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      Drugs & Diseases

      brexucabtagene autoleucel (Rx)

      Brand and Other Names:Tecartus
      • Print

      Dosing & Uses

      AdultPediatric

      Dosage Forms & Strengths

      injection, suspension

      • Single-dose units contain specific amounts of T cells depending on the patient’s body weight that are suspended in a patient-specific infusion bag
      • 2x 106 CAR-positive viable T cells/kg of body weight, with a maximum of 2x 108 CAR-positive viable T cells in ~68 mL

      Mantle Cell Lymphoma

      Indicated for relapsed or refractory mantle cell lymphoma (MCL)

      One treatment course consists of fludarabine- and cyclophosphamide-lymphodepleting chemotherapy followed by IV infusion of brexucabtagene autoleucel

      Confirm availability of brexucabtagene autoleucel before starting lymphodepleting chemotherapy

      Lymphodepleting chemotherapy

      • 3 doses of fludarabine and cyclophosphamide infused IV on the fifth, fourth, and third day before infusion of brexucabtagene autoleucel
      • Fludarabine 30 mg/m2 IV qDay for 3 days
      • Cyclophosphamide 500 mg/m2 IV qDay for 3 days starting with the first dose of fludarabine

      Brexucabtagene autoleucel IV infusion

      • For autologous use only; administer after completing lymphodepleting chemotherapy
      • Dose based on the number of chimeric antigen receptor (CAR)-positive viable T cells
      • Target dose is 2x 106 CAR-positive viable T cells/kg body weight, not to exceed 2x 108 CAR-positive viable T cells
      • Administer autologously prepared, weight-based IV infusion for individual patient within 30 minutes by either gravity or peristaltic pump
      • Do not use a leukocyte-depleting filter

      Acute Lymphoblastic Leukemia

      Indicated for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

      One treatment course consists of fludarabine- and cyclophosphamide-lymphodepleting chemotherapy followed by IV infusion of brexucabtagene autoleucel

      Confirm availability of brexucabtagene autoleucel before starting lymphodepleting chemotherapy

      Lymphodepleting chemotherapy

      • Fludarabine 25 mg/m2 IV over 30 minutes on the fourth, third, and second day before infusion of brexucabtagene autoleucel
      • Cyclophosphamide 900 mg/m2 IV over 60 min on second day before infusion brexucabtagene autoleuce

      Brexucabtagene autoleucel IV infusion

      • For autologous use only; administer after completing lymphodepleting chemotherapy
      • Dose based on the number of chimeric antigen receptor (CAR)-positive viable T cells
      • Target dose is 1x 106 CAR-positive viable T cells/kg body weight, not to exceed 1x 108 CAR-positive viable T cells

      Dosage Modifications

      Cytokine release syndrome (CRS) management

      • Grade 1
        • Symptoms: Fever, nausea, fatigue, headache, myalgia, malaise
        • If not improving after 24 hr, administer tocilizumab 8 mg/kg IV over 1 hr; not to exceed 800 mg
      • Grade 2
        • Symptoms require moderate intervention; oxygen requirement <40% FiO2 or hypotension responsive to fluids or low dose of one vasopressor or Grade 2 organ toxicity
        • Administer tocilizumab 8 mg/kg IV infused over 1 hr; not to exceed 800 mg
        • Repeat tocilizumab q8hr as needed if not responsive to IV fluids or increasing supplemental oxygen; not to exceed 3 doses in a 24-hr period or 4 doses in total
        • If improving, discontinue tocilizumab
        • If no improvement after 24 hr of starting tocilizumab, administer methylprednisolone (1 mg/kg IV BID or dexamethasone 10 mg IV q6hr) until Grade 1, then taper corticosteroids
      • Grade 3
        • Symptoms require aggressive intervention; oxygen requirement ≥40% FiO2 or hypotension requiring high-dose or multiple vasopressors or Grade 3 organ toxicity or Grade 4 transaminitis
        • Tocilizumab administration per Grade 2; if improving, discontinue
        • Corticosteroid dose as for Grade 2; taper if improving or manage as Grade 4 if not improving
      • Grade 4
        • Life-threatening symptoms; requires ventilator support, continuous venovenous hemodialysis, or Grade 4 organ toxicity (excluding transaminitis)
        • Tocilizumab administration per Grade 2; if improving, discontinue
        • Methylprednisolone 1000 mg IV qDay for 3 days; taper if improving or consider alternate immunosuppressants if not improving

