Obecabtagene Autoleucel (Intravenous)
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 removed from blood that is drawn from your body through a vein.
Obecabtagene autoleucel may also be used for purposes not listed in this medication guide.
warnings
What is the most important information I should know about Obecabtagene Autoleucel (Intravenous)?
You should not be treated with obecabtagene autoleucel if you have an active infection (such as fever, chills, 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 this medicine.
Side Effects
What are the side effects of Obecabtagene Autoleucel (Intravenous)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
A common but serious side effect of this medicine is called cytokine release syndrome (CRS). Tell your medical caregivers if you have signs of cytokine release syndrome (CRS), 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.
Call your doctor at once 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 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 FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Obecabtagene Autoleucel (Intravenous) if I’m pregnant or breastfeeding?
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 this medicine.
Interactions
What drugs and food should I avoid while taking Obecabtagene Autoleucel (Intravenous)?
This medicine can cause weakness, drowsiness, confusion, problems with memory or coordination, and make you sleepy. Avoid driving or hazardous activity for at least 8 weeks after you are treated with obecabtagene autoleucel.
Ask your doctor before you receive a "live" vaccine. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Do not donate blood, organs, tissues, or cells for transplantation.
Dosage Guidelines & Tips
How to take Obecabtagene Autoleucel (Intravenous)?
Use Obecabtagene Autoleucel (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Obecabtagene autoleucel is available only at an authorized hospital or clinic, 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 reaction.
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.
Call your doctor for instructions if you miss an appointment for your obecabtagene autoleucel injection.
Overdose Signs
What happens if I overdose on Obecabtagene Autoleucel (Intravenous)?
In a medical setting an overdose would be treated quickly.