Tell your treatment team about:

All of your medical conditions

All of the medicines you take, including prescription medicines, over-the-counter medicines, herbal supplements, and vitamins.

ELZONRIS may harm your unborn baby. If there is a possibility that you may become pregnant during treatment, you should use birth control while you are on ELZONRIS, and for 1 week or more after the last dose.

ELZONRIS may cause fetal harm when administered to a pregnant woman. All pregnancies have a risk of birth defect, loss, or other adverse outcomes.

You should not breastfeed while you are on ELZONRIS. It is not known if ELZONRIS passes into breast milk.

During treatment with ELZONRIS

How:

Through a needle in your vein (IV infusion)

How long:

Each dose will take 15 minutes

How much:

Your dose of ELZONRIS is based on your weight

Each cycle of ELZONRIS treatment is 21 days

You will receive ELZONRIS daily on days 1 to 5 of each treatment cycle. Your healthcare provider may decide to extend this dosing period up to day 10 of the treatment cycle.

  • Your healthcare provider may delay a dose if your blood test or vital signs show that it would be safer to wait. They may also decide if it is safer to skip a dose
  • You will have at least 11 days without treatment

Your doctor will then decide if and when you may receive another 21-day cycle of treatment.

You will receive your first cycle of treatment in the hospital.

  • Your treatment team will monitor your reaction to ELZONRIS for 24 hours after the last dose of cycle 1

Treatment cycle 2 and all additional treatment cycles may be in the hospital or at an outpatient clinic.

  • Your treatment team should observe you for 4 hours after each dose

Keep all of your medical appointments

As with any medicine, 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.

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
  • Low blood pressure (dizziness or lightheadedness, headache, feeling tired, or shortness of breath)

Watching your weight

Your weight gives your treatment team important information during your treatment. Fast weight gain can be a sign of capillary leak syndrome (CLS), a serious side effect.

  • Weigh yourself daily, and write down your weight every day
  • Weigh yourself at the same time every morning, without clothes, with the scale on a hard surface

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)

Your healthcare provider will 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), swelling in your legs or feet, fever, 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 at least 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.

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)

Your healthcare provider will 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), swelling in your legs or feet, fever, 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 at least 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.