b'NowIMPORTANT SAFETY INFORMATION AND INDICATIONSIMPORTANT SAFETY INFORMATION mucositis, arthralgia, nausea, dyspnea, diarrhea, WARNINGS AND PRECAUTIONS rash, dizziness, febrile neutropenia, edema, headache, cough, decreased appetite, upper Approved Myelosuppression: Fatal and seriousrespiratory tract infection, pneumonia, and myelosuppression can occur with INQOVI.transaminase increased. The most common Based on laboratory values, new or worseningGrade 3 or 4 laboratory abnormalities ( 50%) thrombocytopenia occurred in 82% of patients,were leukocytes decreased, platelet count with Grade 3 or 4 occurring in 76%. Neutropeniadecreased, neutrophil count decreased, and occurred in 73% of patients, with Grade3 orhemoglobin decreased. 4 occurring in 71%. Anemia occurred in 71% ofUSE IN SPECIFIC POPULATIONSpatients, with Grade 3 or 4 occurring in 55%. Febrile neutropenia occurred in 33% of patients,Lactation: Because of the potential for serious INQOVI (decitabine and cedazuridine) tabletswith Grade 3 or 4 occurring in 32%. adverse reactions in the breastfed child, advise women not to breastfeed during treatment is therst and only once-daily oral HMA treatmentFatal and serious infectious complications canwith INQOVI and for at least 2 weeks after the occur with INQOVI. Pneumonia occurred in 21% for adult patients with MDS, including CMML 1 of patients, with Grade3 or 4 occurring in 15%.last dose.Sepsis occurred in 14% of patients, with Grade3Renal Impairment: No dosage modi cation of or 4 occurring in 11%. Fatal pneumonia occurredINQOVI is recommended for patients with mild in 1% of patients, fatal sepsis in 1%, and fatal septicor moderate renal impairment (creatinine shock in 1%. clearance [CLcr] of 30 to 89 mL/min based Obtain complete blood cell counts prior toon Cockcroft-Gault). Due to the potential for initiation of INQOVI, prior to each cycle, andincreased adverse reactions, monitor patients as clinically indicated to monitor responsewith moderate renal impairment (CLcr 30 to 59 and toxicity. Administer growth factors andmL/min) frequently for adverse reactions. INQOVI anti-infective therapies for treatment orhas not been studied in patients with severe renal WITH NEW INQOVI, PATIENTS CAN NOW TAKE THEIR MEDICATIONprophylaxis as appropriate. Delay the next cycleimpairment (CLcr 15 to 29 mL/min) or end-stage AT HOME, REDUCING THE NEED FOR FREQUENT OFFICE VISITS TOand resume at the same or reduced doserenal disease (ESRD: CLcr 15 mL/min).RECEIVE INTRAVENOUS THERAPY. 1 as recommended. INDICATIONSThe recommended dose of INQOVI is one tablet taken orally once daily on Day 1 through Day 5Embryo-Fetal Toxicity: INQOVI can cause fetalINQOVI is indicated for treatment of adult patients of each 28-day cycle for minimum of 4 cycles until disease progression or unacceptable toxicity.harm. Advise pregnant women of the potentialwith myelodysplastic syndromes (MDS), including 1 risk to a fetus. Advise patients to use e ectivepreviously treated and untreated, de novo and A complete or partial response may take longer than 4 cycles. contraception during treatment and for 6 monthssecondary MDS with the following French-INDICATIONS(females) or 3 months (males) after last dose. American-British subtypes (refractory anemia, INQOVI is indicated for treatment of adult patients with myelodysplastic syndromes (MDS),refractory anemia with ringed sideroblasts, including previously treated and untreated, de novo and secondary MDS with the followingADVERSE REACTIONS refractory anemia with excess blasts, and French-American-British subtypes (refractory anemia, refractory anemia with ringedSerious adverse reactions in 5% of patientschronic myelomonocytic leukemia [CMML]) and sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemiaincluded febrile neutropenia (30%), pneumoniaintermediate-1, intermediate-2, and high-risk [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring(14%), and sepsis (13%). Fatal adverse reactionsInternational Prognostic Scoring System groups.System groups. 1included sepsis (1%), septic shock (1%), pneumoniaPlease see brief summary of Prescribing (1%), respiratory failure (1%), and one case each ofInformation on the following pages.Please see Important Safety Information on the next page and brief summarycerebral hemorrhage and sudden death. Reference: 1. INQOVI. Prescribing information. of Prescribing Information on the following pages.The most common adverse reactions ( 20%)Taiho Oncology Inc; 2020. HMA=hypomethylating agent; CMML=chronic myelomonocytic leukemia; MDS=myelodysplastic syndromes were fatigue, constipation, hemorrhage, myalgia, Developed byAstex Pharmaceuticals, Inc. Marketed byTaiho Oncology, Inc. INQOVI is a registered trademark of Otsuka Pharmaceutical Co., Ltd. CopyrightTAIHO ONCOLOGY, INC. TO LEARN MORE ABOUT INQOVI, VISIT INQOVI.COM 2020 All rights reserved. 07/2020 CDEC-PM-US-0114'