lisocabtagene maraleucel (Rx)

Brand and Other Names:Breyanzi
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, suspension

  • A single dose contains 50-110 x 106 CAR-positive viable T cells, consisting of CD8 and CD4 components, with each component supplied separately in single-dose vials
  • More than 1 vial of each of the CD8 component and/or CD4 component may be needed to achieve the dose
  • Each vial contains 6.9-322 x 106 CAR-positive viable T cells in 4.6 mL cell suspension (1.5-70 x 106 T cells/mL)
  • Check Rlease for Infusion (RFI) Certificate for specific content

B-Cell Lymphoma

Chimeric antigen receptor (CAR) T-cell immunotherapy (Anti-CD19) indicated for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least 2 prior lines of systemic therapies, including DLBCL not otherwise specified (arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3 B

One treatment course consists of fludarabine- and cyclophosphamide-lymphodepleting chemotherapy followed by IV infusion of lisocabtagene maraleucel

Confirm availability of lisocabtagene maraleucel before starting lymphodepleting chemotherapy

Pretreatment - Lymphodepleting chemotherapy

  • Administer lymphodepleting chemotherapy before infusing lisocabtagene maraleucel
  • Fludarabine 30 mg/m2 IV plus cyclophosphamide 500 mg/m2 IV qDay for 3 days
  • Infuse lisocabtagene maraleucel 2-7 days after completing lymphodepleting chemotherapy
  • Delay lisocabtagene maraleucel infusion if patient has unresolved serious adverse events from lymphodepleting chemotherapy, active uncontrolled infection, or active graft-versus-host disease (GVHD)

Premedication

  • Premedicate with acetaminophen 650 mg PO and diphenhydramine 25-50 mg PO/IV (or other H1 antihistamine) ~30-60 minutes before CAR T-cell infusion
  • Avoid prophylactic use of systemic corticosteroids at all times (may interfere with CAR T-cell activity), except in the case of a life-threatening emergency

Lisocabtagene maraleucel IV infusion

  • For autologous use only; administer 2-7 days after completing lymphodepleting chemotherapy
  • Dose based on the number of CAR-positive viable T-cells per vial
  • A single dose contains 50-110 x 106 CAR-positive viable T-cells (consisting of 1:1 CAR-positive viable T-cells of the CD8 and CD4 components)
  • Each component supplied separately in 1-4 single-dose vials

Dosage Modifications

Cytokine release syndrome (CRS) management

NOTE: If corticosteroids are initiated, continue for at least 3 doses or until complete resolution of symptoms, and consider corticosteroid taper

  • Grade 1
    • Symptoms: Fever
    • <72 hr after CAR T-cell infusion: Consider 8 mg/kg IV over 1 hr, not to exceed 800 mg; may also consider dexamethasone 10 mg IV q24hr
    • ≥72 hr: Treat symptomatically
  • Grade 2
    • Symptoms require and respond to 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; after 2 doses of tocilizumab, consider alternant immunosuppressants
    • If improving, discontinue tocilizumab
    • If <72 hr: Dexamethasone 10 mg IV q12-24hr
    • If ≥72 hr: Consider dexamethasone at above dose
    • No improvement within 24 hr or rapid progression: Repeat tocilizumab and escalate dose and frequency of dexamethasone (10-20 mg IV q6-12hr); if no improvement on maximized dexamethasone, switch to high-dose methylprednisolone 2 mg/kg if needed
  • 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 2 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
    • Corticosteroid dose as for Grade 2; taper if improving or manage as Grade 2 if not improving

