FDA approved in relapsed FL after ≥2 systemic therapies
Imagine what’s possible:
ZYDELIG®—A first-in-class PI3Kδ inhibitor
ZYDELIG is the FIRST AND ONLY
KINASE INHIBITOR APPROVED IN FL.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
RECOMMEND IDELALISIB MONOTHERAPY
AS AN OPTION for appropriate patients
with relapsed/refractory FL.1*
ALT=alanine aminotransferase; AST=aspartate aminotransferase; NCCN®=National Comprehensive Cancer Network®.
*Please see the complete version of the NCCN Guidelines® for Non-Hodgkin’s Lymphomas available on NCCN.org for specific recommendations.
IMPORTANT SAFETY INFORMATION (cont'd)
Contraindications
• History of serious allergic reactions, including
anaphylaxis and toxic epidermal necrolysis (TEN)
Warnings and Precautions
• Hepatotoxicity: Findings were generally observed
within the first 12 weeks of treatment and reversed
with dose interruption. Upon rechallenge at a lower
dose, ALT/AST elevations recurred in 26% of
patients. In all patients, monitor ALT/AST every 2
weeks for the first 3 months, every 4 weeks for the
next 3 months, and every 1 to 3 months thereafter. If
ALT/AST is >3× upper limit of normal (ULN),
monitor for liver toxicity weekly. If ALT/AST is
>5× ULN, withhold ZYDELIG and monitor ALT/AST
and total bilirubin weekly until resolved. Discontinue
ZYDELIG for recurrent hepatotoxicity. Avoid
concurrent use with other hepatotoxic drugs
• Severe diarrhea or colitis: Grade 3+ diarrhea can
occur at any time and responds poorly to antimotility
agents. Avoid concurrent use with other drugs that
cause diarrhea
• Pneumonitis: Evaluate for pneumonitis in patients
presenting with pulmonary symptoms such as cough,
dyspnea, hypoxia, interstitial infiltrates on radiologic
exam, or oxygen saturation decline by ≥5%
• Intestinal perforation: Advise patients to promptly
report any new or worsening abdominal pain, chills,
fever, nausea, or vomiting
• Severe cutaneous reactions: One case of TEN
occurred in a study of ZYDELIG in combination
with rituximab and bendamustine. Other severe or
life-threatening (grade ≥3) cutaneous reactions
have been reported. Monitor patients for the
development of severe cutaneous reactions and
discontinue ZYDELIG if a reaction occurs
• Anaphylaxis: Serious allergic reactions including
anaphylaxis have been reported. Discontinue
ZYDELIG permanently and institute appropriate
supportive measures if a reaction occurs
• Neutropenia: Treatment-emergent grade 3-4
neutropenia occurred in 31% of ZYDELIG-treated
patients in clinical trials. In all patients, monitor
blood counts ≥every 2 weeks for the first 3 months.
In patients with neutrophil counts <1.0 Gi/L,
monitor weekly
• Embryo-fetal toxicity: ZYDELIG may cause fetal
harm. Women who are or become pregnan