Dosing & Uses
Dosage Forms & Strengths
injection, suspension
- Single-dose units contain specific amounts of T cells depending on the patient’s body weight that are suspended in a patient-specific infusion bag
- Maximum of 1 x 108 CAR-positive viable T cells per infusion bag of 5% dimethyl sulfoxide (DMSO)
Multiple Myeloma
Indicated for adults with relapsed or refractory multiple myeloma, after ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
One treatment course consists of fludarabine- and cyclophosphamide-lymphodepleting chemotherapy followed by IV infusion of ciltacabtagene autoleucel
Lymphodepleting chemotherapy
- Confirm availability of ciltacabtagene autoleucel before starting lymphodepleting chemotherapy regimen
- Fludarabine 30 mg/m2 IV qDay for 3 days
- Cyclophosphamide 300 mg/m2 IV qDay for 3 days starting with the first dose of fludarabine
-
Delay lymphodepleting regimen
- Delay if patient has serious adverse reactions from preceding bridging therapies (including clinically significant active infection, cardiac toxicity, and pulmonary toxicity) or active graft versus host disease (GVHD) in patient with prior autologous stem cell transplantation
- Consider repeating lymphodepleting regimen if ciltacabtagene autoleucel dosing delayed >14 days and patient has recovered from toxicity of the first lymphodepleting regimen
Ciltacabtagene autoleucel
- Administer 2-4 days after completing lymphodepleting chemotherapy
- 0.5-1 x 106 CAR-positive viable T cells/kg IV; not to exceed 1 x 108 CAR-T cells per single IV infusion
- Administer autologously prepared, weight-based IV infusion for individual patient within 30 minutes by either gravity or peristaltic pump
- Do not use a leukocyte-depleting filter
-
Delay CAR-T therapy if
- Clinically significant active infection or inflammatory disorders
- Grade ≥3 nonhematologic toxicities of cyclophosphamide and fludarabine conditioning, except for Grade 3 nausea, vomiting, diarrhea, or constipation
- Delay infusion until resolution of these events to Grade ≤1
Dosage Modifications
Cytokine release syndrome (CRS) management
-
Grade 1
- Early onset of fever (temperature ≥38ºC) <72 hr after infusion
- Consider tocilizumab 8 mg/kg IV over 1 hr; not to exceed 800 mg
-
Grade 2
- Symptoms require and respond to moderate intervention
- Fever with hypotension not requiring vasopressors and/or, hypoxia requiring oxygen via cannula or blow-by, or Grade 2 organ toxicity
- Administer tocilizumab 8 mg/kg IV infused over 1 hr (not to exceed 800 mg)
- Repeat tocilizumab q8hr as needed if not responsive to IV fluids or increasing supplemental oxygen
- Consider dexamethasone 10 mg IV q12-24 hr
- If no improvement within 24 hr or rapid progression, repeat tocilizumab and escalate dose and frequency of dexamethasone (20 mg IV q6-12hr)
- If no improvement within 24 hr or continued rapid progression, switch to methylprednisolone 2 mg/kg IV q12hr
- After 2 doses of tocilizumab, consider alternative anti-cytokine agents (eg, monoclonal antibodies targeting cytokines)
- Do not exceed 3 doses/24 hr of tocilizumab, or 4 doses total
-
Grade 3
- Symptoms require aggressive intervention
- Fever with hypotension requiring a vasopressor with or without vasopressin, and/or, hypoxia requiring oxygen via highflow nasal cannula, facemask, nonrebreather mask, or Venturi mask, or, Grade 3 organ toxicity or Grade 4 transaminitis
- Administer tocilizumab (see doses in CRS Grade 2) and dexamethasone 10 mg IV q12hr
- If no improvement within 24 hr or rapid progression, repeat tocilizumab and escalate dose and frequency of dexamethasone (20 mg IV q6-12hr)
- If no improvement within 24 hr or continued rapid progression, switch to methylprednisolone 2 mg/kg IV q12hr
- After 2 doses of tocilizumab, consider alternative anti-cytokine agents
- Do not exceed 3 doses of tocilizumab in 24 hr, or 4 doses total
-
Grade 4
- Life-threatening symptoms; requires ventilator support, continuous venovenous hemodialysis (CVVHD)
- Fever with temperature ≥38°C with hypotension requiring multiple vasopressors (excluding vasopressin), and/or, hypoxia requiring positive pressure (eg, CPAP, BiPAP, intubation, mechanical ventilation), or Grade 4 organ toxicity (excluding transaminitis)
- Administer tocilizumab (see doses in CRS Grade 2) and dexamethasone 20 mg IV q6hr
- After 2 doses of tocilizumab, consider alternative anti-cytokine agents
- Do not exceed 3 doses of tocilizumab in 24 hr, or 4 doses total
- If no improvement within 24 hr, consider methylprednisolone (1-2 g IV, repeat q24hr if needed; taper as clinically indicated) or other immunosuppressants (eg, other anti-T cell therapies)
Neurologic toxicity grading and management
-
Concurrent CRS during the neurologic toxicity event
- Corticosteroids according to the more aggressive intervention based on the CRS and neurologic toxicity grades
- Tocilizumab according to CRS grade as listed above
- Antiseizure medication according to neurologic toxicity
-
Grade 1
- Immune effector cell-associated encephalopathy (ICE) score 7-9 or depressed level of consciousness; awakens spontaneously
- Consider dexamethasone 10 mg IV q12-24hr x 2-3 days
- Consider nonsedating, antiseizure medicines (eg, levetiracetam) for seizure prophylaxis
