Elzonris
Elzonris (tagraxofusp) is an injection used to treat a rare and aggressive blood cancer called blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and children 2 years and older. It’s a CD123-directed cytotoxin, meaning it targets the CD123 protein on cancer cells and delivers a toxin to kill them. The medication is given as an intravenous (IV) infusion once a day for the first 5 days of each 21-day treatment cycle. Common side effects include fever, nausea, tiredness, and a very serious condition called capillary leak syndrome.
What is Elzonris (tagraxofusp)?
What is Elzonris (tagraxofusp) used for?
- Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in people age 2 years or older
How Elzonris (tagraxofusp) works
Elzonris (tagraxofusp) is a CD123-directed cytotoxin made of two parts: interleukin-3 (IL-3), which binds to CD123 (a protein found on cancer cells), and a modified diphtheria toxin.
When Elzonris (tagraxofusp) attaches to cancer cells, it enters the cell and releases the toxin inside. The toxin stops the cell from making proteins, which causes the cancer cell to die.
Drug facts
Side effects of Elzonris (tagraxofusp)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Rise in blood sugar (89%)
- Rise in liver enzymes (up to 79%)
- Lower platelets (68%)
- Lower hemoglobin (61%)
- Lower electrolytes (up to 57%)
- Capillary leak syndrome (53%)
- Tiredness (45%)
- Nausea (45%)
- Fever (43%)
- Swelling in the arms and legs (39%)
- Weight gain (31%)
Less Common Side Effects
- Headache
- Chills
- Higher or lower blood pressure
- Constipation
- Diarrhea
- Vomiting
- Reduced appetite
- Dizziness
- Cough
- Shortness of breath
- Back pain
Elzonris (tagraxofusp) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Capillary leak syndrome: fast weight gain, swelling, trouble breathing, dizziness, headache, tiredness
- Serious allergic reactions: rash, flushing, wheezing, swelling of the face
- Liver damage: tiredness, loss of appetite, yellowing of the skin or eyes, or pain in the upper right side of your stomach
The following Elzonris (tagraxofusp) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Capillary leak syndrome—stomach or muscle pain, unusual weakness or fatigue, feeling faint or lightheaded, decrease in the amount of urine, swelling of the ankles, hands, or feet, trouble breathing
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
- Chills
- Constipation
- Diarrhea
- Fatigue
- Headache
- Nausea
- Swelling of the ankles, hands, or feet
Pros and cons of Elzonris (tagraxofusp)
Pros
- Given as a short infusion, over 15 minutes
- Recommended first-choice option to treat BPDCN
- First FDA approved medication for BPDCN
- Can be used in both adults and children 2 years and older
Cons
- Need to stay in the hospital for the first cycle
- Risk of life-threatening capillary leak syndrome
- Requires regular blood tests
- Must weigh yourself every day
Pharmacist tips for Elzonris (tagraxofusp)
- You’ll receive the first cycle of Elzonris (tagraxofusp) in the hospital so your care team can watch for side effects. After that, you might get the infusion in the hospital or an outpatient clinic depending on how you respond and what your oncologist recommends.
- Elzonris (tagraxofusp) is typically given once a day for the first 5 days of each 21-day cycle. But if you have side effects, your doses might be delayed but should still be given within the first 10 days.
- One hour before each Elzonris (tagraxofusp) infusion, you’ll get medications like diphenhydramine, famotidine, acetaminophen, and methylprednisolone to help prevent allergic reactions. Tell your care team right away if you notice rash, flushing, wheezing, or swelling in your face.
- Elzonris (tagraxofusp) can cause a serious side effect called capillary leak syndrome. Call your care team if you notice swelling, sudden weight gain, dizziness, or shortness of breath after an infusion.
- It’s important to weigh yourself every day while you’re receiving Elzonris (tagraxofusp) since it’s a symptom of capillary leak syndrome. If you notice fluid buildup or weight gain, tell your care team right away.
