Abnormal laboratory findings (grades 1-4) in ≥25% of patients receiving ZEJULA2
- Decrease in hemoglobin (85%), decrease in platelet count (72%), decrease in white blood cell count (66%), decrease in absolute neutrophil count (53%), increase in AST (36%), and increase in ALT (28%)
Low rates of treatment discontinuation were observed due to ARs2
- In the same clinical trial, 15% of the overall population discontinued treatment due to ARs2
Platelet levels decreased initially but showed stabilization after cycle 3 with appropriate dose modification3
- The median time to onset of grade 3/4 thrombocytopenia was 23 days in the ZEJULA treatment arm4
- Most grade 3/4 thrombocytopenia events were transient with dose interruption or dose reduction. The median duration was 10 days4
No clinically significant bleeding events (grade ≥3) were associated with thrombocytopenia.5
- All bleeding events associated with thrombocytopenia were grade 1/2; 1 patient had grade 3 petechiae and hematoma concurrent with a serious adverse event of pancytopenia5
ALT, alanine aminotransferase; AST, aspartate aminotransferase.
Side effects were manageable with dose interruption and modification.
- ARs led to dose reduction or interruption in 69% of patients, most frequently from thrombocytopenia (41%) and anemia (20%)2
- No increase in all-grade diarrhea was observed with ZEJULA vs placebo5
- No on-treatment deaths were reported during the study5