Version July 2025
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.
Note: Ensure adequate cardiac function prior to tagraxofusp initiation. Serum albumin should be ≥3.2 g/dL prior the first dose of cycle 1; monitor serum albumin levels prior to each dose and as clinically necessary. Premedicate with an H1-antagonist (eg, diphenhydramine), an H2-antagonist (eg, famotidine), a corticosteroid (eg, 50 mg IV methylprednisolone or equivalent), and acetaminophen ~60 minutes prior to each tagraxofusp infusion.
Blastic plasmacytoid dendritic cell neoplasm: IV: 12 mcg/kg (based on actual body weight) once daily on days 1 to 5 of a 21-day cycle; continue until disease progression or unacceptable toxicity (Ref). The dosing period may be extended for dose delays up to day 10 of the cycle.
Administer cycle 1 in the inpatient setting; observe patients through at least 24 hours after the last infusion. Subsequent cycles may be administered either inpatient or outpatient (if suitable); ensure appropriate monitoring is available and observe patients for a minimum of 4 hours following each infusion.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Kidney impairment prior to therapy initiation: Kidney function at baseline estimated by the MDRD formula.
eGFR 30 to 89 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling; however, no clinically significant differences in tagraxofusp pharmacokinetics were observed in patients with mild or moderate kidney impairment.
eGFR 15 to 29 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Kidney toxicity during treatment:
Serum creatinine >1.8 mg/dL or CrCl <60 mL/minute: Withhold tagraxofusp until serum creatinine is ≤1.8 mg/dL or CrCl is ≥60 mL/minute.
Hepatic impairment prior to therapy initiation:
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) impairment: There are no dosage adjustments provided in the manufacturer’s labeling; however, no clinically significant differences in tagraxofusp pharmacokinetics were observed in patients with mild or moderate hepatic impairment.
Severe (total bilirubin >3 times ULN and any AST) impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Hepatotoxicity during treatment:
AST or ALT >5 times ULN: Withhold tagraxofusp until AST and/or ALT are ≤2.5 times ULN.
Serum albumin reductions: Refer to Dosage Adjustment for Toxicity
American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2 : The dosing in the FDA-approved prescribing information should be followed in all patients, regardless of obesity status. If a patient with a BMI ≥30 kg/m2 experiences high-grade toxicity from systemic anticancer therapy, the same dosage modification recommendations should be followed for all patients, regardless of obesity status (Ref). Note: Tagraxofusp dosing is based on actual body weight (according to the prescribing information).
Note: Monitor vital signs and obtain serum albumin, transaminases, and creatinine prior to preparing each tagraxofusp dose.
Capillary leak syndrome: Interrupt tagraxofusp therapy for signs/symptoms of capillary leak syndrome (CLS). If tagraxofusp is withheld for signs/symptoms of CLS, may resume tagraxofusp in the same cycle if all CLS signs/symptoms have resolved and hemodynamic instability did not require treatment. Hold tagraxofusp therapy for the remainder of the cycle if CLS signs/symptoms have not resolved or treatment was necessary to manage hemodynamic instability (eg, IV fluid and/or vasopressors to treat hypotension), even if resolved. May resume tagraxofusp in the next cycle only if all CLS signs/symptoms have resolved and the patient is hemodynamically stable.
Prior to first dose of cycle 1: Serum albumin <3.2 g/dL: Do not initiate tagraxofusp until serum albumin is ≥3.2 g/dL.
During tagraxofusp therapy:
Serum albumin <3.5 g/dL or serum albumin reduced by ≥0.5 g/dL from the value measured prior to tagraxofusp dosing initiation of the current cycle: Interrupt tagraxofusp therapy. Administer 25 g IV albumin as clinically necessary until serum albumin is ≥3.5 g/dL and not more than 0.5 g/dL lower than the value measured prior to tagraxofusp dosing initiation of the current cycle.
