Elzonris tagraxofusp 1000 ug/mL Injection, Solution, 1 vial — NDC 72187-0401-1 (Billing 72187-0401-01)
This is a package of 1 vial of Elzonris tagraxofusp 1000 ug/mL Injection, Solution from Stemline Therapeutics, Inc., marketed since Jan 2019 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 72187-0401-1 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 72187 labeler · 0401 product · 1 package
- Package marketed since
- Jan 18, 2019
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0372187040118
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 079401
- GCN: 45879
- GPI-14 (Medi-Span): 21703080302020
- HICL (First Databank): 045555
- AHFS class code: 10:00.00.00
- RxCUI (RxNorm): 2109059
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Cytotoxin class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J9269 | $357.522 / J9269 unit | — |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Sep 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 72187-0401-01 You're viewing this Main listing | 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE | 2019-01-18 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Elzonris 1000 ug/mLthis 72187-0401-01 | Stemline | 1 vial | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Dec 21, 2030 |
Is there a biosimilar for ELZONRIS 1,000 MCG/ML VIAL?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
- FDA Purple Book · refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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4.38 mg / 1 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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50 mg / 1 mL
UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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2.42 mg / 1 mL
UNII 023C2WHX2V
Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Stemline Therapeutics, Inc. labeler code 72187
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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 [see Warnings and Precautions ( 5.1 )] . WARNING: CAPILLARY LEAK SYNDROME See full prescribing information for complete boxed warning.
Capillary Leak Syndrome (CLS), which may be life-threatening or fatal if not properly managed, can occur in patients receiving ELZONRIS. ( 5.1 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. ELZONRIS is a CD123-directed cytotoxin indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Premedicate with an H1-histamine antagonist, acetaminophen, corticosteroid and H2-histamine antagonist prior to each ELZONRIS infusion. ( 2.1 ) Administer ELZONRIS intravenously at 12 mcg/kg over 15 minutes once daily on days 1 to 5 of a 21-day cycle. ( 2.1 ) Administer the first cycle of ELZONRIS in the inpatient setting.
Subsequent cycles may be administered in the inpatient or appropriate outpatient setting. ( 2.1 ) Additional important preparation and administration information is in full prescribing information. See full prescribing information for instructions on preparation and administration.
( 2.3 , 2.4 )
2.1Recommended Dosage Administer ELZONRIS at 12 mcg/kg intravenously over 15 minutes once daily on days 1 to 5 of a 21-day cycle. The dosing period may be extended for dose delays up to day 10 of the cycle. Continue treatment with ELZONRIS until disease progression or unacceptable toxicity.
The dose is calculated based on the patient’s actual weight. Prior to the first dose of the first cycle, ensure serum albumin is greater than or equal to 3.2 g/dL before administering ELZONRIS. Premedicate patients with an H1-histamine antagonist (e.g., diphenhydramine hydrochloride), H2-histamine antagonist (e.g., famotidine), corticosteroid (e.g., 50 mg intravenous methylprednisolone or equivalent) and acetaminophen (or paracetamol) approximately 60 minutes prior to each ELZONRIS infusion.
Administer Cycle 1 of ELZONRIS in the inpatient setting with patient observation through at least 24 hours after the last infusion. Administer subsequent cycles of ELZONRIS in the inpatient setting or in a suitable outpatient ambulatory care setting that is equipped with appropriate monitoring for patients with hematopoietic malignancies undergoing treatment. Observe patients for a minimum of 4 hours following each infusion.
2.2Dosage Modifications Monitor vital signs and check albumin, transaminases, and creatinine prior to preparing each dose of ELZONRIS. See Table 1 for recommended dose modifications and Table 2 for CLS management guidelines. Table 1.
Recommended ELZONRIS Dosage Modifications Parameter Severity Criteria Dosage Modification Serum albumin Serum albumin < 3.5 g/dL or reduced ≥ 0.5 g/dL from value measured prior to initiation of the current cycle See CLS Management Guidelines ( Table 2 ) Body weight Body weight increase ≥ 1.5 kg over pretreatment weight on prior treatment day See CLS Management Guidelines ( Table 2 ) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ALT or AST increase > 5 times the upper limit of normal Withhold ELZONRIS until transaminase elevations are ≤ 2.5 times the upper limit of normal.
