ASH Clinical News FINAL_ACN_3.14_FULL_ISSUE_DIGITAL | Page 19

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IDHIFApro.com/explore
when administered to a pregnant woman. Advise females
of reproductive potential and males with female partners
of reproductive potential to use effective contraception
during treatment with IDHIFA and for at least 1 month
after the last dose. Pregnant women, patients becoming
pregnant while receiving IDHIFA, or male patients with
pregnant female partners should be apprised of the
potential risk to the fetus. • Serious adverse reactions were reported in 77.1% of
patients. The most frequent serious adverse reactions
(≥2%) were leukocytosis (10%), diarrhea (6%), nausea
(5%), vomiting (3%), decreased appetite (3%), tumor
lysis syndrome (5%), and differentiation syndrome (8%).
Differentiation syndrome events characterized as serious
included pyrexia, renal failure acute, hypoxia, respiratory
failure, and multi-organ failure
ADVERSE REACTIONS LACTATION
• The most common adverse reactions (≥20%) included
total bilirubin increased (81%), calcium decreased (74%),
nausea (50%), diarrhea (43%), potassium
decreased (41%), vomiting (34%), decreased
appetite (34%), and phosphorus decreased (27%) Many drugs are excreted in human milk and because of the
potential for adverse reactions in breastfed infants, advise
women not to breastfeed during treatment with IDHIFA and
for at least 1 month after the last dose.
• The most frequently reported ≥Grade 3 adverse reactions
(≥5%) included total bilirubin increased (15%), potassium
decreased (15%), phosphorus decreased (8%), calcium
decreased (8%), diarrhea (8%), differentiation syndrome
(7%), non-infectious leukocytosis (6%), tumor lysis
syndrome (6%), and nausea (5%)
Please see brief summary of full Prescribing Information,
including Boxed WARNING, on the following pages.
IDHIFA ® is a registered trademark of Celgene Corporation.
IDHIFA ® is licensed from Agios Pharmaceuticals, Inc.
© 2017 Celgene Corporation 11/17 US-IDH170001