TECARTUS 1000000 1/68mL
brexucabtagene autoleucel · SUSPENSION · Kite Pharma, Inc.
TECARTUS is a suspension containing brexucabtagene autoleucel at 1000000 1/68mL, taken intravenous. Manufactured by Kite Pharma, Inc..
Key Facts
- Brand Name
- TECARTUS
- Generic Name
- brexucabtagene autoleucel
- NDC Code (Product)
71287-220- Manufacturer
- Kite Pharma, Inc.
- Strength
- 1000000 1/68mL
- Dosage Form
- SUSPENSION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA125703
- Marketing Start
- 10/01/2021
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 TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL). Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). 1.1 Mantle Cell Lymphoma TECARTUS is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). 1.2 Acute Lymphoblastic Leukemia TECARTUS is indicated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For autologous use only. For intravenous use only. Do NOT use a leukodepleting filter. Administer a lymphodepleting regimen of cyclophosphamide and fludarabine before infusion of TECARTUS. ( 2.2 ) Verify the patient's identity prior to infusion. ( 2.2 ) Premedicate with acetaminophen and diphenhydramine. ( 2.2 ) Confirm availability of tocilizumab prior to infusion. ( 2.2 , 5.1 ) Dosing of TECARTUS is based on the number of chimeric antigen receptor (CAR)-positive viable T cells. ( 2.1 ) MCL: dose is 2 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 10 8 CAR-positive viable T cells. ( 2.1 ) ALL: dose is 1 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 1 × 10 8 CAR-positive viable T cells. ( 2.1 ) 2.1 Dose For autologous use only. For intravenous use only. Recommended Dosage for MCL The target dose is 2 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 10 8 CAR-positive viable T cells. Recommended Dosage for ALL The target dose is 1 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 1 × 10 8 CAR-positive viable T cells. 2.2 Administration TECARTUS is fo…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The most common non-laboratory adverse reactions (incidence greater than or equal to 20%) are: MCL: CRS, fever, encephalopathy, hypotension, infection with pathogen unspecified, viral infections, fatigue, tachycardias, chills, hypoxia, tremor, cough, musculoskeletal pain, nausea, edema, headache, constipation, diarrhea, decreased appetite, dyspnea, rash, insomnia, pleural effusion, aphasia, motor dysfunction. ALL: fever, CRS, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Kite at 1-844-454-KITE (5483) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Study 1 (Relapsed/Refractory Mantle Cell Lymphoma) Cohort 1 and 2 The safe…
Frequently Asked Questions
What is TECARTUS used for?
TECARTUS contains brexucabtagene autoleucel. It is a suspension taken intravenous. Consult your doctor for specific uses.
Is TECARTUS a controlled substance?
TECARTUS is not classified as a controlled substance by the DEA.
What is the generic name for TECARTUS?
The generic name for TECARTUS is brexucabtagene autoleucel. There are no other listed brand versions of brexucabtagene autoleucel.
What is the NDC code for TECARTUS 1000000 1/68mL?
The NDC (National Drug Code) for TECARTUS 1000000 1/68mL is 71287-220, listed by Kite Pharma, Inc..
Other TECARTUS Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)