Tagraxofusp-erzs (tag-RAX-oh-fusp - erzs)

Treats blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Brand Name(s):

Elzonris

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. This medicine must be given slowly, so the needle will have to stay in place for at least 15 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Your doctor may also want you to stay for at least 4 hours to check for unwanted effects.
• You may receive other medicines (including allergy medicine, fever medicine, steroid, stomach medicine) about 60 minutes before each infusion to prevent unwanted effects.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control during treatment and for at least 1 week after the last dose. Your doctor will give you a pregnancy test 7 days before starting treatment to make sure you are not pregnant.
• Do not breastfeed during treatment with this medicine and for 1 week after the last dose.
• Tell your doctor if you have liver disease or heart problems.
• This medicine may cause the following problems:
  • Capillary leak syndrome
  • Liver problems
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in the amount of urine, cloudy urine, fainting or lightheadedness, swelling of your hands, ankles, feet, or lower legs
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea
• Headache
• Pain in the arms, back, or legs
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

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