Tisagenlecleucel

What it is used for

KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

Limitations of Use: KYMRIAH is not indicated for treatment of patients with primary central nervous system lymphoma. Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). 1.1 Pediatric and Young Adult Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia KYMRIAH is indicated for treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

1.2 Adult Relapsed or Refractory Diffuse Large B-cell Lymphoma KYMRIAH is indicated for treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

Limitation of Use: KYMRIAH is not indicated for treatment of patients with primary central nervous system lymphoma. 1.3 Adult Relapsed or Refractory Follicular Lymphoma KYMRIAH is indicated for treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.

This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

The most important thing to know

KYMRIAH may cause side effects that are severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following: difficulty breathing fever (100.4°F/38°C or higher) chills/shaking chills confusion severe nausea, vomiting, diarrhea severe muscle or joint pain very low blood pressure dizziness/lightheadedness It is important that you tell your healthcare providers that you have received KYMRIAH.

Your healthcare providers may give you other medicines to treat your side effects. What is KYMRIAH? KYMRIAH is made from your own white blood cells and is a prescription cancer treatment used in patients up to 25 years old who have acute lymphoblastic leukemia (ALL) that is either relapsing (went into remission, then came back) or refractory (did not go into remission after receiving other leukemia treatments).

It is also used in patients with large B-cell lymphoma or follicular lymphoma, two types of non-Hodgkin lymphoma, that have relapsed or are refractory after having at least two other kinds of treatment. How will I get KYMRIAH? Since KYMRIAH is made from your own white blood cells, your healthcare provider has to take some of your blood.

This is called “leukapheresis.” It takes 3 to 6 hours and may need to be repeated. A tube (intravenous catheter) will be placed in your vein to collect your blood. Your blood cells are frozen and sent to the manufacturing site to make KYMRIAH. It takes about 3-4 weeks from the time your cells are received at the manufacturing site and shipped back to your healthcare provider, but the time may vary.

While waiting for KYMRIAH to be made, your healthcare provider may give you therapy to stabilize your cancer. In addition, before you get KYMRIAH, your healthcare provider may give you chemotherapy for a few days to prepare your body. When your body is ready, your healthcare provider will give you KYMRIAH through a tube (intravenous catheter) in your vein.

This usually takes less than one hour. You should plan to stay close to a healthcare facility for at least 2 weeks after getting KYMRIAH. Your healthcare provider will check to see if your treatment is working and help you with any side effects that occur.

What to avoid

Avoid driving for at least 2 weeks after you get KYMRIAH. Do not donate blood, organs, tissues, sperm, oocytes, and other cells. What are the possible or reasonably likely side effects of KYMRIAH? The most common side effects of KYMRIAH are: difficulty breathing fever (100.4°F/38°C or higher) chills/shaking chills confusion severe nausea, vomiting, diarrhea severe muscle or joint pain very low blood pressure dizziness/lightheadedness headache KYMRIAH can increase the risk of life-threatening infections that may lead to death.

Tell your healthcare provider right away if you develop fever, chills, or any signs or symptoms of an infection. KYMRIAH can lower one or more types of your blood cells (red blood cells, white blood cells, or platelets). After treatment, your healthcare provider will test your blood to check for this. Tell your healthcare provider right away if you get a fever, are feeling tired, weak, or short of breath, or have bruising or bleeding.

Having KYMRIAH in your blood may cause a false-positive HIV test result by some commercial tests. KYMRIAH may increase your risk of getting cancers, including certain types of blood cancers. Your healthcare provider should monitor you for this. These are not all the possible side effects of KYMRIAH. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.