tagraxofusp

tag-RAX-oh-fusp

Therapeutic Classification: antineoplastics

Pharmacologic Classification: cytotoxic proteins

High Alert

Blastic plasmacytoid dendritic cell neoplasm.

Fusion protein composed of a recombinant human interleukin-3 and truncated diphtheria toxin that inhibits protein synthesis and causes cell death in cells that express CD123.

Therapeutic effects:

Decreased tumor growth and spread.

Absorption: IV administration results in complete bioavailability.

Distribution: Well distributed to tissues.

Metabolism/Excretion: Unknown.

Half-Life: 42 min.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	unknown	unknown

Contraindicated in:

OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Rep: Women of reproductive potential;
Pedi: Children <2 yr (safety and effectiveness not established);
Geri: ↑risk of mental status changes in older adults.

CV: capillary leak syndrome, hypertension, hypotension, peripheral edema, tachycardia

Derm: petechiae, pruritus

EENT: epistaxis, oropharyngeal pain

Endo: hyperglycemia, hypoglycemia

F and E: hyperkalemia, hypermagnesemia, hypernatremia, hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia

GI: constipation, diarrhea, hepatotoxicity, hyperbilirubinemia, nausea, vomiting

GU: ↑serum creatinine, hematuria

Hemat: anemia, neutropenia, thrombocytopenia

Metab: ↓appetite, hypoalbuminemia, weight gain

MS: back pain

Neuro: anxiety, confusion, dizziness, headache, insomnia

Resp: cough, dyspnea

Misc: chills, fatigue, fever, hypersensitivity reactions

Drug-drug:

None known.

IV (Adults and Children ≥2 yr): 12 mcg/kg once daily on Days 1–5 of every 21-day cycle. Continue until disease progression or unacceptable toxicity.

Solution for injection: 1000 mcg/mL

Monitor vital signs before and during infusion. Hold therapy if HR ≤40 bpm or ≥130 bpm, SBP ≥160 mm Hg or ≤80 mm Hg, and/or body temperature ≥100.4°F. Resume infusion when HR, BP, and temperature are within parameters.
Assess for hypersensitivity reactions (rash, pruritus, stomatitis, wheezing). If mild or moderate hypersensitivity reaction occurs, hold infusion until symptoms resolve and resume at same infusion rate. If severe or life-threatening hypersensitivity reaction occurs, discontinue infusion and provide supportive care as needed. Permanently discontinue tagraxofusp.
Assess for signs and symptoms of hepatotoxicity (jaundice, severe abdominal pain, nausea/vomiting).
Monitor for signs and symptoms of capillary leak syndrome. If capillary leak syndrome occurs, interrupt therapy; may resume the cycle if signs/symptoms have resolved and hemodynamically stable without interventions. Hold therapy if symptoms do not resolve or if treated for hemodynamic instability (IV fluids, vasopressors). May resume therapy in next cycle only if signs/symptoms resolved and hemodynamically stable.
Assess baseline body weight before starting therapy and during infusion. If predose body weight ↑≥1.5 kg over the previous day's predose weight, interrupt therapy. Administer albumin 25 g IV every 12 hr or as clinically necessary and manage fluid status per condition (IV fluids/vasopressors if hypotensive, diuretics if normotensive or hypertensive) until body weight ↑ resolved (no longer ≥1.5 kg than the previous day's predose weight).
Assess and monitor for edema, fluid overload, or hypotension during therapy. If edema, fluid overload, or hypotension occur, interrupt therapy. Administer albumin 25 g IV every 12 hr or as clinically necessary until albumin ≥3.5 g/dL. Administer methylprednisolone (or equivalent) 1 mg/kg/day until resolution of capillary leak syndrome. Administer IV fluids and/or diuretics or other BP management per condition.

