Pronunciation: yes-kar-ta
Generic name: axicabtagene ciloleucel
Dosage form: suspension for intravenous infusion
Drug class: Miscellaneous antineoplastics

Medically reviewed by Carmen Pope, BPharm. Last updated on Jan 4, 2024.

What is Yescarta?

Yescarta (axicabtagene ciloleucel) is an individualized immunotherapy medicine that is given by intravenous infusion and may be used to treat adults with:

• Large B-cell lymphoma that has not responded to first-line chemoimmunotherapy or that returns within 12 months of the first treatment
• Relapsed or refractory large B-cell lymphoma when at least two kinds of treatment have failed to control the cancer.

Yescarta is also used to treat follicular lymphoma when at least two kinds of treatment have failed to control the cancer. Approval for this indication was given under the accelerated approval scheme and continued approval may be based on clinical trial results.

Not indicated for patients with primary central nervous system lymphoma.

Yescarta contains your own T-cells which have been modified in a laboratory. T-cells are a type of white blood cell that are important for your immune response and these are collected by passing your blood through a machine. These separated T-cells are then sent to a laboratory where a special receptor, called a CAR (chimeric antigen receptor) is added to them. CAR improves the ability of your T-cells to latch onto CD19-expressing cancer cells and destroy them. Yescarta is called CD19-directed genetically modified autologous T-cell immunotherapy.

The ZUMA-7 study reported a statistically significant improvement in overall survival (OS) for Yescarta compared with standard treatment (SOC) when Yescarta is used to treat relapsed or refractory large B-cell lymphoma within 12 months of completion of first-line treatment. The estimated 39-month OS rates were 55.9% in the Yescarta arm and 46% in the SOC arm.

Yescarta was FDA-approved on October 18, 2017.

Warnings

A serious side effect of Yescarta is called cytokine release syndrome, which causes fever, chills, trouble breathing, vomiting, and other symptoms. Your caregivers will have medication available to quickly treat this condition if it occurs.

Yescarta can also cause life-threatening nerve problems. Tell your caregivers or seek emergency medical attention if you have problems with speech, problems with thinking or memory, confusion, or a seizure.

Yescarta may increase the risk of infections, decrease serum albumin or immunoglobulin levels, and increase the risk of secondary cancers. It can affect a person's ability to drive or operate machinery.

Yescarta is only available through a special program called the Yescarta and Tecartus REMS (Risk Evaluation and Mitigation Strategy) program. Your healthcare provider will talk to you about this and ensure you understand the risks and benefits of this medicine.

Before taking this medicine

To make sure Yescarta is safe for you, tell your doctor if you have ever had:

• a recent or active infection
• a stroke or memory problems
• a seizure
• lung or breathing problems
• liver or kidney disease
• heart problems.

Also, tell your doctor if you:

• have received a vaccine in the past 2 weeks. Vaccination with live virus vaccines is not recommended for at least 6 weeks before the start of lymphodepleting chemotherapy, during treatment, and until your immune system recovers following treatment with Yescarta
• are pregnant or intend to become pregnant
• are breastfeeding.

Pregnancy

If you are a woman of childbearing potential your healthcare provider may conduct pregnancy testing before receiving this medicine. You may also need to use birth control to prevent pregnancy during and shortly after treatment with Yescarta and chemotherapy.

If you receive Yescarta during pregnancy, your baby's blood may need to be tested after it is born. This is to evaluate any effects the medicine may have had on the baby.

Breastfeeding

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.

How is Yescarta administered?

Yescarta is available only at an authorized hospital or clinic and must be given by specially trained healthcare professionals.

• Yescarta is given after a procedure called leukapheresis (LOO-kuh-fuh-REE-sis) and takes around 3 to 4 hours.
• 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 Yescarta. Because it will take time to process your blood cells into axicabtagene ciloleucel, you will not receive the medicine on the same day your blood cells are drawn.
• About 3 to 5 days before Yescarta is given, you will be pre-treated with chemotherapy to help prepare your body for administration of this medicine.
• Just before you receive this medicine, you will be given other medications to help prevent serious side effects or allergic reactions, such as acetaminophen and diphenhydramine.
• Once your body is ready to receive Yescarta, your care providers will inject the medicine into a vein through an IV.
• You will be watched closely for at least 7 days after you receive Yescarta, to make sure you do not have an allergic reaction or serious side effects.
• You will need frequent blood tests to be sure this medicine has not caused harmful effects.
• For at least 4 weeks, plan to stay near the hospital or clinic where you received Yescarta. Avoid being so far away that it takes you longer than 2 hours to travel back to the hospital.

What happens if I miss a dose?

Call your doctor for instructions if you miss any of your chemotherapy treatment, or if you miss a dose of your medications to prevent the side effects of Yescarta

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving Yescarta?

This medicine can cause weakness, drowsiness, confusion, problems with memory or coordination, and seizures. Avoid driving or operating machinery for at least 8 weeks after you are treated with Yescarta.

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, an organ, or any tissues or cells from your own body.

What are the side effects of Yescarta?

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

A serious side effect of Yescarta is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition such as fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed, or feeling very weak or tired. Your caregivers will have medication available to quickly treat CRS if it occurs.

Also, tell your caregivers or seek emergency medical attention if you have signs of life-threatening nerve problems: problems with speech, problems with thinking or memory, confusion, or a seizure.

Call your doctor at once if you have:

• headaches, dizziness
• tremors, anxiety, trouble sleeping
• unusual thoughts or behaviors
• trouble speaking or understanding what is said to you.

The most common side effects of Yescarta affecting 30% or more people include:

• Laboratory abnormalities – symptoms may include fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath
• CRS
• Fever
• Low blood pressure
• Brain dysfunction (encephalopathy) – symptoms may include memory loss or confusion
• Fatigue
• Fast heartbeat
• Headache
• Nausea
• Diarrhea
• Muscle pain
• Infections
• Chills
• Decreased appetite.

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.

What other drugs will affect Yescarta?

Tell your doctor about all your current medicines and any medicine you start or stop using. Other drugs may interact with Yescarta, including prescription and over-the-counter medicines, vitamins, and herbal products.

• Systemic corticosteroids may interfere with the activity of this drug.

See the prescribing information for a complete list of interactions.

Storage

Each Yescarta infusion bag is individually packed in a metal cassette (NDC 71287-119-02) stored in the vapor phase of liquid nitrogen and supplied in a liquid nitrogen dry shipper.

• Match the identity of the patient with the patient identifiers on the cassette and infusion bag upon receipt.
• Store Yescarta frozen in the vapor phase of liquid nitrogen (less than or equal to minus 150 ºC).
• Thaw before using.

Ingredients

Active: axicabtagene ciloleucel.

Inactive: albumin (human), DMSO (dimethylsulfoxide).

Yescarta is supplied in an infusion bag (NDC 71287-119-01) containing approximately 68 mL of frozen suspension of genetically modified autologous T cells in 5% DMSO and 2.5% albumin (human). A single dose of Yescarta contains 2 × 106 CAR-positive viable T cells per kg of body weight (or a maximum of 2 × 108 CAR-positive viable T cells for patients 100 kg and above)

Manufacturer

Kite Pharma, Inc.

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