Predose body weight increased by ≥1.5 kg over the previous day's predose weight: Interrupt tagraxofusp therapy. Administer 25 g IV albumin as clinically necessary and manage fluid status as clinically indicated (eg, IV fluids/vasopressors if hypotensive and diuretics if normotensive or hypertensive) until body weight increase has resolved (eg, body weight is no longer ≥1.5 kg more than the previous day's predose weight).
Edema, fluid overload, and/or hypotension: Interrupt tagraxofusp therapy. Administer 25 g IV albumin as clinically necessary until serum albumin is ≥3.5 g/dL. Administer 1 mg/kg/day methylprednisolone (or equivalent) until resolution of CLS signs/symptoms or as clinically necessary. Manage fluid status and hypotension aggressively until resolution of CLS signs/symptoms or as clinically necessary; IV fluids and/or diuretics or other blood pressure management may be necessary.
Cardiac effects:
Heart rate ≥130 bpm or ≤40 bpm: Withhold tagraxofusp until heart rate is <130 bpm or >40 bpm.
Systolic blood pressure ≥160 mm Hg or ≤80 mm Hg: Withhold tagraxofusp until systolic blood pressure is <160 mm Hg or >80 mm Hg.
Hypersensitivity reactions: Note: Provide supportive care as clinically necessary.
Mild or moderate: Withhold tagraxofusp until resolution; resume tagraxofusp at the same infusion rate.
Severe or life-threatening: Discontinue tagraxofusp permanently.
Pyrexia: Body temperature ≥38°C: Withhold tagraxofusp until body temperature is <38°C.
Refer to adult dosing.
(For additional information see "Tagraxofusp: Pediatric drug information")
Note: Prior to first dose of first cycle, verify serum albumin ≥3.2 g/dL and patient has adequate cardiac function. Administer the first cycle of doses in an inpatient setting; subsequent cycles may be administered in an inpatient setting or an ambulatory outpatient setting equipped with monitoring capabilities for patients with hematopoietic malignancies. Premedicate 60 minutes prior to each infusion with an H1- and H2-histamine antagonist, corticosteroid (eg, methylprednisolone IV), and acetaminophen.
Blastic plasmacytoid dendritic cell neoplasm (BPDCN): Note: Approval in pediatric patients based on extrapolation of experience in adult patients and pediatric safety (Ref). Dosing should be based on patient's actual body weight.
Children ≥2 years and Adolescents: IV: 12 mcg/kg/dose once daily on days 1 to 5 of a 21-day cycle; dosing period may be extended to delays up to day 10 of the 21-day cycle. Continue treatment until disease progression or unacceptable toxicity.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosing adjustment for toxicity: Children ≥2 years and Adolescents: IV: Data is scant in pediatric patients; use appropriate age-related parameters for children. Monitor vital signs and obtain serum albumin, transaminases, and creatinine prior to preparing each tagraxofusp dose.
Significantly low or high systolic blood pressure (SBP) (eg, in adults SBP ≤80 mm Hg or ≥160 mm Hg): Withhold therapy until SBP returns to normal (eg, in adults to >80 mm Hg or <160 mm Hg).
Significantly low or high heart rate (HR) (eg, in adults HR ≤40 bpm or ≥130 bpm): Withhold therapy until HR returns to normal (eg, in adults to >40 bpm or <130 bpm).
Body temperature ≥38°C: Withhold therapy until body temperature <38°C.
Hypersensitivity reactions:
Mild to moderate: Withhold therapy until resolution of symptoms; resume therapy at the same infusion rate.
Severe or life-threatening: Discontinue permanently.
Capillary leak syndrome (CLS): Note: Data is scant in pediatric patients (minimum reported age: 10 years) (Ref); smaller pediatric patients may require dosing adjustment at different parameters (eg, changes in body weight) or symptoms:
Serum albumin <3.5 g/dL: Interrupt therapy; administer IV albumin until serum albumin raised serum albumin to ≥3.5 g/dL and not more than 0.5 g/dL lower than baseline albumin of the current cycle. Resume therapy upon resolution (see following Note).
