Tagraxofusp
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From MedlinePlus, U.S. National Library of Medicine
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 )
CD123 Interaction, Cytotoxin
Dosing in kidney impairment
| 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. |
Preparation and administration
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Your numbers for tagraxofusp. Take vial strength, diluent, and limits from the label below.
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Dosage 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. [See table below.] [See table below.]
Preparation for Administration Assure the following components required for dose preparation and administration are available prior to thawing ELZONRIS: One infusion syringe pump One empty 10 mL sterile vial 0.9% Sodium Chloride Injection, USP Three 10 mL sterile syringes One 1 mL sterile syringe One mini-bifuse Y-connector Microbore tubing One 0.2 micron polyethersulfone in-line filter Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Thawed ELZONRIS appearance should be a clear, colorless liquid that may contain a few white to translucent particles. Prior to dose preparation thaw at room temperature, between 15°C and 25°C (59°F and 77°F), for 15 to 30 minutes in original carton, and verify thaw visually. Thawed vials may be held at room temperature for approximately 1 hour prior to dosage preparation.
Do not force thaw. Do not refreeze vial once thawed. Use aseptic technique for preparation of the ELZONRIS dose. A 2-step process is required for preparation of the final ELZONRIS dose: - Step 1 - Prepare 10 mL of 100 mcg/mL ELZONRIS - Using a sterile 10 mL syringe, transfer 9 mL of 0.9% Sodium Chloride Injection, USP to an empty sterile 10 mL vial. - Gently swirl the ELZONRIS vial to mix the contents, remove the cap, and using a sterile 1 mL syringe, withdraw 1 mL of thawed ELZONRIS from the product vial. - Transfer the 1 mL of ELZONRIS into the 10 mL vial containing the 0.9% Sodium Chloride Injection, USP.
Gently invert the vial at least 3 times to mix the contents. Do not shake vigorously. - Following dilution the final concentration of ELZONRIS is 100 mcg/mL. - Step 2 – Prepare the ELZONRIS infusion set. - Calculate the required volume of diluted ELZONRIS (100 mcg/mL) according to patient’s weight. - Draw up the required volume into a new syringe (if more than 10 mL of diluted ELZONRIS (100 mcg/mL) is required for the calculated patient dose, repeat step 1 with a second vial of ELZONRIS).
Label the ELZONRIS syringe. - Prepare a separate syringe with at least 3 mL of 0.9% Sodium Chloride Injection, USP to be used to flush the administration set once the ELZONRIS dose is delivered. - Label the 0.9% Sodium Chloride Injection, USP flush syringe. - Connect the 0.9% Sodium Chloride Injection, USP flush syringe to one arm of the Y-connector and ensure the clamp is closed. - Connect the product syringe to the other arm of the Y-connector and 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 the 0.2 micron filter and attach it to the terminal end of the microbore tubing. - Unclamp the arm of the Y-connector connected to the 0.9% Sodium Chloride Injection, USP flush syringe.
Prime the Y-connector up to the intersection (do not prime the full infusion set with 0.9% Sodium Chloride Injection, USP). Re-clamp the Y-connector line on the 0.9% Sodium Chloride Injection, USP flush arm. - Remove the cap on the terminal end of the 0.2 micron filter and set it aside. Unclamp the arm of the Y-connector connected to the product syringe, and prime the entire infusion set, including the filter.
Recap the filter, and re-clamp the Y-connector line on the product side. The infusion set is now ready for delivery for dose administration. Administer ELZONRIS within 4 hours. During this 4-hour window, the prepared dose should remain at room temperature. Do not reuse excess ELZONRIS. Any excess material should be thrown away immediately following infusion.
Administration Establish venous access and maintain with sterile 0.9% Sodium Chloride Injection, USP. Administer the prepared ELZONRIS dose via infusion syringe pump over 15 minutes. The total infusion time will be controlled using a syringe pump to deliver the entire dose and the 0.9% Sodium Chloride Injection, USP flush over 15 minutes.
Insert the ELZONRIS syringe into the syringe pump, open the clamp on the ELZONRIS side of the Y-connector and deliver the prepared ELZONRIS dose. Once the ELZONRIS syringe has been emptied, remove it from the pump and place the 0.9% Sodium Chloride Injection, USP flush syringe in the syringe pump. Open the clamp on the 0.9% Sodium Chloride Injection, USP flush side of the Y-connector and resume infusion via the syringe pump at the pre-specified flow to push remaining ELZONRIS dose out of the infusion line to complete delivery.
Contraindications
None. None ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy 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.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.