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Developed under the direction and sponsorship of Rigel Pharmaceuticals, Inc.
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DURABLE REMISSION IS POSSIBLE
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DURABLE REMISSION IS POSSIBLE
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REZLIDHIA PROVIDED DURABLE AND COMPLETE REMISSIONS
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REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory
acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1)
mutation as detected by an FDA-approved test.
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SELECT IMPORTANT SAFETY INFORMATION
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WARNING: DIFFERENTIATION SYNDROME
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Differentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment. Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and hemodynamic monitoring until symptom resolution.
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ALMOST HALF OF PATIENTS ACHIEVED A COMPOSITE COMPLETE REMISSION
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Clinical Response Rates1-3
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Additional Efficacy Outcomes1,2,4
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Response rates were similar regardless of prior treatment with venetoclax or intensive chemotherapy
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Median time to CR/CRh was 1.9 months (95% CI: 1-2.8)
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11% (16 of 147) of patients underwent stem cell transplant after treatment with REZLIDHIA
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The majority of responders achieved
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Data cutoff=June 15, 2023.
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CI=confidence interval; CR=complete remission; CRc=composite complete remission (CR+CRh+CRi); CRh=CR with partial hematologic recovery; CRi=CR with incomplete blood count recovery; FDA=U.S. Food and Drug Administration; MLFS=morphologic leukemia-free state; PR=partial remission (which required recovery of both neutrophil and platelet counts consistent with a CR).
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MEDIAN DURATION OF RESPONSE IN PATIENTS ACHIEVING CR/CRh WAS GREATER THAN 2 YEARS
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Duration of CR/CRh Response3*
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DOR=duration of response.
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Data from an open-label, single-arm, multicenter clinical trial of 153 adult patients
(147 efficacy evaluable) with relapsed or refractory AML with an IDH1
mutation.1
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Median duration of CR/CRh3
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For patients with mIDH1 AML who relapse or are refractory to
initial treatment, choose REZLIDHIA as the first R/R targeted therapy
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R/R=relapsed or refractory.
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SUPPORT IS AVAILABLE FOR YOU AND YOUR
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PATIENTS THROUGH RIGEL ONECARE®
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IMPORTANT SAFETY INFORMATION (CONT'D)
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REZLIDHIA can cause differentiation syndrome. In the clinical trial of REZLIDHIA in
patients with relapsed or refractory AML, differentiation syndrome occurred in 16% of
patients, with grade 3 or 4 differentiation syndrome occurring in 8% of patients
treated, and fatalities in 1% of patients. Differentiation syndrome is associated with
rapid proliferation and differentiation of myeloid cells and may be life-threatening or
fatal. Symptoms of differentiation syndrome in patients treated with REZLIDHIA included
leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury,
fever, edema, pyrexia, and weight gain. Of the 25 patients who experienced
differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption
of REZLIDHIA. Differentiation syndrome occurred as early as 1 day and up to 18 months
after REZLIDHIA initiation and has been observed with or without concomitant
leukocytosis.
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If differentiation syndrome is suspected, temporarily withhold REZLIDHIA and initiate
systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours) for a minimum of
3 days and until resolution of signs and symptoms. If concomitant leukocytosis is
observed, initiate treatment with hydroxyurea, as clinically indicated. Taper
corticosteroids and hydroxyurea after resolution of symptoms. Differentiation syndrome
may recur with premature discontinuation of corticosteroids and/or hydroxyurea
treatment. Institute supportive measures and hemodynamic monitoring until improvement;
withhold dose of REZLIDHIA and consider dose reduction based on recurrence.
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REZLIDHIA can cause hepatotoxicity, presenting as increased alanine aminotransferase
(ALT), increased aspartate aminotransferase (AST), increased blood alkaline phosphatase,
and/or elevated bilirubin. Of 153 patients with relapsed or refractory AML who received
REZLIDHIA, hepatotoxicity occurred in 23% of patients; 13% experienced grade 3 or 4
hepatotoxicity. One patient treated with REZLIDHIA in combination with azacitidine in
the clinical trial, a combination for which REZLIDHIA is not indicated, died from
complications of drug-induced liver injury. The median time to onset of hepatotoxicity
in patients with relapsed or refractory AML treated with REZLIDHIA was 1.2 months
(range: 1 day to 17.5 months) after REZLIDHIA initiation, and the median time to
resolution was 12 days (range: 1 day to 17 months). The most common hepatotoxicities
were elevations of ALT, AST, blood alkaline phosphatase, and blood bilirubin.
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Monitor patients frequently for clinical symptoms of hepatic dysfunction such as
fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Obtain
baseline liver function tests prior to initiation of REZLIDHIA, at least once weekly for
the first two months, once every other week for the third month, once in the fourth
month, and once every other month for the duration of therapy. If hepatic dysfunction
occurs, withhold, reduce, or permanently discontinue REZLIDHIA based on
recurrence/severity.
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The most common (≥20%) adverse reactions, including laboratory abnormalities, were
aspartate aminotransferase increased, alanine aminotransferase increased, potassium
decreased, sodium decreased, alkaline phosphatase increased, nausea, creatinine
increased, fatigue/malaise, arthralgia, constipation, lymphocytes increased, bilirubin
increased, leukocytosis, uric acid increased, dyspnea, pyrexia, rash, lipase increased,
mucositis, diarrhea and transaminitis.
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Avoid concomitant use of REZLIDHIA with strong or moderate CYP3A inducers.
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Avoid concomitant use of REZLIDHIA with sensitive CYP3A substrates unless otherwise
instructed in the substrates prescribing information. If concomitant use is unavoidable,
monitor patients for loss of therapeutic effect of these drugs.
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Advise women not to breastfeed during treatment with REZLIDHIA and for 2 weeks after the
last dose.
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No overall differences in effectiveness were observed between patients 65 years and
older and younger patients. Compared to patients younger than 65 years of age, an
increase in incidence of hepatotoxicity and hypertension was observed in patients ≥65
years of age.
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In patients with mild or moderate hepatic impairment, closely monitor for increased
probability of differentiation syndrome.
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REFERENCES: 1. REZLIDHIA®. Package insert. Rigel Pharmaceuticals, Inc; 2022.
2. de Botton S, Fenaux P, Yee K, et al. Olutasidenib (FT-2102) induces durable
complete remissions in patients with relapsed or refractory IDH1-mutated AML. Blood
Adv. Published online February 1, 2023. doi:10.1182/bloodadvances.2022009411 3. Cortes J, Curti A, Fenaux P, et al. Olutasidenib for mutated IDH1 acute myeloid leukemia: final five-year results from the phase 2 pivotal cohort. J Hematol Oncol. 2025;18(1):102. doi:10.1186/s13045-025-01751-w 4. Data on file, Rigel Pharmaceuticals, Inc. January 2025.
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© 2026 Rigel Pharmaceuticals, Inc. All rights reserved. REZ_AML-25093 0226
REZLIDHIA and RIGEL ONECARE are registered trademarks of Rigel Pharmaceuticals, Inc.
RIGEL ONECARE is a patient support center sponsored by Rigel Pharmaceuticals, Inc.
611 Gateway Blvd, Suite 900, South San Francisco, CA 94080
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