Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
tisagenlecleucel
Novartis Pharmaceuticals Australia Pty Ltd
Class 4
Included
Kymriah* 1 KYMRIAH* CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 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. More instructions can be found in Section 4. How you will be given Kymriah? in the full CMI. 5. WHAT SHOULD I KNOW AFTER RECEIVING KYMRIAH? THINGS YOU SHOULD DO • Plan to stay within proximity (2 hours travel) from where you were treated for at least 4 weeks after you have been giv Soma hati kamili
1 AUSTRALIAN PI – KYMRIAH ® (TISAGENLECLEUCEL) SUSPENSION WARNING: 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. Treat severe or life threatening CRS with tocilizumab as per the CRS management algorithm. 1 NAME OF THE 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 10 6 to 6.0 x 10 8 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 4.1 T HERAPEUTIC INDICATIONS Kymriah is a genetically modified autologous immunocellular therapy indicated for: • the treatment of paediatric and young adult patients up to 25 years of age with B-cell precursor acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant, or in second or later relapse. • the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Kymriah is not indicated for patients with primary central nervous system lymphoma. 4.2 D OSE AND METHOD OF ADMINISTRATION Manufacture and release of Kymriah usually takes about 3 to 4 weeks. Kymriah must be administered in a treatment centre that has been qualified by the sponsor. Therapy should be initiated under the direction of and supervised by a healthcare professional experienced in 2 the treatment of haematological malignancies and trained for Kymriah administration a Soma hati kamili