Tagraxofusp-erzs (Intravenous)

Tagraxofusp-erzs injection is used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN).

This medicine is to be given only by your doctor or under their direct supervision.

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine may cause a condition called capillary leak syndrome. It can cause fluid to leak from the blood vessels into your body's tissues. Call your doctor right away if you are urinating less often, or have swelling or puffiness, trouble breathing, feeling of fullness, dizziness, or feeling faint. You may also need to weigh yourself daily.

This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

In deciding to use a medicine, you and your doctor need to consider the risks of taking it compared to the benefits it may provide. For this medicine, keep the following points in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients closely.

Pediatric

Studies to date have not shown any pediatric-specific issues that would limit the use of tagraxofusp-erzs injection in children aged 2 years and older. Safety and effectiveness have been confirmed.

Geriatric

Studies to date have not revealed any geriatric-specific issues that would limit the use of tagraxofusp-erzs injection in older adults. However, older patients are more likely to experience unwanted effects (such as confusion, mental issues, dementia, encephalopathy), which may require caution when using this medicine.

Breast Feeding

There are no sufficient studies in women to assess the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the possible risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction could happen. In such cases, your doctor may adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical conditions, especially:

• Heart problems—Use with caution. May worsen side effects.

• Liver problems—Use with caution. May aggravate this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may require medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Black, tarry stools
• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Bloody or cloudy urine
• Blurred vision
• Chest tightness
• Chills
• Confusion
• Cough
• Decrease or increase in the amount of urine
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Fast, pounding, or irregular heartbeat or pulse
• Fever
• Headache
• Itching skin
• Lower back or side pain
• Nausea
• Nervousness
• Nosebleed
• Painful or difficult urination
• Pale skin
• Pounding in the ears
• Rapid weight gain
• Slow heartbeat
• Small red or purple spots on the skin
• Sore throat
• Stomach pain
• Sweating
• Tingling of the hands or feet
• Trouble breathing
• Ulcers, sores, or white spots in the mouth
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Unusual weight gain or loss

Less common

• Clay colored stools
• Dark urine
• Decreased appetite
• Loss of appetite
• Stomach tenderness
• Swelling of the feet or lower legs
• Vomiting
• Yellow eyes or skin

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also provide ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Anxiety
• Arm, back, or leg pain
• Constipation
• Diarrhea
• Mouth or throat pain
• Trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Elzonris

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. This medicine must be given slowly, so the needle will have to stay in place for at least 15 minutes once a day on Days 1 to 5 of a 21-day cycle.

Your doctor may also want you to stay for at least 4 hours to check for unwanted effects.

You may receive other medicines (eg, allergy medicine, fever medicine, steroid, stomach medicine) about 60 minutes before each infusion to prevent unwanted effects.

• What disease is Elzonris (tagraxofusp-erzs) used to treat?