Predose body weight increase (eg, ≥1.5 kg in adult patients) over previous day's predose weight: Interrupt therapy; administer IV albumin and manage fluid status as applicable until body weight increases have resolved (eg, in adults, any predose body weight increase is <1.5 kg from previous day's predose weight). Resume therapy upon resolution (see following Note).
Edema, fluid overload and/or hypotension: Interrupt therapy; administer IV albumin until serum albumin ≥3.5 g/dL, administer IV methylprednisolone (or equivalent), and aggressively manage fluid status/BP as necessary. Resume therapy upon resolution.
Note: When resuming therapy, may resume with the same cycle if any hemodynamic instability did not require interventions to treat; therapy should be withheld for the remainder of a cycle if signs/symptoms of CLS are unresolved or interventions were required to treat hemodynamic instability (even if resolved), and therapy may resume with the next cycle if all CLS signs/symptoms have resolved and hemodynamically stable.
Children ≥2 years and Adolescents:
Baseline (prior to initiation of therapy):
eGFR 30 to 89 mL/minute/1.73 m2: Pediatric-specific data is lacking; in adults (22 to 84 years of age), no pharmacokinetic differences were reported; no dosing adjustment necessary.
eGFR 15 to 29 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.
Nephrotoxicity during therapy: SCr >1.8 mg/dL or CrCl ≤60 mL/minute: Withhold therapy until SCr ≤1.8 mg/dL or CrCl ≥60 mL/minute.
Children ≥2 years and Adolescents:
Baseline (prior to therapy initiation):
Mild hepatic impairment (total bilirubin ≤ ULN and AST > ULN, or total bilirubin 1 to 1.5 times ULN and any AST) or moderate hepatic impairment (total bilirubin >1.5 to 3 times ULN and any AST): Pediatric-specific data is lacking; in adults (22 to 84 years of age), no pharmacokinetic differences were reported; no dosing adjustment necessary.
Severe hepatic impairment (total bilirubin >3 times ULN and any AST): There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.
Hepatotoxicity during therapy: ALT or AST increase >5 times ULN: Withhold therapy until transaminase elevations are ≤2.5 times ULN.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
>10%:
Cardiovascular: Capillary leak syndrome (53%), hypertension (14%), hypotension (25%), peripheral edema (39%), tachycardia (17%)
Endocrine & metabolic: Decreased serum albumin (72%), decreased serum calcium (57%), decreased serum magnesium (25%), decreased serum phosphate (32%), decreased serum potassium (36%), decreased serum sodium (52%), hypermagnesemia (13%), increased serum glucose (89%), increased serum potassium (20%), weight gain (31%)
Gastrointestinal: Constipation (24%), decreased appetite (22%), diarrhea (21%), nausea (45%), vomiting (19%)
Hematologic & oncologic: Decreased hemoglobin (61%; grades ≥3: 30%), decreased neutrophils (38%; grades ≥3: 29%), decreased platelet count (68%; grades ≥3: 49%), febrile neutropenia (19%; grades ≥3: 16%)
Hepatic: Increased serum alanine aminotransferase (79%), increased serum alkaline phosphatase (22%), increased serum aspartate aminotransferase (76%), increased serum bilirubin (11%)
Hypersensitivity: Hypersensitivity reaction (43%)
Immunologic: Antibody development (68% to 99%; neutralizing: 85%)
Nervous system: Anxiety (15%), chills (26%), dizziness (21%), fatigue (45%), headache (28%), insomnia (16%)
Neuromuscular & skeletal: Back pain (19%)
Renal: Increased serum creatinine (26%)
Respiratory: Cough (12%), dyspnea (20%), epistaxis (12%)
Miscellaneous: Fever (43%)
1% to 10%:
Dermatologic: Pruritus (10%)
Endocrine & metabolic: Decreased serum glucose (10%)
Hematologic & oncologic: Tumor lysis syndrome (<10%)
Neuromuscular & skeletal: Limb pain (10%)
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Capillary leak syndrome: In clinical trials, capillary leak syndrome (CLS), including life-threatening and fatal cases, was observed in over half of patients; approximately half of CLS events were grade 1 or 2; grades 3 and 4 CLS events have also been reported. The median time to onset was 4 days (range: 1 to 46 days) with most patients experiencing an event during the first cycle. Signs and symptoms of tagraxofusp-associated CLS include hypoalbuminemia, edema, weight gain, and hypotension.
