ients with Relapsed or Refractory BPDCN
Parameter (N=15)
Gender, N (%)
Male 13 (86.7)
Female 2 (13.3)
Age (years)
Median 72
Minimum, Maximum 44, 80
ECOG, N (%)
0 5 (33.3)
1 10 (66.7)
BPDCN at Baseline, N (%)
Skin 13 (86.7)
Bone marrow 9 (60.0)
Lymph node 8 (53.3)
Visceral 4 (26.7)
Peripheral blood 1 (6.7)
In the 15 patients with relapsed/refractory BPDCN, one patient achieved a CR (duration: 111 days) and onepatient achieved a CRc (duration: 424 days).
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
ELZONRIS (tagraxofusp-erzs) injection is a preservative-free, sterile, clear, colorless, 1,000 mcg in 1 mLsolution supplied in a single-dose glass vial. Each carton contains one vial (NDC 72187-0401-1).
16.2 Storage and Handling
Store in freezer between -25°C and -15°C (-13°F and 5°F). Protect ELZONRIS from light by storing in theoriginal package until time of use. Thaw vials at room temperature between 15°C and 25°C (59°F and 77°F)
prior to preparation [see Preparation for Administration (2.3)]. Do not refreeze the vial once thawed. Do notuse beyond expiration date on container.
17 PATIENT COUNSELING INFORMATION
Capillary Leak Syndrome
Advise patients of the risk of capillary leak syndrome (CLS), and to contact their health care professional forsigns and symptoms associated with CLS including new or worsening edema, weight gain, shortness of breath,and/or hypotension after infusion. Advise patients to weigh themselves daily [see Warnings and Precautions(5.1)].
Hypersensitivity
Advise patients of the risk of hypersensitivity reactions, and to contact their healthcare professional for signsand symptoms associated with hypersensitivity reactions including rash, flushing, wheezing and swelling of theface [see Warnings and Precautions (5.2)].
https://www.stemlinearc.com/resources/ELZONRIS_US_Full_Prescribing_Information.pdf |
