b'25Table 2: Adverse Reactions ( 10%) in Patients Who Received INQOVI20 Includes cellulitis, catheter site cellulitis, and infected bite in Pooled Safety Population 21 Includes blood creatinine increased, acute kidney injury, blood urea Intravenous22 increased, blood creatine increased, and renal failure INQOVI DecitabineINQOVIIncludes hypotension, blood pressure decreased, and cardiogenic Cycle 1Cycle 1All Cycles23 shock N=107 N=106 N=208Includes sinus tachycardia, atrial fibrillation, bradycardia, tachycardia, atrial flutter, sinus bradycardia, and conduction disorder AllGradesAllGradesAllGrades Clinically relevant adverse reactions in10% of patients who received Grades3-4 Grades3-4Grades3-4 INQOVI included: Adverse Reactions (%) (%) (%) (%) (%) (%)InvestigationsAcute febrile neutrophilic dermatosis (Sweets syndrome) (1%)Tumor lysis syndrome (0.5%) Renal impairment21 9 0 8 1 18 0 Table 3: Select Laboratory Abnormalities ( 20%) Worsening from Weight decreased 5 0 3 0 10 1 Baseline in Patients Who Received INQOVI in Pooled Safety PopulationInjury, poisoning, and procedural complications Intravenous Fall 4 0 1 0 12 1 INQOVI DecitabineINQOVIPsychiatric disorders Cycle 1 Cycle 1 All CyclesInsomnia 6 0 2 0 12 0.5 AllGrades AllGrades AllGrades Vascular disorders Grades 3-4Grades 3-4Grades 3-4 Hypotension22 4 0 6 1 11 2 Lab Abnormality* (%) (%) (%) (%) (%) (%)Cardiac Disorders Hematology Arrhythmia23 3 0 2 0 11 1 Leukocytes decreased 79 65 77 59 87 81Includes adverse reactions that occurred during all cycles, includingPlatelet count decreased 79 65 77 67 82 76during treatment with 1 cycle of intravenous decitabine. 1Includes fatigue, asthenia, and lethargyNeutrophil count70 65 62 59 73 712Includes contusion, epistaxis, petechiae, hematuria, conjunctivaldecreasedhemorrhage, mouth hemorrhage, purpura, angina bullosaHemoglobin decreased 58 41 59 36 71 55hemorrhagica, gingival bleeding, hematoma, hemoptysis, eyeChemistrycontusion, hemorrhagic diathesis, increased tendency to bruise, vaginal hemorrhage, abdominal wall hematoma, blood blister, boneGlucose increased 19 0 11 0 54 7contusion, catheter site bruise, ecchymosis, genital hemorrhage, Albumin decreased 22 1 20 0 45 2intra-abdominal hematoma, oral mucosa hematoma, periorbital hemorrhage, procedural hemorrhage, pulmonary alveolar hemorrhage,Alkaline phosphatase22 1 12 0 42 0.5retinal hemorrhage, scleral hemorrhage, thrombotic thrombocytopenicincreasedpurpura, tongue hemorrhage, and vessel puncture site hemorrhageGlucose decreased 14 0 17 0 40 13Includes edema peripheral, peripheral swelling, swelling face, fluidAlanine overload, localized edema, face edema, edema, eye swelling, eyelidaminotransferase13 1 7 0 37 2edema, fluid retention, periorbital swelling, scrotal edema, scrotalincreasedswelling, and swelling 4Includes constipation and feces hardSodium decreased 9 2 8 0 30 45Includes oropharyngeal pain, stomatitis, mouth ulceration, proctalgia,Calcium decreased 16 0 12 0 30 2oral pain, gingivitis, oral disorder, gingival pain, colitis, glossodynia, mouth swelling, pharyngitis, proctitis, duodenitis, enteritis, gingivalAspartate discomfort, gingival swelling, lip disorder, lip ulceration, mucosalaminotransferase6 1 2 0 30 2ulceration, nasal ulcer, noninfective gingivitis, oral mucosal blistering,increasedoral mucosal erythema, pharyngeal erythema, pharyngeal ulceration,Creatinine increased 7 0 8 0 29 0.56 tongue ulceration, and vulvitis* Includes any lab abnormalities that worsened by one or more grades. 