Adverse Reactions in ≥ 10% of Patients Receiving 12 mcg/kg of
ELZONRIS (Cont’d)
N=94
All Grades
% Grade ≥ 3
%
Dyspnea 19 2
Cough 14 0
Epistaxis 14 1
Oropharyngeal pain 12 0
Respiratory, thoracic and mediastinal
disorders
Psychiatric disorders
Insomnia 17 0
Anxiety 15 0
Confusional state 11 0
17 0
Petechiae 10 0
Pruritus 10 0
10 0
Cardiac disorders
Tachycardia
Skin and subcutaneous tissue disorders
Renal and urinary disorders
Hematuria
Capillary leak syndrome 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
Table below summarizes the clinically-important laboratory abnormalities that occurred
in ≥ 10% patients with myeloid malignancies treated with ELZONRIS.
Selected Laboratory Abnormalities in Patients Receiving 12 mcg/kg of ELZONRIS
Treatment-Emergent
Laboratory Abnormalities
All Grades
%
Grade ≥ 3
%
Hematology
Platelets decrease 67 53
Hemoglobin decrease 60 35
Neutrophils decrease 37 31
Chemistry
Glucose increase 87 20
ALT increase 82 30
AST increase 79 37
Albumin decrease 77 0
Calcium decrease 57 2
10
Sodium decrease 50 Potassium decrease 39 4
Phosphate decrease 30 11
Creatinine increase 27 0
Alkaline phosphatase increase 26 1
Potassium increase 21 2
Magnesium decrease 20 0
Magnesium increase 14 3
Bilirubin increase 14 0
Glucose decrease 11 0
Sodium increase 10 0
DRUG INTERACTIONS
No drug-drug interaction studies have been conducted with ELZONRIS.
USE IN SPECIFIC POPULATIONS
Pregnancy
Risk Summary
Based on its mechanism of action, ELZONRIS has the potential for adverse effects on
embryo-fetal development. There are no available data on ELZONRIS use in pregnant
women to inform a drug-associated risk of adverse developmental outcomes.
Animal reproduction or developmental toxicity studies have not been conducted with
tagraxofusp-erzs. Advise pregnant women of the potential risk to the fetus.
The estimated background risk of major birth defects and miscarriage for the indicated
population is unknown. All pregnancies have a risk of birth defect, loss, or other adverse
outcomes. In the US general population, the estimated background risk of major birth
defects and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to
20%, respectively.
Lactation
Risk Summary
No data are available regarding the presence of ELZONRIS in human milk, the effects
on the breastfed child, or the effects on milk production. Because of the potential for
serious adverse reactions in breastfed children from ELZONRIS, breast feeding is not
recommended during treatment and for 1 week after the last dose.
Females and Males of Reproductive Potential
Based on its mechanism of action, ELZONRIS may cause fetal harm when administered
to a pregnant woman.
Pregnancy Testing
Conduct pregnancy testing in females of reproductive potential within 7 days prior to
initiating ELZONRIS treatment.
Contraception
Advise females to use acceptable contraceptive methods during ELZONRIS treatment
and for at least 1 week after the last dose of ELZONRIS.
Pediatric Use
The safety and effectiveness of ELZONRIS for treatment of BPDCN have been
established in pediatric patients 2 years of age and older (no data for pediatric
patients less than 2 years of age). Use of ELZONRIS in these age groups is supported
by evidence from an adequate and well-controlled study of ELZONRIS in adults with
BPDCN and additional safety data from three pediatric patients with BPDCN, including
1 child (2 years to < 12 years old) and 2 adolescents (12 years to < 17 years old),
treated with ELZONRIS at the recommended dosage. The safety profile of ELZONRIS
in the pediatric patients was similar to that seen in the adults. Efficacy for pediatric
patients is extrapolated from the results of STML-401-0114.
Geriatric Use
Of the 94 patients who received ELZONRIS at the labeled dose in STML-401-0114,
23% were 75 years and older. The older patients experienced a higher incidence of
altered mental status (including confusional state, delirium, mental status changes,
dementia, and encephalopathy) than younger patients.
PATIENT COUNSELING INFORMATION
Capillary Leak Syndrome
Advise patients of the risk of capillary leak syndrome (CLS), and to contact their health
care professional for signs 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].
Hypersensitivity
Advise patients of the risk of hypersensitivity reactions, and to contact their
healthcare professional for signs and symptoms associated with hypersensitivity
reactions including rash, flushing, wheezing and swelling of the face [see Warnings
and Precautions].
Hepatic Toxicity
Advise patients to report symptoms that may indicate elevated liver enzymes including
fatigue, anorexia and/or right upper abdominal discomfort [see Warnings and
Precautions].
Contraception
Advise females to avoid pregnancy and to use acceptable contraceptive methods
during ELZONRIS treatment and for at least 1 week after the last dose of ELZONRIS
Lactation
Advise women not to breastfeed [see Use in Specific Populations].
For more detailed information please see full Prescribing Information, including
Boxed WARNING.
To report adverse events, please contact Stemline Therapeutics, Inc. at 1-877-332-7961
or you may report to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Marketed and Distributed by:
Stemline Therapeutics, Inc.
New York, NY 10022
www.stemline.com
US License No. 2088
US-ELZ-1900004