WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGICAL TOXICITIES
KYMRIAH™ (tisagenlecleucel) is available at select treatment centers across the United States. See below to find the nearest KYMRIAH Treatment Center for your patients and begin collaborating on their treatment. Some of these treatment centers are ready to administer KYMRIAH today, while others will be ready soon. For more information, please contact the treatment center.
Please note that the KYMRIAH Treatment Centers listed here are only those that have authorized their participation on our website. Call KYMRIAH CARES™ at 1-844-4KYMRIAH (1-844-459-6742) to find out if there are additional KYMRIAH Treatment Centers closer to your patient.
Novartis does not provide or supervise medical care furnished through these treatment centers, which are independently owned and operated.
*Treatment center is certified to administer KYMRIAH.
Please check back as this list will be updated regularly with newly certified locations.
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.
Important Safety Information
Warnings and Precautions:
Key manifestations of CRS include high fever, lower than normal blood pressure, difficulty breathing, and may be associated with hepatic, renal, and cardiac dysfunction, and coagulopathy.
Risk factors for severe CRS are high pre-infusion tumor burden (greater than 50% blasts in bone marrow), uncontrolled or accelerating tumor burden following lymphodepleting chemotherapy, active infections, and/or inflammatory processes.
Delay the infusion of KYMRIAH after lymphodepleting chemotherapy if the patient has unresolved serious adverse reactions from preceding chemotherapies (including pulmonary toxicity, cardiac toxicity, or hypotension), active uncontrolled infection, active graft versus host disease (GVHD), or worsening of leukemia burden [see Dosage and Administration (2.2)].
Ensure that tocilizumab is available on site prior to infusion of KYMRIAH. Monitor patients for signs or symptoms of CRS for at least 4 weeks after treatment with KYMRIAH. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time [see Patient Counseling Information (17)]. At the first sign of CRS, immediately evaluate patient for hospitalization and institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated [see Dosage and Administration (2.3)].
Monitor patients for neurological events and exclude other causes for neurological symptoms. Provide supportive care as needed for KYMRIAH-associated neurological events.
Further information is available at www.kymriah-rems.com or 1-844-4KYMRIAH.
Febrile neutropenia (Grade 3 or 4) was also observed in 37% of patients after KYMRIAH infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids and other supportive care as medically indicated.
Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs directed against B cells. Hepatitis cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive, and also in patients who are HBsAg-negative but hepatitis B core antibody (anti-HBc) positive. HBV reactivation has occurred in patients who appear to have resolved hepatitis B infection (i.e., HBsAg-negative, anti-HBc-positive and hepatitis B surface antibody [anti-HBs] positive).
HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis, i.e., increase in transaminase levels. In severe cases, increase in bilirubin levels, liver failure, and death can occur.
Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.
Monitor immunoglobulin levels after treatment with KYMRIAH and manage using infection precautions, antibiotic prophylaxis and immunoglobulin replacement standard guidelines.
The safety of immunization with live viral vaccines during or following KYMRIAH treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 2 weeks prior to the start of lymphodepleting chemotherapy, during KYMRIAH treatment, and until immune recovery following treatment with KYMRIAH.
Pregnant women who have received KYMRIAH may have hypogammaglobulinemia. Assess immunoglobulin levels in newborns of mothers treated with KYMRIAH.
The most common adverse reactions (incidence greater than 20%) are cytokine release syndrome, hypogammaglobulinemia, infections-pathogen unspecified, pyrexia, decreased appetite, headache, encephalopathy, bleeding, hypotension, tachycardia, nausea, diarrhea, vomiting, viral infection disorders, hypoxia, fatigue, acute kidney injury, and delirium [see Adverse Reactions (6)].
HIV and the lentivirus used to make KYMRIAH have limited short spans of identical genetic material (RNA). Therefore, some commercial HIV nucleic acid test (NAT) tests may yield false positive results in patients who have received KYMRIAH.
Please see full Prescribing Information for KYMRIAH, including Boxed WARNING, and Medication Guide.