      Neurologic toxicity grading and management

      Grades 2, 3, or 4: Consider nonsedating, antiseizure medicines (eg, levetiracetam) for seizure prophylaxis

      • Grade 1
        • Concurrent CRS: Administer tocilizumab as described for Grade 1 CRS
        • No concurrent CRS: Supportive care
      • Grade 2 with concurrent CRS
        • Administer tocilizumab (see doses in CRS Grade 2)
        • If no improvement within 24 hr after starting tocilizumab, administer dexamethasone 10 mg IV q6hr if not already taking other corticosteroids; continue dexamethasone use until the event is ≤Grade 1, then taper over 3 days
      • Grade 2 or 3 with NO concurrent CRS
        • Administer dexamethasone 10 mg IV q6hr if not already taking other corticosteroids
        • Continue until event is ≤Grade 1, then taper over 3 days
        • If Grade 3 and not improving, manage as Grade 4 (ie, IV methylprednisolone)
      • Grade 3 with concurrent CRS
        • Administer tocilizumab (see doses in CRS Grade 2) AND
        • Administer dexamethasone 10 mg IV q6hr if not already taking other corticosteroids; continue dexamethasone until event is ≤Grade 1, then taper over 3 days
      • Grade 4 with concurrent CRS
        • Administer tocilizumab (see doses in CRS Grade 2)
        • Administer methylprednisolone 1000 mg/day IV for 3 days with first dose of tocilizumab; if improvement, then manage as above
      • Grade 4 with NO concurrent CRS
        • Administer methylprednisolone 1000 mg/day IV for 3 days; if improvement, then manage as above
        • If not improving, consider alternate immunosuppressants

      Dosing Considerations

      Administer at a certified healthcare facility

      Monitor signs/symptoms of CRS and neurologic toxicities for at least daily for 14 days following infusion

      Instruct patients to remain within proximity of the certified healthcare facility at least 4 weeks following infusion

      Safety and efficacy not established

      Next:

      Interactions

      Interaction Checker

      and brexucabtagene autoleucel

      No Results

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                 activity indicator 

                Contraindicated (0)

                  Serious - Use Alternative (196)

                  • abatacept

                    abatacept, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • abrocitinib

                    abrocitinib, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • adalimumab

                    adalimumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • adenovirus types 4 and 7 live, oral

                    brexucabtagene autoleucel decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during brexucabtagene autoleucel treatment, and after treatment until full immune recovery is achieved.

                  • ado-trastuzumab emtansine

                    ado-trastuzumab emtansine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • alefacept

                    alefacept, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • alemtuzumab

                    alemtuzumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • anakinra

                    anakinra, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • ansuvimab

                    ansuvimab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • antithymocyte globulin equine

                    antithymocyte globulin equine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • antithymocyte globulin rabbit

                    antithymocyte globulin rabbit, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • apaziquone

                    apaziquone, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • atoltivimab/maftivimab/odesivimab

                    atoltivimab/maftivimab/odesivimab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • azathioprine

                    azathioprine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • balstilimab

                    balstilimab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • baricitinib

                    baricitinib, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • basiliximab

                    basiliximab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • belatacept

                    belatacept, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • bendamustine

                    bendamustine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • benralizumab

                    benralizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • benznidazole

                    benznidazole, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • betamethasone

                    betamethasone, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

                  • bevacizumab

                    bevacizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • bezlotoxumab

                    bezlotoxumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • bimekizumab

                    bimekizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • botulism immune globulin iv

                    botulism immune globulin iv, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • brodalumab

                    brodalumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • busulfan

                    busulfan, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • C1 esterase inhibitor recombinant

                    C1 esterase inhibitor recombinant, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • C1 inhibitor human

