Capillary leak syndrome (CLS), a dangerous disorder in which portions of the blood leak out of the blood vessels and might cause death, is a reaction that can be caused by the injection of tagraxofusp-erzs. Tell your doctor right away if you have unexpected weight gain, dizziness, shortness of breath, swelling of the face, arms, legs, feet, or anywhere else on your body. Tagraxofusp-erzs treatment may be suspended or stopped, and alternative drugs may be prescribed instead. You should weigh yourself every day to determine whether you are gaining weight.

Keep all of your appointments with your physician and the lab. Before and during your treatment, your doctor will order specific tests to determine whether it is safe for you to get tagraxofusp-erzs and to monitor your body’s reaction to the drug.

Injections of tagraxofusp-erzs are used to treat adults and children 2 years of age and older who have blastic plasmacytoid dendritic cell neoplasm (BPDCN), a blood malignancy that can cause skin lesions and spread to the bone marrow and lymphatic system. A group of drugs known as CD123 cytotoxin includes tagraxofusp-erzs. It kills cancer cells to do its job.

The intravenous (into a vein) injection of tagraxofusp-erzs is a solution (liquid) that must be diluted. It takes 15 minutes to administer. On days 1, 2, 3, 4, and 5 of a 21-day treatment cycle, it is often administered just once per day. You must remain in the hospital for the full 24-hour period following your final (5th) dose of the first treatment cycle so that the medical staff can closely monitor you for any side effects. You will likely only need to stay in the hospital for 4 hours following each dose for the subsequent treatment cycles.

To assist reduce the chance of experiencing some side effects, your doctor may likely prescribe you additional drugs about an hour before each dose. During your tagraxofusp-erzs treatment, be careful to let the doctor know how you are feeling. If you encounter particular side effects, your doctor might need to postpone or halt your treatment.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

Before receiving tagraxofusp-erzs,

• If you have an allergy to tagraxofusp-erzs, any other drugs, or any of the substances in tagraxofusp-erzs injection, notify your doctor right away. Request a list of the components from your pharmacist.
• Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
• If you are pregnant or plan to become pregnant, inform your doctor right away. Within seven days of beginning treatment, you must perform a pregnancy test. Pregnancy should not occur while you are receiving tagraxofusp-erzs therapy. During treatment and for seven days following your last dose, use an effective form of birth control. Call your doctor if you get pregnant while taking tagraxofusp-erzs.
• If you are breastfeeding, let your doctor know. While receiving tagraxofusp-erzs therapy and for seven days following the last dose, you shouldn’t breastfeed.

Keep eating normally unless your doctor instructs you otherwise.

Side effects from tagraxofusp-erzs could exist. If any of these symptoms are severe or do not go away, let your doctor know right once:

• Nausea
• Vomiting
• Constipation
• Diarrhea
• Extreme fatigue
• Headache
• Reduction in appetite
• Unwell throat
• Back, arm, or leg pain
• Cough
• Having trouble falling or staying asleep
• Feeling uncertain or uneasy
• Bloody nose
• Little skin patches that are red, brown, or purple

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you suffer any of these symptoms or any of those noted in the IMPORTANT WARNING section:

• Rash, itchiness, breathing issues, mouth sores, or swelling
• Excessive fatigue, yellowing of the skin or eyes, appetite loss, and upper right stomach pain
• Chills and fever
• Rapid heart rate
• Urinary blood

Other negative effects could be brought on by tagraxofusp-erzs. If you have any strange side effects while taking this medicine, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you have a serious side event.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.