Consumer medicine information

1. Why am I using Kymriah?

Kymriah, also known as tisagenlecleucel, is made from some of your own white blood cells called T-cells. A new gene is put into the T-cells so that they can target the cancer cells in your body. Kymriah is used to treat B-cell precursor acute lymphoblastic leukaemia (B-cell ALL) in children and young adults up to 25 years, that is refractory in relapse post-transplant, or in second or later relapse. It is also used to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
For more information, see Section 1. Why am I given Kymriah? in the full CMI.

2. What should I know before I use Kymriah?

Do not use if you have ever had an allergic reaction to tisagenlecleucel 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 Kymriah? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Kymriah 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 Kymriah?

• Your doctor will give you Kymriah by infusion which means it will be given as a drip through a tube in your vein. This usually takes less than 1 hour.

5. What should I know after receiving Kymriah?

6. Are there any side effects?

There can be some serious side effects before and after Kymriah treatment.
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 Kymriah. Do not administer Kymriah to patients with active infection or inflammatory disorders. Implement CRS management to treat severe or life threatening CRS with tocilizumab as per current guidelines, see Section 4.4 Special Warnings and Precautions for Use.
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 Kymriah, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with Kymriah. Provide supportive care and/or corticosteroids as needed.

1 Name of Medicine

T Cells - Tisagenlecleucel, cryopreserved - T - Kymriah.

2 Qualitative and Quantitative Composition

Tisagenlecleucel: Autologous T cells genetically modified ex vivo using a lentiviral vector encoding an anti-CD19 chimeric antigen receptor (CAR).
1 or more infusion bags containing a total of 1.2 x 10⁶ to 6.0 x 10⁸ CAR-positive viable T cells in 10 to 50 mL. The quantitative information regarding total cells in the product is presented in the Certificate of Analysis.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cell suspension.
Appearance: colourless to slightly yellow suspension of cells.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Conventional genotoxicity assays have not been performed with tisagenlecleucel, and are not appropriate for cell therapy products. A genomic insertion site analysis of the lentiviral vector was performed on Kymriah products from 14 individual donors (12 patients and 2 healthy volunteers). There was no evidence for preferential integration near genes of concern or preferential outgrowth of cells harbouring integration sites of concern. However, a risk for insertional mutagenesis in mature T cells leading to oncogenic transformation cannot be excluded.
Carcinogenicity. Standard rodent carcinogenicity studies have not been performed with tisagenlecleucel. In vitro expansion studies with CAR-positive T-cells (Kymriah) from healthy donors and patients (Kymriah) showed no evidence for transformation and/or immortalization of T-cells. In vivo studies in immunocompromised mice did not show signs of abnormal cell growth or signs of clonal cell expansion for up to 7 months after cell injection.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The CAR-19 protein is comprised of a murine single chain antibody fragment, a CD8 hinge and transmembrane region, a 4-1BB (CD137) and CD3-zeta signalling domain.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSTISAGE.gif CAS number. Not established.

7 Medicine Schedule (Poisons Standard)

Not determined.

Summary Table of Changes

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