Tagraxofusp

Tagraxofusp is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN).

• Tagraxofusp is available under the following different brand names: Elzonris, tagraxofusp-erzs

Common side effects of Tagraxofusp include:

• capillary leak syndrome
• high or low blood pressure
• nausea
• fatigue
• swelling of extremities
• fever
• weight gain
• constipation
• vomiting
• diarrhea
• chills
• headache
• dizziness
• decreased appetite
• back pain
• pain in extremities
• shortness of breath
• cough
• nosebleed
• sore throat or mouth pain
• insomnia
• anxiety
• confusion
• fast heart rate
• itching
• small red or purple spots on the skin
• blood in the urine

Serious side effects of Tagraxofusp include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• rash
• itching
• mouth sores
• sudden warmth or tingly feeling
• tiredness
• dizziness
• thirst
• decreased urination
• sudden swelling
• weight gain

Rare side effects of Tagraxofusp include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 1000 mcg/mL (single-dose vial)

Blastic plasmacytoid dendritic cell neoplasm

Adult dosage

• Each cycle is 21 days
  • Premedicate with H1-histamine antagonist, H2- histamine antagonist, corticosteroid, and acetaminophen 60 minutes before each dose
  • Days 1 to 5: 12 mcg/kg IV once a day
  • Continue treatment until the disease progresses or has unacceptable toxicity
  • Dosing period may be extended for dose delays up to Day 10 of the cycle

Pediatric dosage

• Children aged younger than 2 years: Safety and efficacy not established
• Children aged 2 years and older:
  • Each cycle is 21 days
  • Premedicate with H1-histamine antagonist, H2- histamine antagonist, corticosteroid, and acetaminophen 60 minutes before each dose
  • Days 1 to 5: 12 mcg/kg IV once a day
  • Continue treatment until disease progression or unacceptable toxicity
  • The dosing period may be extended for dose delays up to Day 10 of the cycle

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Tagraxofusp has severe interactions with no other drugs
• Tagraxofusp has serious interactions with no other drugs
• Tagraxofusp has moderate interactions with the following drug:
  • siponimod
• Tagraxofusp has minor interactions with noother drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tagraxofusp?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tagraxofusp?”

Cautions

• Capillary leak syndrome reported; interrupt dose and manage according to presenting symptoms
• May cause severe hypersensitivity reactions (e.g., rash, pruritus, stomatitis, wheezing); monitor for hypersensitivity reactions during treatment; interrupt the infusion and provide supportive care as needed if a hypersensitivity reaction occurs
• Treatment was associated with elevations in liver enzymes; monitor AST/ALT before each infusion; elevation of liver enzymes reversible following dose interruption

Pregnancy and Lactation

• Based on its mechanism of action, therapy has the 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 women of reproductive potential within 7 days before initiating treatment
• Contraception
  • Advise women to use acceptable contraceptive methods during treatment and for at least 1 week after the last dose
• Lactation
  • No data are available on the presence of drugs in human milk, the effects on the breastfed child, or the effects on milk production
  • Because of the potential for serious adverse reactions in breastfed children from tagraxofusp, breastfeeding is not recommended during treatment and for 1 week after the last dose