                    C1 inhibitor human, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • canakinumab

                    canakinumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • capecitabine

                    capecitabine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • caplacizumab

                    caplacizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • carboplatin

                    carboplatin, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • carmustine

                    carmustine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • certolizumab pegol

                    certolizumab pegol, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • cetuximab

                    cetuximab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • chlorambucil

                    chlorambucil, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • cisplatin

                    cisplatin, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • cladribine

                    cladribine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • clofarabine

                    clofarabine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • corticotropin

                    corticotropin, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

                  • cortisone

                    cortisone, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

                  • cyclophosphamide

                    cyclophosphamide, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • cyclosporine

                    cyclosporine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • cytarabine

                    cytarabine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • cytomegalovirus immune globulin (CMV IG)

                    cytomegalovirus immune globulin (CMV IG), brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • dacarbazine

                    dacarbazine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • daclizumab

                    daclizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • daratumumab

                    daratumumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • deflazacort

                    deflazacort, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

                  • denosumab

                    denosumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • dexamethasone

                    dexamethasone, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

                    brexucabtagene autoleucel, dexamethasone. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

                  • dimethyl fumarate

                    dimethyl fumarate, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • dinutuximab

                    dinutuximab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • diroximel fumarate

                    diroximel fumarate, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • dupilumab

                    dupilumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • ecallantide

                    ecallantide, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • eculizumab

                    eculizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • elotuzumab

                    elotuzumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • emapalumab

                    emapalumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • emicizumab

                    emicizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • etanercept

                    etanercept, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • fexinidazole

                    fexinidazole, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • filgotinib

                    filgotinib, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • fingolimod

                    fingolimod, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • flavocoxid/citrated zinc bisglycinate (DSC)

                    flavocoxid/citrated zinc bisglycinate (DSC), brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

                  • floxuridine

                    floxuridine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • fludarabine

                    fludarabine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • fludrocortisone

                    fludrocortisone, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

                  • fluorouracil

                    fluorouracil, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • gemcitabine

                    gemcitabine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • gemtuzumab

                    gemtuzumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • glatiramer

                    glatiramer, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • golimumab

                    golimumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • guselkumab

                    guselkumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • hepatitis B immune globulin (HBIG)

                    hepatitis B immune globulin (HBIG), brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • hydrocortisone

                    hydrocortisone, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

                  • hydroxychloroquine sulfate

                    hydroxychloroquine sulfate, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • hydroxyurea

                    hydroxyurea, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • ibritumomab tiuxetan

                    ibritumomab tiuxetan, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • icatibant

                    icatibant, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • ifosfamide

                    ifosfamide, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • immune globulin IM (IGIM)

                    immune globulin IM (IGIM), brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • immune globulin IV (IGIV)

                    immune globulin IV (IGIV), brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • immune globulin SC

                    immune globulin SC, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • inebilizumab

                    inebilizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • infliximab

                    infliximab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • interferon alfa n3

                    interferon alfa n3, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • interferon alfacon 1

                    interferon alfacon 1, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • interferon beta 1a

                    interferon beta 1a, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • interferon beta 1b

                    interferon beta 1b, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • iodoquinol

                    iodoquinol, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • ipilimumab

                    ipilimumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • isotretinoin

                    isotretinoin, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • ixekizumab

                    ixekizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • leflunomide

                    leflunomide, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • lomustine

                    lomustine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • lurbinectedin

                    lurbinectedin, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • measles mumps and rubella vaccine, live

                    brexucabtagene autoleucel decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during brexucabtagene autoleucel treatment, and after treatment until full immune recovery is achieved.

                  • measles, mumps, rubella and varicella vaccine, live

                    brexucabtagene autoleucel decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during brexucabtagene autoleucel treatment, and after treatment until full immune recovery is achieved.

