tisagenlecleucel (Rx)

Brand and Other Names:Kymriah
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

Single-dose units contain specific amounts of T-cell depending on the patient’s body weight that are suspended in a patient-specific infusion bag

See the certificate of analysis (CoA) for actual cell count following individual preparation

injection, suspension for pediatric and young adult B-cell ALL (<25 years)

  • ≤50 kg: 0.2-5 x 10^6 CAR-positive viable T cells/kg
  • >50 kg: 0.1-2.5 x 10^8 CAR-positive viable T cells/kg

injection, suspension for adult relapsed or refractory diffuse large B-cell lymphoma

  • 0.6-6 x 10^8 CAR-positive viable T cells

Acute Lymphoblastic Leukemia

CD19-directed genetically modified autologous T-cell immunotherapy indicated for young adults aged <25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse

One treatment course consists of fludarabine and cyclophosphamide lymphodepleting chemotherapy followed by IV infusion of tisagenlecleucel

Lymphodepleting chemotherapy

  • Fludarabine 30 mg/m² IV qDay for 4 days PLUS
  • Cyclophosphamide 500 mg/m² IV qDay for 2 days starting with the first dose of fludarabine

Tisagenlecleucel IV infusion

  • Administer 2-14 days after completing lymphodepleting chemotherapy
  • Premedicate with acetaminophen and diphenhydramine (see Administration)
  • ≤50 kg: 0.2-5 x 10^6 CAR-positive viable T cells/kg
  • >50 kg: 0.1-2.5 x 10^8 CAR-positive viable T cells/kg
  • Infuse autologously prepared, weight-based IV for individual patient at 10-20 mL/min
  • Do not use a leukocyte-depleting filter
  • Adjust infusion rate as appropriate for smaller children and smaller volumes
  • Also see Administration

Large B-Cell Lymphoma

Indicated for adults with relapsed or refractory large B-cell lymphoma (r/rDLBCL) after ≥2 lines of systemic therapy including DLBCL not otherwise specified, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma

One treatment course consists of fludarabine and cyclophosphamide lymphodepleting chemotherapy followed by IV infusion of tisagenlecleucel

Lymphodepleting chemotherapy

  • Lymphodepleting chemotherapy may be omitted if WBC count ≤1 x 10^9/L within 1 week before tisagenlecleucel infusion
  • Fludarabine 25 mg/m² IV qDay for 3 days PLUS
  • Cyclophosphamide 250 mg/m² IV qDay for 3 days starting with the first dose of fludarabine
  • Alternate lymphodepleting chemotherapy
    • Bendamustine 90 mg/m² IV qDay for 2 days if a patient experienced a previous Grade 4 hemorrhagic cystitis with cyclophosphamide or demonstrates resistance to a previous cyclophosphamide containing regimen

Tisagenlecleucel IV infusion

  • Administer 2-11 days after completing lymphodepleting chemotherapy
  • Premedicate with acetaminophen and diphenhydramine (see Administration)
  • 0.6-6 x 10^8 CAR-positive viable T cells/kg
  • Also see Administration

Dosage Modifications

Cytokine release syndrome (CRS) management

  • Prodromal syndrome
    • Symptoms: Low-grade fever, fatigue, anorexia
    • Observe in person; exclude infection; administer antibiotics per local guidelines if neutropenic; provide symptomatic support
  • CRS requiring mild intervention
    • 1 or more symptoms of the following: High fever, hypoxia, mild hypotension
    • Administer antipyretics, oxygen, IV fluids, and/or low-dose vasopressors as needed
  • CRS requiring moderate to aggressive intervention
    • 1 or more symptoms of the following: Hemodynamic instability despite IV fluids and vasopressor support, and/or worsening respiratory distress (including pulmonary infiltrates, increasing oxygen requirement including high-flow oxygen, and/or need for mechanical ventilation), and/or rapid clinical deterioration
    • Administer high-dose or multiple vasopressors, oxygen, mechanical ventilation, and/or other supportive care as needed
    • Administer tocilizumab, weight <30 kg: 12 mg/kg IV infused over 1 hr
    • Administer tocilizumab, weight ≥30 kg: 8 mg/kg IV infused over 1 hr; not to exceed 800 mg/dose
    • Repeat tocilizumab as needed at a minimum interval of 8 hr if there is no clinical improvement
    • If no response to second dose of tocilizumab, consider a third dose or pursue alternative measures for CRS treatment
    • Not to exceed a total of 4 tocilizumab doses
    • If no clinical improvement within 12-18 hr after the first tocilizumab dose, or worsening at any time, administer methylprednisolone 2 mg/kg as an initial dose, then 2 mg/kg/day until vasopressors and high flow oxygen are no longer needed, then taper methylprednisolone