Serum creatinine Serum creatinine > 1.8 mg/dL (159 micromol/L) or creatinine clearance < 60 mL/minute Withhold ELZONRIS until serum creatinine resolves to ≤ 1.8 mg/dL (159 micromol/L) or creatinine clearance ≥ 60 mL/minute. Systolic blood pressure Systolic blood pressure ≥ 160 mmHg or ≤ 80 mmHg Withhold ELZONRIS until systolic blood pressure is < 160 mmHg or > 80 mmHg. Heart rate Heart rate ≥ 130 bpm or ≤ 40 bpm Withhold ELZONRIS until heart rate is < 130 bpm or > 40 bpm.
Body temperature Body temperature ≥ 38°C Withhold ELZONRIS until body temperature is < 38°C. Hypersensitivity reactions Mild or moderate Withhold ELZONRIS until resolution of any mild or moderate hypersensitivity reaction. Resume ELZONRIS at the same infusion rate.
Severe or life-threatening Discontinue ELZONRIS permanently. Table 2. CLS Management Guidelines 1 If ELZONRIS dose is held: ELZONRIS administration may resume in the same cycle if all CLS signs/symptoms have resolved and the patient did not require measures to treat hemodynamic instability ELZONRIS administration should be held for the remainder of the cycle if CLS signs/symptoms have not resolved or the patient required measures to treat hemodynamic instability (e.g., required administration of intravenous fluids and/or vasopressors to treat hypo… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 1,000 mcg in 1 mL clear colorless solution in a single-dose vial. Injection: 1,000 mcg in 1 mL in a single-dose vial ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity: Monitor patients for signs/symptoms and treat appropriately. ( 5.2 ) Hepatotoxicity: Monitor ALT and AST. Interrupt ELZONRIS if the transaminases rise to greater than 5 times the upper limit of normal. ( 5.3 )
5.1Capillary Leak Syndrome Capillary leak syndrome (CLS), including life-threatening and fatal cases, has been reported among patients treated with ELZONRIS. In patients receiving ELZONRIS in clinical trials, the overall incidence of CLS was 53% (65/122), including Grade 1 or 2 in 43% (52/122) of patients, Grade 3 in 7% (8/122) of patients, Grade 4 in 1% (1/122) of patients, and four fatalities (3%) [see Adverse Reactions (6.1) ] . The median time to onset was 4 days (range - 1 to 46 days), and all but 5 patients experienced an event in Cycle 1.
Before initiating therapy with ELZONRIS, ensure that the patient has adequate cardiac function and serum albumin is greater than or equal to 3.2 g/dL. During treatment with ELZONRIS, monitor serum albumin levels prior to the initiation of each dose of ELZONRIS and as indicated clinically thereafter, and assess patients for other signs or symptoms of CLS, including weight gain, new onset or worsening edema, including pulmonary edema, hypotension or hemodynamic instability [see Dosage and Administration (2.2) ].
5.2Hypersensitivity Reactions ELZONRIS can cause severe hypersensitivity reactions. In patients receiving ELZONRIS in clinical trials, hypersensitivity reactions were reported in 43% (53/122) of patients treated with ELZONRIS and were Grade ≥ 3 in 7% (9/122) [see Adverse Reactions (6.1) ] . Manifestations of hypersensitivity reported in ≥ 5% of patients include rash, pruritus, and stomatitis.
Monitor patients for hypersensitivity reactions during treatment with ELZONRIS. Interrupt ELZONRIS infusion and provide supportive care as needed if a hypersensitivity reaction should occur [see Dosage and Administration (2.2) ] .
5.3Hepatotoxicity Treatment with ELZONRIS was associated with elevations in liver enzymes. In patients receiving ELZONRIS in clinical trials, elevations in ALT occurred in 79% (96/122) and elevations in AST occurred in 76% (93/122) [see Adverse Reactions (6.1) ] . Grade 3 ALT elevations were reported in 26% (32/122) of patients.
Grade 3 AST elevations were reported in 30% (36/122) and Grade 4 AST elevations were reported in 3% (4/122) of patients. Elevated liver enzymes occurred in the majority of patients in Cycle 1 and were reversible following dose interruption. Monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) prior to each infusion with ELZONRIS.
Withhold ELZONRIS temporarily if the transaminases rise to greater than 5 times the upper limit of normal and resume treatment upon normalization or when resolved [see Dosage and Administration (2.2) ] .