Neurologic toxicity grading and management

  • Grade 1
    • Start nonsedating, antiseizure medicines (eg, levetiracetam) for seizure prophylaxis
    • <72 hr: Consider dexamethasone 10 mg IV q12-24hr for 2-3 days
    • ≥72 hr: Observe
  • Grade 2
    • Start nonsedating, antiseizure medicines (eg, levetiracetam) for seizure prophylaxis
    • Dexamethasone 10 mg IV q12hr for 2-3 days, or longer for persistent symptoms; consider taper for total steroid exposure >3 days
    • If no improvement after 24 hr or worsening of neurologic toxicity, increase dexamethasone to up to 20 mg IV q6hr
    • If no improvement after another 24 hr, rapidly progressing symptoms, or life-threatening complications arise, give methylprednisolone (2 mg/kg loading dose, followed by 2 mg/kg QID; taper within 7 days)
  • Grade 3
    • Start nonsedating, antiseizure medicines (eg, levetiracetam) for seizure prophylaxis
    • Dexamethasone 10-20 mg IV q8-12
    • Steroids not recommended for isolated Grade 3 headaches
    • If no improvement after 24 hr or worsening of neurologic toxicity, escalate to methylprednisolone (dose and frequency as per Grade 2)
    • If cerebral edema suspected, consider hyperventilation and hyperosmolar therapy; administer high-dose methylprednisolone 1-2 g IV q24hr prn; taper as clinically indicated and cyclophosphamide 1.5 g/m2
  • Grade 4
    • Start nonsedating, antiseizure medicines (eg, levetiracetam) for seizure prophylaxis
    • Dexamethasone 20 mg IV q6hr
    • If no improvement after 24 hr or worsening of neurologic toxicity, escalate to methylprednisolone (dose and frequency as per Grade 2)
    • If cerebral edema suspected, consider hyperventilation and hyperosmolar therapy; give high-dose methylprednisolone and cyclophosphamide (dose and frequency as per Grade 3)

Dosing Considerations

Limitation of use: Not indicated for treatment primary CNS lymphoma

Administer at a certified healthcare facility

Monitor for signs/symptoms of CRS and neurologic toxicities at least daily for 7 days following infusion

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

Verify pregnancy status of females with reproductive potential

Safety and efficacy not established

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Interactions

Interaction Checker

and lisocabtagene maraleucel

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              Serious - Use Alternative (187)

              • abatacept

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

              • abrocitinib

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

              • adalimumab

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

              • ado-trastuzumab emtansine

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

              • alefacept

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

              • alemtuzumab

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

              • anakinra

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

              • ansuvimab

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

              • antithymocyte globulin equine

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

              • antithymocyte globulin rabbit

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

              • apaziquone

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

              • atoltivimab/maftivimab/odesivimab

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

              • azathioprine

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

              • balstilimab

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

              • baricitinib

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

              • basiliximab

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

              • belatacept

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

              • bendamustine

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

              • benralizumab

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

              • benznidazole

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

              • betamethasone

                betamethasone, lisocabtagene maraleucel. 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, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • bezlotoxumab

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

              • bimekizumab

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

              • brodalumab

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

              • busulfan

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

              • C1 inhibitor human

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

              • canakinumab

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

              • capecitabine

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

              • caplacizumab

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

              • carboplatin

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

              • carmustine

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

              • certolizumab pegol

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

              • cetuximab

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

              • chlorambucil

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

              • cisplatin

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

              • cladribine

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

              • clofarabine

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

              • corticotropin

                corticotropin, lisocabtagene maraleucel. 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, lisocabtagene maraleucel. 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, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • cyclosporine

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

              • cytarabine

                cytarabine, lisocabtagene maraleucel. 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), lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • dacarbazine

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

              • daclizumab

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

              • daratumumab

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

              • deflazacort

                deflazacort, lisocabtagene maraleucel. 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, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • dexamethasone

                dexamethasone, lisocabtagene maraleucel. 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.

                lisocabtagene maraleucel, 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, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • dinutuximab

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

              • diroximel fumarate

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

              • dupilumab

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

              • ecallantide

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

              • eculizumab

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

              • elotuzumab

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

              • emapalumab

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

              • emicizumab

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

              • etanercept

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

              • fexinidazole

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

              • filgotinib

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

              • fingolimod

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

              • floxuridine

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

              • fludarabine

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

              • fludrocortisone

                fludrocortisone, lisocabtagene maraleucel. 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, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • gemcitabine