Dosing Considerations

For autologous use only

Adult relapsed or refractory DLBCL

  • Limitation of use: Not indicated for treatment of patients with primary central nervous system lymphoma

Dosage Forms & Strengths

injection, suspension for pediatric and young adult B-cell ALL (<25 years)

  • Single-dose units contain specific amounts of T-cell depending on the patient’s body weight that are suspended in a patient-specific infusion bag
  • ≤50 kg: 0.2-5 x 10^6 CAR-positive viable T cells/kg
  • >50 kg: 0.1-2.5 x 10^8 CAR-positive viable T cells/kg
  • See the certificate of analysis (CoA) for actual cell count following individual preparation

Acute Lymphoblastic Leukemia

CD19-directed genetically modified autologous T-cell immunotherapy indicated for patients aged <25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse

One treatment course consists of fludarabine and cyclophosphamide lymphodepleting chemotherapy followed by IV infusion of tisagenlecleucel

Lymphodepleting chemotherapy

  • Fludarabine 30 mg/m² IV qDay for 4 days PLUS
  • Cyclophosphamide 500 mg/m² IV qDay for 2 days starting with the first dose of fludarabine

Tisagenlecleucel IV infusion

  • Administer 2-14 days after completing lymphodepleting chemotherapy
  • Premedicate with acetaminophen and diphenhydramine (see Administration)
  • ≤50 kg: 0.2-5 x 10^6 CAR-positive viable T cells/kg
  • >50 kg: 0.1-2.5 x 10^8 CAR-positive viable T cells/kg
  • Infuse autologously prepared, weight-based IV for individual patient at 10-20 mL/min
  • Do not use a leukocyte-depleting filter
  • Adjust infusion rate as appropriate for smaller children and smaller volumes
  • Also see Administration

Dosage Modifications

Cytokine release syndrome (CRS) management

  • Prodromal syndrome
    • Symptoms: Low-grade fever, fatigue, anorexia
    • Observe in person; exclude infection; administer antibiotics per local guidelines if neutropenic; provide symptomatic support
  • CRS requiring mild intervention
    • 1 or more symptoms of the following: High fever, hypoxia, mild hypotension
    • Administer antipyretics, oxygen, IV fluids, and/or low-dose vasopressors as needed
  • CRS requiring moderate to aggressive intervention
    • 1 or more symptoms of the following: Hemodynamic instability despite IV fluids and vasopressor support, and/or worsening respiratory distress (including pulmonary infiltrates, increasing oxygen requirement including high-flow oxygen, and/or need for mechanical ventilation), and/or rapid clinical deterioration
    • Administer high-dose or multiple vasopressors, oxygen, mechanical ventilation, and/or other supportive care as needed
    • Administer tocilizumab, weight <30 kg: 12 mg/kg IV infused over 1 hr
    • Administer tocilizumab, weight ≥30 kg: 8 mg/kg IV infused over 1 hr; not to exceed 800 mg/dose
    • Repeat tocilizumab as needed at a minimum interval of 8 hr if there is no clinical improvement
    • If no response to second dose of tocilizumab, consider a third dose or pursue alternative measures for CRS treatment
    • Not to exceed a total of 4 tocilizumab doses
    • If no clinical improvement within 12-18 hr after the first tocilizumab dose, or worsening at any time, administer methylprednisolone 2 mg/kg as an initial dose, then 2 mg/kg/day until vasopressors and high flow oxygen are no longer needed, then taper methylprednisolone

Dosing Considerations

For autologous use only

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Interactions

Interaction Checker

and tisagenlecleucel

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              Serious - Use Alternative (203)

              • abatacept

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

              • abrocitinib

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

              • adalimumab

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

              • adenovirus types 4 and 7 live, oral

                tisagenlecleucel decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .

