NexCAR19

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Talicabtagene autoleucel (formerly Actalycabtagene autoleucel)

View information about NexCAR19 for your relapsed/refractory B-cell lymphoma or B-acute lymphoblastic leukaemia

About NexCAR19

How NexCAR19 works

Patient Support Details

Partner Hospitals

FAQs

How will I receive NexCAR19?

Since NexCAR19 is made from your own white blood cells, your blood will be collected by a process called “leukapheresis” (loo-kah-fur-ee-sis), which will concentrate your white blood cells.
Your blood cells will be sent to a manufacturing center to make your NexCAR19.
Before you get NexCAR19, you will get 3 days of chemotherapy to prepare your body.
When your NexCAR19 is ready, your healthcare provider will give it to you through a catheter placed into your vein (intravenous infusion). The infusion usually takes less than 30 minutes.
You will be monitored where you received your treatment daily for at least 7 days for patients with MCL and at least 14 days for patients with ALL after the infusion.
You should plan to stay close to the location where you received your treatment for at least 4 weeks after getting NexCAR19. Your healthcare provider will help you with any side effects that may occur.
You may be hospitalized for side effects. Your healthcare provider will discharge you if your side effects are under control and it is safe for you to leave the hospital.
Your healthcare provider will want to do blood tests to follow your progress. It is important that you do have your blood tested. If you miss an appointment, call your healthcare provider as soon as possible to reschedule.

What should I avoid after receiving NexCAR19?

Do not drive, operate heavy machinery, or do other dangerous things for 8 weeks after you get NexCAR19 because the treatment can cause sleepiness, confusion, weakness, and temporary memory and coordination problems.
Do not donate blood, organs, tissues, or cells for transplantation.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about NexCAR19?

NexCAR19 may cause side effects that are life-threatening and can lead to death.

Call or see your healthcare provider or get emergency help right away if you get any of the following:

Fever (100.4°F/38°C or higher)
Difficulty breathing
Chills or shaking chills
Confusion
Dizziness or lightheadedness
Severe nausea, vomiting, or diarrhea
Fast or irregular heartbeat
Severe fatigue or weakness

Cytokine Release Syndrome

Cytokine release syndrome (CRS) may occur when your immune system becomes highly active. It is the most common and expected side effect of NexCAR19, as well as other CAR-T therapies. Symptoms range from fever or low blood pressure to irregular or rapid heartbeat. CRS may be associated with liver, kidney, and heart dysfunction and bleeding disorders. If CRS events occur, they are usually seen within 10 days of infusion. Your treatment team will check your progress after infusion. Members of your team are trained to recognize the symptoms of CRS and have specific medicines to treat it.

Neurological Events

NexCAR19 may also have effects on the central nervous system, making you feel confused, agitated, dizzy, or disoriented. More severe symptoms might affect your speech or consciousness or cause seizures. Be sure to tell your treatment team right away if you experience any neurological symptoms.

HLH/Hemophagocytic lymphocytosis

Upon administration of NexCAR19, HLH may occur due to excessive activation of the immune system, this can present with fever and low blood counts. It is diagnosed based on certain specific blood tests. This is treated with supportive medicines to suppress inflammation by your treating oncologist.

Prolonged Low Blood Cell Counts (Cytopenia)

NexCAR19 may cause a condition called cytopenia. This is when you have low levels of 1 or more types of blood cells. Your treatment team will do blood tests to check all your blood cell counts after treatment with NexCAR19. Cytopenia that lasts a long time (prolonged) may increase your risk of infection. Cytopenia will be monitored, and your treatment team is prepared to manage it. Tell your doctor right away if you get a fever, are feeling tired, or have bruising or bleeding.

Other cautionary measures post-treatment with NexCAR19:

Do not drive, operate heavy machinery, or participate in any physically intensive activity for approximately 8 weeks after you get NexCAR19, as the treatment can affect short term motor coordination, inducing sleepiness, confusion, weakness, dizziness, and seizures.

Do not donate blood, organs, tissues, sperm, oocytes, and other cells without consulting your physician.

It is important to tell your healthcare provider that you received NexCAR19. Your healthcare provider may give you other medicines to treat your side effects.

Before getting NexCAR19, tell your healthcare provider about all your medical problems, including if you have or have had:

Neurologic problems (such as seizures, stroke, or memory loss)
Lung or breathing problems
Heart problems
Liver problems
Kidney problems
A recent or active infection

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

APPROVED USE

NexCAR19 is commercially approved in India for the treatment of B-lymphomas and B-Acute Lymphoblastic Leukaemia where one or more lines of treatment have failed or have been rendered inadequate or insufficient to render a response.