Pronunciation:

brex-u-KAB-ta-jeen au-toe-LOO-sel

Brand Names:

• Tecartus

Dosage Forms:

• Suspension

Warnings:

Warning: Cytokine Release Syndrome and Neurologic ToxicitiesCytokine Release Syndrome (CRS), including life-threatening reactions, occurred in patients receiving brexucabtagene autoleucel. Do not administer brexucabtagene autoleucel to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.Neurologic toxicities, including life-threatening reactions, occurred in patients receiving brexucabtagene autoleucel, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with brexucabtagene autoleucel. Provide supportive care and/or corticosteroids, as needed.Brexucabtagene autoleucel is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta(TM) and Tectartus(TM) REMS Program .

Classifications:

Therapeutic—

Immunological Agent

Chemical—

CAR T-Cell Agent

Uses of This Medicine:

Brexucabtagene autoleucel injection is used to treat mantle cell lymphoma (MCL) and acute lymphoblastic leukemia (ALL) in patients who have received other cancer medicines but did not work well.

Brexucabtagene autoleucel is an antineoplastic (cancer) medicine that is made from your own white blood cells, which have been modified to recognize and attack your cancer cells. Before you begin treatment, talk to your doctor about the benefits of this medicine as well as the possible risks of receiving it.

This medicine is available only under a restricted distribution program called the Yescarta™ and Tecartus™ REMS (Risk Evaluation and Mitigation Strategy) Program.

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 have not been performed on the relationship of age to the effects of brexucabtagene autoleucel injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of brexucagtagene autoleucel injection in the elderly.

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

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 or
• Infections (including hepatitis B), active or history of or
• Lung or breathing problems or
• Seizures, history of or
• Stroke, history of—Use with caution. May cause side effects to become worse.

• Kidney disease or
• Liver disease—This medicine has not been studied in patients with these conditions.

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 using a pump. The medicine must be injected slowly, so your IV tube will need to stay in place for less than 30 minutes. It is given 3 days after completing treatment with other cancer medicines (eg, fludarabine, cyclophosphamide).

Your doctor will check you for unwanted effects at least daily for 7 days. Your doctor may also want you to stay close to the hospital or center for at least 4 weeks after your infusion.

It is very important that you understand the requirements of the Yescarta™ and Tecartus™ REMS program, and become familiar with the Tecartus™ medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.

You may be given other medicines (eg, allergy medicine, fever medicine) 1 hour before starting treatment with this medicine.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Tell your doctor right away if pregnancy occurs while you are using this medicine.

This medicine may cause cytokine release syndrome (CRS). This may be life-threatening and requires immediate attention. Tell your doctor right away if you have fever, chills, headache, nausea, lightheadedness, dizziness, fainting, skin rash, trouble breathing, or tiredness or weakness.

Check with your doctor right away if you have seizures, loss of balance, loss of consciousness, confusion, disorientation, difficulty with speaking, or slurred speech. These could be symptoms of a serious nerve problem.

This medicine may cause a severe inflammatory condition that could be life-threatening, including hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), which is caused by an overactive immune system. Check with your doctor right away if you have a fever, cough that does not go away, right upper abdominal or stomach pain and fullness, rash, redness in one part of your body, swollen, painful, or tender lymph glands in the neck, armpit, or groin, mental status changes, shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination, seizures, or warm feeling or swelling of your skin.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, dizziness, fainting, fast heartbeat, trouble breathing or swallowing, or chest tightness while you are using this medicine.

This medicine can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may increase your risks for hypogammaglobulinemia (immune system problem) and getting other cancers. Talk to your doctor if you have questions about these risks.

This medicine may cause dizziness, confusion, seizures, or decreased alertness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you, for at least 8 weeks after treatment.

While you are being treated with brexucabtagene autoleucel injection, do not have any immunizations (vaccinations) without your doctor's approval. Live virus vaccinations should not be given for at least 6 weeks before start of treatment, during treatment, and until recovery following the last cycle of this medicine.

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

Agitation

anxiety

back pain

bloody urine

blurred vision

chest pain or tightness

chills

coma

confusion as to time, place, or person

cough

decreased frequency in urinating

diarrhea

difficulty swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drooling

drowsiness

dry mouth

fast, pounding, or irregular heartbeat or pulse

fever

hallucinations

headache

heartburn

hoarseness

holding false beliefs that cannot be changed by fact

increased thirst

irritability

loss of appetite

lower back or side pain

mood or mental changes

muscle or bone pain

muscle spasm or twitching

nausea and vomiting

problems with speech or speaking

seizures

stiff neck

stomach pain

sweating

swelling of the face, fingers, feet, or lower legs

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins at the injection site

trouble breathing

unusual excitement, nervousness, or restlessness

unusual tiredness or weakness

weight gain

Less common

Blue lips and fingernails

difficult, fast, noisy breathing

pale skin

unsteadiness, trembling, or other problems with muscle control or coordination

Incidence not known

Dark urine

hives, itching, skin rash

light-colored stools

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

upper right stomach pain

yellow eyes and 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

Constipation

trouble sleeping

Less common

Darkening of the skin

dry skin

increased sweating

loss or thinning of the hair

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.