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

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             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)

                  Previous
                  Next:

                  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%)
                  Previous
                  Next:

                  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
                  Previous
                  Next:

                  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.

                  Previous
                  Next:

                  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)

                  Previous
                  Next:

                  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
                  Previous
                  Next:

                  Images

                  No images available for this drug.
                  Previous
                  Next:

                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
                  Previous
                  Next:

                  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.

                  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.

                  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.
                  Additional Offers
                  Email to Patient

                  From:

                  To:

                  The recipient will receive more details and instructions to access this offer.

                  By clicking send, you acknowledge that you have permission to email the recipient with this information.

                  Email Forms to Patient

                  From:

                  To:

                  The recipient will receive more details and instructions to access this offer.

                  By clicking send, you acknowledge that you have permission to email the recipient with this information.

                  Previous
                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.