Kite Pharma Yescarta (Axicabtagene Ciloleucel) Product Information

Generic Name: Axicabtagene Ciloleucel Injection

Brand Name: Yescarta

Indications

1. Large B-Cell Lymphoma

Yescarta is indicated for the treatment of:

1. Adult patients with large B-cell lymphoma that is refractory to or relapses within 12 months after first-line chemoimmunotherapy.
2. 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, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Limitation of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.

2. Follicular Lymphoma

Yescarta is indicated for the treatment of 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).

Dosage and Administration

Dosage Form and Strength

Yescarta is a cell suspension for infusion, supplied as a frozen suspension of anti-CD19 CAR T cells in one patient-specific infusion bag, containing a suspension of chimeric antigen receptor (CAR)-positive viable T cells at a target dose of 2 × 10⁶ CAR-positive viable T cells/kg body weight (maximum of 2 × 10⁸ CAR-positive viable T cells) in approximately 68 mL.

Recommended Dosage

Yescarta is intended for autologous use only. The patient’s identity must match the patient identifiers on the Yescarta infusion bag. Do not infuse Yescarta if the information on the patient-specific label does not match the intended patient.

The target dose is 2 × 10⁶ CAR-positive viable T cells/kg body weight, with a maximum of 2 × 10⁸ CAR-positive viable T cells.

Patient Preparation

Confirm that the patient is an appropriate candidate for Yescarta prior to infusion. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.

Pretreatment

Administer a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m² intravenously and fludarabine 30 mg/m² intravenously on the 3 days preceding infusion of Yescarta.

Premedication

Administer acetaminophen 650 mg orally and diphenhydramine 12.5 mg intravenously or orally approximately 1 hour before infusion of Yescarta. Corticosteroids may also be administered on the day before and the day of Yescarta infusion at the discretion of the healthcare provider after assessing the risks and benefits.

Administration

1. Inspect the infusion bag for any breaks or cracks prior to thawing and infusion. If the infusion bag appears to have been damaged, do not infuse and discard the product.
2. Coordinate the timing of Yescarta thaw and infusion. Thaw Yescarta at approximately 37°C using either a water bath or dry thaw method until there is no visible solid ice in the infusion bag. Gently mix the contents of the infusion bag to disperse clumped cellular material. If there are remaining clumps, continue to gently mix the contents of the infusion bag. Thawing should take approximately 3-6 minutes. Do not wash, spin down, and/or re-suspend Yescarta in new media prior to infusion. Once thawed, Yescarta may be stored at room temperature (20°C to 25°C) for up to 3 hours.
3. Confirm the patient’s identity matches the patient identifiers on the Yescarta infusion bag. Gently mix the contents of the infusion bag again prior to infusion.
4. Infuse the entire contents of the Yescarta infusion bag by intravenous infusion over 30 minutes by gravity or a peristaltic pump. After the entire contents of Yescarta have been infused, rinse the infusion line with D5W or 0.9% Sodium Chloride at the same rate as the Yescarta infusion, to ensure all Yescarta contents have been administered.

Dose Modifications

Manage severe cytokine release syndrome (CRS) and neurological toxicities according to the recommendations in the prescribing information.

Adverse Reactions

The most common non-laboratory adverse reactions (incidence ≥20%) in patients with relapsed/refractory large B-cell lymphoma were fever, cytokine release syndrome, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with unspecified pathogen, maculopapular rash, edema, tremor, decreased appetite, dizziness, constipation, vomiting, and hypoxia.

The most common non-laboratory adverse reactions (incidence ≥20%) in patients with relapsed/refractory follicular lymphoma were fever, cytokine release syndrome, hypotension, encephalopathy, fatigue, headache, infection with unspecified pathogen, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness.

Use in Specific Populations

• Pregnancy: Based on the mechanism of action, Yescarta poses potential risks to a pregnant woman. Advise pregnant women of the potential risk to the fetus.
• Lactation: There is no information regarding the presence of Yescarta in human milk, the effects on the breastfed infant, or the effects on milk production.
• Females and Males of Reproductive Potential: Pregnancy testing is recommended for females of reproductive potential prior to initiating Yescarta.
• Pediatric Use: The safety and efficacy of Yescarta have not been established in pediatric patients.
• Geriatric Use: No differences in safety or efficacy were observed between patients ≥65 years and younger patients.

Contraindications

None.

Description

Yescarta is an autologous immunocellular therapy consisting of anti-CD19 chimeric antigen receptor (CAR) T cells for intravenous infusion.

Storage and Handling

Yescarta is supplied in a patient-specific infusion bag for cryopreservation. Cryopreserve Yescarta at ≤ -150°C until infusion. Thaw prior to infusion. Yescarta may be stored at room temperature (20°C to 25°C) for up to 3 hours after thawing.