ZYDELIG® safety profile in relapsed follicular lymphoma

BOXED WARNING: FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, INFECTIONS, AND INTESTINAL PERFORATION

  • Fatal and/or serious hepatotoxicity occurred in 16% to 18% of ZYDELIG-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue ZYDELIG.
  • Fatal and/or serious and severe diarrhea or colitis occurred in 14% to 20% of ZYDELIG-treated patients. Monitor for the development of severe diarrhea or colitis. Interrupt and then reduce or discontinue ZYDELIG.
  • Fatal and/or serious pneumonitis occurred in 4% of ZYDELIG-treated patients. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Interrupt or discontinue ZYDELIG.
  • Fatal and/or serious infections occurred in 21% to 48% of ZYDELIG-treated patients. Monitor for signs and symptoms of infection. Interrupt ZYDELIG if infection is suspected.
  • Fatal and serious intestinal perforation can occur in ZYDELIG-treated patients. Discontinue ZYDELIG if intestinal perforation is suspected.

AEs reported in ≥20% of patients in follicular lymphoma/SLL clinical trials (N=146)*

AE
Any grade, n (%)
Grade ≥3, n (%)
Diarrhea
68 (47)
20 (14)
Fatigue
44 (30)
2 (1)
Nausea
42 (29)
2 (1)
Cough
42 (29)
1 (1)
Pyrexia
41 (28)
3 (2)
Abdominal pain
38 (26)
3 (2)
Pneumonia
37 (25)
23 (16)
Rash
31 (21)
4 (3)
  • AEs (any grade/grade ≥3) reported in ≥10% to <20% of patients were dyspnea (17%/4%), decreased appetite (16%/1%), vomiting (15%/1%), asthenia (12%/2%), insomnia (12%/0%), night sweats (12%/0%), upper respiratory tract infection (12%/0%), headache (11%/1%), and peripheral edema (10%/2%)
  • Most frequent serious adverse reactions were pneumonia (15%), diarrhea (11%), and pyrexia (9%); serious adverse reactions were reported in 50% of patients
  • Discontinuation rate due to AEs was 20% in the trial.2‡ AEs resulted in interruption or discontinuation for 78 (53%) patients

Hematologic and hepatic lab abnormalities reported in ≥30% of patients in follicular lymphoma/SLL clinical trials (N=146)*

Lab abnormality
Any grade, n (%)
Grade 3, n (%)
Grade 4, n (%)
Neutrophils decreased
78 (53)
20 (14)
16 (11)
ALT increased
73 (50)
20 (14)
7 (5)
AST increased
60 (41)
12 (8)
6 (4)
  • ALT/AST elevations were typically asymptomatic, reversible, and observed during the first 12 weeks of treatment2
  • Hematologic and hepatic lab abnormalities (any grade/grade 3/grade 4) reported in <30% of patients were hemoglobin decreased (28%/2%/0%) and platelets decreased (26%/3%/3%)

Efficacy in relapsed
follicular lymphoma

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Adverse event monitoring
& management

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ZYDELIG®
AccessConnect®

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*Safety data reflect exposure to ZYDELIG from three open-label clinical trials (Studies 101-09, 101-02, 101-10) in 146 patients with iNHL, including patients with follicular lymphoma and SLL.
†Diarrhea, abdominal pain, pneumonia, and rash include multiple preferred terms.
‡Includes patients of all iNHL histologies enrolled in Study 101-09 (N=125), not just patients with follicular lymphoma.2

AE=adverse event; ALT=alanine aminotransferase; AST=aspartate aminotransferase; iNHL=indolent non-Hodgkin lymphoma; SLL=small lymphocytic lymphoma.

References:

  1. ZYDELIG® (idelalisib) [prescribing information]. Foster City, CA: Gilead Sciences, Inc.; rev January 2018.
  2. Gopal AK, Kahl BS, de Vos S, et al. PI3Kδ inhibition by idelalisib in patients with relapsed indolent lymphoma. N Engl J Med. 2014;370(11):1008-1018.