-
Grade 2
- ICE score 3-6 or depressed level of consciousness; awakens to voice
- Administer dexamethasone 10 mg IV q12hr x 2- 3 days, or longer for persistent symptoms
- Consider steroid taper if total corticosteroid exposure >3 days
- If no improvement after 24 hr or worsening of neurologic toxicity, increase dose and/or frequency of dexamethasone up to maximum of 20 mg IV q6 hr
- Consider nonsedating, antiseizure medicines (eg, levetiracetam) for seizure prophylaxis
-
Grade 3
- ICE score 0-2 (if ICE score is 0, but patient is arousable [eg, awake with global aphasia] and able to perform assessment) or depressed level of consciousness (awakens only to tactile stimulus), or seizures (either any clinical seizure, focal or generalized, that resolves rapidly, or nonconvulsive seizures on EEG that resolve with intervention), or raised intracranial pressure (ICP) with focal/local edema on neuroimaging
- Administer dexamethasone 10-20 mg IV q6hr
- If no improvement after 24 hr or worsening of neurologic toxicity, escalate dexamethasone dose to at least 20 mg IV q6hr, OR escalate to high-dose methylprednisolone (1-2 g/day, repeat q24hr if needed; taper as clinically indicated)
- Consider nonsedating, antiseizure medicines (eg, levetiracetam) for seizure prophylaxis
- If cerebral edema suspected, consider hyperventilation and hyperosmolar therapy; give high-dose methylprednisolone (1-2 g, repeat q24hr if needed; taper as clinically indicated)
-
Grade 4
- ICE score-0: Patient is unarousable and unable to perform ICE assessment or depressed level of consciousness either patient is unarousable or requires vigorous or repetitive tactile stimuli to arouse, or stupor or coma, or seizures, either life-threatening prolonged seizure (>5 min), or repetitive clinical or electrical seizures without return to baseline in between, or motor findings (deep focal motor weakness such as hemiparesis or paraparesis); or raised ICP/cerebral edema, with signs/symptoms (eg, diffuse cerebral edema on neuroimaging, or decerebrate or decorticate posturing, or cranial nerve VI palsy, or papilledema, or Cushing triad)
- Administer dexamethasone 20 mg IV q6hr
- If no improvement after 24 hr or worsening neurologic toxicity, escalate to high-dose methylprednisolone (1-2 g/day, repeated q24hr if needed; taper as clinically indicated)
- Consider nonsedating, antiseizure medicines (eg, levetiracetam) for seizure prophylaxis
- If raised ICP/cerebral edema suspected, consider hyperventilation and hyperosmolar therapy; give high-dose methylprednisolone (1-2 g/day, repeat q24hr if needed; taper as clinically indicated), and consider neurology and/or neurosurgery consultation
Dosing Considerations
Verify pregnancy status of females with reproductive potential before initiating
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (202)
- abatacept
abatacept, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- abrocitinib
abrocitinib, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- adalimumab
adalimumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- adenovirus types 4 and 7 live, oral
ciltacabtagene autoleucel 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, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- alefacept
alefacept, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- alemtuzumab
alemtuzumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- anakinra
anakinra, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ansuvimab
ansuvimab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- antithymocyte globulin equine
antithymocyte globulin equine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- antithymocyte globulin rabbit
antithymocyte globulin rabbit, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- apaziquone
apaziquone, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- atoltivimab/maftivimab/odesivimab
atoltivimab/maftivimab/odesivimab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- azathioprine
azathioprine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- balstilimab
balstilimab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- baricitinib
baricitinib, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- basiliximab
basiliximab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- belatacept
belatacept, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- bendamustine
bendamustine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- benralizumab
benralizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- benznidazole
benznidazole, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- betamethasone
betamethasone, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- bevacizumab
bevacizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- bezlotoxumab
bezlotoxumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- bimekizumab
bimekizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- botulism immune globulin iv
botulism immune globulin iv, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- brodalumab
brodalumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- busulfan
busulfan, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- C1 esterase inhibitor recombinant
