Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 1000mcg/mL (single-dose vial)
Blastic Plasmacytoid Dendritic Cell Neoplasm
CD123-directed cytotoxin for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN)
Each cycle is 21 days
Premedicate with H1-histamine antagonist, H2- histamine antagonist, corticosteroid, and acetaminophen 60 minutes before each dose
Days 1-5: 12 mcg/kg IV qDay
Continue treatment until disease progression or unacceptable toxicity
Dosing period may be extended for dose delays up to Day 10 of the cycle
Dosage Modifications
Dosage modifications based on parameter and severity criteria
- ALT or AST increase >5x ULN: Withhold until AST/ALT ≤2.5x ULN
- Serum creatinine >1.8 mg/dL or CrCl ≤60 mL/min: Withhold until serum creatinine ≤1.8 mg/dL or CrCl ≥60 mL/min
- Systolic blood pressure (SBP) ≥160 mm Hg or ≤80 mm Hg: Withhold until SBP <160 mm Hg or >80 mm Hg
- Heart rate (HR) ≥130 bpm or ≤40 bpm: Withhold until HR is <130 bpm or >40 bpm
- Body temperature ≥38°C: Withhold until body temperature <38°C
-
Hypersensitivity reactions
- Mild or moderate: Withhold until any mild or moderate hypersensitivity reaction resolves; resume at the same infusion rate
- Severe or life-threatening: Discontinue permanently
Capillary leak syndrome (CLS) guidelines
-
Before first dose in Cycle 1
- Serum albumin <3.2 g/dL: Administer when serum albumin ≥3.2 g/dL
-
During treatment
- Interrupt dosing until relevant CLS sign/symptom resolves while implementing the following actions
- Serum albumin <3.5 g/dL or reduced by ≥0.5 g/dL from albumin before dosing initiation of current cycle: Administer albumin 25g IV (q12h or more frequently) until serum albumin ≥3.5 g/dL AND ≤0.5 g/dL lower than albumin before dosing initiation of the current cycle
- Predose body weight increased by ≥1.5 kg over previous day’s predose weight: Administer albumin 25g IV (q12h or more frequently) and manage fluid status as clinically indicated (eg, IV fluids and vasopressors if hypotensive and diuretics if normotensive and hypertensive) until body weight increase has resolved
- Edema, fluid overload, and/or hypotension: Administer albumin 25g IV (q12h or more frequently) until serum albumin ≥3.5 g/dL, methylprednisolone (or equivalent) 1 mg/kg/day IV, and aggressive management of fluid status and hypotension if present (may include IV fluids and/or diuretics or other blood pressure management) until CLS sign/symptom resolves or as clinically indicated
Dosing Considerations
Before first dose in Cycle 1, ensure patient has adequate cardiac function and serum albumin ≥3.2 g/dL
During treatment, monitor vital signs and check albumin, ALT/AST, and creatinine before preparing each dose and as clinically indicsated
Conduct pregnancy testing in females of reproductive potential within 7 days before initiating treatment
Dosage Forms & Strengths
injectable solution
- 1000mcg/mL (single-dose vial)
Blastic Plasmacytoid Dendritic Cell Neoplasm
CD123-directed cytotoxin for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN)
<2 years: Safety and efficacy not established
≥2 years
- Each cycle is 21 days
- Premedicate with H1-histamine antagonist, H2- histamine antagonist, corticosteroid, and acetaminophen 60 minutes before each dose
- Days 1-5: 12 mcg/kg IV qDay
- Continue treatment until disease progression or unacceptable toxicity
- Dosing period may be extended for dose delays up to Day 10 of the cycle
Dosage Modifications
Dosage modifications based on parameter and severity criteria
- ALT or AST increase >5x ULN: Withhold until AST/ALT ≤2.5x ULN
- Serum creatinine >1.8 mg/dL or CrCl ≤60 mL/min: Withhold until serum creatinine ≤1.8 mg/dL or CrCl ≥60 mL/min
- Systolic blood pressure (SBP) ≥160 mm Hg or ≤80 mm Hg: Withhold until SBP <160 mm Hg or >80 mm Hg
- Heart rate (HR) ≥130 bpm or ≤40 bpm: Withhold until HR is <130 bpm or >40 bpm
- Body temperature ≥38°C: Withhold until body temperature <38°C
-
Hypersensitivity reactions
- Mild or moderate: Withhold until any mild or moderate hypersensitivity reaction resolves; resume at the same infusion rate
- Severe or life-threatening: Discontinue permanently
Capillary leak syndrome (CLS) guidelines
-
Before first dose in Cycle 1
- Serum albumin <3.2 g/dL: Administer when serum albumin ≥3.2 g/dL
-
During treatment
- Interrupt dosing until relevant CLS sign/symptom resolves while implementing the following actions
