S:6.75”
Most common adverse reactions leading to dose reductions in 15% of
subjects were elevated transaminases, diarrhea or colitis, and rash. Most
common adverse reactions leading to discontinuation in 10% of subjects
were hepatotoxicity and diarrhea/colitis.
• Laboratory Abnormalities: Treatment emergent laboratory abnormalities
(incidence ≥10% and occurring at ≥5% higher incidence in ZYDELIGtreated subjects; all Grades) were decreased neutrophils (60%),
hypertriglyceridemia (56%), hyperglycemia (54%), increased ALT (35%),
increased GGT (26%), increased lymphocytes (25%), increased AST (25%),
decreased lymphocytes (20%), hyponatremia (20%), and hypoglycemia (11%).
Subjects with Indolent Non-Hodgkin Lymphoma (iNHL):
The safety assessment of ZYDELIG 150 mg BID is based on data from 146 adult
subjects with iNHL. The median duration of exposure to ZYDELIG was 6.1 months
(range: 0.3 to 26.4 months).
• Adverse Reactions: Most common serious adverse reactions reported in
50% of subjects were pneumonia (15%), diarrhea (11%), and pyrexia (9%).
Most common adverse reactions (incidence ≥10%; all Grades) were diarrhea
(47%), fatigue (30%), cough (29%), nausea (29%), pyrexia (28%), abdominal
pain (26%), pneumonia (25%), rash (21%), dyspnea (17%), decreased
appetite (16%), vomiting (15%), upper respiratory tract infection (12%),
asthenia (12%), night sweats (12%), insomnia (12%), headache (11%), and
peripheral edema (10%). Most common adverse reactions leading to dose
interruption or discontinuation in 53% of subjects were diarrhea (11%),
pneumonia (11%), and elevated transaminases (10%).
• Laboratory Abnormalities: Treatment emergent laboratory abnormalities (all
Grades) were decreased neutrophils (53%), increased ALT (50%), increased
AST (41%), decreased hemoglobin (28%), and decrease platelets (26%).
DRUG INTERACTIONS:
USE IN SPECIFIC POPULATIONS:
Pregnancy: ZYDELIG is Pregnancy Category D and may cause fetal harm. In
pregnant rats, embryo-fetal toxicities were observed, including decreased fetal
weights, external malformations (short tail), skeletal variations (delayed ossification
and/or unossification of the skull, vertebrae and sternebrae), urogenital blood
loss, complete resorption, increased post-implantation loss, and malformations
(vertebral agenesis with anury, hydrocephaly, microphthalmia/anophthalmia).
Women who are or become pregnant during ZYDELIG treatment should be
apprised of the potential hazard to the fetus [See Warnings and Precautions].
Nursing Mothers: It is not known whether idelalisib is excreted in human milk.
Because many drugs are excreted in human milk and because of the potential
for serious adverse reactions in nursing infants from ZYDELIG, a decision should
be made whether to discontinue nursing or ZYDELIG, taking into account the
importance of ZYDELIG to the mother.
Pediatric Use: Safety and effectiveness of ZYDELIG in children <18 years of age
have not been established.
Geriatric Use: In clinical trials of ZYDELIG in patients with FL, SLL, and CLL, 63% of
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