                  • mechlorethamine

                    mechlorethamine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • mechlorethamine topical

                    mechlorethamine topical, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • melphalan

                    melphalan, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • melphalan flufenamide

                    melphalan flufenamide, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • mepolizumab

                    mepolizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • mercaptopurine

                    mercaptopurine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • methotrexate

                    methotrexate, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • methylprednisolone

                    methylprednisolone, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

                    brexucabtagene autoleucel, methylprednisolone. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

                  • mineral oil topical

                    mineral oil topical, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • mitoxantrone

                    mitoxantrone, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • mogamulizumab

                    mogamulizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • mometasone sinus implant

                    mometasone sinus implant, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

                  • monomethyl fumarate

                    monomethyl fumarate, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • moxetumomab pasudotox

                    moxetumomab pasudotox, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • muromonab CD3

                    muromonab CD3, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • mycophenolate

                    mycophenolate, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • narsoplimab

                    narsoplimab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • natalizumab

                    natalizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                    brexucabtagene autoleucel, natalizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • nelarabine

                    nelarabine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • nitazoxanide

                    nitazoxanide, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • nivolumab

                    nivolumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • obinutuzumab

                    obinutuzumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • ocrelizumab

                    ocrelizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • ofatumumab

                    ofatumumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • ofatumumab SC

                    ofatumumab SC, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • olaratumab

                    olaratumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • omalizumab

                    omalizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • oportuzumab monatox

                    oportuzumab monatox, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • oxaliplatin

                    oxaliplatin, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • panitumumab

                    panitumumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • paromomycin

                    paromomycin, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • peginterferon beta-1a

                    peginterferon beta-1a, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • pembrolizumab

                    pembrolizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • pemetrexed

                    pemetrexed, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • pentostatin

                    pentostatin, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • pimecrolimus

                    pimecrolimus, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • pralatrexate

                    pralatrexate, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • prednisolone

                    prednisolone, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

                  • prednisone

                    prednisone, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

                  • procarbazine

                    procarbazine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • rabies immune globulin, human (RIG)

                    rabies immune globulin, human (RIG), brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • ravulizumab

                    ravulizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • raxibacumab

                    raxibacumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • reltecimod

                    reltecimod, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                    brexucabtagene autoleucel, reltecimod. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • remestemcel-L

                    remestemcel-L, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • reslizumab

                    reslizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • Rho(D) immune globulin

                    Rho(D) immune globulin, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • rilonacept

                    rilonacept, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • risankizumab

                    risankizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • rituximab

                    rituximab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                    brexucabtagene autoleucel, rituximab. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • rituximab-hyaluronidase

                    rituximab-hyaluronidase, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • ropeginterferon alfa 2b

                    ropeginterferon alfa 2b, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • rotavirus oral vaccine, live

                    brexucabtagene autoleucel decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during brexucabtagene autoleucel treatment, and after treatment until full immune recovery is achieved.

                  • ruxolitinib topical

                    ruxolitinib topical, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • sarilumab

                    sarilumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • secukinumab

                    secukinumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • siltuximab

                    siltuximab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • sintilimab

                    sintilimab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • sirolimus

                    sirolimus, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • sirolimus intravitreal

                    sirolimus intravitreal, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • sirukumab

                    sirukumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • smallpox (vaccinia) vaccine, live

                    brexucabtagene autoleucel decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during brexucabtagene autoleucel treatment, and after treatment until full immune recovery is achieved.

                  • spesolimab

                    spesolimab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • streptozocin

                    streptozocin, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • sulfasalazine

                    sulfasalazine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                    brexucabtagene autoleucel, sulfasalazine. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • sutimlimab

                    sutimlimab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • tacrolimus

                    tacrolimus, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • tacrolimus ointment

                    tacrolimus ointment, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • temozolomide

                    temozolomide, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • teplizumab

                    teplizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • teriflunomide

                    teriflunomide, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • tetanus immune globulin (TIG)

                    tetanus immune globulin (TIG), brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • thioguanine

                    thioguanine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • thiotepa

                    thiotepa, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • tinidazole

                    tinidazole, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • tocilizumab

                    tocilizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • tofacitinib

                    tofacitinib, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • tositumomab

                    tositumomab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • trabectedin

                    trabectedin, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • tralokinumab

                    tralokinumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • trastuzumab

                    trastuzumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • trastuzumab deruxtecan

                    trastuzumab deruxtecan, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • treosulfan

                    treosulfan, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • triamcinolone acetonide extended-release injectable suspension

                    triamcinolone acetonide extended-release injectable suspension, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