              • ado-trastuzumab emtansine

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

              • alefacept

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

              • alemtuzumab

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

              • anakinra

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

              • ansuvimab

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

              • antithymocyte globulin equine

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

              • antithymocyte globulin rabbit

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

              • apaziquone

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

              • atoltivimab/maftivimab/odesivimab

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

              • azathioprine

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

              • balstilimab

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

              • baricitinib

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

              • basiliximab

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

              • belatacept

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

              • bendamustine

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

              • benralizumab

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

              • benznidazole

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

              • betamethasone

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

              • bezlotoxumab

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

              • bimekizumab

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

              • brodalumab

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

              • busulfan

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

              • C1 inhibitor human

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

              • canakinumab

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

              • capecitabine

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

              • caplacizumab

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

              • carboplatin

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

              • carmustine

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

              • certolizumab pegol

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

              • cetuximab

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

              • chlorambucil

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

              • cisplatin

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

              • cladribine

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

              • clofarabine

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

              • corticotropin

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

              • cyclosporine

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

              • cytarabine

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

              • dacarbazine

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

              • daclizumab

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

              • daratumumab

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

              • deflazacort

                deflazacort, tisagenlecleucel. 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.

              • dengue vaccine

                tisagenlecleucel decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .

              • denosumab

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

              • dexamethasone

                dexamethasone, tisagenlecleucel. 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.

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

              • dinutuximab

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

              • diroximel fumarate

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

              • dupilumab

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

              • Ebola Zaire vaccine

                tisagenlecleucel decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .

              • ecallantide

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

              • eculizumab

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

              • elotuzumab

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

              • emapalumab

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

              • emicizumab

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

              • etanercept

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

              • fexinidazole

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

              • filgotinib

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

              • fingolimod

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

              • floxuridine

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

              • fludarabine

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

              • fludrocortisone

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

              • gemcitabine

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

              • gemtuzumab

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

              • glatiramer

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

              • golimumab

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

              • guselkumab

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

              • hydrocortisone

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

              • hydroxyurea

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

              • ibritumomab tiuxetan

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

              • icatibant

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

              • ifosfamide

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

              • immune globulin SC

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

              • inebilizumab

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

              • infliximab

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

              • influenza virus vaccine quadrivalent, intranasal

                tisagenlecleucel decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .

              • inolimomab

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

              • interferon alfa n3

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

              • interferon alfacon 1

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

              • interferon beta 1a

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

              • interferon beta 1b

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

              • iodoquinol

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

              • ipilimumab

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

              • isotretinoin

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

              • ixekizumab

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

              • leflunomide

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

              • lomustine

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

              • lurbinectedin

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

              • measles (rubeola) vaccine

                tisagenlecleucel decreases effects of measles (rubeola) vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .

              • measles mumps and rubella vaccine, live

                tisagenlecleucel decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .

              • measles, mumps, rubella and varicella vaccine, live

                tisagenlecleucel decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .

              • mechlorethamine

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

              • mechlorethamine topical

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

              • melphalan

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

              • melphalan flufenamide

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

              • mepolizumab

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

              • mercaptopurine

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

              • methotrexate

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

              • methylprednisolone

                methylprednisolone, tisagenlecleucel. 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.

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

              • mitoxantrone

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

              • mogamulizumab

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

              • mometasone sinus implant

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

              • moxetumomab pasudotox

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

              • muromonab CD3

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

              • mycophenolate

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

              • narsoplimab

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

              • natalizumab

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

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

              • nelarabine

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

              • nitazoxanide

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

              • nivolumab

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

              • obinutuzumab

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

              • ocrelizumab

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

              • ofatumumab

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

              • ofatumumab SC

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

              • olaratumab

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

              • omalizumab

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

              • oportuzumab monatox

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

              • oxaliplatin

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

              • panitumumab

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

              • paromomycin

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

              • peginterferon beta-1a

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

              • pembrolizumab

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

              • pemetrexed

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

              • pentostatin

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

              • pimecrolimus

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

              • poliovirus vaccine live oral trivalent

                tisagenlecleucel decreases effects of poliovirus vaccine live oral trivalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .

