Prescribing INQOVI

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The only oral HMA for MDS, including CMML, that
patients can take from the comfort of home1

Oral Dosing

INQOVI® (decitabine and cedazuridine) tablets are a fixed-dose combination tablet containing decitabine (35 mg) and cedazuridine (100 mg) that patients take once a day at approximately the same time on days 1 through 5 of each 28-day cycle for a minimum of 4 cycles. A complete or partial response may take longer than 4 cycles.

Image of INQOVI tablet

Tablet shown is not actual size. Actual tablet size is 7.94 mm x 14.29 mm.

28-day dosing cycle

Chart of INQOVI 28-day dosing schedule
  • Patients should avoid eating for 2 hours before and 2 hours after taking INQOVI
  • Tablets must be swallowed whole—not cut, crushed, or chewed
  • Consider administering antiemetics prior to each dose to minimize nausea and vomiting
  • Do NOT substitute INQOVI for an IV decitabine product within a cycle
  • Patients should take INQOVI at the same time each day

Storage and handling with INQOVI

  • Store INQOVI tablets in original packaging at room temperature at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F)
Image of an INQOVI DosePak

DosePak is 7.35 in x 2.45 in.

Monitoring and Dosing Modifications1

Dose interruptions due to an adverse reaction occurred in 41% of patients who received INQOVI® (decitabine and cedazuridine) tablets. Dose reductions due to an adverse reaction occurred in 19% of patients who received INQOVI.

  • The most frequent cause of dose reduction or interruption was myelosuppression (thrombocytopenia, neutropenia, anemia, and febrile neutropenia)
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Monitor Response1

  • Obtain complete blood cell counts prior to initiating INQOVI and before each cycle
  • Manage toxicity using dose delay, dose modification, growth factors, and anti-infective therapies for treatment or prophylaxis as needed
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When to delay or reduce the dose1

Delay the next cycle if absolute neutrophil count is <1000/μL and platelets are <50,000/μL in the absence of active disease. Monitor complete blood cell counts until ANC is ≥1000/μL and platelets are ≥50,000/μL.

If hematologic recovery does not occur within 2 weeks of achieving remission:

  • Delay INQOVI for up to 2 additional weeks, AND
  • Resume at a reduced dose by administering INQOVI on days 1 through 4
  • Consider further dose reductions if myelosuppression persists after a dose reduction
  • Maintain or increase dose in subsequent cycles as clinically indicated

Delay the next cycle for the following nonhematologic adverse reactions and resume at the same or reduced dose once they are resolved:

  • Serum creatinine ≥2 mg/dL
  • Serum bilirubin ≥2 times upper limit of normal (ULN)
  • Aspartate aminotransferase or alanine aminotransferase ≥2 times ULN
  • Active or uncontrolled infection

Recommended dose reductions for myelosuppression*

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1st dose reduction

Dosage

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2nd dose reduction

Dosage

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3rd dose reduction

Dosage

  • Manage persistent severe neutropenia and febrile neutropenia with supportive treatment

*Myelosuppression includes thrombocytopenia, neutropenia, anemia, and febrile neutropenia.

What to do if a dose of INQOVI is missed1

Within 12 hours of the time it is usually taken:

  • Take the missed dose as soon as possible and resume the normal daily dosing schedule
  • Extend the dosing period by 1 day for every missed dose to complete 5 daily doses for each cycle

Due to vomiting following dosing:

  • No additional dose should be taken that day
  • Continue with next scheduled dose
Icon of 12 hours

Diagnosis Coding

The ICD-10 diagnostic codes contained in this guide are designed to provide important reimbursement information that will be helpful for your practice. ICD codes continually change, so it is recommended that you consult your ICD-10 code book or contact the payer for coding and billing guidance.

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.

