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Identifying and addressing AEs early may enable patients to continue benefiting from ZYDELIG®-based therapy*
Monitor at least weekly while neutrophil counts are <1.0 × 109/L
ALT/AST elevations were generally observed within the first 12 weeks of treatment
Diarrhea can occur at any time
Serious or fatal PJP or CMV occurred in <1% of patients treated with ZYDELIG
ZYDELIG at recommended dose 150 mg PO BID
Interrupt/withhold
ZYDELIG and monitor
at least weekly until
toxicity has resolved
ZYDELIG at 100 mg
PO BID
Interrupt/withhold
ZYDELIG and monitor
at least weekly until
toxicity has resolved
ZYDELIG at 100 mg
PO BID
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Withhold drug until toxicity is resolved. If resuming ZYDELIG after interruption for other severe or life-threatening toxicities, reduce the dose to 100 mg twice daily. Discontinue ZYDELIG permanently for recurrence of other severe or life-threatening ZYDELIG-related toxicity upon rechallenge.
Among patients experiencing grade 3 hepatotoxicity§:
Among patients experiencing grade ≥3 diarrhea or colitis2:
Adverse reactions resulted in interruption for 42 (38%) CLL patients.
Discontinuation rate due to AEs was 20% in the trial that included follicular lymphoma.3‡ Adverse reactions resulted in interruption or discontinuation for 78 of 146 (53%) patients.‡
Withhold drug until toxicity is resolved. If resuming ZYDELIG after interruption for other severe or life-threatening toxicities, reduce the dose to 100 mg twice daily. Discontinue ZYDELIG permanently for recurrence of other severe or life-threatening ZYDELIG-related toxicity upon rechallenge.
Dosing guide
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*Please see full Prescribing Information for a complete list of AEs.
†Mild diarrhea=grade 1: increase of <4 stools per day over baseline; moderate diarrhea=grade 2: increase of 4-6 stools per day over baseline; severe diarrhea=grade 3: increase of ≥7 stools per day over baseline; life-threatening diarrhea=grade 4.5
‡Follicular lymphoma dose reduction data and discontinuation rate (20%) data reflect exposure to ZYDELIG monotherapy in 125 patients with iNHL, including 72 patients with follicular lymphoma.3 Rates of serious and fatal hepatotoxicity, grade ≥3 diarrhea or colitis, and interruption or discontinuation in 53% of patients reflect exposure to ZYDELIG monotherapy in 146 patients with iNHL, including patients with follicular lymphoma.
§ALT/AST elevations were generally observed within the first 12 weeks of treatment.
AE=adverse event; ALT=alanine aminotransferase; ANC=absolute neutrophil count; AST=aspartate aminotransferase; BID=twice daily; CLL=chronic lymphocytic leukemia; CMV=cytomegalovirus; iNHL= indolent non-Hodgkin lymphoma; IV=intravenous; PCR=polymerase chain reaction; PJP=Pneumocystis jirovecii pneumonia; PO=orally; SLL=small lymphocytic lymphoma; ULN=upper limit of normal; USPI=United States Prescribing Information.
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