|
|
| For
U.S. Healthcare Professionals Only |
|
|
|
|
|
In a noninterventional survey of patients with MDS (n=184), |
|
76.6% |
of patients would prefer to switch to oral treatment when offered alongside
other options1 |
|
|
Please see Indications and Important Safety Information below. |
|
Your patients rely on you to keep their needs at the forefront, and receiving HMA
treatment can be challenging. Some
patients need to frequently travel to receive their HMA treatment, and some HMA
options require venous access and
parenteral administration.2,3 |
|
Gaining back time and overcoming treatment administration hurdles are
patient priorities.1 |
|
|
|
STUDY DESIGN: A noninterventional, cross-sectional, mixed-methods study of patients with
MDS using qualitative and
quantitative methods to develop a survey and analyze responses. The survey was
completed by 184 of the 275 individuals
who initially responded to the invitation.1
|
|
|
|
INDICATIONS |
|
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.4
|
|
|
|
Please see Important Safety Information below. |
|
Consider INQOVI for patients who4: |
|
|
Wish to take their HMA therapy in the comfort of their own home
|
|
|
|
Are unable to have, or do not wish to have, infusion port placement
|
|
|
|
Cannot manage travel to the infusion center
|
|
|
|
|
Could INQOVI be the preferred treatment option for your appropriate patients with
MDS or CMML? |
|
|
|
|
|
|
CMML=chronic myelomonocytic leukemia; HMA=hypomethylating agent;
MDS=myelodysplastic syndromes.
|
|
|
|
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%.
Myelosuppression (thrombocytopenia, neutropenia, anemia, and febrile neutropenia) is
the
most frequent cause of INQOVI dose reduction or interruption, occurring in 36% of
patients.
Permanent discontinuation due to myelosuppression (febrile neutropenia) occurred in 1%
of
patients. Myelosuppression and worsening neutropenia may occur more frequently in
the first
or second treatment cycles and may not necessarily indicate progression of underlying
MDS.
|
|
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
(55%), constipation (44%),
hemorrhage (43%), myalgia (42%),
mucositis (41%), arthralgia
(40%), nausea (40%),
dyspnea
(38%), diarrhea (37%), rash (33%),
dizziness (33%), febrile
neutropenia (33%), edema (30%),
headache (30%), cough
(28%), decreased appetite (24%), upper respiratory tract
infection (23%),
pneumonia (21%), and transaminase
increased (21%). The most
common Grade 3 or 4
laboratory
abnormalities (≥ 50%) were leukocytes decreased
(81%),
platelet count
decreased (76%), neutrophil count decreased
(71%), and
hemoglobin decreased (55%).
|
|
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 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. |
References: 1. Zeidan AM, Tsaai J-H, Karimi L, et
al. Patient preferences for benefits, risks, and administration route
of hypomethylating agents in myelodysplastic syndromes. Clin Lymphoma Myeloma Leuk. 22(9);e853-e866.
doi:10.1016/
j.clml.2022.04.023 2. Savona MR, Odenike O, Amrein PC, et
al. An oral
fixed-dose combination of decitabine
and cedazuridine in myelodysplastic syndromes: a multicentre, open-label,
dose-escalation,
phase 1 study. Lancet
Haematol. 2019;6(4): e194-e203. doi:10.1016/S2352-3026(19)30030-4 3. Vidaza [package insert]. Summit, NJ: Celgene
Corporation; 2022. 4. INQOVI [package insert].
Princeton, NJ: Taiho Oncology, Inc.; 2022.
|
|
|
|
|
|
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. 2023
All rights reserved. |
|
[11/23] INQ-PM-US-0508 |
|
|
|
|
|
|
 
|
|
|
| About this email: SmartBrief will occasionally
send emails from our business partners promoting products and services likely to
be of interest to our readers. The content of these messages does not necessarily reflect
the view of SmartBrief or its association partners. |
|
|
|
|
| Copyright © 2025 SmartBrief. All Rights Reserved. A division of Future US LLC. |
| Full 7th Floor, 130 West 42nd Street, New York, NY, 10036. |
|
|
|