- Elzonris (tagraxofusp) can affect your liver. Your care team will monitor your liver with blood tests regularly. Let them know if you have symptoms like tiredness, loss of appetite, yellowing of the skin or eyes, or pain in the upper right side of your stomach.
- Elzonris (tagraxofusp) can harm an unborn baby. If you’re able to become pregnant, your oncologist will have you do a pregnancy test before starting treatment. To prevent pregnancy, use effective birth control during treatment and for 1 week after your last dose.
- It’s not known if Elzonris (tagraxofusp) passes into breast milk. To be safe, don’t breastfeed during treatment or for 1 week after your last dose.
Common questions about Elzonris (tagraxofusp)
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a very rare and aggressive blood cancer. It starts in your plasmacytoid dendritic cells, which are special immune cells that help fight off infections. With BPDCN, these cells grow out of control and can spread to your skin, bone marrow, lymph nodes, and other organs. You might notice purple or red skin spots, along with symptoms like tiredness, fever, or weight loss. Elzonris (tagraxofusp) can help get rid of BPDCN cells in the body.
Yes. Elzonris (tagraxofusp) was FDA approved to treat BPDCN in adults and children 2 years and older in December 2018. It’s the first FDA approved medication to treat BPDCN.
You can only get Elzonris (tagraxofusp) with a prescription from your oncologist or specialist. Because it can cause serious side effects, it must be given by a trained healthcare professional in a hospital or infusion center. Talk to your oncologist if you have questions about how to get this medication.
Elzonris (tagraxofusp) is an intravenous (IV) infusion. You’ll get it once a day for the first 5 days of a 21-day treatment cycle. Your first cycle is always done in the hospital so your care team can watch you closely for serious side effects. Before each infusion, you’ll usually receive medications like steroids, antihistamines, or acetaminophen to help lower the risk of side effects.
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Risks and warnings for Elzonris (tagraxofusp)
Elzonris (tagraxofusp) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Capillary leak syndrome
People receiving Elzonris (tagraxofusp) can develop a side effect called capillary leak syndrome. This happens when fluid leaks from your blood vessels into other parts of your body. It can cause swelling, breathing problems, low blood pressure, and sometimes kidney damage. Most of the time this side effect is mild and your oncologist can manage it, but in rare cases it can become serious or life-threatening.
Before starting Elzonris (tagraxofusp), your oncologist will check your heart health and your blood protein levels (albumin) to make sure it’s safe. In studies, capillary leak syndrome usually started within the first few days of treatment. That’s why you’ll receive your first cycle (5 doses) in the hospital so your care team can watch you closely and treat symptoms if they happen. Tell your care team right away if you notice sudden weight gain, swelling, trouble breathing, or dizziness.
Allergic reactions
It’s common to have an allergic reaction to the Elzonris (tagraxofusp) infusion, but most reactions are mild and can be managed by your care team. To help prevent this, you’ll receive medications such as diphenhydramine, famotidine, acetaminophen, and corticosteroids (like methylprednisolone) before each infusion. Tell your care team right away if you notice signs of an allergic reaction, such as rash, flushing, wheezing, or swelling of your face.
Liver problems
Elzonris (tagraxofusp) can raise your liver enzyme levels. In studies, many people had experienced this, especially during the first treatment cycle. These changes were usually temporary and got better when treatment was paused.
Your care team will check your liver enzymes before each infusion of Elzonris (tagraxofusp). If your levels get too high, your oncologist will stop treatment for a while and restart when your labs improve. Tell your care team right away if you feel very tired, lose your appetite, have yellow skin or eyes, or feel pain on the upper right side of your stomach.
Elzonris (tagraxofusp) dosage
Typical dosage for Elzonris (tagraxofusp)
Elzonris (tagraxofusp) is given in 21-day treatment cycles. Your oncologist will determine your specific dose based on your weight.
The typical dose is 12 mcg/kg infused through the vein (IV) on days 1 to 5 of each 21-day cycle.