Diagnosis codes for Myelodysplastic Syndromes (MDS)

ICD‑10‑CM Description
D46.0 Refractory anemia without ring sideroblasts, so stated

Refractory anemia without sideroblasts, without excess of blasts
D46.1 Refractory anemia with ring sideroblasts RARS
D46.2 Refractory anemia with excess of blasts RAEB
D46.20 Refractory anemia with excess of blasts, unspecified RAEB NOS
D46.21 Refractory anemia with excess of blasts 1 RAEB 1
D46.22 Refractory anemia with excess of blasts 2 RAEB 2
D46.A Refractory cytopenia with multilineage dysplasia
D46.B Refractory cytopenia with multilineage dysplasia and ring sideroblasts RCMD R5
D46.C Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality

Myelodysplastic syndrome with 5q deletion 5q minus syndrome NOS
D46.4 Refractory Anemia, unspecified
D46.Z Other myelodysplastic syndromes EXCLUDES chronic myelomonocytic leukemia (C93.1-)
D46.9 Myelodysplastic syndrome, unspecified

Myelodysplasia NOS

ICD‑10‑CM EXPERT: for Providers & Facilities, AAPC, 2020, p. 505.

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.

Diagnosis codes for Chronic Myelomonocytic Leukemia (CMML)

ICD‑10‑CM Description
C93.1 Chronic myelomonocytic leukemia

Chronic monocytic leukemia

CMML-1

CMML-2

CMML with eosinophilia
C93.10 Chronic myelomonocytic leukemia not having achieved remission

Chronic myelomonocytic leukemia with failed remission

Chronic myelomonocytic leukemia NOS
C93.11 Chronic myelomonocytic leukemia, in remission
C93.12 Chronic myelomonocytic leukemia, in relapse

ICD‑10‑CM EXPERT: for Providers & Facilities, AAPC, 2020, p. 494.

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Taiho Oncology Patient Support™ for you and your patients

Accessing treatments can be challenging at times. Taiho Oncology Patient Support™ offers personalized services to give patients, caregivers and healthcare professionals the help they need in getting started with Taiho Oncology products. This includes insurance verification, help with medication costs, and treatment plan support. For support, please visit or refer patients to TaihoPatientSupport.com

Meeting the access needs of your patients
We know that getting patients access to their medicine is an important step. We strive to make this process as simple as possible.

We are here to assist with:

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Insurance Coverage Support

  • Benefits verification to determine coverage for the patient's Taiho Oncology medicine and help explaining those benefits to the patient
  • Prior authorization assistance to meet payer requirements
  • Appeals assistance for denied prior authorization
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Specialty Pharmacy Prescription Coordination

We will triage the patient's prescription; coordinate with the in-network specialty pharmacy, self-dispensing practice, or hospital outpatient pharmacy, and communicate with the patient about his or her prescription status.

Personalized Nurse Support

Our nurse support services are available as needed to support patient care, including education about the importance of taking the medicine as prescribed and refill reminders.

Taiho Oncology Patient Support Co-pay Program

Eligible, privately insured patients can enroll in the Taiho Oncology patient support Co-pay program and reduce out‑of‑pocket expenses to $0 for their treatment with INQOVI.

To determine patient eligibility, go to TaihoOncologyCopay.com or call 1‑844‑TAIHO‑4U (1‑844‑824‑4648)

Support starts with an easy‑to‑complete Enrollment Form that can be downloaded at TaihoPatientSupport.com/how‑to‑enroll

To register or learn more, visit or refer patients to TaihoPatientSupport.com or call 1‑844‑TAIHO‑4U (1‑844‑824‑4648) Monday to Friday,
8 AM to 8 PM ET.

Visit TaihoPatientSupport.com to see full eligibility criteria.
If selected on the Patient Enrollment Form, a Nurse Navigator will be assigned to provide telephone support and will address general inquiries about INQOVI treatment.

The INQOVI Treatment Kit

The INQOVI Treatment Kit is here to help patients and
caregivers with INQOVI treatment for MDS. The kit includes:

1

A comprehensive patient brochure

2

Accompanying caregiver brochure

3

Blister pack opener available in Q1 2021

4

Health journal

5

Advocacy support brochure

Treatment kit is approximately
10.125 in x 11.125 in x 1.625 in.

Patient advocacy organizations

These organizations offer patients information, support, and community. Feel free to share the following resources with your patients:

The Myelodysplastic Syndromes (MDS) Foundation Inc.

Visit mds-foundation.org or call 1‑800‑MDS‑0839 (1‑800‑637‑0839)

The Aplastic Anemia and MDS International Foundation (AAMDSIF)

Visit aamds.org or call 1‑800‑747‑2820

The Leukemia & Lymphoma Society (LLS)

Visit lls.org or call 1‑800‑955‑4572

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

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