C1 esterase inhibitor recombinant, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- C1 inhibitor human
C1 inhibitor human, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- canakinumab
canakinumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- capecitabine
capecitabine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- caplacizumab
caplacizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- carboplatin
carboplatin, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- carmustine
carmustine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- certolizumab pegol
certolizumab pegol, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cetuximab
cetuximab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- chlorambucil
chlorambucil, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cisplatin
cisplatin, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cladribine
cladribine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- clofarabine
clofarabine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- corticotropin
corticotropin, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- cortisone
cortisone, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- cyclophosphamide
cyclophosphamide, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cyclosporine
cyclosporine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cytarabine
cytarabine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cytomegalovirus immune globulin (CMV IG)
cytomegalovirus immune globulin (CMV IG), ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- dacarbazine
dacarbazine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- daclizumab
daclizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- daratumumab
daratumumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- deflazacort
deflazacort, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- dengue vaccine
ciltacabtagene autoleucel 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, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- dexamethasone
dexamethasone, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
ciltacabtagene autoleucel, dexamethasone. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity. - dimethyl fumarate
dimethyl fumarate, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- dinutuximab
dinutuximab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- diroximel fumarate
diroximel fumarate, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- dupilumab
dupilumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- Ebola Zaire vaccine
ciltacabtagene autoleucel 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, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- eculizumab
eculizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- elotuzumab
elotuzumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- emapalumab
emapalumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- emicizumab
emicizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- etanercept
etanercept, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- fexinidazole
fexinidazole, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- filgotinib
filgotinib, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- fingolimod
fingolimod, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- floxuridine
floxuridine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- fludarabine
fludarabine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- fludrocortisone
fludrocortisone, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- fluorouracil
fluorouracil, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- gemcitabine
gemcitabine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- gemtuzumab
gemtuzumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- glatiramer
glatiramer, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- golimumab
golimumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- guselkumab
guselkumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- hepatitis B immune globulin (HBIG)
hepatitis B immune globulin (HBIG), ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- hydrocortisone
hydrocortisone, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- hydroxychloroquine sulfate
hydroxychloroquine sulfate, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- hydroxyurea
hydroxyurea, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ibritumomab tiuxetan
ibritumomab tiuxetan, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- icatibant
icatibant, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ifosfamide
ifosfamide, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- immune globulin IM (IGIM)
immune globulin IM (IGIM), ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- immune globulin IV (IGIV)
immune globulin IV (IGIV), ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- immune globulin SC
immune globulin SC, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- inebilizumab
inebilizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- infliximab
infliximab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- influenza virus vaccine quadrivalent, intranasal
ciltacabtagene autoleucel 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. .
