Tagraxofusp

What is Tagraxofusp?

• Tagraxofusp (Elzonris) is a CD123-directed cytotoxin used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN).

What are the uses of this medicine?

• This medicine is used for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older.

How does this medicine work?

• (tag-RAK-soh-fusp) A drug used to treat a rare blood cancer called blastic plasmacytoid dendritic cell neoplasm.
• It is also being studied in the treatment of other types of cancer.
• Tagraxofusp is made up of interleukin-3 (IL-3) , which binds to an IL-3 receptor protein called CD123.
• CD123 may be found in higher than normal amounts on some types of cancer cells.
• Tagraxofusp is also made up of a diphtheria toxin, which may help kill cancer cells.
• Tagraxofusp is a type of cytotoxin.

Who Should Not Use this medicine ?

• This medcine have no usage limitations.

What drug interactions can this medicine cause?

• No clinically important drug interactions have been observed with Elzonris.

Is this medicine FDA approved?

• It was approved for use in the United States in 2018.

How should this medicine be used?

• Premedicate with an H1-histamine antagonist, acetaminophen, corticosteroid and H2-histamine antagonist prior to each Elzonris infusion.
• Prior to the first dose of the first cycle, ensure serum albumin is greater than or equal to 3.2 g/dL before administering Elzonris.

Recommended Dosage ;

• Administer Elzonris at 12 mcg/kg intravenously over 15 minutes once daily on days 1 to 5 of a 21-day cycle.
• The dosing period may be extended for dose delays up to day 10 of the cycle.
• Continue treatment with Elzonris until disease progression or unacceptable toxicity.

Administration

• Administer the first cycle of Elzonris in the inpatient setting.
• Subsequent cycles may be administered in the inpatient or appropriate outpatient setting.
• 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.
• Use aseptic technique for preparation of the Elzonris dose.
• 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.
• 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 saline 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 saline flush syringe in the syringe pump.
• Open the clamp on the saline 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 1,000 mcg in 1 mL in a single-dose vial.

This medicine is available in fallowing brand namesː

• Elzonris

What side effects can this medication cause?

The most common side effects ,laboratory abnormalitiesof this medicine include:

• capillary leak syndrome
• nausea
• fatigue
• peripheral edema
• pyrexia
• weight increase
• decreases in albumin
• decreases in platelets
• decreases in hemoglobin
• decreases in calcium
• decreases in sodium
• increases in glucose, ALT and AST

What special precautions should I follow?

• Capillary leak syndrome (CLS), including life-threatening and fatal cases, has been reported among patients treated with Elzonris. During treatment with Elzonris, monitor serum albumin levels prior to the initiation of each dose of Elzonris and as indicated clinically thereafter, and assess patients for other signs or symptoms of CLS, including weight gain, new onset or worsening edema, including pulmonary edema, hypotension or hemodynamic instability.
• Elzonris can cause severe hypersensitivity reactions. Monitor patients for signs/symptoms and treat appropriately.
• Treatment with Elzonris was associated with elevations in liver enzymes. Monitor ALT and AST. Interrupt Elzonris if the transaminases rise to greater than 5 times the upper limit of normal.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on its mechanism of action, Elzonris has the potential for adverse effects on embryo-fetal development .
• There are no available data on Elzonris use in pregnant women to inform a drug-associated risk of adverse developmental outcomes.

Can this medicine be used in children?

• The safety and effectiveness of Elzonris for treatment of BPDCN have been established in pediatric patients 2 years of age and older.
• No data for pediatric patients less than 2 years of age.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• TAGRAXOFUSP

Inactive ingredients:

• SODIUM CHLORIDE
• SORBITOL
• TROMETHAMINE
• WATER

Who manufactures and distributes this medicine?

Packager: Stemline Therapeutics, Inc.

What should I know about storage and disposal of this medication?

• Store in freezer between -25°C and -15°C (-13°F and 5°F).
• Protect Elzonris from light by storing in the original package until time of use.
• Thaw vials at room temperature between 15°C and 25°C (59°F and 77°F) prior to preparation.
• Do not refreeze the vial once thawed.
• Do not use beyond expiration date on container.

• Dailymed label info on Tagraxofusp
• FDA Tagraxofusp

Tagraxofusp Resources
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Tagraxofusp Resources
Need Help Finding a Doctor? Need help finding a doctor or specialist anywhere in the world? Explore our world directory. WikiMD's DocFinder can assist you in locating millions of physicians.	Medical Knowledge Access the latest research - Most recent articles Ongoing trials.

Translate to: East Asian 中文, 日本, 한국어, South Asian हिन्दी, Urdu, বাংলা, తెలుగు, தமிழ், ಕನ್ನಡ,
Southeast Asian Indonesian, Vietnamese, Thai, မြန်မာဘာသာ, European español, Deutsch, français, русский, português do Brasil, Italian, polski