              • pralatrexate

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

              • prednisolone

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

              • ravulizumab

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

              • raxibacumab

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

              • reltecimod

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

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

              • remestemcel-L

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

              • reslizumab

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

              • rilonacept

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

              • risankizumab

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

              • rituximab

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

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

              • rituximab-hyaluronidase

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

              • ropeginterferon alfa 2b

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

              • rotavirus oral vaccine, live

                tisagenlecleucel decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .

              • rubella vaccine

                tisagenlecleucel decreases effects of rubella vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .

              • ruxolitinib topical

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

              • sarilumab

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

              • secukinumab

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

              • siltuximab

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

              • sintilimab

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

              • sirolimus

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

              • sirolimus intravitreal

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

              • sirukumab

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

              • smallpox (vaccinia) and monkeypox vaccine, live, nonreplicating

                tisagenlecleucel decreases effects of smallpox (vaccinia) vaccine, attenuated by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .

              • smallpox (vaccinia) vaccine, attenuated

                tisagenlecleucel decreases effects of smallpox (vaccinia) vaccine, attenuated by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .

              • smallpox (vaccinia) vaccine, live

                tisagenlecleucel decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .

              • spesolimab

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

              • streptozocin

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

              • sulfasalazine

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

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

              • sutimlimab

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

              • tacrolimus

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

              • tacrolimus ointment

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

              • temozolomide

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

              • teplizumab

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

              • teriflunomide

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

              • thioguanine

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

              • thiotepa

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

              • tinidazole

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

              • tocilizumab

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

              • tofacitinib

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

              • tositumomab

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

              • trabectedin

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

              • tralokinumab

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

              • trastuzumab

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

              • trastuzumab deruxtecan

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

              • treosulfan

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

              • upadacitinib

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

              • ustekinumab

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

              • varicella virus vaccine live

                tisagenlecleucel decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .

              • varicella zoster immune globulin, human

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

              • vedolizumab

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

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

              • voclosporin

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

              • yellow fever vaccine

                tisagenlecleucel decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .

              Monitor Closely (0)

                Minor (0)

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                  Adverse Effects

                  Percentages include all grades unless otherwise noted

                  >10% (Pediatric & Young Adults with ALL)

                  Cytokine release syndrome (79%)

                  Cytokine release syndrome, grades 3-4 (49%)

                  Hypogammaglobulinemia (43%)

                  Infection, unspecified pathogen (41%)

                  Pyrexia (40%)

                  Prolonged neutropenia, Day 28 (40%)

                  Febrile neutropenia, grades 3-4 (37%)

                  Decreased appetite (37%)

                  Headache (37%)

                  Encephalopathy (34%)

                  Hypotension (31%)

                  Increased AST, grades 3-4 (28%)

                  Hypokalemia, grades 3-4 (27%)

                  Prolonged thrombocytopenia, Day 28 (27%)

                  Viral infection (26%)

                  Tachycardia (26%)

                  Nausea (26%)

                  Diarrhea (26%)

                  Vomiting (26%)

                  Fatigue (25%)

                  Hypoxia (24%)

                  Acute kidney injury (24%)

                  Hypotension, grades 3-4 (22%)

                  Edema (21%)

                  Cough (21%)

                  Increased ALT, grades 3-4 (21%)

                  Increased bilirubin, grades 3-4 (21%)

                  Delirium (21%)

                  Hypophosphatemia, grades 3-4 (19%)

                  Hypertension (19%)

                  Bacterial infection (19%)

                  Constipation (18%)

                  Viral infection, grades 3-4 (18%)

                  Hypoxia, grades 3-4 (18%)

                  Pain (18%)

                  Prolonged neutropenia, Day 56 (17%)

                  Infection, unspecified pathogen, grades 3-4 (16%)

