lisocabtagene maraleucel

High Alert

Large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified (including diffuse large B-cell lymphoma arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, in patients who have refractory disease to 1st-line chemoimmunotherapy or relapse within 12 mo of 1st-line chemoimmunotherapy.
Large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified (including diffuse large B-cell lymphoma arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, in patients who have refractory disease to 1st-line chemoimmunotherapy or relapse after 1st-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation due to comorbidities or age.
Large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified (including diffuse large B-cell lymphoma arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, in patients who have relapsed or refractory disease after ≥2 lines of systemic therapy.
Relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma in patients who have received ≥2 prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor.
Relapsed or refractory follicular lymphoma in patients who have received ≥2 prior lines of systemic therapy.
Relapsed or refractory mantle cell lymphoma in patients who have received ≥2 prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Active infection;
Inflammatory disorders;
OB: Pregnancy.

Use Cautiously in:

Rep: Women of reproductive potential;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: edema, hypertension, hypotension, tachycardia, thrombosis

Derm: rash

EENT: blurred vision

F and E: hypocalcemia, hyponatremia, hypophosphatemia

GI: ↓appetite, abdominal pain, constipation, diarrhea, nausea, vomiting, dyspepsia

GU: renal failure

Hemat: ↓fibrinogen, anemia, bleeding, hypogammaglobulinemia, lymphopenia, neutropenia, thrombocytopenia, HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS/MACROPHAGE ACTIVATION SYNDROME

Metab: hyperuricemia

MS: pain

Neuro: anxiety, dizziness, ENCEPHALOPATHY, fatigue, headache, IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME (ICANS), insomnia, motor dysfunction, taste disturbance, tremor, aphasia, ataxia, delirium, peripheral neuropathy

Resp: cough, dyspnea, pleural effusion

Misc: chills, cytokine release syndrome (CRS), fever, hypersensitivity reactions (including anaphylaxis), infection (including hepatitis B reactivation), tumor lysis syndrome, SECONDARY MALIGNANCY

Interactions ⬆ ⬇

Drug-drug:

May ↓ antibody response to and ↑ risk of adverse reactions from live vaccines; use of live vaccines is not recommended for ≥6 wk prior to the start of lymphodepleting chemotherapy, during lisocabtagene maraleucel treatment, and until immune recovery following treatment with lisocabtagene maraleucel.

Availability ⬆ ⬇

Suspension for injection: 4.6 mL of frozen suspension of genetically modified autologous T cells in 7.5% dimethyl sulfoxide

Route/Dosage ⬆ ⬇

Large B-Cell Lymphoma (After 2 Lines of Therapy)

IV (Adults ): 50–110 × 10⁶CAR-positive viable T cells.

Large B-Cell Lymphoma (After One Line of Therapy), Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Follicular Lymphoma, or Mantle Cell Lymphoma

IV (Adults ): 90–110 × 10⁶CAR-positive viable T cells.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

A CD19-directed genetically modified autologous T-cell immunotherapy that involves genetically modifying a patient’s own T cells to equip them with chimeric antigen receptors (CARs) to identify and eliminate CD19-expressing malignant and normal cells.

Therapeutic effects:

Improved event-free survival in large B-cell lymphoma.
Decreased progression of chronic lymphocytic leukemia, small lymphocytic lymphoma, follicular lymphoma, or mantle cell lymphoma.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: CAR T-cell therapy

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: High distribution in the bone marrow.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(concentrations of anti-BCMA CAR T cells)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	10–14 days	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of lisocabtagene maraleucel. Do not stop receiving drug without consulting health care provider. If an appointment is missed, reschedule as soon as possible. Advise patient to read Patient Information before starting and periodically during therapy in case of changes.
Explain need for continued medical follow-up to assess effectiveness and possible side effects of medication. Periodic lab tests will be needed.
Advise patient to immediately report symptoms of CRS or neurologic toxicity.
Tell patient to avoid driving and engagement in hazardous activities for ≥8 wk following treatment because of potential for neurologic events.
Advise patient to notify health care provider promptly if signs/symptoms of anemia (fatigue, weakness), neutropenia (sore throat, fever, signs of infection), or thrombocytopenia (unusual bleeding or bruising) occur and to report any infections as soon as suspected.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other medications.
Rep: May cause fetal harm. Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

Pronunciation ⬆ ⬇

LIS-oh-KAB-ta-jeen MAR-a-LOO-sel

Code ⬆

NDC Code

73153- Juno Therapeutics, Inc.
- 73153-900- BREYANZI
  - 73153-900-01- 1 KIT in 1 CARTON (73153-900-01) * 5 mL in 1 VIAL, SINGLE-DOSE (73153-902-04) * 5 mL in 1 VIAL, SINGLE-DOSE (73153-901-08)

84684- Symbiosis Pharmaceutical Services Limited
- 84684-002-
  - 84684-002-01- 1.212 g in 1 VIAL (84684-002-01)

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Indications ⬇