Pronunciation:

tag-RAX-oh-fusp - erzs

Brand Names:

• Elzonris

Dosage Forms:

• Solution

Warnings:

Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving tagraxofusp-erzs. Monitor for signs and symptoms of CLS and take actions as recommended

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

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

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tagraxofusp-erzs injection in children 2 years of age and older. Safety and efficacy have been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tagraxofusp-erzs injection in the elderly. However, elderly patients are more likely to have unwanted effects (eg, confusion, mental problems, dementia, encephalopathy), which may require caution in patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart problems—Use with caution. May cause side effects to become worse.

• Liver problems—Use with caution. May make this condition worse.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

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

Check with your doctor or nurse immediately 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 occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or 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.