| DRUG INFORMATION |
| Classification | Chimeric antigen receptor (CAR) T-cell immunotherapy |
| Mechanism of Action | Lisocabtagene maraleucel is a CD19-directed, genetically modified, autologous CD4 and CD8 T-cell immunotherapy (https://www.ons.org/books/chemotherapy-and-immunotherapy-guidelines-and-recommendations-practice-second-edition). It binds to CD19 expressed on the surface of the tumor and healthy B cells and activates a signaling cascade that induces T-cell activation and proliferation, releases proinflammatory cytokines and chemokines, and leads to CD19-expressing cell death. |
| Indications | Adult patients with: - LBCL (including DLBCL not otherwise specified and DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade IIIB follicular lymphoma who have:
- Disease refractory to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy
- Disease refractory to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for transplant because of comorbidities or age
- Relapsed or refractory disease after two or more lines of systemic therapy
- Relapsed or refractory CLL or SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a B-cell lymphoma 2 inhibitor (under accelerated approval)
- Relapsed or refractory FL who have received two or more prior lines of systemic therapy (under accelerated approval)
- Relapsed or refractory MCL who have received at least two or more lines of systemic therapy, including a BTK inhibitor
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| ADMINISTRATION |
| Dosing, Frequency, and Administration | - Patients with LBCL receive a one-time administration dose of 90–110 × 106 CAR-positive viable T cells after one line of therapy and 50–110 × 106 CAR-positive viable T cells after two or more lines of therapy.
- Patients with CLL, SLL, FL, or MCL receive a one-time administration dose of 90–110 × 106 CAR-positive viable T cells.
|
| Route | IV |
| Safe Handling | |
| ADVERSE REACTIONS |
Although adverse reactions vary by type of cancer, at least 30% of patients in the immunotherapy’s clinical trials reported experiencing: - Cytokine release syndrome (CRS)
- Immune effector cell–associated neurotoxicity syndrome (ICANS)
- Diarrhea
- Edema
- Encephalopathy
- Fatigue
- Fever
- Grade 3–4 laboratory abnormalities: decreased hemoglobin, lymphocyte, neutrophil, and platelet counts
- Musculoskeletal pain
- Nausea
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| WARNINGS |
- Black Box Warnings
- CRS
- Neurologic toxicities
- Secondary malignancies
- Other Warnings
- Effects on ability to drive and use machines
- Hypersensitivity reactions
- Hypogammaglobulinemia
- Serious infections
- Prolonged cytopenias
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| NURSING CONSIDERATIONS |
| Pretreatment | - The treatment must be administered at a Risk Evaluation and Mitigation Strategy (REMS)–certified healthcare facility.
- Administer the lymphodepleting chemotherapy regimen before infusing lisocabtagene maraleucel.
- Infuse lisocabtagene maraleucel two to seven days after completion of lymphodepleting chemotherapy.
- Delay the infusion if the patient has unresolved serious adverse events from preceding chemotherapies, active uncontrolled infection, or active graft-versus-host disease.
- Premedicate with acetaminophen and diphenhydramine (or another H1 antihistamine) 30–60 minutes prior to treatment to prevent infusion reactions.
- Avoid prophylactic use of systemic corticosteroids because they may interfere with lisocabtagene maraleucel’s activity.
- Confirm that tocilizumab and emergency equipment are available prior to starting the infusion per REMS requirements.
- Confirm the infusion start time before thawing and preparing the dose.
- Refer to the full prescribing information (https://www.fda.gov/media/145711/download?attachment=) for all pretreatment considerations.
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| Administration | - Do not use a leukodepleting filter.
- Administer within two hours of removing the treatment from frozen storage.
- Use normal saline to flush all infusion tubing prior to and after each CD8 or CD4 component administration.
- Administer the entire volume of the CD8 component at an infusion rate of approximately 0.5 ml per minute, using the closest port or Y-arm.
- If a full dose of the CD8 component requires more than one syringe, administer each consecutively without any time between the syringes, unless there is a clinical reason to hold the dose.
- After the CD8 component has been administered, flush the tubing with normal saline, using enough volume to clear the tubing and the length of the IV catheter.
- Administer the CD4 component immediately after completing the CD8 component and flushing the line. After completing the CD4 component, flush the tubing with enough normal saline to clear the tubing and the length of the IV catheter.
- Each component should be infused in less than 15 minutes.
- Monitor for hypersensitivity reaction during each infusion.
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| Post-Treatment | - Monitor complete blood cell counts prior to and after infusion.
- Monitor patients daily for at least seven days following the infusion for signs and symptoms of CRS and neurologic toxicities.
- If signs of CRS or neurotoxicity occur, grade the toxicity, notify provider, and anticipate administration of tocilizumab, corticosteroids, and supportive treatment as indicated.
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| PATIENT EDUCATION |
- If manufacturing fails, we may attempt a second manufacturing. While awaiting the second product, you may need additional bridging therapy.
- Stay within a two-hour drive of the REMS-certified healthcare facility for the first four weeks following your infusion.
- Do not drive or operate any heavy machinery for at least eight weeks following your infusion.
- Report signs of CRS (e.g., difficulty breathing, fever, chills), signs of ICANS (e.g., confusion, mild issues of language expression or understanding), signs of low blood counts (e.g., fever, fatigue, bruising or bleeding), severe nausea, vomiting, diarrhea, fast or irregular heartbeat, dizziness or lightheadedness, and severe fatigue or weakness.
- If you seek medical attention, show the healthcare provider your lisocabtagene maraleucel wallet card.
- Maintain your schedule for follow-up and toxicity monitoring.
- Your provider will monitor you for secondary malignancies.
- Lisocabtagene maraleucel may cause a false-positive HIV test result with some commercial tests.
- Pregnancy is not recommended during treatment. Discuss your plans for pregnancy or breastfeeding/chestfeeding after the infusion with your healthcare provider.
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| RESOURCES |
| Patient Resources | Patient assistance program (https://www.celltherapy360.com/) |
| Healthcare Professional Resources | |
| Other Resources | |
