|Nausea||107 (50)||11 (5)|
|Diarrhea||91 (43)||17 (8)|
|Vomiting||73 (34)||4 (2)|
|Metabolism and nutrition disorders|
|Decreased appetite||73 (34)||9 (4)|
|Tumor lysis syndrome (TLS)b||13 (6)||12 (6)|
|Blood and lymphatic system disorders|
|Differentiation syndromec||29 (14)||15 (7)|
|Noninfectious leukocytosis||26 (12)||12 (6)|
|Nervous system disorders|
|Dysgeusia||25 (12)||0 (0)|
aGastrointestinal disorders observed with IDHIFA treatment can be associated with other commonly reported events, such as abdominal pain and weight decrease.
bTLS observed with IDHIFA treatment can be associated with commonly reported uric acid increase.
cDifferentiation syndrome can be associated with other commonly reported events such as respiratory failure, dyspnea, hypoxia, pyrexia, peripheral edema, rash, or renal insufficiency.
|Parametera||All grades (%)||≥Grade 3 (%)|
|Total bilirubin increased||81||15|
aIncludes abnormalities occurring up to 28 days after last IDHIFA dose, if new or worsened by at least 1 grade from baseline, or if baseline was unknown. The denominator varies based on data collected for each parameter (N=213, except phosphorus [N=209]).
The median duration of exposure to IDHIFA was 4.3 months (range, 0.3 to 23.6).
IDHIFA demonstrated 30-day and 60-day mortality rates of 4.2% (9/214) and 11.7% (25/214), respectively.
Other clinically significant ARs occurring in ≤10% of patients included Respiratory, Thoracic, and Mediastinal Disorders (pulmonary edema, acute respiratory distress syndrome).
43% of patients experienced an AR leading to a dose interruption
5% of patients had a dose reduction due to an AR
17% of patients permanently discontinued therapy due to an AR
Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells.
Differentiation syndrome may be life-threatening or fatal if not treated.
Hospitalization for close observation and monitoring of patients with pulmonary and/or renal manifestation is recommended.
Based on animal embryo-fetal toxicity studies, IDHIFA can cause embryo-fetal harm when administered to a pregnant woman.
IDHIFA may interfere with bilirubin metabolism through inhibition of UGT1A1.
12% of patients experienced leukocytosis
Tumor lysis syndrome
6% of patients experienced TLS
Patients must meet the following criteria to enroll:
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