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Pharmacokinetics, Efficacy & Safety
Prescribing INQOVI
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.
Tablet shown is not actual size. Actual tablet size is 7.94 mm x 14.29 mm.
28-day dosing cycle
- 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)
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)
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
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*
1st dose reduction
Dosage
2nd dose reduction
Dosage
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
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.
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:
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
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
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