Breyanzi (lisocabtagene maraleucel)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

For autologous use only. For IV use only.

*Do NOT use a leukodepleting filter.

*Administer a lymphodepleting regimen of fludarabine and cyclophosphamide before infusion of lisocabtagene maraleucel. Confirm the availability of lisocabtagene maraleucel before starting lymphodepleting chemotherapy. Infuse lisocabtagene maraleucel 2 to 7 days after completion of lymphodepleting chemotherapy.

*Verify the patient's identity prior to infusion. Check that the patient's identity matches the patient identifiers on the cartons, vials, and syringe labels. Do not administer the therapy if the information on the patient-specific labels does not match the intended patient.

*Premedicate with acetaminophen and an H1 antihistamine.

*Confirm availability of tocilizumab prior to infusion.

*Dosing of lisocabtagene maraleucel is based on the number of chimeric antigen receptor (CAR)-positive viable T cells.

*For relapsed or refractory large B-cell lymphoma (LBCL) after one line of therapy, the dose is 90 to 110 x 106 CAR-positive viable T cells.

*For relapsed or refractory LBCL after two or more lines of therapy, the dose is 50 to 110 x 106 CAR-positive viable T cells.

*For CLL/SLL, the dose is 90 to 110 x 106 CAR-positive viable T cells.

*For FL, the dose is 90 to 110 x 106 CAR-positive viable T cells.

*For MCL, the dose is 90 to 110 x 106 CAR-positive viable T cells.

*For MZL, the dose is 90 to 110 x 106 CAR-positive viable T cells.

*See Full Prescribing Information for detailed instructions on preparation and administration, and recommendations for management of adverse reactions.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

None

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

*The most common adverse reactions (incidence >= 30%) in patients with LBCL: fever, CRS, fatigue, musculoskeletal pain, and nausea. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease.

*The most common adverse reactions (incidence >= 30%) in patients with CLL/SL: CRS, encephalopathy, fatigue, musculoskeletal pain, nausea, edema and diarrhea. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease.

*The most common adverse reactions (incidence >= 30%) in patients with FL: CRS. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decreased, neutrophil count decreased, and white blood cell decreased.

*The most common adverse reactions (incidence >= 30%) in patients with MCL: CRS, fatigue, musculoskeletal pain, and encephalopathy. The most commonGrade 3-4 laboratory abnormalities include neutrophil count decrease, white blood celldecrease, and platelet count decrease.

*The most common adverse reactions (incidence >= 30%) in patients with MZL: CRS. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decreased, neutrophil count decreased, and white blood cell decreased.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

The safety and efficacy of lisocabtagene maraleucel have not been established in pediatric patients.

There are no available data with lisocabtagene maraleucel use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with lisocabtagene maraleucel to assess whether it can cause fetal harm when administered to a pregnant woman.

It is not known if lisocabtagene maraleucel has the potential to be transferred to the fetus. Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia and hypogammaglobulinemia. Therefore, lisocabtagene maraleucel is not recommended for women who are pregnant, and pregnancy after lisocabtagene maraleucel infusion should be discussed with the treating physician.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

There is no information regarding the presence of lisocabtagene maraleucel in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for lisocabtagene maraleucel and any potential adverse effects on the breastfed infant from lisocabtagene maraleucel or from the underlying maternal condition.

In clinical trials of lisocabtagene maraleucel, 111 (41%) of 268 patients with two or more prior lines of therapy for LBCL, and 89 (59%) of 150 patients with one prior line of therapy for LBCL, were 65 years of age or older; 27 (10%) and 28 (19%) were 75 years of age or older, respectively. In patients with CLL/SLL, 51 (57%) of 89 patients were 65 years of age or older, and 9 (10%) were 75 years of age or older. In patients with FL, 42 (39%) of 107 patients were 65 years of age or older, and 10 (9%) were 75 years of age or older. In patients with MCL, 64 (73%) of 88 patients were 65 years of age or older, and 18 (21%) were75 years of age or older. In patients with MZL, 30 (45%) of 67 patients were 65 years of age orolder, and 10 (15%) were 75 years of age or older. No clinically important differences in safety or effectiveness of lisocabtagene maraleucel were observed between patients >= 65 years of age and younger patients.