- interferon alfa n3
interferon alfa n3, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- interferon alfacon 1
interferon alfacon 1, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- interferon beta 1a
interferon beta 1a, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- interferon beta 1b
interferon beta 1b, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- iodoquinol
iodoquinol, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ipilimumab
ipilimumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- isotretinoin
isotretinoin, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ixekizumab
ixekizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- leflunomide
leflunomide, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lomustine
lomustine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lurbinectedin
lurbinectedin, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- measles (rubeola) vaccine
ciltacabtagene autoleucel 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
ciltacabtagene autoleucel 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
ciltacabtagene autoleucel 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, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mechlorethamine topical
mechlorethamine topical, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- melphalan
melphalan, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- melphalan flufenamide
melphalan flufenamide, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mepolizumab
mepolizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mercaptopurine
mercaptopurine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- methotrexate
methotrexate, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- methylprednisolone
methylprednisolone, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
ciltacabtagene autoleucel, methylprednisolone. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity. - mineral oil topical
mineral oil topical, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mitoxantrone
mitoxantrone, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mogamulizumab
mogamulizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mometasone sinus implant
mometasone sinus implant, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- monomethyl fumarate
monomethyl fumarate, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- moxetumomab pasudotox
moxetumomab pasudotox, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- muromonab CD3
muromonab CD3, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mycophenolate
mycophenolate, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- narsoplimab
narsoplimab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- natalizumab
natalizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
ciltacabtagene autoleucel, natalizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. - nelarabine
nelarabine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- nitazoxanide
nitazoxanide, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- nivolumab
nivolumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- obinutuzumab
obinutuzumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ocrelizumab
ocrelizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ofatumumab
ofatumumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ofatumumab SC
ofatumumab SC, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- olaratumab
olaratumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- omalizumab
omalizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- oportuzumab monatox
oportuzumab monatox, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- oxaliplatin
oxaliplatin, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- panitumumab
panitumumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- paromomycin
paromomycin, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- peginterferon beta-1a
peginterferon beta-1a, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- pembrolizumab
pembrolizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- pemetrexed
pemetrexed, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- pentostatin
pentostatin, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- pimecrolimus
pimecrolimus, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- poliovirus vaccine live oral trivalent
ciltacabtagene autoleucel 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, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- prednisolone
prednisolone, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- prednisone
prednisone, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- procarbazine
procarbazine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- rabies immune globulin, human (RIG)
rabies immune globulin, human (RIG), ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ravulizumab
ravulizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- raxibacumab
raxibacumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- reltecimod
reltecimod, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
ciltacabtagene autoleucel, reltecimod. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. - remestemcel-L
remestemcel-L, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- reslizumab
reslizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- Rho(D) immune globulin
Rho(D) immune globulin, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- rilonacept
rilonacept, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- risankizumab
risankizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- rituximab
rituximab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
ciltacabtagene autoleucel, rituximab. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. - rituximab-hyaluronidase
rituximab-hyaluronidase, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- rotavirus oral vaccine, live
ciltacabtagene autoleucel 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
ciltacabtagene autoleucel 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, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- sarilumab
sarilumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- secukinumab
secukinumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- siltuximab
siltuximab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- sintilimab
sintilimab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- sirolimus
sirolimus, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- sirolimus intravitreal
sirolimus intravitreal, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- sirukumab
sirukumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- smallpox (vaccinia) and monkeypox vaccine, live, nonreplicating
ciltacabtagene autoleucel 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
ciltacabtagene autoleucel 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
ciltacabtagene autoleucel 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, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- streptozocin
streptozocin, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- sulfasalazine
sulfasalazine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
