b'23VA Approved Criteria for Use; Rxs PermittedINQOVI (decitabine and cedazuridine) tablets containTRICARE Approved Uniform Formulary With35 mg of decitabine and 100 mg of cedazuridine1Prior Authorization Required Week 1 Take 1 tablet once daily for 5 days 2 days offWeek 2 No medication INQOVI cannot be substituted for IV-administered INQOVI is the Only Oral Hypomethylating Agent (HMA) for theWeek 3 No medication decitabine within the same cycle. Week 4 No medicationTreatment of Myelodysplastic Syndromes (MDS), Including CMML The VA National PBM-MAP-VPE Monograph on INQOVI can be viewed at https://www.pbm.va.gov/PBM/clinicalguidance/drugmonographs.aspCMML=chronic myelomonocytic leukemia. IMPORTANT SAFETY INFORMATION (contd)WARNINGS AND PRECAUTIONS (contd)INDICATIONSEmbryo-Fetal Toxicity: INQOVI can cause fetal harm. Advise pregnant women of the potential risk to a fetus. INQOVI is indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previouslyAdvise patients to use effective contraception during treatment and for 6 months (females) or 3 months treated and untreated, de novo and secondary MDS with the following French-American-British subtypes(males) after last dose.(refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, andADVERSE REACTIONSchronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk InternationalSerious adverse reactions in 5% of patients included febrile neutropenia (30%), pneumonia (14%), and sepsis Prognostic Scoring System groups.(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.IMPORTANT SAFETY INFORMATIONWARNINGS AND PRECAUTIONS The most common adverse reactions ( 20%) were fatigue (55%), constipation (44%), hemorrhage (43%), Myelosuppression: Fatal and serious myelosuppression can occur with INQOVI. Based on laboratory values,myalgia (42%), mucositis (41%), arthralgia (40%), nausea (40%), dyspnea (38%), diarrhea (37%), rash (33%), new or worsening thrombocytopenia occurred in 82% of patients, with Grade 3 or 4 occurring in 76%.dizziness (33%), febrile neutropenia(33%), edema (30%), headache (30%), cough (28%), decreased appetite Neutropenia occurred in 73% of patients, with Grade 3 or 4 occurring in 71%. Anemia occurred in 71% of(24%), upper respiratory tract infection (23%), pneumonia (21%), and transaminase increased (21%). The most patients, with Grade 3 or 4 occurring in 55%. Febrile neutropenia occurred in 33% of patients, with Grade 3common Grade 3 or 4 laboratory abnormalities ( 50%) were leukocytes decreased (81%), platelet count or 4 occurring in 32%. Myelosuppression (thrombocytopenia, neutropenia, anemia, and febrile neutropenia) isdecreased (76%), neutrophil count decreased (71%), and hemoglobin decreased (55%).the most frequent cause of INQOVI dose reduction or interruption, occurring in 36% of patients. PermanentUSE IN SPECIFIC POPULATIONSdiscontinuation due to myelosuppression (febrile neutropenia) occurred in 1% of patients. MyelosuppressionLactation: Because of the potential for serious adverse reactions in the breastfed child, advise women not to and worsening neutropenia may occur more frequently in the first or second treatment cycles and may notbreastfeed during treatment with INQOVI and for 2 weeks after the last dose.necessarily indicate progression of underlying MDS. Renal Impairment: No dosage modification of INQOVI is recommended for patients with mild or moderate Fatal and serious infectious complications can occur with INQOVI. Pneumonia occurred in 21% of patients,renal impairment (creatinine clearance [CLcr] of 30 to 89 mL/min based on Cockcroft-Gault). Due to the with Grade 3 or 4 occurring in 15%. Sepsis occurred in 14% of patients, with Grade 3 or 4 occurring in 11%.potential for increased adverse reactions, monitor patients with moderate renal impairment (CLcr 30 to Fatal pneumonia occurred in 1% of patients, fatal sepsis in 1%, and fatal septic shock in 1%. 59 mL/min) frequently for adverse reactions. INQOVI has not been studied in patients with severe renal Obtain complete blood cell counts prior to initiation of INQOVI, prior to each cycle, and as clinically indicatedimpairment (CLcr 15 to 29 mL/min) or end-stage renal disease (ESRD: CLcr 15 mL/min).to monitor response and toxicity. Administer growth factors and anti-infective therapies for treatment orReference: 1. INQOVI. Package insert. Taiho Oncology Inc; 2022.prophylaxis as appropriate. Delay the next cycle and resume at the same or reduced dose as recommended.Please see additional Important Safety Information on next page. Please see brief summary of Prescribing Information on adjacent pages.Developed byAstex Pharmaceuticals, Inc.Marketed byTaiho Oncology, Inc. INQOVI is a registered trademark of Otsuka Pharmaceutical Co., Ltd.TAIHO ONCOLOGY, INC. 2022 All rights reserved. 04/2022 INQ-PM-US-0429 v2INQOVI_Compendium_Spread_Ad_L05.indd 1 4/13/22 11:20 AM'