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse drug reactions are described elsewhere in the labeling: Capillary Leak Syndrome [see Warnings and Precautions ( 5.1 ) ] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 ) ] Hepatotoxicity [see Warnings and Precautions ( 5.3 ) ] Most common adverse reactions (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, pyrexia, peripheral edema, and weight increase. Most common laboratory abnormalities (incidence ≥ 50%) are decreases in albumin, platelets, hemoglobin, calcium, and sodium, and increases in glucose, ALT and AST.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Safety of ELZONRIS was assessed in a single-arm clinical trial that included 122 adults with newly diagnosed or relapsed/refractory myeloid malignancies, including 86 with BPDCN, treated with ELZONRIS 12 mcg/kg daily for 5 days of a 21-day cycle.
The overall median number of cycles started was 2.5 (range, 1-76), and 4 in patients with BPDCN (range, 1-76). Four (3%) patients (4/122) had fatal adverse reactions, all of which were related to capillary leak syndrome. Overall, 8% (10/122) of patients discontinued treatment with ELZONRIS due to an adverse reaction; the most common adverse reactions resulting in treatment discontinuation were hepatic toxicities, hypoalbuminemia and CLS (2% each).
Table 3 summarizes the common (≥ 10%) adverse reactions with ELZONRIS in patients with myeloid malignancies. The rate of any given adverse reaction or lab abnormality was derived from all the reported events of that type. Table 3.
Adverse Reactions in ≥ 10% of Patients Receiving 12 mcg/kg of ELZONRIS 1 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). N=122 All Grades % Grade ≥ 3 % Vascular disorders Capillary leak syndrome 1 53 11 Hypotension 25 7 Hypertension 14 6 General disorders and administration site conditions Fatigue 45 7 Pyrexia 43 0 Peripheral edema 39 1 Chills 26 1 Gastrointestinal disorders Nausea 45 0 Constipation 24 0 Diarrhea 21 0 Vomiting 19 0 Investigations Weight increase 31 0 Nervous system disorders Headache 28 0 Dizziness 21 0 Metabolism and nutrition disorders Decreased appetite 22 0 Respiratory, thoracic and mediastinal disorders Dyspnea 20 3 Epistaxis 12 1 Cough 12 0 Blood and lymphatic system disorders Febrile neutropenia 19 16 Musculoskeletal and connective tissue disorders Back pain 19 2 Pain in extremity 10 2 Cardiac disorders Tachycardia 17 0 Psychiatric disorders Insomnia 16 0 Anxiety 15 0 Skin and subcutaneous tissue disorders Pruritus 10 0 Clinically relevant adverse reactions occurring in less than 10% of patients treated with ELZONRIS included tumor lysis syndrome.
Table 4 summarizes the clinically important laboratory abnormalities that occurred in ≥ 10% patients with myeloid malignancies treated with ELZONRIS. Table 4. Selected Laboratory Abnormalities in Patients Receiving 12 mcg/kg of ELZONRIS Treatment-Emergent Laboratory Abnormalities All Grades % Grade ≥ 3 % Hematology Platelets decrease 68 49 Hemoglobin decrease 61 30 Neutrophils decrease 38 29 Chemistry Glucose increase 89 21 ALT increase 79 26 AST increase 76 33 Albumin decrease 72 1 Calcium decrease 57 2 Sodium decrease 52 9 Potassium decrease 36 6 Phosphate decrease 32 10 Creatinine increase 26 0 Magnesium d… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Advise women not to breastfeed ( 8.2 )
8.1Pregnancy Risk Summary Based on its mechanism of action, ELZONRIS has the potential for adverse effects on embryo-fetal development [see Clinical Pharmacology ( 12.1 )] . 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.
8.2Lactation 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.
8.3Females and Males of Reproductive Potential Based on its mechanism of action, ELZONRIS may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] 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 1 week after the last dose of ELZONRIS.
8.4Pediatric 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 [see Clinical Studies 14.1 , 14.2 ]. Safety and effectiveness have not been established in pediatric patients younger than 2 years of age.
8.5Geriatric Use Of the 86 patients who received ELZONRIS for BPDCN at the labeled dose in STML-401-0114, 63% were 65 years and older and 22% were 75 years and older. Patients 75 years or older experienced a higher incidence of altered mental status (including confusional state, delirium, mental status changes, dementia, and encephalopathy) than patients under 75 years of age.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on its mechanism of action, ELZONRIS has the potential for adverse effects on embryo-fetal development [see Clinical Pharmacology ( 12.1 )] . 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.