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

              • gemtuzumab

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

              • glatiramer

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

              • golimumab

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

              • guselkumab

                guselkumab, lisocabtagene maraleucel. 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), lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • hydrocortisone

                hydrocortisone, lisocabtagene maraleucel. 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, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • hydroxyurea

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

              • ibritumomab tiuxetan

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

              • icatibant

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

              • ifosfamide

                ifosfamide, lisocabtagene maraleucel. 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), lisocabtagene maraleucel. 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), lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • immune globulin SC

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

              • inebilizumab

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

              • infliximab

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

              • interferon alfa n3

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

              • interferon alfacon 1

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

              • interferon beta 1a

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

              • interferon beta 1b

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

              • iodoquinol

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

              • ipilimumab

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

              • isotretinoin

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

              • ixekizumab

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

              • leflunomide

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

              • lomustine

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

              • lurbinectedin

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

              • mechlorethamine

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

              • mechlorethamine topical

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

              • melphalan

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

              • melphalan flufenamide

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

              • mepolizumab

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

              • mercaptopurine

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

              • methotrexate

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

              • methylprednisolone

                methylprednisolone, lisocabtagene maraleucel. 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.

                lisocabtagene maraleucel, 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, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • mitoxantrone

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

              • mogamulizumab

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

              • mometasone sinus implant

                mometasone sinus implant, lisocabtagene maraleucel. 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, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • moxetumomab pasudotox

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

              • muromonab CD3

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

              • mycophenolate

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

              • narsoplimab

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

              • natalizumab

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

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

              • nelarabine

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

              • nitazoxanide

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

              • nivolumab

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

              • obinutuzumab

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

              • ocrelizumab

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

              • ofatumumab

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

              • ofatumumab SC

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

              • olaratumab

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

              • omalizumab

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

              • oportuzumab monatox

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

              • oxaliplatin

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

              • panitumumab

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

              • paromomycin

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

              • peginterferon beta-1a

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

              • pembrolizumab

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

              • pemetrexed

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

              • pentostatin

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

              • pimecrolimus

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

              • pralatrexate

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

              • prednisolone

                prednisolone, lisocabtagene maraleucel. 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, lisocabtagene maraleucel. 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, lisocabtagene maraleucel. 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), lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • ravulizumab

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

              • raxibacumab

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

              • reltecimod

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

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

              • remestemcel-L

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

              • reslizumab

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

              • rilonacept

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

              • risankizumab

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

              • rituximab

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

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

              • rituximab-hyaluronidase

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

              • ropeginterferon alfa 2b

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

              • ruxolitinib topical

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

              • sarilumab

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

              • secukinumab

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

              • siltuximab

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

              • sintilimab

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

              • sirolimus

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

              • sirolimus intravitreal

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

              • sirukumab

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

              • spesolimab

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

              • streptozocin

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

              • sulfasalazine

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

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

              • sutimlimab

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

              • tacrolimus

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

              • tacrolimus ointment

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

              • temozolomide

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

              • teplizumab

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

              • teriflunomide

                teriflunomide, lisocabtagene maraleucel. 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), lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • thioguanine

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

              • thiotepa

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

              • tinidazole

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

              • tocilizumab

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

              • tofacitinib

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

              • tositumomab

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

              • trabectedin

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

              • tralokinumab

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

              • trastuzumab

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

              • trastuzumab deruxtecan

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

              • treosulfan

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

              • upadacitinib

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

              • ustekinumab

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

              • varicella zoster immune globulin, human

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

              • vedolizumab

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

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

              • voclosporin

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

              Monitor Closely (0)

                Minor (0)

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                  Adverse Effects

                  >10%

                  All grades

                  • Fatigue (48%)
                  • Cytokine release syndrome (46%)
                  • Musculoskeletal pain (37%)
                  • Nausea (33%)
                  • Hypogammaglobulinemia (32%)
                  • Headache (30%)
                  • Encephalopathy (29%)
                  • Infections (29%)
                  • Decreased appetite (28%)
                  • Diarrhea (26%)
                  • Hypotension (26%)
                  • Tachycardia (25%)
                  • Dizziness (24%)
                  • Constipation (23%)
                  • Cough (23%)
                  • Abdominal pain (21%)
                  • Vomiting (21%)
                  • Edema (21%)
                  • Tremor (16%)
                  • Fever (16%)
                  • Dyspnea (16%)
                  • Insomnia (14%)
                  • Hypertension (14%)
                  • Bacterial infections (13%)
                  • Upper respiratory tract infection (13%)
                  • Rash (13%)
                  • Chills (12%)
                  • Peripheral neuropathy (11%)
                  • Renal failure (11%)

