Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (197)
- 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.
- etrasimod
etrasimod, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Risk of additive immune system effects with etrasimod has not been studied in combination with antineoplastic, immune-modulating, or noncorticosteroid immunosuppressive therapies. Avoid coadministration during and in the weeks following administration of etrasimod.
- 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)
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%)
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
FDA MedWatch alert
- November 28, 2023: FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR-T cell immunotherapies
- Reports came from clinical trials and/or postmarketing adverse event data sources
- FDA determined the risk of T-cell malignancies is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR-T cell immunotherapies
- Although overall benefits continue to outweigh their potential risks for approved uses, FDA is investigating the identified risk of T-cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action
- Monitor patients and clinical trial participants receiving treatment for life-long for new malignancies
- If new malignancy occurs following treatment, contact manufacturer to report event and obtain instructions on collection of patient samples for testing for presence of CAR transgene
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
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.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)
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
Images
Formulary
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