- Serum albumin <3.5 g/dL or reduced by ≥0.5 g/dL from albumin before dosing initiation of current cycle: Administer albumin 25g IV (q12h or more frequently) until serum albumin ≥3.5 g/dL AND ≤0.5 g/dL lower than albumin before dosing initiation of the current cycle
- Predose body weight increased by ≥1.5 kg over previous day’s predose weight: Administer albumin 25g IV (q12h or more frequently) and manage fluid status as clinically indicated (eg, IV fluids and vasopressors if hypotensive and diuretics if normotensive and hypertensive) until body weight increase has resolved
- Edema, fluid overload, and/or hypotension: Administer albumin 25g IV (q12h or more frequently) until serum albumin ≥3.5 g/dL, methylprednisolone (or equivalent) 1 mg/kg/day IV, and aggressive management of fluid status and hypotension if present (may include IV fluids and/or diuretics or other blood pressure management) until CLS sign/symptom resolves or as clinically indicated
Dosing Considerations
Before first dose in Cycle 1, ensure patient has adequate cardiac function and serum albumin ≥3.2 g/dL
During treatment, monitor vital signs and check albumin, ALT/AST, and creatinine before preparing each dose and as clinically indicated
Conduct pregnancy testing in females of reproductive potential within 7 days before initiating treatment
Of the 94 patients who received tagraxofusp at labeled dose in STML-401-0114, 23% were ≥75 years; older patients experienced a higher incidence of altered mental status (including confusional state, delirium, mental status changes, dementia, and encephalopathy) than younger patients
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (1)
- siponimod
siponimod and tagraxofusp both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
Minor (0)
Adverse Effects
>10% (All Grades)
Glucose increased (87%)
ALT increased (82%)
AST increased (79%)
Albumin decreased (77%)
Platelets decreased (67%)
Hemoglobin decreased (60%)
Calcium decreased (57%)
Capillary leak syndrome (55%)
Sodium decreased (50%)
Nausea (49%)
Fatigue (45%)
Peripheral edema (43%)
Pyrexia (43%)
Neutrophils decreased (37%)
Weight increased (31%)
Phosphate decreased (30%)
Chills (29%)
Headache (29%)
Hypotension (29%)
Creatinine increased (27%)
Alkaline phosphatase increased (26%)
Decreased appetite (24%)
Constipation (23%)
Potassium increased (21%)
Vomiting (21%)
Diarrhea (20%)
Magnesium decreased (20%)
Dizziness (20%)
Febrile neutropenia (20%)
Back pain (20%)
Dyspnea (19%)
Tachycardia (17%)
Insomnia (17%)
Anxiety (15%)
Hypertension (15%)
Cough (14%)
Magnesium increased (14%)
Bilirubin increased (14%)
Epistaxis (14%)
Oropharyngeal pain (12%)
Anxiety (15%)
Confusional state (11%)
Glucose decreased (11%)
>10% (Grade 3 or 4)
Platelets decreased (53%)
AST increased (37%)
Hemoglobin decreased (35%)
Neutrophils decreased (31%)
ALT increase (30%)
Glucose increased (20%)
Febrile neutropenia (18%)
Phosphate decreased (11%)
1-10% (All Grades)
Petechiae (10%)
Pruritus (10%)
Hematuria (10%)
Sodium increased (10%)
Pain in extremity (10%)
1-10% (Grade 3 or 4)
Capillary leak syndrome (9%)
Hypotension (9%)
Fatigue (7%)
Hypertension (6%)
Magnesium increased (3%)
Potassium increased (2%)
Back pain (2%)
Pain in extremity (2%)
Dyspnea (2%)
Calcium decreased (2%)
Peripheral edema (1%)
Chills (1%)
Epistaxis (1%)
Alkaline phosphatase increased (1%)
Postmarketing Reports
Hypoalbuminemia
Tumor lysis syndrome
Warnings
Black Box Warnings
Capillary leak syndrome
- Capillary leak syndrome (CLS), which may be life-threatening or fatal, can occur in patients receiving tagraxofusp
- Monitor for signs and symptoms of CLS and take actions as recommended
- Before initiating therapy, ensure patient has adequate cardiac function and serum albumin ≥3.2 g/d
- During treatment, monitor serum albumin levels prior to initiation of each dose and as indicated clinically thereafter, and assess patients for other signs or symptoms of CLS, including weight gain and new-onset or worsening edema (eg, pulmonary edema, hypotension, hemodynamic instability)
Contraindications
None
Cautions
Capillary leak syndrome reported; interrupt dose and manage according to presenting symptoms
May cause severe hypersensitivity reactions (eg, rash, pruritus, stomatitis, wheezing); monitor for hypersensitivity reactions during treatment; interrupt infusion and provide supportive care as needed if a hypersensitivity reaction occurs