Lab Test Considerations:

Verify a negative pregnancy test 7 days before starting therapy.
Obtain hepatitis B virus screening and management before starting treatment.
Monitor serum albumin before 1st cycle and during therapy. If albumin <3.2 g/dL, hold dose until ≥3.2 g/dL. If albumin <3.5 g/dL or ↓ by ≥0.5 g/dL from value taken before dosing start of current cycle, interrupt therapy. Administer albumin 25 g IV as clinically necessary until ≥3.5 g/dL and not >0.5 g/dL lower than the value measured before starting current cycle.
Monitor AST and ALT. If AST or ALT >5 times upper limit of normal (ULN), hold therapy until AST and ALT ≤2.5 times ULN.
Monitor serum creatinine and CCr. If serum creatinine >1.8 mg/dL or CCr <60 mL/min, hold dose until serum creatinine ≤1.8 mg/dL or CCr ≥60 mL/min.
May ↓ hemoglobin, neutrophils, and platelets. Monitor for bleeding.
May ↑ glucose, ↓ calcium, sodium, and phosphate. May ↑ or ↓ magnesium and potassium.

Administer 1st cycle in the inpatient setting with appropriate monitoring and close observation for >24 hr after last infusion. After subsequent cycles, observe for ≥4 hr after infusion.
Premedicate with histamine-1 antagonist (e.g., diphenhydramine), histamine-2 antagonist (e.g., famotidine), corticosteroid (e.g., methylprednisolone 50 mg IV or equivalent), and acetaminophen 60 min before infusion.
Visually inspect for particulate matter and discoloration. Solution should be clear and colorless; may contain a few white to translucent particles.

IV Administration:

Intermittent Infusion: Diluent: Thaw vials at room temperature for 15–30 min. Thawed vials may remain at room temperature for 1 hr before preparation. Transfer 9 mL of 0.9% NaCl into an empty, sterile-10 mL vial. Gently swirl the tagraxofusp vial; withdraw 1 mL of thawed tagraxofusp and transfer to vial containing 9 mL 0.9% NaCl. Gently invert vial 3 times; do not shake. Concentration: 100 mcg/mL. Rate: Infuse over 15 min.
Draw up required volume of diluted tagraxofusp in a new sterile syringe and label; if >10 mL is necessary, repeat reconstitution with a 2nd vial of thawed tagraxofusp. Prepare another syringe with 3 mL of 0.9% NaCl to flush after administration. Connect saline flush to one arm of mini-bifuse Y-connector and ensure clamp is closed. Connect tagraxofusp syringe to the other arm of the Y-connector; ensure 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 0.9% NaCl); reclamp 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 reclamp the Y-connector line on the tagraxofusp side. Administer via syringe pump.
Y-Site Incompatibility: Do not administer other drugs through same IV line.

Explain purpose and side effects of medication to patient. Advise to read Patient Information before starting therapy.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Advise patient of the risk of capillary leak syndrome and to notify health care professional if new or worsening edema, weight gain, shortness of breath, or low BP occur after infusion. Advise patient to weigh themselves daily.
Advise patient to notify health care professional if rash, flushing, wheezing, or swelling of the face occurs. Seek immediate medical attention if needed.
Inform patient to report any symptoms of elevated liver enzymes, including tiredness, anorexia, or right upper abdominal discomfort.
Advise patient to avoid large crowds and people who are sick and to report flu-like symptoms and fever.
Advise patient to report any signs of bleeding including bruising easily, bleeding gums, or nosebleeds.
Rep: May cause fetal harm. Advise women of reproductive potential to notify health care professional if pregnancy is suspected or planned. Advise patient to use acceptable contraceptive methods and to avoid breastfeeding during treatment and for 1 wk after last dose.

Decreased tumor growth and spread.

Elzonris

NDC Code

63508- FUJIFILM Diosynth Biotechnologies UK Ltd.
- 63508-006-
  - 63508-006-01- 1000 mL in 1 BOTTLE (63508-006-01)

72187- Stemline Therapeutics, Inc.
- 72187-0401- Elzonris
  - 72187-0401-1- 1 VIAL, SINGLE-DOSE in 1 CARTON (72187-0401-1) / 1 mL in 1 VIAL, SINGLE-DOSE

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