KYMRIAH 2000000 1/1
tisagenlecleucel · INJECTION, SUSPENSION · Novartis Pharmaceuticals Corporation
KYMRIAH is a injection, suspension containing tisagenlecleucel at 2000000 1/1, taken intravenous. Manufactured by Novartis Pharmaceuticals Corporation.
Key Facts
- Brand Name
- KYMRIAH
- Generic Name
- tisagenlecleucel
- NDC Code (Product)
0078-0846- Manufacturer
- Novartis Pharmaceuticals Corporation
- Strength
- 2000000 1/1
- Dosage Form
- INJECTION, SUSPENSION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA125646
- Drug Class
- CD19-directed Chimeric Antigen Receptor [EPC]; Genetically-modified Autologous T Cells [EPC]
- Marketing Start
- 08/30/2017
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. ( 1.1 ) 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. ( 1.2 ) 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). ( 1.3 ) 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 …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For autologous use only. For intravenous use only. Administer a lymphodepleting regimen if needed before infusion of KYMRIAH. ( 2.2) Do NOT use a leukodepleting filter. ( 2.2 ) Verify the patient’s identity prior to infusion. ( 2.2 ) Premedicate with acetaminophen and an H1-antihistamine. ( 2.2 ) Confirm availability of tocilizumab prior to infusion. ( 2.2 , 5.1 ) Dosing of KYMRIAH is based on the number of chimeric antigen receptor (CAR)-positive viable T cells. Pediatric and Young Adult B-cell ALL (up to 25 years of age) • For patients 50 kg or less, administer 0.2 to 5.0 x 10 6 CAR-positive viable T cells per kg body weight intravenously. ( 2.1 ) • For patients above 50 kg, administer 0.1 to 2.5 x 10 8 total CAR-positive viable T cells (non-weight based) intravenously. ( 2.1 ) Adult Relapsed or Refractory Diffuse Large B-cell Lymphoma and Follicular Lymphoma • Administer 0.6 to 6.0 x 10 8 CAR-positive viable T cells intravenously. ( 2.1 ) Note: The patient identifier number may be preceded by the letters DIN or Aph ID. Figure 1. KYMRIAH Infusion Bag 2.1 Recommended Dose For autologous use only. For intravenous use only. Pediatric and Young Adult Relap…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS HIV and the lentivirus used to make KYMRIAH have limited, short spans of identical genetic material (RNA). Therefore, some commercial HIV nucleic acid tests (NATs) may yield false-positive results in patients who have received KYMRIAH.
Adverse Reactions
6 ADVERSE REACTIONS Pediatric and Young Adult B-cell ALL (up to 25 years of age): The most common adverse reactions (incidence greater than 20%) are CRS, infections-pathogen unspecified, hypogammaglobulinemia, fever, decreased appetite, viral infectious disorders, headache, febrile neutropenia, hemorrhage, musculoskeletal pain, vomiting, encephalopathy, diarrhea, hypotension, cough, nausea, bacterial infectious disorders, pain, hypoxia, tachycardia, edema, fatigue, and acute kidney injury. ( 6.1 ) Adult Relapsed or Refractory Diffuse Large B-cell Lymphoma: The most common adverse reactions (incidence greater than 20%) are CRS, infections-pathogen unspecified, fever, diarrhea, nausea, fatigue, hypotension, edema, hemorrhage, dyspnea, and headache. ( 6.1 ) Adult Relapsed or Refractory Follicular Lymphoma: The most common adverse reactions (incidence greater than 20%) are CRS, infections-pathogens unspecified, fatigue, musculoskeletal pain, headache, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are cond…
Frequently Asked Questions
What is KYMRIAH used for?
KYMRIAH contains tisagenlecleucel. It is a injection, suspension taken intravenous. Consult your doctor for specific uses.
Is KYMRIAH a controlled substance?
KYMRIAH is not classified as a controlled substance by the DEA.
What is the generic name for KYMRIAH?
The generic name for KYMRIAH is tisagenlecleucel. There are no other listed brand versions of tisagenlecleucel.
What is the NDC code for KYMRIAH 2000000 1/1?
The NDC (National Drug Code) for KYMRIAH 2000000 1/1 is 0078-0846, listed by Novartis Pharmaceuticals Corporation.
Other KYMRIAH Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)