Treatment was associated with elevations in liver enzymes; monitor AST/ALT prior to each infusion; elevation of liver enzymes reversible following dose interruption
Pregnancy
Pregnancy
Based on its mechanism of action, therapy has potential for adverse effects on embryo-fetal development
Data are not available on use in pregnant women to inform a drug-associated risk of adverse developmental outcomes
Advise pregnant women of potential risks to the fetus
Conduct pregnancy testing in females of reproductive potential within 7 days before initiating treatment
Contraception
- Advise females to use acceptable contraceptive methods during treatment and for at least 1 week after last dose
Lactation
No data are available on the presence of drug in human milk, the effects on the breastfed child, or the effects on milk production
Because of potential for serious adverse reactions in breastfed children from tagraxofusp, breastfeeding is not recommended during treatment and for 1 week after last dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
CD123-directed cytotoxin, which is a fusion protein composed of a recombinant human interleukin 3 and truncated diphtheria toxin
Inhibits protein synthesis and causes cell death in CD123-expressing cells
Absorption
AUC: 231 hr·mcg/L
Peak plasma concentration: 162 mcg/L
Distribution
Vd: 5.1 L (blastic plasmacytoid dendritic cell neoplasm patients)
Elimination
Clearance: 7.1 L/hr (blastic plasmacytoid dendritic cell neoplasm patients)
Half-life: 0.7 hr
Administration
IV Compatibilities
0.9% NaCl
IV Preparation
Prior to dose preparation, thaw at room temperature, 15-25°C (59-77°F), for 15-30 min in original carton, and verify thaw visually; may be held at room temperature for ~1 hr prior to dosage preparation
Do not force-thaw; do not refreeze vial once thawed
Visually inspect vial for particulate matter and discoloration prior to administration
Thawed drug appears as a clear, colorless liquid that may contain a few white-to-translucent particles
Prepare 10 mL of tagraxofusp 100 mcg/mL
- Transfer 9 mL of 0.9% NaCl to an empty sterile 10-mL vial
- Gently swirl drug vial to mix contents, remove cap, and withdraw 1 mL of thawed drug
- Transfer 1 mL into sterile 10-mL vial containing 0.9% NaCl
- Gently invert vial ≥3x to mix contents; do not shake vigorously
- Final concentration of diluted solution is 100 mcg/mL
Prepare infusion set
- Calculate and draw up required volume of diluted solution (100 mcg/mL) according to patient’s weight
- If dose requires >10 mL, prepare a second vial of diluted solution
- Refer to prescribing information for further details on infusion set setup
- Do not reuse excess diluted drug solution; discard any excess material immediately following infusion
Premedication
Premedicate with an H1-histamine antagonist (eg, diphenhydramine), H2-histamine antagonist (eg, famotidine), corticosteroid (eg, 50 mg IV methylprednisolone or equivalent) and acetaminophen ~60 min before each infusion
IV Administration
Administration setting
- Cycle 1: Administer in an inpatient setting with patient observation through at least 24 hr after the last infusion
- Subsequent cycles: Administer in an inpatient setting or suitable outpatient ambulatory care setting equipped with appropriate monitoring for patients with hematopoietic malignancies undergoing treatment; observe patients for at least 4 hr after each infusion
Infusion
- Establish IV access and maintain with sterile 0.9% NaCl
- Administer prepared dose via infusion syringe pump over 15 min
- Total infusion time is controlled using a syringe pump to deliver entire dose and saline flush over 15 minutes
- After infusion setup: Administer within 4 hr; during this time, prepared dose should remain at room temperature
- Refer to prescribing information for infusion pump set up
Storage
Protect from light by storing in the original package until time of use
Unopened vials: Store in freezer at -25 to -15°C (-13 to -5°F)
Thawed vials
- Store at room temperature, 15-25°C (59-77°F) prior to preparation; may be held at room temperature for ~1 hr before dose preparation
- Do not refreeze the vial once thawed; do not use beyond expiration date on container
After infusion setup: Administer within 4 hr at room temperature
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
Elzonris intravenous - | 1,000 mcg/mL vial | ![]() |
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