• Hepatotoxicity: Hepatic transaminase elevations (ALT, AST) have been reported in close to 80% of patients. Grade 3 toxicity occurred in approximately one-third of patients; grade 4 elevations were also reported. Hepatic transaminase elevations occurred mainly during the first cycle of therapy and were reversible upon therapy interruption.
• Hypersensitivity: Severe hypersensitivity reactions may occur. In clinical trials, hypersensitivity reactions occurred in close to half of patients; 10% of events were ≥ grade 3. Reactions included rash, pruritus, stomatitis, and wheezing.
Special populations:
• Older adult: Patients ≥75 years experienced a higher incidence of altered mental status (eg, confusion, delirium, mental status changes, dementia, encephalopathy) compared to patients <75 years of age.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Elzonris: Tagraxofusp-erzs 1000 mcg/mL (1 mL)
No
Solution (Elzonris Intravenous)
1000 mcg/mL (per mL): $40,507.98
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IV: Administer the tagraxofusp dose and the saline flush via infusion syringe pump over a total infusion time of 15 minutes. Establish IV access and maintain with NS.
Use the prepared/primed mini-bifuse Y-connector, infusion set and 0.2-micron polyethersulfone inline filter. Insert the tagraxofusp syringe into the syringe pump, open the clamp on the tagraxofusp side of the Y-connector and deliver the dose. Once the tagraxofusp infusion is completed, remove it from the pump and place the saline flush syringe in the pump. Open the clamp on the saline flush side of the Y-connector and resume infusion at the pre-specified flow to push remaining tagraxofusp dose out of the infusion line. Administer within 4 hours of preparation.
Premedicate with an H1-antagonist (eg, diphenhydramine), an H2-antagonist (eg, famotidine), a corticosteroid (eg, methylprednisolone 50 mg IV or equivalent), and acetaminophen ~60 minutes prior to each tagraxofusp infusion. Administer cycle 1 in the inpatient setting; observe patients through at least 24 hours after the last infusion. Subsequent cycles may be administered either inpatient or outpatient (if suitable); ensure appropriate monitoring is available and observe patients for a minimum of 4 hours following each infusion.
Note: Premedicate ~60 minutes prior to each tagraxofusp infusion with an H1-antagonist (eg, diphenhydramine), an H2-antagonist (eg, famotidine), a corticosteroid (eg, methylprednisolone IV), and acetaminophen. Administer cycle 1 in the inpatient setting; observe patients through at least 24 hours after the last infusion. Subsequent cycles may be administered either inpatient or outpatient (if suitable); ensure appropriate monitoring is available and observe patients for a minimum of 4 hours following each infusion.
IV: Administer the tagraxofusp dose and the saline flush via IV infusion syringe pump over a total infusion time of 15 minutes.
Prepare and prime the mini-bifuse Y-connector, infusion set and 0.2-micron polyethersulfone inline filter: Connect the saline flush syringe to one arm of a mini-bifuse Y-connector and ensure the clamp is closed. Connect the tagraxofusp syringe to the other arm of the Y-connector; ensure the clamp is closed. Connect the terminal end of the Y-connector to the microbore tubing. Remove the cap from the supply side of a 0.2-micron polyethersulfone in-line filter and attach it to the terminal end of the microbore tubing. Unclamp the arm of the Y-connector connected to the saline flush syringe; prime the Y-connector up to the intersection (do not prime the full infusion set with NS); re-clamp the Y-connector line on the saline flush arm. Remove the cap on the terminal end of the 0.2-micron filter (save cap); unclamp the arm of the Y-connector connected to the tagraxofusp syringe and prime the entire infusion set, including the filter. Recap the filter, and re-clamp the Y-connector line on the tagraxofusp side; infusion set is now prepared for tagraxofusp infusion.
