tagraxofusp (Rx)

Brand and Other Names:Elzonris, tagraxofusp-erzs
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Dosing & Uses

AdultPediatricGeriatric

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

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 the first dose in Cycle 1, ensure serum albumin ≥3.2 g/dL

Monitor vital signs and check albumin, transaminases, and creatinine prior to preparing each dose

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
  • 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 the first dose in Cycle 1, ensure serum albumin ≥3.2 g/dL

Monitor vital signs and check albumin, transaminases, and creatinine prior to preparing each dose

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

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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%)

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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

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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.

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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

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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, ranitidine), corticosteroid (eg, 50 mg IV methylprednisolone or equivalent) and acetaminophen (or paracetamol) ~60 min prior to each infusion

IV Administration

Administration setting

  • Cycle 1: Administer in an inpatient setting with patient observation through ≤24 hr after last infusion
  • Subsequent cycles: Administer in an inpatient setting or a suitable outpatient ambulatory care setting equipped with appropriate monitoring for patients with hematopoietic malignancies undergoing treatment

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 set setup: Administer within 4 hr at room temperature

Refer to the 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

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Images

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.