                  Hypofibrinogenemia with grades 3-4 CRS (16%)

                  Abdominal pain (16%)

                  Pain in extremity (16%)

                  Pulmonary edema (16%)

                  Rash (16%)

                  Decreased appetite, grades 3-4 (15%)

                  Pyrexia, grades 3-4 (15%)

                  Myalgia (15%)

                  Fungal infection (13%)

                  Anxiety (13%)

                  Bacterial infection, grades 3-4 (13%)

                  Acute kidney injury, grades 3-4 (13%)

                  Increased INR (13%)

                  Dyspnea, grades 3-4 (12%)

                  Prolonged thrombocytopenia, Day 56 (12%)

                  Arthralgia (12%)

                  Tachypnea (12%)

                  >10% (Adults with DLBCL)

                  Lymphopenia, grades 3-4 (97%)

                  Neutropenia, grades 3-4 (81%)

                  Leukopenia, grades 3-4 (77%)

                  Cytokine release syndrome (74%)

                  Anemia, grades 3-4 (58%)

                  Thrombocytopenia, grades 3-4 (54%)

                  Infection, unspecified pathogen (42%)

                  Pyrexia (34%)

                  Diarrhea (31%)

                  Nausea (27%)

                  Fatigue (26%)

                  Hypotension (26%)

                  Infection, unspecified pathogen grades 3-4 (25%)

                  Hypophosphatemia (24%)

                  Cytokine release syndrome, grades 3-4 (23%)

                  Edema (23%)

                  Headache (21%)

                  Cough (19%)

                  Dyspnea (18%)

                  Febrile neutropenia, grades 3-4 (17%)

                  Acute kidney injury (17%)

                  Constipation (16%)

                  Encephalopathy (16%)

                  Pain (15%)

                  Hypogammaglobulinemia (14%)

                  Tachycardia (13%)

                  Chills (13%)

                  Decreased appetite (12%)

                  Hypokalemia (12%)

                  Hyponatremia (11%)

                  Decreased weight (11%)

                  Dizziness (11%)

                  Encephalopathy, grades 3-4 (11%)

                  1-10% (Pediatric & Young Adults with ALL)

                  Sleep disorders (10%)

                  Face edema (10%)

                  Peripheral edema, grades 3-4 (10%)

                  Chills (10%)

                  Fluid overload (10%)

                  Back pain (10%)

                  Pleural effusion (10%)

                  Nasal congestion (10%)

                  Pulmonary edema, grades 3-4 (10%)

                  Encephalopathy, grades 3-4 (10%)

                  Fungal infection, grades 3-4 (7%)

                  Blood and lymphatic system disorders: DIC (9%)

                  Histiocytosis lymphocytic hemophagocytosis (7%)

                  Coagulopathy (6%)

                  Blood creatinine increased (7%)

                  aPTT prolonged (6%)

                  Respiratory, thoracic, and mediastinal disorders: Respiratory distress (6%), respiratory failure (6%), acute RDS (4%)

                  Cardiac disorders: Cardiac arrest (4%), cardiac failure (7%)

                  Metabolism and nutrition disorders: Tumor lysis syndrome (6%)

                  Vascular disorders: Capillary leak syndrome (3%)

                  General disorders and administration site conditions: Multiple organ dysfunction syndrome (3%)

                  Nervous System: Intracranial hemorrhage (1%), seizure (3%)

                  Gastrointestinal disorders: Abdominal compartment syndrome (1%)

                  Immune system disorders: GVHD (1%)

                  1-10% (Adults with DLBCL)

                  Arthralgia (10%)

                  Hypotension, grades 3-4 (8%)

                  Fatigue, grades 3-4 (7%)

                  Pyrexia, grades 3-4 (6%)

                  Acute kidney injury, grades 3-4 (6%)

                  Dyspnea, grades 3-4 (6%)

                  Hypogammaglobulinemia, grades 3-4 (4%)

                  Appetite decreased, grades 3-4 (4%)

                  Tachycardia, grades 3-4 (3%)

                  Pain, grades 3-4 (3%)

                  Weight decreased, grades 3-4 (3%)