                  • triamcinolone acetonide injectable suspension

                    triamcinolone acetonide injectable suspension, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

                  • ublituximab

                    ublituximab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • upadacitinib

                    upadacitinib, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • ustekinumab

                    ustekinumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • vaccinia immune globulin intravenous

                    vaccinia immune globulin intravenous, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • varicella virus vaccine live

                    brexucabtagene autoleucel decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during brexucabtagene autoleucel treatment, and after treatment until full immune recovery is achieved.

                  • varicella zoster immune globulin, human

                    varicella zoster immune globulin, human, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • vedolizumab

                    vedolizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                    brexucabtagene autoleucel, vedolizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • voclosporin

                    voclosporin, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

                  • yellow fever vaccine

                    brexucabtagene autoleucel decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during brexucabtagene autoleucel treatment, and after treatment until full immune recovery is achieved.

                  • zoster vaccine live

                    brexucabtagene autoleucel decreases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during brexucabtagene autoleucel treatment, and after treatment until full immune recovery is achieved.

                  Monitor Closely (0)

                    Minor (0)

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                      Adverse Effects

                      >10% (Any Grade)

                      MCL

                      • Pyrexia (94%)
                      • Cytokine release syndrome (91%)
                      • Hypotension (57%)
                      • Encephalopathy (51%)
                      • Fatigue (49%)
                      • Tachycardia (45%)
                      • Infection (43%)
                      • Chills (41%)
                      • Hypoxia (40%)
                      • Cough (38%)
                      • Tremor (38%)
                      • Musculoskeletal pain (37%)
                      • Edema (35%)
                      • Nausea (35%)
                      • Headache (35%)
                      • Constipation (29%)
                      • Diarrhea (28%)
                      • Decreased appetite (26%)
                      • Dyspnea (24%)
                      • Rash (22%)
                      • Pleural effusion (21%)
                      • Aphasia (20%)
                      • Viral infection (18%)
                      • Dizziness (18%)
                      • Renal insufficiency (18%)
                      • Hypertension (18%)
                      • Thrombosis (17%)
                      • Abdominal pain (17%)
                      • Pain (17%)
                      • Motor dysfunction (17%)
                      • Oral pain (16%)
                      • Hypogammaglobulinemia (16%)
                      • Anxiety (16%)
                      • Vomiting (13%)
                      • Bacterial infection (13%)
                      • Decreased urine output (11%)

                      ALL

                      • Fever (96%)
                      • Cytokine release syndrome (92%)
                      • Hypotension (69%)
                      • Tachycardias (63%)
                      • Encephalopathy (63%)
                      • Nausea (41%)
                      • Chills (40%)
                      • Headache (38%)
                      • Fatigue (37%)
                      • Febrile neutropenia (35%)
                      • Diarrhea (32%)
                      • Musculoskeletal pain (32%)
                      • Rash (31%)
                      • Hypoxia (31%)
                      • Edema (29%)
                      • Tremor (29%)
                      • Infection with pathogen unspecified (28%)
                      • Constipation (24%)
                      • Decreased appetite (22%)
                      • Vomiting (21%)
                      • Abdominal pain (19%)
                      • Delirium (18%)
                      • Coagulopathy (17%)
                      • Arrhythmia (15%)
                      • Bacterial infections (15%)
                      • Muscular weakness (14%)
                      • Pain (13%)
                      • Fungal infections (13%)
                      • Dizziness (13%)
                      • Hemorrhage (13%)
                      • Hypertension (13%)
                      • Insomnia (13%)
                      • Cough (12%)
                      • Dyspnea (12%)
                      • Anxiety (12%)

                      >10% (Grade ≥3)

