SLL
Approved in
relapsed SLL after 2
systemic therapies

ZYDELIG®
Safety Profile

Safety and tolerability profile in a
pretreated patient population

AEs Reported in ≥10% of Patients in FL and SLL Clinical Trials (N=146)
AE* Any grade (%) Grade ≥3 (%)
Pneumonia 25 16
Diarrhea 47 14
Dyspnea 17 4
Rash 21 3
Pyrexia 28 2
Abdominal pain 26 2
Asthenia 12 2
Peripheral edema 10 2
Fatigue 30 1
Nausea 29 1
Cough 29 1
Decreased appetite 16 1
Vomiting 15 1
Headache 11 1
Night sweats 12 0
Upper respiratory tract infection 12 0
Insomnia 12 0
  • Most frequent serious adverse reactions (SAR) in clinical studies when used alone were pneumonia (15%), diarrhea (11%), and pyrexia (9%); SAR were reported in 50% of patients, and 53% discontinued due to adverse reactions
  • Median duration of exposure to ZYDELIG was 6.1 months

*AEs are listed in descending order based on grade ≥3 occurrence.

†Diarrhea, abdominal pain, pneumonia, and rash include multiple preferred terms.

AE=adverse event; FL=follicular B-cell non-Hodgkin lymphoma; SLL=small lymphocytic lymphoma.

Treatment-Emergent Lab Abnormalities Reported in ≥30% of Patients (N=146)
Lab abnormality Any grade (%) Grade 3 (%) Grade 4 (%)
Neutrophils decreased 53 14 11
ALT increased 50 14 5
AST increased 41 8 4
  • Treatment-emergent lab abnormalities (any grade/grade 3/grade 4) reported in <30% of patients with ZYDELIG were hemoglobin decreased (28%/2%/0) and platelets decreased (26%/3%/3%)

ALT=alanine aminotransferase; AST=aspartate aminotransferase.