                  Edema, grades 3-4 (2%)

                  Diarrhea, grades 3-4 (1%)

                  Nausea, grades 3-4 (1%)

                  Constipation, grades 3-4 (1%)

                  Dizziness, grades 3-4 (1%)

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                  Warnings

                  Black Box Warnings

                  Cytokine release syndrome

                  • Cytokine release syndrome (CRS), including fatal or life-threatening reactions, reported in a majority of patients (see Adverse Effects)
                  • Median time to CRS onset was 3 days (range: 1-22 days)
                  • Key manifestations of CRS include high fever, lower than normal blood pressure, and difficulty breathing, and may be associated with hepatic, renal, and cardiac dysfunction and coagulopathy
                  • Risk factors for severe CRS are high preinfusion tumor burden (>50% blasts in bone marrow), uncontrolled or accelerating tumor burden following lymphodepleting chemotherapy, active infections, and/or inflammatory processes
                  • Do not administer to patients with active infection or inflammatory disorders
                  • Delay tisagenlecleucel administration after lymphodepleting chemotherapy if patient has unresolved serious adverse reactions from preceding chemotherapies (including pulmonary toxicity, cardiac toxicity, or hypotension), active uncontrolled infection, active graft versus host disease (GVHD), or worsening of leukemia burden
                  • Treat severe or life-threatening CRS with tocilizumab
                    • Ensure that 2 doses of tocilizumab are available on site prior to tisagenlecleucel administration
                    • Monitor for CRS signs or symptoms for at least 4 weeks after treatment
                    • Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time
                    • At the first sign of CRS, immediately evaluate patient for hospitalization and institute treatment with supportive care, tocilizumab, and/or corticosteroids as indicated

                  Neurological toxicities

                  • Neurological toxicities, which may be severe or life-threatening, can occur following treatment, including concurrently with CRS
                  • The majority of neurological toxicities occurred within 8 weeks after treatment
                  • The most common neurological toxicities were headache, encephalopathy, delirium, anxiety, and tremor (also see Adverse Effects)
                  • Other manifestations of neurological toxicities included disturbances in consciousness, disorientation, confusion, agitation, seizures, mutism, and aphasia
                  • Monitor for neurological events after treatment; provide supportive care as needed

                  Restricted access program

                  • Available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYMRIAH REMS
                  • Further information is available at www.kymriah-rems.com or 1-844-4KYMRIAH
                  • REMS requirements
                    • Healthcare facilities that dispense and administer tisagenlecleucel 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 tisagenlecleucel IV infusion, if needed for treatment of CRS
                    • Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer tisagenlecleucel 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)

                  Neurological toxicities, which may be severe or life-threatening, can occur following treatment (see Black Box Warnings)

                  Available only through a restricted access program (see Black Box Warnings)

                  Allergic reactions may occur during infusion; serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide (DMSO) or dextran 40 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 treat appropriately

                  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 (HCV), 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 tisagenlecleucel; prolonged neutropenia has been associated with increased risk of infection; myeloid growth factors, particularly GM-CSF, are not recommended during the first 3 weeks after tisagenlecleucel infusion or until CRS has resolved

                  Hypogammaglobulinemia and agammaglobulinemia (IgG) can occur in patients with a complete remission (CR); monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement standard guidelines

                  Secondary malignancies or recurrence of leukemia may occur; monitor patient life-long for secondary malignancies

                  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

                  HIV and the lentivirus used to make tisagenlecleucel have limited, short spans of identical genetic material (RNA); therefore, some commercial HIV nucleic acid test (NAT) tests may yield false-positive results in patients who have received tisagenlecleucel

                  Immunization with live viral vaccines

                  • The 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 2 weeks prior to the start of lymphodepleting chemotherapy, during tisagenlecleucel treatment, and until immune recovery afterwards
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                  Pregnancy

                  Pregnancy

                  Data are not available in pregnant women; not recommended for women who are pregnant, and discuss with the treating physician about pregnancy after administration; report pregnancies to Novartis Pharmaceuticals Corporation at 1-888-669-6682