🧒 Pediatric Use ▾
8.4Pediatric 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 [see Clinical Studies 14.1 , 14.2 ]. Safety and effectiveness have not been established in pediatric patients younger than 2 years of age.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 86 patients who received ELZONRIS for BPDCN at the labeled dose in STML-401-0114, 63% were 65 years and older and 22% were 75 years and older. Patients 75 years or older experienced a higher incidence of altered mental status (including confusional state, delirium, mental status changes, dementia, and encephalopathy) than patients under 75 years of age.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Tagraxofusp-erzs is a CD123-directed cytotoxin composed of recombinant human interleukin-3 (IL-3) and truncated diphtheria toxin (DT) fusion protein that inhibits protein synthesis and causes cell death in CD123-expressing cells.
12.2Pharmacodynamics The exposure-response relationships and the time course of pharmacodynamic response for ELZONRIS have not been fully characterized.
12.3Pharmacokinetics Following administration of tagraxofusp-erzs 12 mcg/kg via 15-minute infusion in patients with BPDCN, the mean (SD) area under the plasma drug concentration over time curve (AUC) was 231 (123) hr·mcg/L and maximum plasma concentration (Cmax) was 162 (58.1) mcg/L. Distribution Mean (SD) volume of distribution of tagraxofusp-erzs is 5.1 (1.9) L in patients with BPDCN. Elimination Mean (SD) clearance is 7.1 (7.2) L/hr in patients with BPDCN.
Mean (SD) terminal half-life of tagraxofusp-erzs is 0.7 (0.3) hours. Specific Population No clinically significant differences in the pharmacokinetics of tagraxofusp-erzs were observed based on age (22 to 84 years), sex, mild to moderate renal impairment (eGFR 30 to 89 mL/min/1.73 m 2 , estimated by MDRD), mild (total bilirubin ≤ ULN and AST >ULN, or total bilirubin 1 to 1.5 times ULN and any AST) or moderate (total bilirubin >1.5 to 3 times ULN and any AST) hepatic impairment or body weight after adjusting dose by body weight.
The effect of severe renal impairment (eGFR 15 to 29 mL/min/1.73 m 2 ), or severe hepatic impairment (total bilirubin >3 times ULN and any AST) on tagraxofusp-erzs pharmacokinetics is unknown. Drug Interaction Studies No drug-drug interaction studies have been conducted with ELZONRIS.
12.6Immunogenicity The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to ELZONRIS with the incidences of antibodies to other products may be misleading.
Immune response to ELZONRIS was evaluated by assessment of serum binding reactivity against ELZONRIS (anti-drug antibodies; ADA) and neutralizing antibodies by inhibition of functional activity. Immune response to ELZONRIS was assessed using two immunoassays. The first assay detected reactivity directed against ELZONRIS (ADA), and the second assay detected reactivity against the interleukin-3 (IL-3) portion of ELZONRIS.
Two cell-based assays were used to investigate the presence of neutralizing antibodies by inhibition of a cell-based functional activity. In 130 patients treated with ELZONRIS in 4 clinical trials: 96% (115/120) of patients evaluable for the presence of pre-existing ADA at baseline before treatment were confirmed positive with 21% being positive for the presence of neutralizing antibodies. The high prevalence of ADA at baseline was anticipated due to diphtheria immunization.
99% (107/108) of patients evaluable for treatment-emergent ADA tested positive with most patients showing an increase in ADA titer by the end of Cycle 2 of ELZONRIS. 85% (86/101) of ADA-positive patients evaluable for the presence of neutralizing antibodies were neutralizing antibody-positive. 68% (73/108) of patients evaluable for treatment-emergent anti-IL-3 antibodies tested positive with most patients testing positive by Cycle 3 of ELZONRIS.
Anti-Product Antibody Effects on Pharmacokinetics The presence of ADA had a clinically significant effect on the pharmacokinetics of tagraxofusp-erzs. Pharmacokinetic data obtained following doses given in Cycle 3 showed increased titers of anti-drug antibodies and reduced free ELZONRIS concentration in most plasma samples. Following administration of tagraxofusp-erzs 12 mcg/kg via 15-min… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Tagraxofusp-erzs is a CD123-directed cytotoxin composed of recombinant human interleukin-3 (IL-3) and truncated diphtheria toxin (DT) fusion protein that inhibits protein synthesis and causes cell death in CD123-expressing cells.
12.2Pharmacodynamics The exposure-response relationships and the time course of pharmacodynamic response for ELZONRIS have not been fully characterized.
12.6Immunogenicity The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to ELZONRIS with the incidences of antibodies to other products may be misleading.
