Obecabtagene autoleucel

Obecabtagene autoleucel is used in adults to treat acute lymphoblastic leukemia. Obecabtagene autoleucel is given after other treatments did not work or stopped working.

Obecabtagene autoleucel is made using cells taken from blood drawn from your body through a vein.

Obecabtagene autoleucel may also be used for purposes not listed in this medication guide.

Obecabtagene autoleucel is only available at authorized hospitals or clinics and must be given by specially trained healthcare professionals.

Obecabtagene autoleucel is given after a procedure called leukapheresis.

During leukapheresis, some of your blood is collected through a small tube (catheter) placed into a vein. The catheter is connected to a machine that separates your white blood cells from other parts of the blood.

The cells are then sent to a laboratory where they are made into obecabtagene autoleucel. Because it will take time to process your blood cells into obecabtagene autoleucel, you will not receive obecabtagene autoleucel on the same day your blood cells are drawn.

Before this medicine is given, you will be pretreated with chemotherapy to help prepare your body for obecabtagene autoleucel.

About 30 minutes before you receive obecabtagene autoleucel, you will be given other medications to help prevent serious side effects or allergic reactions.

Once your body is ready to receive obecabtagene autoleucel, your care providers will inject the medicine as an infusion into a vein.

Your doctor will need to check your progress on a daily basis for at least 4 weeks after the infusion.

For at least 4 weeks, plan to stay near the hospital or clinic where you received obecabtagene autoleucel.

Obecabtagene autoleucel affects your immune system. You may get infections more easily, even serious or fatal infections.

If you've ever had hepatitis B, using obecabtagene autoleucel can cause this virus to become active or get worse. You may need frequent liver function tests.

Obecabtagene autoleucel can have long-lasting effects on your body. You may need frequent medical tests while using this medicine and for a short time after your last dose.

Obecabtagene autoleucel can cause a serious side effect known as cytokine release syndrome. This can lead to fever, chills, trouble breathing, vomiting, confusion, tremors, and heart problems.

Obecabtagene autoleucel may increase your risk of developing other cancers.

Obecabtagene autoleucel may cause severe or life-threatening nervous system reactions. These can include headache, restlessness, confusion, anxiety, sleep problems, shaking, loss of consciousness, agitation, seizures, pain or numbness, loss of balance, and trouble speaking or understanding what is said to you.

You should not receive obecabtagene autoleucel if you have an active infection (such as fever, chills, or flu-like symptoms) or an inflammatory disorder.

Tell your doctor if you have or have ever had:

• an active or chronic infection;
• a stroke;
• a seizure;
• memory problems;
• breathing problems;
• hepatitis B or C;
• HIV;
• heart problems;
• if you have received a vaccine within the past 6 weeks;
• kidney disease; or
• liver disease.

Using obecabtagene autoleucel may increase your risk of developing other cancers. Ask your doctor about this risk.

You will need to take a pregnancy test before, during, and after treatment with obecabtagene autoleucel.

Obecabtagene autoleucel may harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using obecabtagene autoleucel.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

A common but serious side effect of obecabtagene autoleucel is called cytokine release syndrome (CRS). Tell your medical caregivers if you have signs of cytokine release syndrome (CRS), which is a serious side effect: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed or very tired. Your caregivers will have medication available to quickly treat CRS if it occurs.

Obecabtagene autoleucel may cause serious side effects. Call your doctor right away if you have:

• fever, chills, sore throat;
• mouth sores, red or swollen gums;
• pale skin, easy bruising, unusual bleeding;
• chest discomfort, wheezing, dry cough or hack, rapid weight loss;
• hemolytic anemia;
• severe drowsiness;
• pain or numbness;
• trouble speaking or writing;
• trouble with daily activities;
• tremors or shaking, seizure;
• severe ongoing nausea, vomiting, or diarrhea;
• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• kidney problems--swelling, urinating less, feeling tired or short of breath.

You may need to be treated in a hospital if you have certain side effects.

Common side effects of obecabtagene autoleucel may include:

• trouble speaking, slurred speech;
• nausea, fatigue, feeling short of breath, feeling tired;
• fast or irregular heartbeats;
• diarrhea, fever, infections;
• muscle or joint pain;
• confusion, dizziness, headache;
• low white blood cell (WBC) counts;
• bleeding problems; or
• low blood pressure (feeling like you might pass out).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Acute Lymphoblastic Leukemia:

The total recommended dose is 410 x 10(6) CD19 chimeric antigen receptor-positive viable T cells intravenously, supplied in 3 to 5 infusion bags. Comments:-The manufacturer product information should be consulted.-The treatment regimen consists of a split dose infusion to be administered on Day 1 and Day 10. -The dosing regimen is determined by the tumor burden assessed by bone marrow blast percentage from a sample that's been obtained 7 days prior to the start of lymphodepletion. -The volume to be infused is variable and is calculated based on the concentration of CD19 CAR-positive viable T cells. -Reference the Release for Infusion certificate and Dose Schedule Planner for actual cell counts, volumes to be infused, and appropriate dosing regimen. Use: For the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Call your doctor for instructions if you miss an appointment for your Obecabtagene autoleucel injection.

In a medical setting, an overdose would be treated quickly.

obecabtagene autoleucel can cause weakness, drowsiness, confusion, problems with memory or coordination, and can make you sleepy. Avoid driving or doing dangerous activities for at least 8 weeks after your treatment with obecabtagene autoleucel.

Ask your doctor before receiving a "live" vaccine. Live vaccines may include measles, mumps, rubella (MMR), varicella (chickenpox), nasal flu vaccine, and others.

Do not donate blood, organs, tissues, or cells for transplantation.

Other drugs may affect obecabtagene autoleucel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.