Elzonris

Elzonris is a prescription medication used to treat certain types of leukemia (type of blood cancer) in adults and children 2 years of age and older.

Elzonris belongs to a group of drugs called CD123-directed cytotoxins (cell toxin), which destroy cancer cells. Proteins are found on the surface of all cells in the body. BPDCN cells have a high number of the protein CD123. By targeting the CD123 protein on the surface of BPDCN cells, Elzonris can find and kill these cells.

This medication is available in an injectable form to be given directly into a vein by a healthcare professional. Each Elzonris dose will take 15 minutes and is given daily on days 1 to 5 of each 21-day cycle. This dosing period may be extended up to day 10 of the treatment cycle, if necessary. Additional treatment cycles may be required.

Common side effects of Elzonris include nausea, fatigue, swelling, fever, weight increase, and abnormal leaking of fluid into body tissues.

Elzonris is a prescription medication used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients 2 years of age and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Elzonris, See the “Elzonris Precautions” section.

Common side effects of Elzonris include the following:

• Capillary leak syndrome (a condition where fluid and proteins leak into tissues from blood vessels)
• Nausea
• Fatigue
• Swelling in the legs/ankles/feet
• Weight gain

This is not a complete list of Elzonris side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been determined by the manufacturer. However, tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Elzonris including the following:

• Capillary leak syndrome, where fluid and proteins spill out of blood vessels into surrounding tissues. Tell your healthcare provider right away if you have some or all of the following symptoms of capillary leak syndrome:

  • Fluid accumulation (swelling) in the face/arms/hands/legs/feet
  • Weight gain
  • Shortness of breath
  • low blood pressure (dizziness or lightheadedness, headache, feeling tired, or shortness of breath)
• Hypersensitivity (severe allergic reaction). Tell your healthcare provider about any signs or symptoms of hypersensitivity, which include the following:
  • rash
  • itching (pruritus)
  • wheezing,
  • swelling in your face, including around your eyes and/or in and around your mouth

• Liver damage. Your healthcare provider will regularly check labs to determine your current liver function. Symptoms of liver damage include:

  • Feeling tired (fatigue)
  • Loss of appetite
  • Yellowing of your skin or the whites of your eyes (jaundice)
  • Upper right abdominal pain or discomfort

Contact your healthcare provider immediately if you have any of these symptoms.

Do not take Elzonris if you are allergic to Elzonris or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Elzonris, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Elzonris, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Elzonris or to any of its ingredients
• are pregnant or plan to become pregnant. Elzonris may harm your unborn baby.
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

No studies have been done in animals, and no well-controlled studies have been done in pregnant women. However, due to how Elzonris works, this medication may harm your unborn baby.

• If you are a female who can become pregnant, you should use effective birth control during Elzonris treatment and for at least 1 week after the last dose.
• Tell your healthcare provider right away if you become pregnant during treatment with Elzonris.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Elzonris crosses into human milk. However, based on how the medication works, breastfeeding is not recommended while on this medication and 1 week after it has been stopped.

You and your healthcare provider should decide if you will receive Elzonris or breastfeed. You should not do both.

Take Elzonris exactly as prescribed.

• Medicines are given about an hour before each Elzonris treatment to help reduce possible side effects of Elzonris. 
• Routine tests are performed before each dose. This will also show blood, liver, and kidney function during treatment.
• Body weight and vital signs will also be measured before each dose. Vital signs are blood pressure, heart rate, temperature, and breathing rate.
• Elzonris comes in an injectable form to be given directly into a vein by a healthcare professional.
• Each dose will take 15 minutes.
• Elzonris is give daily on days 1 to 5 of each 21-day treatment cycle. Dosing periods may be extended up to day 10 of the treatment cycle.
• Doses may be delayed or skipped if blood tests or vital signs show that it would be safer to wait. 
• Additional 21-day treatment cycles may be required.
• It is important to follow the schedule set by your healthcare provider. If you miss an appointment, call your healthcare provider as soon as possible to reschedule.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated

• other medical conditions you have

• other medications you are taking

• how you respond to this medication

• your weight

The recommended dose of Elzonris is 12 mcg/kg once daily for 5 days every 21 days. The dose and frequency may change depending on labwork and vital signs.

Elzonris is administered by a healthcare provider in a medical setting, making it unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to the medication.

Capillary Leak Syndrome (CLS), which may be lifethreatening or fatal if not properly managed, can occur in patients receiving Elzonris.