                      MCL

                      • Leukopenia (95%)
                      • Neutropenia (95%)
                      • Lymphopenia (86%)
                      • Thrombocytopenia (63%)
                      • Anemia (55%)
                      • Hypophosphatemia (30%)
                      • Hypotension (27%)
                      • Infection (24%)
                      • Encephalopathy (24%)
                      • Hypocalcemia (21%)
                      • Hypoxia (20%)
                      • Cytokine release syndrome (18%)
                      • Increased blood uric acid (17%)
                      • Hyponatremia (16%)
                      • Increased AST/ALT (15%)
                      • Pyrexia (15%)
                      • Hypertension (11%)

                      ALL

                      • Fever (96%)
                      • Cytokine release syndrome (92%)
                      • Hypotension (69%)
                      • Tachycardias (63%)
                      • Encephalopathy (63%)
                      • Nausea (41%)
                      • Chills (40%)
                      • Headache (38%)
                      • Fatigue (37%)
                      • Febrile neutropenia (35%)
                      • Diarrhea (32%)
                      • Musculoskeletal pain (32%)
                      • Rash (31%)
                      • Hypoxia (31%)
                      • Edema (29%)
                      • Tremor (29%)
                      • Infection with pathogen unspecified (28%)
                      • Constipation (24%)
                      • Decreased appetite (22%)
                      • Vomiting (21%)
                      • Abdominal pain (19%)
                      • Delirium (18%)
                      • Coagulopathy (17%)
                      • Arrhythmia (15%)
                      • Bacterial infections (15%)
                      • Muscular weakness (14%)
                      • Pain (13%)
                      • Fungal infections (13%)
                      • Dizziness (13%)
                      • Hemorrhage (13%)
                      • Hypertension (13%)
                      • Insomnia (13%)
                      • Cough (12%)
                      • Dyspnea (12%)
                      • Anxiety (12%)

                      1-10% (All Grades)

                      MCL

                      • Coagulopathy (10%)
                      • Dysphagia (10%)
                      • Bradycardia (10%)
                      • Nonventricular arrhythmia (10%)
                      • Fungal infection (9%)
                      • Rash (9%)
                      • Dry mouth (7%)
                      • Ataxia (7%)
                      • Hemorrhage (7%)
                      • Dehydration (6%)
                      • Respiratory failure (6%)
                      • Seizure (5%)
                      • Pulmonary edema (4%)
                      • Increased ICP (2%)

                      1-10% (Grade ≥3)

                      MCL

                      • Hypokalemia (10%)
                      • Renal insufficiency (9%)
                      • Aphasia (7%)
                      • Dizziness (6%)
                      • Bacterial infection (6%)
                      • Dyspnea (6%)
                      • Diarrhea (5%)
                      • Delirium (5%)
                      • Pleural effusion (5%)
                      • Nonventricular arrhythmias (4%)
                      • Viral infection (4%)
                      • Motor dysfunction (4%)
                      • Rash (4%)
                      • Thrombosis (4%)
                      • Coagulopathy (2%)
                      • Dysphagia (2%)
                      • Edema (2%)
                      • Pain (2%)
                      • Musculoskeletal pain (2%)
                      • Tremor (2%)
                      • Neuropathy (2%)
                      • Nausea (1%)
                      • Fatigue (1%)
                      • Hypogammaglobulinemia (1%)
                      • Headache (1%)
                      • Urine output decreased (1%)

                      ALL

                      • Bacterial infections (8%)
                      • Tachycardias (6%)
                      • Hypertension (6%)
                      • Diarrhea (6%)
                      • Coagulopathy (5%)
                      • Edema (5%)
                      • Delirium (5%)
                      • Fungal infections (5%)
                      • Musculoskeletal pain (5%)
                      • Hemorrhage (4%)
                      • Vomiting (3%)
                      • Arrhythmia (1%)
                      • Nausea (1%)
                      • Fatigue (1%)
                      • Pain (1%)
                      • Decreased appetite (1%)
                      • Muscular weakness (1%)
                      • Headache (1%)
                      • Tremor (1%)
                      • Dizziness (1%)
                      • Dyspnea (1%)
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                      Warnings

