Discover this now approved treatment choice for your adult patients.
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For U.S. Health Care Professionals Only

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Prescribing Information

Patient Information

Important Safety Information

Now

Approved

For adult patients with MDS, including CMML1

INQOVI is indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.1

INQOVI IS THE FIRST AND ONLY ONCE-DAILY ORAL HYPOMETHYLATING AGENT (HMA) TREATMENT FOR ADULT PATIENTS WITH MDS, INCLUDING CMML1

Selected 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%.

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Please see additional Important Safety Information below.

WITH NEW INQOVI, PATIENTS CAN NOW TAKE THEIR MEDICATION AT HOME, REDUCING THE NEED FOR FREQUENT OFFICE VISITS TO RECEIVE INTRAVENOUS THERAPY.1

The recommended dose of INQOVI is one tablet taken orally once daily on Day 1 through Day 5 of each 28-day cycle for a minimum of 4 cycles until disease progression or unacceptable toxicity. A complete or partial response may take longer than 4 cycles.

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INQOVI should be taken on an empty stomach at approximately the same time each day.

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Your patient should avoid eating 2 hours before and 2 hours after each dose.

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Your patient should swallow INQOVI tablets whole. Do not cut, crush, or chew the tablet.

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If your patient misses a dose within 12 hours of time it's taken, instruct them to take the missed dose as soon as possible.

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If your patient missed a dose by more than 12 hours, do not take additional doses to make up for the missed dose. Instruct them to take the next scheduled dose on the following day at the usual time.

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Your patient should not take an additional dose if vomiting occurs after administration but continue with the next scheduled dose.

One tablet, taken orally once daily on days 1 through 5 of each 28 day cycle for a minimum of 4 cycles until disease progression or unacceptable toxicity. Each INQOVI tablet contains 35 mg decitabine and 100 mg cedazuridine.

Find out more about a new treatment option for your adult patients with MDS, including CMML.1

Please see below for Important Safety Information.

DISCOVER INQOVI

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS (continued)

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%.

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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.

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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.

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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.

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The most common adverse reactions (≥ 20%) were fatigue, constipation, hemorrhage, myalgia, mucositis, arthralgia, nausea, dyspnea, diarrhea, rash, dizziness, febrile neutropenia, edema, headache, cough, decreased appetite, upper respiratory tract infection, pneumonia, and transaminase increased. The most common Grade 3 or 4 laboratory abnormalities (≥ 50%) were leukocytes decreased, platelet count decreased, neutrophil count decreased, and hemoglobin decreased.

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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 at least 2 weeks after the last dose.

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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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Please see full Prescribing Information.

Reference: 1. INQOVI. Prescribing information. Taiho Oncology Inc; 2020.

Developed by © Astex Pharmaceuticals, Inc. Marketed by © Taiho Oncology, Inc. INQOVI® is a registered trademark of Otsuka Pharmaceutical Co., Ltd. Copyright © TAIHO ONCOLOGY, INC. 101 Carnegie Center, Suite 101 Princeton, NJ 08540. 2020 All rights reserved.

07/2020 CDEC-PM-US-0071

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