Immune response to ELZONRIS was evaluated by assessment of serum binding reactivity against ELZONRIS (anti-drug antibodies; ADA) and neutralizing antibodies by inhibition of functional activity. Immune response to ELZONRIS was assessed using two immunoassays. The first assay detected reactivity directed against ELZONRIS (ADA), and the second assay detected reactivity against the interleukin-3 (IL-3) portion of ELZONRIS.
Two cell-based assays were used to investigate the presence of neutralizing antibodies by inhibition of a cell-based functional activity. In 130 patients treated with ELZONRIS in 4 clinical trials: 96% (115/120) of patients evaluable for the presence of pre-existing ADA at baseline before treatment were confirmed positive with 21% being positive for the presence of neutralizing antibodies. The high prevalence of ADA at baseline was anticipated due to diphtheria immunization.
99% (107/108) of patients evaluable for treatment-emergent ADA tested positive with most patients showing an increase in ADA titer by the end of Cycle 2 of ELZONRIS. 85% (86/101) of ADA-positive patients evaluable for the presence of neutralizing antibodies were neutralizing antibody-positive. 68% (73/108) of patients evaluable for treatment-emergent anti-IL-3 antibodies tested positive with most patients testing positive by Cycle 3 of ELZONRIS.
Anti-Product Antibody Effects on Pharmacokinetics The presence of ADA had a clinically significant effect on the pharmacokinetics of tagraxofusp-erzs. Pharmacokinetic data obtained following doses given in Cycle 3 showed increased titers of anti-drug antibodies and reduced free ELZONRIS concentration in most plasma samples. Following administration of tagraxofusp-erzs 12 mcg/kg via 15-minute infusion in patients with pre-existing anti-drug antibodies, the mean (SD) volume of distribution of tagraxofusp-erzs is 21.2 (25.4) L, clearance is 13.9 (19.4) L/hr, AUC is 151 (89.2) hr·mcg/L and Cmax is 80.0 (82.2) mcg/L.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ELZONRIS (tagraxofusp-erzs) injection is a preservative-free, sterile, clear, colorless, 1,000 mcg in 1 mL solution supplied in a single-dose glass vial. Each carton contains one vial (NDC 72187-0401-1). Storage and Handling Store in freezer between -25°C and -15°C (-13°F and 5°F).
Protect ELZONRIS from light by storing in the original 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 Dosage and Administration ( 2.3 )] . Do not refreeze the vial once thawed.
Do not use beyond expiration date on container.
📋 Description ▾
11 DESCRIPTION Tagraxofusp-erzs, a CD123-directed cytotoxin, is a fusion protein comprised of a recombinant human interleukin-3 (IL-3) and truncated diphtheria toxin (DT). Tagraxofusp-erzs has an approximate molecular weight of 57,695 Daltons. Tagraxofusp-erzs is constructed by recombinant DNA technology and produced in Escherichia coli cells.
ELZONRIS (tagraxofusp-erzs) injection is a preservative-free, sterile, clear, colorless solution that may contain a few white to translucent particles and requires dilution prior to intravenous infusion. ELZONRIS is supplied at a concentration of 1,000 mcg/mL in a single-dose vial. Each mL of ELZONRIS contains 1,000 mcg tagraxofusp-erzs, sodium chloride (4.38 mg), sorbitol (50 mg), tromethamine (2.42 mg) and Water for Injection, USP and pH is 7.5.
💬 Information for Patients ▾
17 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 ( 5.1 )]. 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 ( 5.2 )].
Hepatotoxicity Advise patients to report symptoms that may indicate elevated liver enzymes including fatigue, anorexia and/or right upper abdominal discomfort [see Warnings and Precautions ( 5.3 )]. Contraception Advise females to avoid pregnancy and to use acceptable contraceptive methods during ELZONRIS treatment and for 1 week after the last dose of ELZONRIS [see Use in Specific Populations ( 8.3 )] . Lactation Advise women not to breastfeed [see Use in Specific Populations ( 8.2 )] .
Manufactured by: Stemline Therapeutics, Inc. New York, NY 10022 US License No. 2088 Stemline ® A Menarini Group Company
🧬 Pharmacodynamics ▾
12.3Pharmacokinetics Following administration of tagraxofusp-erzs 12 mcg/kg via 15-minute infusion in patients with BPDCN, the mean (SD) area under the plasma drug concentration over time curve (AUC) was 231 (123) hr·mcg/L and maximum plasma concentration (Cmax) was 162 (58.1) mcg/L. Distribution Mean (SD) volume of distribution of tagraxofusp-erzs is 5.1 (1.9) L in patients with BPDCN. Elimination Mean (SD) clearance is 7.1 (7.2) L/hr in patients with BPDCN.