                  Grade >3

                  • Neutropenia (76%)
                  • Thrombocytopenia (39%)
                  • Anemia (23%)
                  • Infections (16%)
                  • Hypofibrinogenemia (15%)
                  • Hypophosphatemia (13%)

                  1-10%

                  All grades

                  • Viral infectious disorders (10%)
                  • Motor dysfunction (10%)
                  • Aphasia (10%)
                  • Anxiety (10%)
                  • Delirium (10%)
                  • Hemorrhage (10%)

                  Grade >3

                  • Encephalopathy (9%)
                  • Bacterial infections (5%)
                  • Hypertension (4.5%)
                  • Cytokine release syndrome (4.1%)
                  • Fatigue (3.4%)
                  • Hypotension (3.4%)
                  • Abdominal pain (3%)
                  • Renal failure (3%)
                  • Decreased appetite (2.6%)
                  • Dizziness (2.6%)
                  • Dyspnea (2.6%)
                  • Musculoskeletal pain (2.2%)
                  • Aphasia (2.2%)
                  • Delirium (2.2%)
                  • Nausea (1.5%)
                  • Hemorrhage (1.5%)
                  • Viral infections (1.5%)
                  • Edema (1.1%)
                  • Motor dysfunction (1.1%)
                  • Headache (1.1%)

                  <1%

                  Grade >3

                  • Upper respiratory tract infection (0.7%)
                  • Diarrhea (0.4%)
                  • Vomiting (0.4%)
                  • Insomnia (0.4%)
                  • Rash (0.4%)
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                  Warnings

                  Black Box Warnings

                  Cytokine release syndrome

                  • Cytokine release syndrome (CRS), including fatal or life-threatening reactions, reported in a majority of patients
                  • Do not administer to patients with active infection or inflammatory disorders
                  • Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids
                  • Patients should seek immediate medical attention if signs or symptoms of CRS occur at any time; at the first sign of CRS, institute treatment with supportive care, tocilizumab or tocilizumab, and corticosteroids as indicated

                  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 Breyanzi REMS program
                  • Further information is available at www.yescartatecartusrems.com or 1-888-423-5436
                  • REMS requirements
                    • Healthcare facilities that dispense and administer lisocabtagene maraleucel 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 CAR T-cell IV infusion, if needed for treatment of CRS
                    • Certified healthcare facilities must ensure training about CRS management and neurological toxicities for healthcare providers who prescribe, dispense, or administer CAR T-cells

                  Contraindications

                  None

                  Cautions

                  CRS, including fatal or life-threatening reactions, occurred (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 dimethyl sulfoxide in the product

                  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 manage infections with broad-spectrum antibiotics, fluids, and other supportive care

                  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 CAR T-cell infusion; monitor blood cell counts prior to and after therapy administration

                  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

                  Neurological toxicities

                  • Neurological toxicities, which may be severe or life-threatening, can occur following treatment
                  • The most common neurologic toxicities include encephalopathy, tremor, aphasia, delirium, headache, ataxia, and dizziness
                  • Serious events including cerebral edema and seizures occurred; fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, were reported
                  • 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
                  • Monitor daily during first week following infusion for signs and symptoms of neurologic toxicities, then at least weekly for 4 weeks
                  • HIV and the lentivirus used to make lisocabtagene maraleucel have limited, short spans of identical genetic material (RNA); therefore, some commercial HIV nucleic acid tests may yield false-positive results in patients who have received lisocabtagene maraleucel

                  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 CAR T-cell treatment, and until immune recovery afterwards
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                  Pregnancy & Lactation

                  Pregnancy

                  Data are not available in pregnant females

                  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 and hypogammaglobulinemia

                  Not recommended during pregnancy, and pregnancy after infusion should be discussed with 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

                  Infertility: Data are unavailable

                  Contraception

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

                  Lactation

                  Unknown if distributed in human breast milk

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

                  Pregnancy Categories

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

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

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

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

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

                  NA: Information not available.