Infusion: Insert the tagraxofusp syringe into the syringe pump, open the clamp on the tagraxofusp side of the Y-connector, and deliver the dose. Once the tagraxofusp infusion is completed, remove it from the pump and place the saline flush syringe in the pump. Open the clamp on the saline flush side of the Y-connector and resume infusion at the pre-specified flow to push remaining tagraxofusp dose out of the infusion line. Administer within 4 hours of preparation.
Blastic plasmacytoid dendritic cell neoplasm: Treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients ≥2 years of age.
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Alfuzosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Amifostine: Blood Pressure Lowering Agents may increase hypotensive effects of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider Therapy Modification
Amisulpride (Oral): May increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor
Androgens: Hypertension-Associated Agents may increase hypertensive effects of Androgens. Risk C: Monitor
Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may increase hypotensive effects of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor
Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor
Arginine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Barbiturates: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
BCG (Intravesical): Myelosuppressive Agents may decrease therapeutic effects of BCG (Intravesical). Myelosuppressive Agents may increase adverse/toxic effects of BCG (Intravesical). Risk X: Avoid
Benperidol: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Blood Pressure Lowering Agents: May increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor
Brimonidine (Topical): May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Bromperidol: May decrease hypotensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase hypotensive effects of Bromperidol. Risk X: Avoid
Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor
Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid
Cladribine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk X: Avoid
CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor
Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification
Diazoxide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
DULoxetine: Blood Pressure Lowering Agents may increase hypotensive effects of DULoxetine. Risk C: Monitor
Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid
Herbal Products with Blood Pressure Lowering Effects: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Hypotension-Associated Agents: Blood Pressure Lowering Agents may increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor
Iloperidone: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Levodopa-Foslevodopa: Blood Pressure Lowering Agents may increase hypotensive effects of Levodopa-Foslevodopa. Risk C: Monitor
Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Lormetazepam: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Metergoline: May decrease antihypertensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase orthostatic hypotensive effects of Metergoline. Risk C: Monitor
Molsidomine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Naftopidil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Nicergoline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Nicorandil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Nitroprusside: Blood Pressure Lowering Agents may increase hypotensive effects of Nitroprusside. Risk C: Monitor
Obinutuzumab: May increase hypotensive effects of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider Therapy Modification
Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor
Pentoxifylline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Pholcodine: Blood Pressure Lowering Agents may increase hypotensive effects of Pholcodine. Risk C: Monitor
Phosphodiesterase 5 Inhibitors: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Prostacyclin Analogues: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Quinagolide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification
Silodosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Solriamfetol: May increase hypertensive effects of Hypertension-Associated Agents. Risk C: Monitor
Evaluate pregnancy status within 7 days prior to therapy initiation in patients who could become pregnant. Effective contraception should be used during treatment and for at least 1 week after the last tagraxofusp dose.
Animal reproduction studies have not been conducted. Based on the mechanism of action, adverse effects on fetal development may occur following in utero exposure to tagraxofusp.
It is not known if tagraxofusp is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during treatment or for 1 week after the last tagraxofusp dose.
Monitor serum albumin, transaminases, and creatinine prior to each dose and as clinically indicated thereafter. Evaluate pregnancy status within 7 days prior to initiating tagraxofusp therapy (in patients who could become pregnant). Monitor vital signs (eg, heart rate, BP, weight) prior to each dose; monitor for signs/symptoms of capillary leak syndrome (eg, weight gain, new onset or worsening edema, pulmonary edema, hypotension, hemodynamic instability), hepatotoxicity, and hypersensitivity reactions.
The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Tagraxofusp is a CD123-directed fusion protein which is composed of human interleukin-3 (IL-3) and truncated diphtheria toxin (DT). After binding to CD123, tagraxofusp is internalized, leading to inhibition of protein synthesis and cell death (Sun 2018).
Distribution: 5.1 L; 21.2 L in patients with preexisting anti-drug antibodies
Half-life elimination: 0.7 hours
Excretion: Clearance: 7.1 L/hour; 13.9 L/hour in patients with preexisting anti-drug antibodies
