Corporate Member Update: Taiho-FDA Approved – INQOVI®

Corporate Member Update: Taiho-FDA Approved – INQOVI®

INQOVI®
August, 2020


Now FDA Approved – INQOVI® (decitabine and cedazuridine) tablets, for oral use

We are sending this communication on behalf of Taiho Oncology to announce the approval of INQOVI® (decitabine and cedazuridine) tablets, for oral use, by the US Food and Drug Administration (FDA) on July 7, 2020.¹ 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.²

Please see Important Safety Information below and the full Prescribing Information for INQOVI.
 

Product Name Strength National Drug Code (NDC)³ Wholesale Acquisition Cost (WAC)
INQOVI® (decitabine and cedazuridine) tablets, for oral use Each tablet contains 35 mg decitabine and 100 mg cedazuridine 64842-0727-09* $7,495


*The NDC has been “zero‑filled” to ensure creation of an 11‑digit code that meets Health Insurance Portability and Accountability Act (HIPAA) standards. The zero‑fill location is indicated in bold.

INQOVI is available as 5 tablets in one blister card in a child-resistant carton.

DOSAGE
The recommended dosage of INQOVI is 1 tablet (35 mg decitabine and 100 mg cedazuridine) 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. A complete or partial response may take longer than 4 cycles.

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%.

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%.

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.

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.

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.

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.

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.

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).

Please see full Prescribing Information.

For more information, please visit INQOVI.com.

 

Aaron Franczek
Consultant
DK Pierce and Associates, Inc.
10910 Creek Way
Zionsville, IN 46077
(317) 873-0303
aaron.franczek@dkpierce.net


References:
1. US Food and Drug Administration. INQOVI NDA approval. https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-myelodysplastic-syndromes-mds-can-be-taken-home. Accessed July 7, 2020.
2. INQOVI® (decitabine and cedazuridine). Prescribing information. Taiho Oncology, Inc; 2020.
3. National Drug Code database background information. US Food and Drug Administration. Accessed June 29, 2020. https://www.fda.gov/drugs/development-approval-process-drugs/national-drug-code-database-background-information.

Developed by © Astex Pharmaceuticals, Inc.
Marketed by © Taiho Oncology, Inc.
INQOVI ® is a registered trademark of Otsuka Pharmaceutical Co., Ltd.
© 2020 Taiho Oncology, Inc. All rights reserved. CDEC-PM-US-0134 07/2020

 
 
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