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Safety
Demonstrated Safety Profile in Patients With Myeloid Malignancies
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
| N=94 | ||
|---|---|---|
| All Grades (%) |
Grade ≥ 3 (%) |
|
| Capillary leak syndromea | 55 | 9 |
| Nausea | 49 | 0 |
| Fatigue | 45 | 7 |
| Peripheral edema | 43 | 1 |
| Pyrexia | 43 | 0 |
| Weight increase | 31 | 0 |
| Chills | 29 | 1 |
| Headache | 29 | 0 |
| Hypotension | 29 | 9 |
| Decreased appetite | 24 | 0 |
| Constipation | 23 | 0 |
| Vomiting | 21 | 0 |
| Back pain | 20 | 2 |
| Diarrhea | 20 | 0 |
| Dizziness | 20 | 0 |
| Febrile neutropenia | 20 | 18 |
| Dyspnea | 19 | 2 |
| Insomnia | 17 | 0 |
| Tachycardia | 17 | 0 |
| Anxiety | 15 | 0 |
| Hypertension | 15 | 6 |
| Cough | 14 | 0 |
| Epistaxis | 14 | 1 |
| Oropharyngeal pain | 12 | 0 |
| Confusional state | 11 | 0 |
| Hematuria | 10 | 0 |
| Pain in extremity | 10 | 2 |
| Petechiae | 10 | 0 |
| Pruritus | 10 | 0 |
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
References: 1. ELZONRIS [prescribing information]. New York, NY, US: Stemline Therapeutics, Inc.; December 2018. 2. Data on file. Stemline Therapeutics, Inc.
INDICATION
- ELZONRIS is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older
IMPORTANT SAFETY INFORMATION
Boxed WARNING: CAPILLARY LEAK SYNDROME
- Capillary Leak Syndrome (CLS), which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended
WARNINGS AND PRECAUTIONS
Capillary Leak Syndrome
- ELZONRIS can cause capillary leak syndrome (CLS), which may be life-threatening or fatal if not properly managed. The overall incidence of CLS in clinical trials was 55% in patients receiving ELZONRIS, including 46% in Grades 1 or 2, 6% in Grade 3, 1% in Grade 4, and 2 fatal events. Common signs and symptoms (incidence ≥ 20%) associated with CLS that were reported during treatment with ELZONRIS include hypoalbuminemia, edema, weight gain, and hypotension
- Before initiating therapy with ELZONRIS, ensure that the patient has adequate cardiac function and serum albumin is ≥ 3.2 g/dL
- During treatment with ELZONRIS, ensure that serum albumin levels are ≥ 3.5 g/dL and have not been reduced by ≥ 0.5 g/dL from the albumin value measured prior to dosing initiation of the current cycle. Monitor serum albumin levels prior to the initiation of each dose or more often as indicated clinically thereafter. Additionally, assess patients for other signs or symptoms of CLS, including weight gain, new onset or worsening edema including pulmonary edema, hypotension, or hemodynamic instability
- Counsel patients to seek immediate medical attention should signs or symptoms of CLS occur at any time
Hypersensitivity Reactions
- ELZONRIS can cause severe hypersensitivity reactions. Grade 3 or higher events were reported in 10% of patients in clinical trials. Monitor patients for hypersensitivity reactions during treatment with ELZONRIS. Interrupt ELZONRIS infusion and provide supportive care as needed if a hypersensitivity reaction should occur. If the reaction is severe, discontinue ELZONRIS permanently
Hepatotoxicity
- Elevations in liver enzymes can occur with ELZONRIS. Grade 3 or higher elevations in liver enzymes occurred in approximately 40% of patients in clinical trials
- Monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) prior to each infusion with ELZONRIS. Temporarily withhold ELZONRIS if the transaminases rise to greater than 5 times the upper limit of normal (ULN) and resume treatment upon normalization or when resolved
ADVERSE REACTIONS:
The most common adverse reactions in the clinical trials (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, peripheral edema, pyrexia, and weight increase. The most common laboratory abnormalities (incidence ≥ 50%) are decreases in albumin, platelets, hemoglobin, calcium, sodium, and increases in glucose, ALT, and AST.
Please see full Prescribing Information, including Boxed WARNING.
To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
IMPORTANT SAFETY INFORMATION
INDICATION
- ELZONRIS is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older
IMPORTANT SAFETY INFORMATION
Boxed WARNING: CAPILLARY LEAK SYNDROME
- Capillary Leak Syndrome (CLS), which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended
WARNINGS AND PRECAUTIONS
Capillary Leak Syndrome
- ELZONRIS can cause capillary leak syndrome (CLS), which may be life-threatening or fatal if not properly managed. The overall incidence of CLS in clinical trials was 55% in patients receiving ELZONRIS, including 46% in Grades 1 or 2, 6% in Grade 3, 1% in Grade 4, and 2 fatal events. Common signs and symptoms (incidence ≥ 20%) associated with CLS that were reported during treatment with ELZONRIS include hypoalbuminemia, edema, weight gain, and hypotension
- Before initiating therapy with ELZONRIS, ensure that the patient has adequate cardiac function and serum albumin is ≥ 3.2 g/dL
- During treatment with ELZONRIS, ensure that serum albumin levels are ≥ 3.5 g/dL and have not been reduced by ≥ 0.5 g/dL from the albumin value measured prior to dosing initiation of the current cycle. Monitor serum albumin levels prior to the initiation of each dose or more often as indicated clinically thereafter. Additionally, assess patients for other signs or symptoms of CLS, including weight gain, new onset or worsening edema including pulmonary edema, hypotension, or hemodynamic instability
- Counsel patients to seek immediate medical attention should signs or symptoms of CLS occur at any time
Hypersensitivity Reactions
- ELZONRIS can cause severe hypersensitivity reactions. Grade 3 or higher events were reported in 10% of patients in clinical trials. Monitor patients for hypersensitivity reactions during treatment with ELZONRIS. Interrupt ELZONRIS infusion and provide supportive care as needed if a hypersensitivity reaction should occur. If the reaction is severe, discontinue ELZONRIS permanently
Hepatotoxicity
- Elevations in liver enzymes can occur with ELZONRIS. Grade 3 or higher elevations in liver enzymes occurred in approximately 40% of patients in clinical trials
- Monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) prior to each infusion with ELZONRIS. Temporarily withhold ELZONRIS if the transaminases rise to greater than 5 times the upper limit of normal (ULN) and resume treatment upon normalization or when resolved
ADVERSE REACTIONS:
The most common adverse reactions in the clinical trials (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, peripheral edema, pyrexia, and weight increase. The most common laboratory abnormalities (incidence ≥ 50%) are decreases in albumin, platelets, hemoglobin, calcium, sodium, and increases in glucose, ALT, and AST.
Please see full Prescribing Information, including Boxed WARNING.
To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.