Yescarta
Pronunciation: yes-kar-ta
Generic name: axicabtagene ciloleucel
Dosage form: suspension for intravenous infusion
Drug class: Miscellaneous antineoplastics
What is Yescarta?
Yescarta is used to treat large B-cell lymphoma and follicular lymphoma, two types of non-Hodgkin lymphoma. It is given as an intravenous infusion over 30 minutes.
Yescarta (axicabtagene ciloleucel) is different than other cancer medicines because it is made from your own white blood cells, which have been modified to recognize and attack your lymphoma cells. It is called a CD19-directed genetically modified autologous T-cell immunotherapy (CAR T-cell therapy).
- The complete process takes several weeks and involves collecting your white blood cells, sending them to a specialized center where they are modified, and then infusing them back into your body.
- You will need to stay close to a certified healthcare facility for at least 4 weeks after the infusion.
FDA approvals and indications
Yescarta is approved to treat adults with:
- Large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or has relapsed within 12 months of first-line chemoimmunotherapy
- Relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma
- Relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy.
- This indication is under the accelerated approval designation where continued approval for this indication may be contingent upon a clinical benefit being shown in further clinical trials.
This therapy is not for use in patients with primary central nervous system lymphoma.
Yescarta gained FDA approval on October 18, 2017. There is no generic.
How does Yescarta work?
Yescarta's mechanism involves collecting T-cells and then enhancing them with a receptor called a CAR (chimeric antigen receptor). This improves the ability of your T-cells to latch onto CD19-expressing cancer cells, destroying them, and strengthening your immune response against certain cancers.
Side effects
The most common side effects of Yescarta are:
- Cytokine release syndrome
- Fever (100.4°F/38°C or higher)
- Low white and red blood cells and platelets
- Low blood pressure (dizziness or lightheadedness, headache, feeling tired, short of breath)
- Fast heartbeat
- Confusion
- Difficulty speaking or slurred speech
- Nausea
- Diarrhea
- Musculoskeletal pain
- Infections
- Decreased appetite
- Tiredness/fatigue
- Headache
- Chills
- Low phosphate levels.
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Serious side effects and warnings
Yescarta may cause the following serious side effects:
- Hypersensitivity (allergic) reactions, including anaphylaxis, may occur during a Yescarta infusion. These may be due to dimethyl sulfoxide (DMSO) or the residual gentamicin in the infusion
- An increased risk of getting cancer, including certain types of blood cancers. Your healthcare provider should monitor you for this
- Serious infections can occur after a Yescarta infusion.
- Cytokine release syndrome (CRS), a potentially life-threatening condition where the immune system overreacts and releases excessive amounts of cytokines, leading to widespread inflammation and organ dysfunction. Symptoms may include fever, low blood pressure, trouble breathing, or vomiting. Your caregivers will have medication available to quickly treat this condition
- Life-threatening nerve problems. including encephalopathy (a disturbance in your brain function), headache, tremor, dizziness, speech difficulties, delirium, and insomnia
- Prolonged cytopenias (low blood cell levels), such as neutropenia, thrombocytopenia, and anemia may persist for several weeks following a Yescarta infusion
- Low levels of immunoglobulins in your blood (hypogammaglobulinemia) and B-cell aplasia can occur in Yescarta-treated patients. Your healthcare provider will monitor your immunoglobulin levels
- Effects on your ability to drive and operate machinery. Patients receiving Yescarta are at risk for altered or decreased consciousness or coordination in the 8 weeks following the infusion.
Some of these side effects 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.
It is important to tell your healthcare provider that you have received Yescarta and to show them your Yescarta Patient Wallet Card. Your healthcare provider may give you other medicines to treat your side effects.
These are not all the possible side effects of Yescarta. Call your healthcare provider about any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.
Yescarta REMS
Because of the risk of CRS and neurologic toxicities, Yescarta is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS. This requires Healthcare facilities that dispense and administer Yescarta to:
- Be enrolled and comply with the REMS requirements
- Have on-site, immediate access to tocilizumab, and ensure that a minimum of 2 doses of tocilizumab are available for each patient for infusion within 2 hours after Yescarta infusion, if needed for treatment of CRS.
Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).
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 will I receive Yescarta?
Since Yescarta 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 Yescarta.
- Before you get Yescarta, you will get 3 days of chemotherapy to prepare your body.
- When your Yescarta 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 after the infusion.
- You should plan to stay close to a certified healthcare facility for at least 4 weeks after getting Yescarta. Your healthcare provider will help you with any side effects that may occur.
- You may be hospitalized for side effects and 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 Yescarta?
Do not drive, operate heavy machinery, or do other dangerous things for 8 weeks after you get Yescarta because the treatment can cause sleepiness, confusion, weakness, and temporary memory and coordination problems.
Do not donate blood, organs, tissues, or cells for transplantation.
Do not 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 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.
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
Yescarta is made by Kite Pharma, a subsidiary of Gilead Sciences. Kite Pharma's headquarters is in Santa Monica, California, USA.
Popular FAQ
What is the cost of Yescarta?
The cost of Yescarta is about $424,000 per treatment regimen, but most people do not pay this amount. Your insurance or the manufacturer may cover many of the costs for this treatment. Each dose of Yescarta is a customized treatment created using a patient’s own immune system to help fight lymphoma (a type of blood cancer). Continue reading
What's the difference between Kymriah and Yescarta?
Kymriah and Yescarta are two cell-based gene therapies. A few differences between the two medications include who and what they are FDA approved for, their dosage, and which companies make them. Continue reading
How is Yescarta administered?
Yescarta (axicabtagene ciloleucel) is given through a catheter placed into your vein (intravenous infusion). The infusion usually takes less than 30 minutes and is given as a one-time infusion. Yescarta is administered only in a certified healthcare facility. Continue reading
What type of drug is Yescarta (axicabtagene ciloleucel)?
Yescarta (axicabtagene ciloleucel) is a CD19-directed chimeric antigen receptor T cell (CAR T) therapy used for adults with relapsed or refractory (r/r) large B-cell lymphoma and r/r follicular lymphoma (FL). In CAR T, a patient's T cells (type of white blood cell) are separated out and engineered to express a chimeric antigen receptor (CAR) to target the tumor antigen CD19. Continue reading
References
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- Drug class: miscellaneous antineoplastics
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.