Dosing & Uses
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 106 CAR-positive viable T cells/kg
- >50 kg: 0.1-2.5 x 108 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 109/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 108 CAR-positive viable T cells/kg
- Also see Administration
Follicular Lymphoma
Indicated for relapsed or refractory (r/r) follicular lymphoma (FL) after ≥2 lines of systemic therapy
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 109/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 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 2-6 days after completing lymphodepleting chemotherapy
- Premedicate with acetaminophen and diphenhydramine (see Administration)
- 0.6-6 x 108 CAR-positive viable T cells/kg
- Also see Administration
Dosage Modifications
Cytokine release syndrome (CRS) management
- Identify CRS based on clinical presentation
- Evaluate for and treat other causes of fever, hypoxia, and hypotension
- If CRS is suspected, manage according to the recommendations below
- Alternative CRS management strategies may be implemented based on appropriate institutional or academic guidelines
-
Grade 1
- Mild symptoms: Low-grade fever, fatigue, anorexia
- Exclude other causes (eg, infection)
- Treat symptoms with antipyretics, antiemetics, or analgesics
- Use tocilizumab: In patients with persistent (>3 days) or refractory fever, consider managing as Grade 2 CRS
-
Grade 2
- Symptoms require and respond to moderate intervention
- Oxygen requirement <40% or hypotension responsive to fluids or low dose of one vasopressor or Grade 2 organ toxicity
- Administer antipyretics, oxygen, IV fluids, and/or low dose vasopressors 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 minimum interval of 8 hr if no clinical improvement
- If no response to second dose of tocilizumab, consider third dose or pursue alternative measures for CRS treatment
- Limit to 3 doses/24 hr; not to exceed 4 doses
- If no clinical improvement within 24 hr of tocilizumab, administer methylprednisolone 2 mg/kg IV (or equivalent) until vasopressors and high flow oxygen are no longer needed, then taper methylprednisolone
- If not improving, manage as appropriate grade below
-
Grade 3
- Symptoms require and respond to aggressive intervention
- Oxygen requirement ≥40%, hypotension requiring high dose or multiple vasopressors, Grade 3 organ toxicity, or Grade 4 transaminitis
- Treat with high-flow oxygen, IV fluids, and high-dose or multiple vasopressors
- Treat other organ toxicities as per local guidelines
- For tocilizumab: Per Grade 2; if not improving, consider alternative therapy
- Alternative therapy includes anticytokine and anti-T cell therapies as per institutional policy and published guidelines such as (but not limited to) anakinra, siltuximab, ruxolitinib, cyclophosphamide, immunoglobulin (IVIG), and antithymocyte globulin (ATG)
- For corticosteroids: Per Grade 2; if not improving, manage as Grade 4
-
Grade 4
- Life-threatening symptoms
- Requirement for ventilator support or Grade 4 organ toxicity (excluding transaminitis)
- Treat with mechanical ventilation, IV fluids, and high-dose vasopressor(s)
- Treat other organ toxicities as per local guidelines
- For tocilizumab: Per Grade 2; if not improving, consider alternative therapy
- For corticosteroids: Administer methylprednisolone 1000 mg IV q12-24hr for 3 days; if not improving, consider methylprednisolone 1000 mg IV q12hr or q8hr or alternate therapy as listed in Grade 3
- Continue corticosteroids until improvement to Grade 1, and then taper as clinically appropriate
Neurological toxicities
- Monitor for neurologic toxicities, including Immune effector cell-associated neurotoxicity syndrome (ICANS), following infusion, particularly during and after resolution of CRS
- Identify neurologic toxicities based on clinical presentation
- Evaluate for and treat other causes of neurological symptoms
- Consider nonsedating seizure prophylaxis (eg, levetiracetam) for patients at higher risk of seizure, such as those with seizure history, CNS disease, concerning EEG findings, or neoplastic brain lesions
- Alternative neurologic toxicities management strategies may be implemented based on appropriate institutional, academic, or consensus guidelines
-
Grade 1
- ICE score: 7-9 with no depressed level of consciousness
- No concurrent CRS: Supportive care with IV hydration and aspiration precautions
- With CRS: Administer tocilizumab at any grade CRS, as per dosage recommendation in listed under CRS; use caution with repeated tocilizumab doses in patients with ICANS; consider adding corticosteroids to tocilizumab past first dose
-
Grade 2
- ICE score: 3-6 and/or mild somnolence awaking to voice
- No concurrent CRS: Supportive care; consider dexamethasone 10 mg IV q6-12 hr or methylprednisolone equivalent (1 mg/kg IV q12hr) until Grade ≤1; if improving, taper corticosteroids
- With CRS: Administer tocilizumab at any grade CRS, as per dosage recommendation in listed under CRS; if refractory to tocilizumab after first dose, administer dexamethasone 10 mg IV q6-12 hr or methylprednisolone equivalent (1 mg/kg IV q12hr) until Grade ≤1; if improving, taper corticosteroids
-
Grade 3
- ICE score: 0-2 and/or depressed level of consciousness awakening only to tactile stimulus and/or any clinical seizure focal or generalized that resolves rapidly or nonconvulsive seizures on EEG that resolve with intervention and/or focal or local edema on neuroimaging
- NOTE: ICE score of 0 may be classified as Grade 3 ICANS if awake with global aphasia, but ICE score of 0 may be classified as Grade 4 ICANS if unarousable
- No concurrent CRS: Administer dexamethasone 10 mg IV q6-12 hr or methylprednisolone equivalent (1 mg/kg IV q12hr) until Grade ≤1; if improving, taper corticosteroids
- With CRS: Administer tocilizumab at any grade CRS, as per dosage recommendation in listed under CRS; if refractory to tocilizumab after first dose, administer dexamethasone 10 mg IV q6-12 hr or methylprednisolone equivalent (1 mg/kg IV q12hr) until Grade ≤1; if improving, taper corticosteroids; if not improving, manage as Grade 4
-
Grade 4
- ICE score: 0 (patient is unarousable and unable to perform ICE) and/or stupor or coma and/or life-threatening prolonged seizure (>5 min) or repetitive clinical or electrical seizures without return to baseline in between and/or diffuse cerebral edema on neuroimaging, decerebrate or decorticate posturing or papilledema, cranial nerve VI palsy, or Cushing triad
- No concurrent CRS: Consider mechanical ventilation for airway protection; administer methylprednisolone 1000 mg IV q12-24hr for 3 days; if not improving, consider methylprednisolone 1000 mg IV q12hr or q8hr or alternate therapy as listed in CRS; continue corticosteroids until improvement to Grade 1, and then taper as clinically appropriate; treat seizures, status epilepticus, and cerebral edema as per institutional guidelines
- With CRS: Administer tocilizumab at any grade CRS, as per dosage recommendation in listed under CRS; administer methylprednisolone 1000 mg IV q12-24hr for 3 days; if not improving, consider methylprednisolone 1000 mg IV q12hr or q8hr or alternate therapy as listed in CRS; continue corticosteroids until improvement to Grade 1, and then taper as clinically appropriate; treat seizures, status epilepticus, and cerebral edema as per institutional guidelines
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
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)
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%)
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
Hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS), which can be life-threatening or fatal, has occurred; all HLH events occurred during ongoing CRS and resolved; treat HLH as per institutional standards
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
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.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)
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
Images
Formulary
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- View the formulary and any restrictions for each plan.
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