Safety was assessed in1:
94 adult patients with newly diagnosed or relapsed/refractory myeloid malignancies*
- 58 patients had BPDCN
- All patients received 12 mcg/kg
The overall median number of cycles administered for patients evaluated for safety was 2 (range, 1-43 cycles; N=94)1*
- The median number of cycles administered for patients with BPDCN was 4 (range, 1-43 cycles; N=58)
- Two (2%) patients had a fatal adverse reaction, both capillary leak syndrome (CLS)
- Overall, 10 (11%) patients discontinued treatment with ELZONRIS due to an adverse reaction; the most common adverse reactions resulting in treatment discontinuation were hepatic toxicities and CLS
Adverse reactions in ≥ 10% of patients receiving 12 mcg/kg of ELZONRIS1
|All grades %||Grade ≥ 3 %|
|Capillary leak syndromea||55||9|
|Pain in extremity||10||2|
aCapillary leak syndrome (CLS) defined as any event reported as CLS during treatment with ELZONRIS or the occurrence of at least 2 of the following CLS manifestations within 7 days of each other: hypoalbuminemia (including albumin value less than 3.0 g/dL), edema (including weight increase of 5 kg or more), hypotension (including systolic blood pressure less than 90 mmHg).1
*This population included patients with acute myeloid leukemia.2
- ELZONRIS [prescribing information]. New York, NY, US: Stemline Therapeutics, Inc.; December 2018.
- Data on file. Stemline Therapeutics, Inc.