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                  Pharmacology

                  Mechanism of Action

                  CD19-directed genetically modified autologous T-cell immunotherapy that involves reprogramming a patient’s own T cells with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate CD19-expressing malignant and normal cells

                  Following anti-CD19 CAR T-cell engagement with CD19-expressing target cells, the CD28, 4-1BB (CD137), and CD3-zeta co-stimulatory 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: 12 days

                  Peak plasma concentration, median: 35,335 copies/mcg (responsive patients); 15,527 copies/mcg (nonresponsive [NR] patients)

                  AUC (0-28d): 273,552 copies/mcg⋅day (responsive patients); 155,240 copies/mcg⋅day (NR patients)

                  Elimination

                  Present in peripheral blood for up to 2 yr

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                  Administration

                  IV Preparation

                  Thawing

                  • Carefully remove vials from cartons and place on protective barrier pad
                  • Thaw at room temperature until there is no visible ice in vials
                  • Thaw all vials at the same time
                  • Keep CD8 and CD4 components separate

                  Preparing syringes

                  • Based on concentration of CAR-positive viable T cells for each component, >1 vial of each of the CD8 and CD4 components may be required to complete a dose
                  • Prepare separate syringes for each CD8 or CD4 component vial received
                  • Volume drawn up and infused may differ for each component as indicated on the RFI Certificate; do NOT draw up excess volume into syringe
                  • Each vial contains 5 mL with a total extractable volume of 4.6 mL of CD8 or CD4 component T cells; RFI Certificate for each component indicates the volume (mL) of cells to be drawn up into each syringe
                  • Use the smallest Luer-lock tip syringe necessary (1, 3, or 5 mL) to draw up specified volume from each vial
                  • Use 5-mL syringe for volumes <3 mL
                  • Draw up CD8 component first; affix CD8 syringe labels to syringe(s) beforehand
                  • See specific instructions and diagrams in prescribing information for needle gauge, length, and angle when puncturing port septum
                  • Repeat process for CD4 component

                  IV Administration

                  • For autologous use only
                  • Do NOT use leukodepleting filter
                  • Ensure tocilizumab and emergency equipment are available before infusion and during the recovery period
                  • Confirm patient identity matches identifiers on syringe label
                  • Proceed with administration as soon as possible after preparation
                  • Total time from removal from frozen storage to patient administration should not exceed 2 hr as indicated by the time entered on the syringe label

                  Administration steps

                  • Use IV 0.9% NaCl to flush all infusion tubing before and after each CD8 or CD4 component administration
                  • Administer entire volume of CD8 component IV at infusion rate of ~0.5 mL/minute, using the closest port or Y-arm
                  • NOTE: Infusion time will vary, but usually <15 minutes for each component
                  • If >1 syringe required for full cell dose of CD8 component, administer volume in each syringe consecutively without any time between administering the contents of the syringes (unless there is a clinical reason [eg, infusion reaction] to hold the dose)
                  • After CD8 component administered, flush tubing with 0.9% NaCl, using enough volume to clear tubing and length of IV catheter
                  • Administer CD4 component second, immediately after administration of CD8 component completed, using steps described for the CD8 component, then flush tubing as described
                  • Follow universal precautions and local biosafety guidelines applicable for handling and disposal, to avoid potential transmission of infectious disease

                  Storage

                  Shipped directly to cell lab or clinical pharmacy associated with infusion center in vapor phase of a liquid nitrogen shipper

                  Store vials in the vapor phase of liquid nitrogen (≤ -130ºC) in a temperature-monitored system

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                  Images

                  No images available for this drug.
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                  Patient Handout

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

                  FormularyPatient Discounts

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

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

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