YESCARTA 2000000 1/68mL
axicabtagene ciloleucel · SUSPENSION · Kite Pharma, Inc.
YESCARTA is a suspension containing axicabtagene ciloleucel at 2000000 1/68mL, taken intravenous. Manufactured by Kite Pharma, Inc..
Key Facts
- Brand Name
- YESCARTA
- Generic Name
- axicabtagene ciloleucel
- NDC Code (Product)
71287-119- Manufacturer
- Kite Pharma, Inc.
- Strength
- 2000000 1/68mL
- Dosage Form
- SUSPENSION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA125643
- Drug Class
- CD19-directed Chimeric Antigen Receptor [EPC]; Genetically-modified Autologous T Cells [EPC]
- Marketing Start
- 10/18/2017
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. ( 1.1 ) Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. ( 1.1 ) 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). ( 1.2 ) 1.1 Large B-cell Lymphoma YESCARTA is indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Adult patients wit…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For autologous use only. For intravenous use only. Do NOT use a leukodepleting filter. ( 2.2 ) Administer a lymphodepleting regimen of cyclophosphamide and fludarabine before infusion of YESCARTA. ( 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 YESCARTA is based on the number of chimeric antigen receptor (CAR)-positive viable T cells. ( 2.1 ) The target YESCARTA 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 ) 2.1 Dose For autologous use only. For intravenous use only. Each single infusion bag of YESCARTA contains a suspension of chimeric antigen receptor (CAR)-positive T cells in approximately 68 mL. 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. 2.2 Administration YESCARTA is for autologous use only. The patient's identity must match the patient identifiers on the YESCARTA cassette and infusion bag. Do not infuse YESCARTA if the info…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥ 30%), excluding laboratory abnormalities, in patients with non-Hodgkin lymphoma are CRS, fever, hypotension, encephalopathy, fatigue, tachycardia, headache, nausea, febrile neutropenia, diarrhea, musculoskeletal pain, infections with pathogen unspecified, chills and decreased appetite. ( 6.1 ) The most common Grade 3-4 laboratory abnormalities (≥ 30%) are leukopenia, lymphopenia, neutropenia, anemia, thrombocytopenia, and hypophosphatemia. ( 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. The safety data described in the WARNINGS AND PRECAUTIONS and in the ADVERSE REACTIONS sections reflect exposure to a single dose of YESCARTA in four clinical studies, including 168 patients with relapsed or refractory LBCL (Study 1), 108 patients with relaps…
Frequently Asked Questions
What is YESCARTA used for?
YESCARTA contains axicabtagene ciloleucel. It is a suspension taken intravenous. Consult your doctor for specific uses.
Is YESCARTA a controlled substance?
YESCARTA is not classified as a controlled substance by the DEA.
What is the generic name for YESCARTA?
The generic name for YESCARTA is axicabtagene ciloleucel. There are no other listed brand versions of axicabtagene ciloleucel.
What is the NDC code for YESCARTA 2000000 1/68mL?
The NDC (National Drug Code) for YESCARTA 2000000 1/68mL is 71287-119, listed by Kite Pharma, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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