                      Black Box Warnings

                      Cytokine release syndrome

                      • Cytokine release syndrome (CRS), including fatal or life-threatening reactions, reported in a majority of patients
                      • Do not administer to patients with active infection or inflammatory disorders
                      • Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids

                      Neurological toxicities

                      • Neurologic toxicities, including life-threatening reactions, reported; these may occur concurrently with CRS or after CRS resolution; monitor and provide supportive care and/or corticosteroids as needed
                      • The most common neurological toxicities were encephalopathy, headache, tremor, aphasia, and delirium
                      • Monitor for neurological events for at least 7 days at the certified healthcare facility following infusion for signs and symptoms of neurologic toxicities

                      Restricted access program

                      • Available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS program
                      • Further information is available at www.yescartatecartusrems.com or 1-844-454-KITE (5483)
                      • REMS requirements
                        • Healthcare facilities that dispense and administer brexucabtagene autoleucel must be enrolled and comply with the REMS requirements
                        • Certified healthcare facilities must have onsite immediate access to tocilizumab and ensure that a minimum of 2 doses of tocilizumab are available for each patient for administration within 2 hr after brexucabtagene autoleucel IV infusion, if needed for treatment of CRS
                        • Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer brexucabtagene autoleucel are trained about the management of CRS and neurological toxicities

                      Contraindications

                      None

                      Cautions

                      Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment in a majority of patients (see Black Box Warnings and Adverse Effects)

                      Available only through a restricted access program

                      Allergic reactions may occur during infusion; serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide or residual gentamicin in the product

                      Viral reactivation can occur; hepatitis B virus (HBV) reactivation can result in fulminant hepatitis, hepatic failure, and death; perform screening for HBV, hepatitis C virus, and HIV in accordance with clinical guidelines before collection of cells for manufacturing

                      Prolonged cytopenias may occur and last for several weeks following lymphodepleting chemotherapy and brexucabtagene autoleucel infusion; monitor blood cell counts

                      B-cell aplasia and hypogammaglobulinemia can occur; monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement standard guidelines

                      Secondary malignancies may develop; monitor patient life-long for secondary malignancies

                      Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), including life-threatening reactions reported; patients with HLH/MAS reported to have CRS symptoms and neurologic events after infusion; administer HLH/MAS treatment per institutional standards

                      Infection risk

                      • Serious infections, including life-threatening or fatal infections, reported; before administering, infection prophylaxis for neutropenia should follow local guidelines; monitor for signs and symptoms of infection after treatment and treat appropriately
                      • Life-threatening and fatal opportunistic infections reported in immunosuppressed patients; consider possibility of rare infectious etiologies (eg, fungal and viral infections such as HHV-6 and progressive multifocal leukoencephalopathy) in patients with neurologic events; perform appropriate diagnostic procedures
                      • Viral reactivation can occur; hepatitis B virus (HBV) reactivation can result in fulminant hepatitis, hepatic failure, and death; perform screening for HBV, hepatitis C virus, and HIV in accordance with clinical guidelines before collection of cells for manufacturing

                      Neurologic effects

                      • Neurological toxicities, which may be severe or life-threatening, can occur following treatment
                      • Owing to the potential for neurological events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following treatment; advise patients to refrain from driving and engaging in hazardous occupations or activities

                      Immunization with live viral vaccines

                      • Safety of immunization with live viral vaccines during or following treatment has not been studied
                      • Vaccination with live-virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during brexucabtagene autoleucel treatment, and until immune recovery afterwards
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                      Pregnancy & Lactation

                      Pregnancy

                      Data are not available in pregnant women

                      No animal reproductive and developmental toxicity studies have been conducted

                      Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia

                      Therefore, brexucabtagene autoleucel is not recommended during pregnancy, and pregnancy after infusion should be discussed with the treating physician

                      Verify pregnancy status of females with reproductive potential; sexually active females of reproductive potential should have a pregnancy test prior to starting treatment

                      Contraception

                      • See the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy
                      • Limited exposure data available concerning the duration of contraception following treatment

                      Lactation

                      Unknown if distributed in human breast milk

                      Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

                      Pregnancy Categories

                      A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                      B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                      C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                      D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                      X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                      NA: Information not available.

