Haematol. 2019;6(4): e194‑e203. doi:10.1016/S2352‑3026(19)30030‑4
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).