Consumer medicine information

1. Why am I given YESCARTA?

YESCARTA also known as axicabtagene ciloleucel is a type of medicine called a “genetically modified cell therapy”. YESCARTA is used to treat adults with aggressive large B-cell lymphoma (LBCL) and follicular lymphoma (FL) affecting your lymph tissue (part of the immune system) that affects a type of white blood cell called B lymphocytes and other organs in your body. Too many of these abnormal white blood cells accumulate in your tissue and this is the cause of the symptoms you may have.
For more information, see Section 1. Why am I given YESCARTA? in the full CMI.

2. What should I know before I am given YESCARTA?

Do not use if you have ever had an allergic reaction to axicabtagene ciloleucel or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I am given YESCARTA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with YESCARTA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How am I given YESCARTA?

• YESCARTA is made specially for you as a single administration of your own modified white blood cells.

• Your doctor will give you YESCARTA by a drip (infusion) into a vein (intravenously).

5. What should I know after I am given YESCARTA?

6. Are there any side effects?

There can be some serious side effects before and after YESCARTA treatment. Serious side effects may include symptoms of cytokine release syndrome (CRS), disturbances of brain function or infection.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Boxed Warnings

Cytokine release syndrome. Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving Yescarta. Do not administer Yescarta to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Immune effector cell-associated neurotoxicity syndrome. Immune effector cell-associated neurotoxicity syndrome (ICANS), which may be fatal or life-threatening, has occurred following treatment with Yescarta, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with Yescarta. Provide supportive care and/or corticosteroids as needed.

1 Name of Medicine

Yescarta (axicabtagene ciloleucel), 1 x 10⁶ - 2.4 x 10⁶ anti-CD19 CAR T cells/kg suspension for infusion.

2 Qualitative and Quantitative Composition

General description. Yescarta (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy. To prepare Yescarta, patient's own T cells are harvested and genetically modified ex vivo by retroviral transduction to express a chimeric antigen receptor (CAR) comprising a murine anti-CD19 single chain variable fragment (scFv) linked to CD28 and CD3 zeta co-stimulatory domains. The anti-CD19 CAR-positive viable T cells are expanded and infused back into the patient, where they can recognise and eliminate CD19 expressing target cells.
Yescarta is prepared from the patient's peripheral blood mononuclear cells, which are obtained via a standard leukapheresis procedure. The mononuclear cells are enriched for T cells and activated with anti-CD3 antibody in the presence of IL-2, then transduced with the replication incompetent retroviral vector containing the anti-CD19 CAR transgene. The transduced T cells are expanded in cell culture, washed, formulated into a suspension, and cryopreserved. The product must pass a sterility test before release for shipping as a frozen suspension in a patient-specific infusion bag. The product is thawed prior to infusion.
In addition to T cells, Yescarta may contain NK and NK-T cells. The formulation contains 5% dimethylsulfoxide (DMSO) and 2.5% albumin (human).
Qualitative and quantitative composition. Each patient-specific single infusion bag of Yescarta contains a suspension of anti-CD19 CAR-positive viable T cells in approximately 68 mL for a target dose of 2 x 10⁶ anti-CD19 CAR T cells/kg body weight (range: 1 x 10⁶ - 2.4 x 10⁶ cells/kg), with a maximum of 2 x 10⁸ anti-CD19 CAR T cells.
Excipients with known effect. Each bag of Yescarta contains 300 mg sodium.
For the full list of excipients, see Section 6.1.

3 Pharmaceutical Form

Suspension for infusion.
A clear to opaque, white to red dispersion.

4 Clinical Particulars

4.9 Overdose

There have been no instances of overdose from Yescarta.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Conventional genotoxicity assays have not been performed with axicabtagene ciloleucel and are not appropriate for cell therapy products. Experience in clinical studies suggest a low risk of insertional mutagenesis following T cell transduction with γ-retroviral CAR constructs compared to transduction of haematopoietic stem cells (HSC) and T cells with γ-retroviral vectors.
Carcinogenicity. Standard rodent carcinogenicity studies have not been performed with axicabtagene ciloleucel and are not appropriate for cell therapy products. A review of published clinical studies employing γ-retroviral vector transduced T cells did not reveal any cases of secondary malignancies.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Axicabtagene ciloleucel is an engineered autologous T cell immunotherapy by which a patient's own T cells are harvested and engineered ex vivo by retroviral transduction of a chimeric antigen receptor (CAR) construct encoding an anti-CD19 CAR. Therefore, a defined structure is not available for axicabtagene ciloleucel.
CAS number. No data available.

7 Medicine Schedule (Poisons Standard)

Class 4 Biological.

Summary Table of Changes

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