Mean (SD) terminal half-life of tagraxofusp-erzs is 0.7 (0.3) hours. Specific Population No clinically significant differences in the pharmacokinetics of tagraxofusp-erzs were observed based on age (22 to 84 years), sex, mild to moderate renal impairment (eGFR 30 to 89 mL/min/1.73 m 2 , estimated by MDRD), mild (total bilirubin ≤ ULN and AST >ULN, or total bilirubin 1 to 1.5 times ULN and any AST) or moderate (total bilirubin >1.5 to 3 times ULN and any AST) hepatic impairment or body weight after adjusting dose by body weight.
The effect of severe renal impairment (eGFR 15 to 29 mL/min/1.73 m 2 ), or severe hepatic impairment (total bilirubin >3 times ULN and any AST) on tagraxofusp-erzs pharmacokinetics is unknown. Drug Interaction Studies No drug-drug interaction studies have been conducted with ELZONRIS.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1First-Line Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) STML-401-0114 (NCT 02113982; Study 0114) was a multicenter, open-label, single-arm, clinical trial that included a prospective cohort of 13 patients with treatment-naive BPDCN. Treatment consisted of ELZONRIS 12 mcg/kg intravenously over 15 minutes once daily on days 1 to 5 of a 21-day cycle. Patient baseline characteristics are presented in Table 5 .
Table 5. Baseline Demographics of Patients with Treatment-Naive BPDCN Parameter N=13 Gender, N (%) Male 11 (84.6) Female 2 (15.4) Age (years), N (%) Median
65.0Minimum, Maximum 22, 84 ECOG, N (%) 0 8 (61.5) 1 5 (38.5) BPDCN at Baseline, N (%) Skin 13 (100.0) Bone Marrow 7 (53.8) Peripheral Blood 3 (23.1) Lymph Nodes 6 (46.2) Viscera 2 (15.4) The efficacy of ELZONRIS in patients with treatment-naive BPDCN was based on the rate of complete response or clinical complete response (CR/CRc). Key efficacy measures are presented in Table 6 . The median time to CR/CRc was 57 days (range: 14 to 107).
Table 6. Efficacy Measures in Patients with Treatment-Naive BPDCN * CRc is defined as complete response with residual skin abnormality not indicative of active disease. Parameter N=13 CR/CRc* Rate, N (%) 7 (53.8) (95% CI) (25.1, 80.8) Duration of CR/CRc (months) Median Not reached Minimum, Maximum 3.9,
12.2 Duration of follow up (months) Median
11.5Minimum, Maximum 0.2, 12.7
14.2Relapsed or Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) STML-401-0114 (NCT02113982; Study 0114) was a multicenter, open-label, single-arm, clinical trial that included 15 patients with relapsed or refractory BPDCN. Treatment consisted of ELZONRIS 12 mcg/kg on days 1 to 5 of each 21-day cycle. Patient baseline characteristics are presented in Table 7 .
Table 7. Baseline Demographics of Patients 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 one patient achieved a CRc (duration: 424 days).
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been conducted to assess the carcinogenic or genotoxic potential of tagraxofusp. Animal fertility studies have not been conducted with tagraxofusp-erzs.
13.2Animal Toxicology and/or Pharmacology At human equivalent doses greater than or equal to 1.6 times the recommended dose based on body surface area, severe kidney tubular degeneration/necrosis was observed in cynomolgus monkeys. At human equivalent doses equal to the recommended dose, degeneration/necrosis of the choroid plexus in the brain was observed in cynomolgus monkeys. The reversibility of this finding was not assessed at lower doses, but the finding was irreversible and became progressively more severe at a human equivalent dose 1.6 times the recommended dose, 3 weeks after dosing stopped.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been conducted to assess the carcinogenic or genotoxic potential of tagraxofusp. Animal fertility studies have not been conducted with tagraxofusp-erzs.
📄 Recent Major Changes ▾
Dosage and Administration, Recommended Dosage (2.1) 7/2023 Warnings and Precautions, Capillary Leak Syndrome (5.1) 10/2022 Warnings and Precautions, Hepatotoxicity (5.3) 10/2022
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - NDC: 72187-0401-1 - 1000 mcg/mL Vial Label 1000 mcgg/mL Vial Label
PRINCIPAL DISPLAY PANEL - NDC: 72187-0401-1 - 1000 mcg/mL Carton Label 1000 mcgg/mL Carton Label
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