TAVALISSE safety profile
The most common adverse reactions reported in TAVALISSE and placebo patients were categorized as mild, moderate, and severe1
Incidence of common adverse reactions (≥5% of patients)—FIT-1 and FIT-21
ALT=alanine aminotransferase; AST=aspartate aminotransferase.
- Includes diarrhea and frequent bowel movement.
- Includes hypertension, blood pressure (BP) increased, BP diastolic abnormal, and BP diastolic increased.
- Includes upper respiratory tract infection, respiratory tract infection, lower respiratory tract infection, and viral upper respiratory tract infection.
- Includes rash, rash erythematous, and rash macular.
- Includes abdominal pain and abdominal pain upper.
- Includes neutropenia and neutrophil count decreased.
Observations from the placebo-controlled trials (FIT-1 + FIT-2)
- Diarrhea was the most common adverse reaction observed1
- Diarrhea should be managed with supportive measures (eg, dietary changes, hydration, and/or antidiarrheal medication). If diarrhea becomes severe, interrupt, reduce, or discontinue TAVALISSE (see dose modification guidelines)
- 10 patients discontinued treatment with TAVALISSE due to adverse reactions3
- 5 severe AEs led to treatment withdrawal in the TAVALISSE arm: syncope, pneumonia, chest pain, thrombocytopenia, and neutropenia
- Nonsevere adverse events leading to withdrawal in the TAVALISSE arm included: alanine aminotransferase increased, diarrhea, neutropenia, abdominal pain, and headache
Most AEs were mild/moderate and resolved or were managed with dose reduction, dose interruption, and/or secondary medication.
References: 1. TAVALISSE® [package insert]. South San Francisco, CA: Rigel Pharmaceuticals, Inc.; April 2018. 2. Bussel JB, Arnold DM, Boxer MA, et al. Long-term fostamatinib treatment of adults with immune thrombocytopenia during the phase 3 clinical trial program. Am J Hematol. 2019;94(5):546-553. 3. Data on file, Rigel Pharmaceuticals, Inc. April 2018.