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                      Pharmacology

                      Mechanism of Action

                      CD19-directed genetically modified autologous T-cell immunotherapy that involves reengineering a patient’s own T cells to express a chimeric antigen receptor (CAR) to identify and bind to CD19-expressing malignant and normal B cells

                      Following anti-CD19 CAR T-cell engagement with CD19-expressing target cells, the CD28 and CD3-zeta costimulatory domains activate downstream signaling cascades that lead to T-cell activation, proliferation, acquisition of effector functions and secretion of inflammatory cytokines and chemokines

                      This cascade of events leads to killing of CD19-expressing cells

                      Absorption

                      Peak plasma time: 7-15 days

                      Peak plasma concentration, median: 102.4 cells/mcL (responsive patients); 12 cells/mcL (nonresponsive [NR] patients)

                      AUC (0-28d): 1487 cells/mcL⋅days (responsive patients); 169.5 cells/mcL⋅days (NR patients)

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                      Administration

                      IV Preparation

                      Confirm infusion time in advance, and adjust start time for thawing CAR-T cells to be available for infusion when recipient is ready

                      Confirm patient identity prior to preparation, and match the patient's identity with the patient identifiers on the infusion bag

                      Inspect infusion bag for any breaks or cracks before thawing; if bag is compromised, do not infuse the contents; contact Kite at 1-844-454-KITE

                      Place infusion bag inside a second, sterile bag as per local guidelines

                      Thaw infusion bag at 37ºC using either a water bath or dry thaw method until there is no visible ice in the infusion bag

                      Gently mix contents of bag to disperse small clumps of cellular material; if visible cell clumps remain, continue to gently mix contents of bag

                      Do not wash, spin down, or resuspend in new media before IV infusion

                      Once thawed, stored at room temperature (20-25ºC) for up to 3 hr

                      IV Administration

                      For autologous use only

                      Ensure that tocilizumab and emergency equipment are available prior to infusion and during the recovery period

                      Do not use a leukodepleting filter

                      Premedicate with acetaminophen PO and diphenhydramine PO or IV (or other H1 antihistamine) ~30-60 minutes; avoid prophylactic systemic corticosteroids, except in case of life-threatening emergency

                      Central venous access recommended for the infusion

                      Prime tubing with 0.9% NaCl prior to infusion

                      Infuse entire contents of the bag within 30 minutes by either gravity or a peristaltic pump

                      Thawed infusion bag is stable at room temperature for up to 3 hr

                      Gently agitate the product bag during infusion to prevent cell clumping

                      After completing infusion, rinse tubing with 0.9% NaCl at the same infusion rate to ensure all product is delivered

                      Follow local biosafety guidelines applicable for handling and disposal of such products

                      Storage

                      Frozen product

                      • Store infusion bag in the vapor phase of liquid nitrogen ≤-238ºF (≤-150ºC) supplied in a liquid nitrogen dry shipper
                      • Use closed, break-proof, leak-proof containers when transporting infusion bags within the facility

                      Thawed infusion bag

                      • Stored at room temperature 68-77ºF (20-25ºC) for up to 3 hr
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                      Images

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                      Patient Handout

                      A Patient Handout is not currently available for this monograph.
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                      Formulary

                      FormularyPatient Discounts

                      Adding plans allows you to compare formulary status to other drugs in the same class.

                      To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                      Create Your List of Plans

                      Adding plans allows you to:

                      • View the formulary and any restrictions for each plan.
                      • Manage and view all your plans together – even plans in different states.
                      • Compare formulary status to other drugs in the same class.
                      • Access your plan list on any device – mobile or desktop.

                      The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                      View explanations for tiers and restrictions
                      Tier Description
                      1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                      2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                      3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                      4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                      5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                      6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                      NC NOT COVERED – Drugs that are not covered by the plan.
                      Code Definition
                      PA Prior Authorization
                      Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                      QL Quantity Limits
                      Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                      ST Step Therapy
                      Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                      OR Other Restrictions
                      Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                      Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.
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