ARIEL3 Safety & Tolerability

Rubraca Has a Well-Established Safety & Tolerability Profile

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There was limited association with Grades 3 or 4 hematologic adverse reactions and lab abnormalities with Rubraca1
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A low overall incidence of Grades 3-4 thrombocytopenia (5%) was reported in ARIEL3 with Rubraca1

The Majority of Adverse Reactions and Lab Abnormalities Associated with Rubraca were Grades 1 or 21

Adverse reactions reported in ≥20% of patients (N=561)

Bar chart that represents adverse reactions reported in Rubraca patients

Laboratory abnormalities reported in ≥25% of patients (N=561)

Bar chart that represents laboratory abnormalities reported in Rubraca patients
The most frequently reported Grade 3-4 laboratory abnormalities in patients treated with Rubraca (≥5%) were decreased hemoglobin (13%), increased ALT (7%), decreased neutrophils (6%), and decreased lymphocytes (5%)1
No requirement for routine weekly monitoring for hematologic adverse events at baseline. Monitor CBC for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment1
For prolonged hematologic toxicities (>4 weeks), dose interruptions or reductions are recommended; monitor blood counts weekly until recovery1
In the 6-year long-term follow up period from the first patient enrolled in ARIEL3, the incidence of MDS/AML cases that have been reported in the Rubraca arm is 3.7%, vs 2.1% on placebo2

Dose Interruptions and Dose Reductions Were Used
to Manage Adverse Reactions1

Rubraca allows flexible dosing to manage side effects while maintaining therapy

Dose interruptions, dose reductions, and treatment discontinuations

Table that represents dose interruptions, dose reductions, and treatment discontinuations data for both Rubraca and placebo
  • Adverse reactions most frequently leading to dose interruption or dose reduction of Rubraca were thrombocytopenia (18%), anemia (17%), nausea (15%), and fatigue/asthenia (13%)1
  • Adverse reactions most frequently leading to discontinuation of Rubraca were anemia (3%), thrombocytopenia (3%), and nausea (3%)1

Rubraca Resources

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  • ALT, alanine aminotransferase; AST, aspartate aminotransferase; URTI, upper respiratory tract infection.

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