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Pharmacokinetics, Efficacy & Safety
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.
DosePak is 7.35 in x 2.45 in.
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.
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 the next cycle for the following nonhematologic adverse reactions and resume at the same or reduced dose once they are resolved:
1st dose reduction
Dosage
2nd dose reduction
Dosage
3rd dose reduction
Dosage
*Myelosuppression includes thrombocytopenia, neutropenia, anemia, and febrile neutropenia.
Within 12 hours of the time it is usually taken:
Due to vomiting following dosing:
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.
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.
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.
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.
Insurance Coverage Support†
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.
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
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
Reference: 1. INQOVI. Prescribing information. Taiho Oncology Inc; 2020.
Pharmacokinetics, Efficacy & Safety