7 Includes diarrhea and feces softGrade 3-4 includes any lab abnormalities that worsened to Grade 3 or Includes alanine aminotransferase increased, aspartateGrade 4. aminotransferase increased, blood alkaline phosphatase increased, The denominator used to calculate the rate varied from 103 to 107 for gamma-glutamyltransferase increased, liver function test increased,INQOVI Cycle 1, from 102 to 106 for Intravenous Decitabine Cycle and 8 and transaminases increasedfrom 203 to 208 for INQOVI All Cycles based on the number of patients Includes abdominal pain, abdominal pain upper, abdominal pain lower,with a baseline value and at least one post-treatment value.9 epigastric discomfort, and abdominal discomfort6.2 Postmarketing Experience Includes myalgia, pain in extremity, muscle spasms, pain, musculoskeletalThe following adverse reactions have been identified during postapproval pain, non-cardiac chest pain, muscular weakness, musculoskeletaluse of intravenous decitabine. Because these reactions are reported chest pain, flank pain, musculoskeletal stiffness, muscle strain, andvoluntarily from a population of uncertain size, it is not always possible to 10 musculoskeletal discomfortreliably estimate their frequency or establish a causal relationship to drugIncludes arthralgia, back pain, neck pain, joint stiffness, pain in jaw,exposure. joint swelling, bursitis, joint range of motion decreased, and joint injury 11 Includes dyspnea, dyspnea exertional, hypoxia, wheezing, chronicBlood and Lymphatic System Disorders: Differentiation syndrome obstructive pulmonary disease, and tachypnoeaRespiratory, Thoracic and Mediastinal Disorders: Interstitial lung disease 12 Includes cough and productive cough 13 Includes maculo-papular rash, rash, erythema, skin lesion, folliculitis,Cardiac Disorders: Cardiomyopathy dermatitis, dermatitis acneiform, eczema, erythema multiforme, rash7 DRUG INTERACTIONS erythematous, seborrheic keratosis, skin ulcer, dermatitis allergic,7.1 Effects of INQOVI on Other Drugs dermatitis contact, eczema nummular, genital erythema, rash papular,Drugs Metabolized by Cytidine Deaminase rash pruritic, rash pustular, seborrheic dermatitis, skin exfoliation,Cedazuridine is an inhibitor of the cytidine deaminase (CDA) enzyme. skin irritation, stasis dermatitis, and ulcerative keratitisCoadministration of INQOVI with drugs that are metabolized by CDA may 14 Includes dizziness, vertigo, postural dizziness, and positional vertigoresult in increased systemic exposure with potential for increased toxicity 15 Includes headache, sinus pain, and sinus headacheof these drugs [see Clinical Pharmacology (12.3) in the full Prescribing 16 Includes hypoesthesia, paresthesia, neuropathy peripheral, gaitInformation]. Avoid coadministration of INQOVI with drugs that are disturbance, peripheral sensory neuropathy, ataxia, balance disorder,metabolized by CDA. 17 brachial plexopathy, carpal tunnel syndrome, and radicular pain8 USE IN SPECIFIC POPULATIONSIncludes upper respiratory tract infection, nasopharyngitis, sinusitis,8.1 Pregnancy 18 and viral upper respiratory tract infectionRisk SummaryIncludes pneumonia, pneumonitis, atypical pneumonia, and lungBased on findings from human data, animal studies, and its mechanism of 19 infectionaction [see Clinical Pharmacology (12.1) in the full Prescribing Information],Includes sepsis, bacteremia, septic shock, endocarditis, pseudomonalINQOVI can cause fetal harm when administered to a pregnant woman. A bacteremia, and staphylococcal bacteremia'