ZYDELIG® safety profile in relapsed CLL

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 ≥10% of patients and at a higher incidence in the ZYDELIG + rituximab arm

 

ZYDELIG + R (n=110)

Placebo + R (n=108)

AE
Any grade, n (%)
Grade ≥3, n (%)
Any grade, n (%)
Grade ≥3, n (%)
Pyrexia
44 (40)
3 (3)
20 (19)
1 (1)
Diarrhea*
35 (32)
12 (11)
20 (19)
0
Pneumonia*
33 (30)
23 (21)
20 (19)
14 (13)
Nausea
30 (27)
1 (1)
25 (23)
0
Chills
27 (25)
2 (2)
17 (16)
0
Rash*
27 (25)
4 (4)
7 (6)
1 (1)
Abdominal pain*
20 (18)
1 (1)
17 (16)
2 (2)
Decreased appetite
18 (16)
2 (2)
12 (11)
2 (2)
Vomiting
17 (15)
0
9 (8)
0
Gastroesophageal reflux disease
11 (10)
1 (1)
0
0
  • Median duration of exposure to ZYDELIG was 8 months
  • Most frequent serious adverse reactions in patients treated with ZYDELIG + R were pneumonia (23%), diarrhea (10%), pyrexia (9%), sepsis (8%), and febrile neutropenia (5%); serious adverse reactions were reported in 59% of patients, and 17% discontinued therapy due to adverse reactions

Hematologic and hepatic lab abnormalities reported in ≥10% of patients and occured at ≥5% higher incidence in the ZYDELIG + R arm

 

ZYDELIG + R (n=110)

Placebo + R (n=108)

Lab abnormality
Any grade, n (%)
Grade 3-4, n (%)
Any grade, n (%)
Grade 3-4, n (%)
Hematology abnormalities
Neutropenia
71 (65)
46 (42)
61 (56)
33 (31)
Leukopenia
34 (31)
9 (8)
25 (23)
9 (8)
Lymphocytopenia
23 (21)
11 (10)
13 (12)
4 (4)
Serum chemistry abnormalities
ALT increased
43 (39)
10 (9)
13 (12)
1 (1)
AST increased
31 (28)
6 (5)
16 (15)
0
  • Most common lab abnormalities (incidence ≥30%) were neutropenia, ALT elevations, and leukopenia

Efficacy in relapsed CLL

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Adverse event monitoring
& management

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ZYDELIG®
AccessConnect®

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

AE=adverse event; ALT=alanine aminotransferase; AST=aspartate aminotransferase; CLL=chronic lymphocytic leukemia; R=rituximab.

Reference:

  1. ZYDELIG® (idelalisib) [prescribing information]. Foster City, CA: Gilead Sciences, Inc.; rev January 2018.