Shree Axis Tablets

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. …

• 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 YESCARTA
• Verify the patient's identity prior to infusion
• Premedicate with acetaminophen and an H1-antihistamine
• Confirm availability of tocilizumab prior to infusion
• Dosing of YESCARTA is based on the number of chimeric antigen receptor (CAR)-positive viable T cells
• 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
• 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
• Administration YESCARTA is for autologous use only

YESCARTA is available as a cell suspension for infusion. A single dose of YESCARTA contains 2 × 10 6 CAR-positive viable T cells per kg of body weight (or maximum of 2 × 10 8 CAR-positive viable T cells for patients 100 kg and above) in approximately 68 mL suspension in an infusion bag [see How Supplied/Storage and Handling (16) ] . YESCARTA is available as a cell suspension for infusion. …

• The safety and efficacy of YESCARTA have not been established
• Pediatric patients

Of the 422 patients with NHL who received YESCARTA in clinical trials, 127 patients (30%) were 65 years of age and older. No clinically important differences in safety or effectiveness were observed between patients aged 65 years and older and younger patients.

• Advise the patient to read the FDA-approved patient labeling (Medication Guide)
• Ensure that patients understand the risk of manufacturing failure (< 1% in clinical trials)
• In case of a manufacturing failure, a second manufacturing of YESCARTA may be attempted
• In addition, while the patient awaits the product, additional chemotherapy (not the lymphodepletion) may be necessary and may increase the risk of adverse events during the pre-infusion period. …

• None
• None

Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion. ( 5.3 ) Serious Infections: Monitor patients for signs and symptoms of infection; treat appropriately. ( 5.4 ) Prolonged Cytopenias: Patients may exhibit Grade 3 or higher cytopenias for several weeks following YESCARTA infusion. Monitor complete blood counts. ( 5.5 ) Hypogammaglobulinemia: Monitor and provide replacement therapy. ( 5.6 ) Secondary Malignancies: T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA ( 5.7 ). …

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. …

8.1 Pregnancy Risk Summary There are no available data with YESCARTA use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with YESCARTA to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if YESCARTA has the potential to be transferred to the fetus. …

Each YESCARTA infusion bag is individually packed in a metal cassette (NDC 71287-119-02). YESCARTA is supplied in a liquid nitrogen dry shipper at ≤ -150°C. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.