Goals of treatment

The goal of treatment with ELZONRIS is to get rid of as many BPDCN cells as possible.

People respond differently to treatment with ELZONRIS. For some, ELZONRIS may get rid of all BPDCN cells in the body, while others may only get rid of some of the BPDCN cells in the body.

For some people, another goal is to get a stem cell transplant as part of their treatment plan after ELZONRIS. Talk to your healthcare provider about what this means, and if this is a possibility for you.

How ELZONRIS was studied

The study on ELZONRIS was the largest one of its kind for BPDCN. Forty-four people with BPDCN were enrolled, including:

  • 29 people who had never received treatment
  • 15 people who had previously received treatment for their disease

Who was in this study?

ELZONRIS was studied in people who had never received treatment for BPDCN before and in people who had been previously treated with other treatments, like chemotherapy.

What were the study results?

Among the 29 people who had not previously received treatment for BPDCN:

Nine out of 10 patients had a response to ELZONRIS® (tagraxofusp-erzs) treatment

9 in 10

90% had a response to ELZONRIS treatment. This means that ELZONRIS reduced the number of BPDCN cells at the end of treatment.

Seven out of 10 patients had a complete response to ELZONRIS® (tagraxofusp-erzs)

More than 7 in 10

72% had a complete response. This means that no BPDCN cells were found at the end of treatment.

45 percent received a stem cell transplant at the end of ELZONRIS® (tagraxofusp-erzs) treatment

More than 4 in 10

45% received a stem cell transplant at the end of ELZONRIS treatment.

Of these 29 people, 13 were studied to confirm
the effectiveness of ELZONRIS

More than 7 in 10

77% had a response to ELZONRIS treatment.

More than 5 in 10

54% had a complete response.

More than 4 in 10

46% received a stem cell transplant at the end of ELZONRIS treatment.

Among the 15 people who had previously received treatment:

More than 6 in 10

67% had a response to ELZONRIS treatment.

About 1 in 10

13% had a complete response.

Fewer than 1 in 10

7% received a stem cell transplant at the end of ELZONRIS treatment.

About ELZONRIS® (tagraxofusp-erzs)

ELZONRIS is a prescription medicine used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients 2 years and older.

IMPORTANT SAFETY INFORMATION

ELZONRIS can cause serious side effects, including:

  • Capillary Leak Syndrome (CLS). ELZONRIS can cause fluid to leak from small blood vessels into your body's tissues. This is called "Capillary Leak Syndrome." CLS can quickly cause you to have symptoms that may become life-threatening or fatal (ie, lead to death). Get emergency medical help immediately if you develop any of the following symptoms:
    • fast weight gain
    • swelling of your face, arms, hands, legs, or feet
    • shortness of breath or difficulty breathing
    • low blood pressure (dizziness or lightheadedness, headache, feeling tired, or shortness of breath)

Weigh yourself daily. Your healthcare provider will also check your weight and test your blood before you receive each dose of ELZONRIS and as needed during treatment.

  • Hypersensitivity reactions may occur with ELZONRIS. Symptoms may include rash, itching (pruritus), wheezing, or swelling in your face, including around your eyes and/or in and around your mouth
  • Liver damage is usually detected through blood tests. Symptoms may include feeling tired (fatigue), loss of appetite, yellowing of your skin or the whites of your eyes (jaundice), or upper right abdominal pain or discomfort

Your healthcare provider will periodically test your blood while you are on ELZONRIS to check for liver damage.

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

Getting medical treatment right away may help keep these problems from becoming more serious.

If you have any side effects during treatment with ELZONRIS, your healthcare provider may hold your treatment for a period of time or completely stop your treatment with ELZONRIS.

The most common side effects of ELZONRIS include CLS, nausea, feeling tired (fatigue), fever, swelling in your legs or feet, and weight gain.

These are not all of the possible side effects of ELZONRIS. If any new side effects start or an existing one gets worse, contact your healthcare provider immediately. For more information, talk to your treatment team.

Be sure to tell your treatment team about:

  • all of your medical conditions, including if you
    • are pregnant or plan to become pregnant. ELZONRIS 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 1 week after the last dose
      • Tell your healthcare provider right away if you become pregnant during treatment with ELZONRIS
    • are breastfeeding or plan to breastfeed. It is not known if ELZONRIS passes into breast milk. You and your healthcare provider should decide if you will receive ELZONRIS or breastfeed. You should not do both
  • all of the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements

You can report any side effects to Stemline Therapeutics, Inc. at 1-877-332-7961 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


Please see full Prescribing Information, including Boxed WARNING, for ELZONRIS to learn more.

The risk information provided here is not comprehensive. To learn more, talk about ELZONRIS (tagraxofusp-erzs) with your healthcare provider or pharmacist. The FDA-approved product labeling can be found here.

IMPORTANT SAFETY INFORMATION

About ELZONRIS® (tagraxofusp-erzs)

ELZONRIS is a prescription medicine used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients 2 years and older.

IMPORTANT SAFETY INFORMATION

ELZONRIS can cause serious side effects, including:

  • Capillary Leak Syndrome (CLS). ELZONRIS can cause fluid to leak from small blood vessels into your body's tissues. This is called "Capillary Leak Syndrome." CLS can quickly cause you to have symptoms that may become life-threatening or fatal (ie, lead to death). Get emergency medical help immediately if you develop any of the following symptoms:
    • fast weight gain
    • swelling of your face, arms, hands, legs, or feet
    • shortness of breath or difficulty breathing
    • low blood pressure (dizziness or lightheadedness, headache, feeling tired, or shortness of breath)

Weigh yourself daily. Your healthcare provider will also check your weight and test your blood before you receive each dose of ELZONRIS and as needed during treatment.

  • Hypersensitivity reactions may occur with ELZONRIS. Symptoms may include rash, itching (pruritus), wheezing, or swelling in your face, including around your eyes and/or in and around your mouth
  • Liver damage is usually detected through blood tests. Symptoms may include feeling tired (fatigue), loss of appetite, yellowing of your skin or the whites of your eyes (jaundice), or upper right abdominal pain or discomfort

Your healthcare provider will periodically test your blood while you are on ELZONRIS to check for liver damage.

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

Getting medical treatment right away may help keep these problems from becoming more serious.

If you have any side effects during treatment with ELZONRIS, your healthcare provider may hold your treatment for a period of time or completely stop your treatment with ELZONRIS.

The most common side effects of ELZONRIS include CLS, nausea, feeling tired (fatigue), fever, swelling in your legs or feet, and weight gain.

These are not all of the possible side effects of ELZONRIS. If any new side effects start or an existing one gets worse, contact your healthcare provider immediately. For more information, talk to your treatment team.

Be sure to tell your treatment team about:

  • all of your medical conditions, including if you
    • are pregnant or plan to become pregnant. ELZONRIS 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 1 week after the last dose
      • Tell your healthcare provider right away if you become pregnant during treatment with ELZONRIS
    • are breastfeeding or plan to breastfeed. It is not known if ELZONRIS passes into breast milk. You and your healthcare provider should decide if you will receive ELZONRIS or breastfeed. You should not do both
  • all of the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements

You can report any side effects to Stemline Therapeutics, Inc. at 1-877-332-7961 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


Please see full Prescribing Information, including Boxed WARNING, for ELZONRIS to learn more.

The risk information provided here is not comprehensive. To learn more, talk about ELZONRIS (tagraxofusp-erzs) with your healthcare provider or pharmacist. The FDA-approved product labeling can be found here.