Pronunciation:

oh-be-KAB-ta-jeen aw-toe-LOO-sel

Dosage Forms:

• Suspension

Warnings:

Warning: Cytokine Release Syndrome, Neurologic Toxicities and Secondary Hematological malignanciesCytokine Release Syndrome (CRS), occurred in patients receiving obecabtagene autoleucel. Do not administer obecabtagene autoleucel to patients with active infection or inflammatory disorders. Prior to administering obecabtagene autoleucel, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS.Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including fatal or life-threatening reactions, occurred in patients receiving obecabtagene autoleucel, including concurrently with CRS or after CRS resolution. Monitor for neurologic signs and symptoms after treatment with obecabtagene autoleucel. Prior to administering obecabtagene autoleucel, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage neurologic toxicities. Provide supportive care and/or corticosteroids, as needed.T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies .

Classifications:

Therapeutic—

Immunological Agent

Chemical—

CAR T-Cell Agent

Uses of This Medicine:

Obecabtagene autoleucel injection is used to treat patients with acute lymphoblastic leukemia (ALL) that has come back or who have received other cancer medicines that did not work well.

Obecabtagene autoleucel injection 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 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 have not been performed on the relationship of age to the effects of obecabtagene 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 obecabtagene 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

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 Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Cholera Vaccine
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Rotavirus 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, 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 hospital or cancer center. It is given through an IV catheter that is placed into one of your veins. This medicine must be given slowly, so your IV will need to stay in place for at least 60 minutes. It is given 2 or 4 days after completing treatment with other cancer medicines (eg, fludarabine, cyclophosphamide).

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Your doctor will check you for unwanted effects daily for at least 14 days. Your doctor will also want you to stay close to the hospital or center for at least 4 weeks after your first infusion.

You may be given other medicines (eg, fever medicine) 30 minutes 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 get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Tell your doctor right away if pregnancy occurs while you are using this medicine.

This medicine may cause cytokine release syndrome (CRS), which may be life-threatening and require 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.

This medicine may cause serious nerve problems, which may be life-threatening and require immediate attention, including immune effector cell-associated neurotoxicity syndrome (ICANS). Check with your doctor right away if you have seizures, loss of balance, loss of consciousness, confusion, disorientation, difficulty with speaking, or slurred speech.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

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

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.

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. These may be symptoms of serious allergic reactions, including anaphylaxis, which may be life-threatening and require immediate medical attention.

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 obecabtagene 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

being forgetful

black, tarry stools

bleeding gums

blue lips, fingernails, or skin

blurred vision

changes in patterns and rhythms of speech

chest pain

chills

coma

confusion

cough or hoarseness

coughing up blood

decrease amount of urine

defects in intelligence, short-term memory, learning ability, and attention

diarrhea

dizziness

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

drowsiness

excitement

fast, pounding, or irregular heartbeat or pulse

fever

hallucinations

headache

increased blood pressure

increased menstrual flow or vaginal bleeding

increased thirst

irritability

loss of taste or smell

lower back or side pain

mood or mental changes

muscle or body aches

nausea or vomiting

nervousness

nosebleeds

painful or difficult urination

pale skin

paralysis

problems with speech or speaking

prolonged bleeding from cuts

red or dark brown urine

restlessness

seizures

shakiness in the legs, arms, hands, or feet

slurred speech

sore throat

stiff neck

stuffy or runny nose

sweating

swelling

swelling of the face, fingers, or lower legs

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

trembling or shaking of the hands

trouble breathing

trouble in speaking

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness

unusual tiredness or weakness

weight gain

Less common

Chest discomfort or tightness

darkening of the skin

dilated neck veins

disturbed color perception

double vision

flushing

halos around lights

loss of appetite

mental depression

night blindness

overbright appearance of lights

seizures

skin rash

stomach pain and bloating

tunnel vision

Incidence not known

Hives, itching

pinpoint red spots on the skin

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

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

muscle or bone pain

swelling or inflammation of the mouth

weight decreased

Less common

Sores or ulcers on the skin

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.