                  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

                  Pregnant women who have received tisagenlecleucel may have hypogammaglobulinemia; assess immunoglobulin levels in newborns of treated mothers

                  Pregnancy status of females with reproductive potential should be verified; 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 with tisagenlecleucel

                  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

                  CAR is composed of a murine single-chain antibody fragment that recognizes CD19 and is fused to intracellular signaling domains from 4-1BB (CD137) and CD3 zeta

                  CD3 zeta component is critical for initiating T-cell activation and antitumor activity, while 4-1BB enhances expansion and persistence of tisagenlecleucel

                  CAR transmits a signal to promote T-cell expansion owing to binding of CD19 expressed cells, activation, target cell elimination, and persistence of tisagenlecleucel cells

                  Absorption

                  Peak plasma concentration: 34,700 copies/mcg (responsive patients); 20,000 copies/mcg (nonresponsive [NR] patients)

                  Peak plasma time: 9.91 days (responsive patients); 20 days (NR patients)

                  AUC: 318,000 copies/mcg·day (responsive patients); 156,000 (NR patients)

                  Peak plasma concentration and AUC were ~2-fold higher in CR/CRi patients compared with NR patients

                  Distribution

                  Tisagenlecleucel was present in blood as well as bone marrow and was measurable beyond 2 yr

                  Blood to bone marrow partitioning suggested that tisagenlecleucel distribution in bone marrow was 44% of that present in blood at day 28, while at months 3 and 6 tisagenlecleucel distributed at 67% and 69%, respectively, indicating high distribution to bone marrow

                  Elimination

                  Half-life: 16.8 days (responsive patients); 2.52 days (NR patients)

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                  Administration

                  IV Preparation

                  Confirm infusion time in advance, and adjust start time for thaw so that tisagenlecleucel is available for infusion when recipient is ready

                  Ensure 2 doses of tocilizumab and emergency equipment are available prior to infusion and during the recovery period; premedicate patient; see Dosing

                  Confirm patient identity prior to preparation, match the patient's identity with the patient identifiers on the tisagenlecleucel infusion bag; tisagenlecleucel is for autologous use only

                  Inspect the infusion bag for any breaks or cracks before thawing; if bag is compromised, do not infuse the contents; contact Novartis at 1-844-4KYMRIAH

                  Place infusion bag inside a second, sterile bag in case of a leak and to protect ports from contamination; thaw infusion bag at 37°C using either a water bath or dry thaw method until there is no visible ice in the infusion bag

                  Remove bag from thawing device immediately; do not store product bag at 37°C

                  Once thawed, stored at room temperature (20-25°C) for up to 30 minutes

                  Do not wash, spin down, and/or resuspend tisagenlecleucel in new media prior to infusion; inspect contents of the thawed infusion bag for any visible cell clump; if visible cell clumps remain, gently mix the contents of the bag; small clumps of cellular material should disperse with gentle manual mixing

                  Do not infuse tisagenlecleucel if clumps are not dispersed, the infusion bag is damaged or leaking, or otherwise appears to be compromised; if this occurs, contact Novartis at 1-844-4KYMRIAH

                  IV Administration

                  Premedication

                  • Premedicate with acetaminophen and diphenhydramine or another H1-antihistamine ~30-60 minutes before tisagenlecleucel infusion
                  • Do not use corticosteroids at any time except in the case of a life-threatening emergency

                  Tisagenlecleucel infusion

                  • Administer IV infusion at 10-20 mL/min, adjusted as appropriate for smaller children and smaller volume
                  • Infusion bag volume ranges from 10-50 mL
                  • Do not use a leukocyte-depleting filter; prime tubing prior to infusion with 0.9% NaCl
                  • Infuse all contents of the infusion bag; rinse infusion bag with 10-30 mL 0.9% NaCl while maintaining a closed tubing system to assure as many cells as possible are infused into the patient
                  • 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 ≤-148°F (≤-120°C) in a temperature-monitored system
                  • Use closed, break-proof, leak-proof containers when transporting infusion bags within the facility

                  Thawed infusion bag

                  • Stored at room temperature 68-77°F (20-25°C) for up to 30 minutes
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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.
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                  • 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.