Axicabtagene ciloleucel

What is Axicabtagene ciloleucel?

• Axicabtagene ciloleucel (Yescarta) is a CD19-directed genetically modified autologous T cell immunotherapy used to treat certain types of large B-cell non-Hodgkin lymphoma that relapsed (came back) or did not get better after treatment with at least two other types of anticancer therapy.

What are the uses of this medicine?

Axicabtagene ciloleucel (Yescarta) used to treat two types of non-Hodgkin lymphoma:

• large B-cell lymphoma when your first treatment did not work or your cancer returned within a year of first treatment, OR when at least two kinds of treatment have failed to control your cancer.
• follicular lymphoma when at least two kinds of treatment have failed to control your cancer.
• Yescarta 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

Limitations of use:

• Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.

How does this medicine work?

• Yescarta, a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells.
• Axicabtagene ciloleucel binds to a protein called CD19, which is found on most B cell lymphoma cells.
• This helps the body’s immune system kill cancer cells.
• Axicabtagene ciloleucel is a type of CAR T-cell therapy.

Who Should Not Use this medicine ?

Limitations of use:

• Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Yescarta.

Is this medicine FDA approved?

• Axicabtagene ciloleucel was awarded U.S. Food and Drug Administration (FDA) breakthrough therapy designation on 18 October 2017, for diffuse large B-cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma.
• The FDA granted approval on 18 October 2017, for the second-line treatment of diffuse large B-cell lymphoma.
• On 1 April 2022, the FDA approved axicabtagene ciloleucel for adults with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within twelve months of first-line chemoimmunotherapy.
• It is not indicated for the treatment of patients with primary central nervous system lymphoma.

How should this medicine be used?

• Administer a lymphodepleting regimen of cyclophosphamide and fludarabine before infusion of Yescarta.
• Verify the patient's identity prior to infusion.
• Premedicate with acetaminophen and an H1-antihistamine.
• Confirm availability of tocilizumab prior to infusion.

Recommended dosage:

• Each single infusion bag of Yescarta contains a suspension of chimeric antigen receptor (CAR)-positive T cells in approximately 68 mL.
• The target dose is 2 × 106 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 108 CAR-positive viable T cells.

Administration:

• 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 the location where you received your treatment 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 are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a cell suspension for infusion.
• Yescarta comprises a suspension of 2 × 106 CAR-positive viable T cells per kg of body weight, with a maximum of 2 × 108 CAR-positive viable T cells in approximately 68 mL.

This medicine is available in fallowing brand namesː

• Yescarta

What side effects can this medication cause?

The most common side effects of this medicine include:

• Fever (100.4°F/38°C or higher)
• Low white blood cells (can occur with a fever)
• Low red blood cells
• Low blood pressure (dizziness or lightheadedness, headache, feeling tired, short of breath)
• Fast heartbeat
• Confusion
• Difficulty speaking or slurred speech
• Nausea
• Diarrhea

Yescarta may cause side effects that are life-threatening and can lead to death as fallows:

• 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

What special precautions should I follow?

• CRS, including fatal or life-threatening reactions, occurred following treatment with Yescarta. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.
• Neurologic toxicities (including ICANS) that were fatal or life-threatening occurred following treatment with Yescarta. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of neurologic toxicities. Monitor patients for signs or symptoms of neurologic toxicities for 4 weeks after infusion and treat promptly.
• 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 Program.
• Allergic reactions may occur with the infusion of Yescarta. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) or residual gentamicin in Yescarta. Monitor for hypersensitivity reactions during infusion.
• Severe or life-threatening infections occurred in patients after Yescarta infusion. Monitor patients for signs and symptoms of infection; treat appropriately.
• Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Yescarta infusion. Monitor complete blood counts.
• B-cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with Yescarta. Monitor and provide replacement therapy.
• Patients treated with Yescarta may develop secondary malignancies. In the event that a secondary malignancy occurs after treatment with Yescarta, contact Kite at 1-844-454-KITE (5483).
• Due to the potential for neurologic events, including altered mental status or seizures, patients receiving Yescarta are at risk for altered or decreased consciousness or coordination in the 8 weeks following Yescarta infusion.
• 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.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data with Yescarta use in pregnant women.
• It is not known if Yescarta has the potential to be transferred to the fetus.
• Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia.
• Therefore, Yescarta is not recommended for women who are pregnant.

Can this medicine be used in children?

• The safety and efficacy of Yescarta have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredients: axicabtagene ciloleucel.
• Inactive ingredients: albumin (human); DMSO.

Who manufactures and distributes this medicine?

Manufactured by, Packed by, Distributed by:

• Kite Pharma, Inc.
• Santa Monica, CA
• Yescarta is a trademark of Kite Pharma, Inc.

What should I know about storage and disposal of this medication?

• Store Yescarta frozen in the vapor phase of liquid nitrogen (less than or equal to minus 150°C).
• Thaw before using.

• Dailymed label info on Axicabtagene ciloleucel
• FDA Axicabtagene ciloleucel

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