ciltacabtagene autoleucel, sulfasalazine. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. - sutimlimab
sutimlimab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tacrolimus
tacrolimus, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tacrolimus ointment
tacrolimus ointment, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- temozolomide
temozolomide, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- teplizumab
teplizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- teriflunomide
teriflunomide, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tetanus immune globulin (TIG)
tetanus immune globulin (TIG), ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- thioguanine
thioguanine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- thiotepa
thiotepa, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tinidazole
tinidazole, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tocilizumab
tocilizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tofacitinib
tofacitinib, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tositumomab
tositumomab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- trabectedin
trabectedin, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tralokinumab
tralokinumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- trastuzumab
trastuzumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- trastuzumab deruxtecan
trastuzumab deruxtecan, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- treosulfan
treosulfan, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- triamcinolone acetonide extended-release injectable suspension
triamcinolone acetonide extended-release injectable suspension, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- triamcinolone acetonide injectable suspension
triamcinolone acetonide injectable suspension, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- ublituximab
ublituximab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- upadacitinib
upadacitinib, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ustekinumab
ustekinumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- vaccinia immune globulin intravenous
vaccinia immune globulin intravenous, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- varicella virus vaccine live
ciltacabtagene autoleucel 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, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- vedolizumab
vedolizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
ciltacabtagene autoleucel, vedolizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. - voclosporin
voclosporin, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- yellow fever vaccine
ciltacabtagene autoleucel 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
>10%
Any grade
- Pyrexia (96%)
- CRS (95%)
- Hypogammaglobulinemia (94%)
- Hypotension (51%)
- Musculoskeletal pain (48%)
- Fatigue (47%)
- Infections, unspecified pathogen (41%)
- Cough (39%)
- Chills (33%)
- Diarrhea (33%)
- Nausea (31%)
- Encephalopathy (30%)
- Decreased appetite (29%)
- Upper respiratory tract infection (28%)
- Tachycardia (27%)
- Headache (27%)
- Edema (23%)
- Viral infections (23%)
- Dizziness (23%)
- Dyspnea (23%)
- Coagulopathy (22%)
- Constipation (22%)
- Vomiting (20%)
- Hypertension (19%)
- Motor dysfunction (16%)
- Nasal congestion (15%)
- Hemorrhage (15%)
- Insomnia (13%)
- Pneumonia (12%)
- Hypoxia (12%)
Grade ≥3
- Lymphopenia (99%)
- Neutropenia (98%)
- White blood cell count decreased (98%)
- Anemia (72%)
- Thrombocytopenia (63%)
- AST increased (21%)
- Infections, unspecified pathogen (17%)
- Pneumonia (11%)
1-10%
Any grade
- Febrile neutropenia (10%)
- Sepsis (10%)
- Bacterial infections (10%)
Grade ≥3
- Febrile neutropenia (10%)
- Hypotension (10%)
- Sepsis (7%)
- Fatigue (7%)
- Viral infections (7%)
- Encephalopathy (6%)
- Hypertension (6%)
- Pyrexia (5%)
- CRS (5%)
- Hypoxia (4%)
- Hemorrhage (4%)
- Upper respiratory tract infection (3%)
- Bacterial infections (3%)
- Motor dysfunction (3%)
- Dyspnea (3%)
- Coagulopathy (2.1%)
- Hypogammaglobulinemia (2%)
- Musculoskeletal pain (2%)
- Tachycardia (1%)
- Diarrhea (1%)
- Nausea (1%)
- Decreased appetite (1%)
- Dizziness (1%)
Other clinically important adverse reactions
- Cardiac disorders: Cardiac arrhythmias (8%), chest pain (7%)
- Eye disorders: Diplopia (1%)
- Gastrointestinal disorders: Dysphagia (1%)
- Immune system disorders: Hemophagocytic lymphohistiocytosis (1%), hypersensitivity reaction (5%)
- Infections and infestations: Urinary tract infection (4.1%)
- Injury, poisoning, and procedural complications: Fall (3.1%)
- Metabolism and nutrition disorders: Tumor lysis syndrome (1%)
- Musculoskeletal and connective tissue disorders: Posture abnormal (1%)
- Nervous system disorders: Aphasia (8%), ataxia (8%), tremor (6%), paresis (4.1%), parkinsonism (4.1%), peripheral neuropathy (6%), micrographia (4.1%), dysgraphia (3.1%), reduced facial expression (3.1%), bradykinesia (2.1%), cogwheel rigidity (1%), cerebrovascular accident (1%), seizure (1%), low speech (1%), nystagmus (1%)
- Psychiatric disorders: Delirium (5%) depression (4.1%), psychomotor retardation (1%)
- Renal and urinary disorders: Renal failure (7%)
- Skin and subcutaneous tissues: Rash (8%)
- Vascular disorders: Thrombosis (5%)
Warnings
Black Box Warnings
Cytokine release syndrome
- Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment
- Do not administer to patients with active infection or inflammatory disorders
- Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids
Neurological toxicities
- Immune effector cell-associated neurotoxicity syndrome (ICANS), including severe or life-threatening reactions, reported; these may occur concurrently with CRS, after CRS resolution, or in the absence of CRS
- Monitor and provide supportive care and/or corticosteroids as needed
- Parkinsonism and Guillain-Barré syndrome and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment
Hemophagocytic lymphohistiocytosis/macrophage activation syndrome
- Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred following treatment
- HLH/MAS can occur with CRS or neurologic toxicities
Prolonged cytopenia
- Prolonged cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment
Restricted access program
- Available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Carvykti REMS program
- Further information is available at www.carvyktirems.com or 1-844-672-0067
-
REMS requirements
- Healthcare facilities that dispense and administer ciltacabtagene autoleucel must be enrolled and comply with the REMS requirements
- Certified healthcare facilities must have onsite immediate access to tocilizumab
- Ensure that a minimum of 2 doses of tocilizumab are available for each patient for administration within 2 hr after ciltacabtagene autoleucel IV infusion, if needed
- Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer ciltacabtagene autoleucel are trained about the management of CRS and neurological toxicities
Contraindications
None
Cautions
Available only through a restricted access program
Hypogammaglobulinemia can occur; monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic/antiviral prophylaxis, and immunoglobulin replacement standard guidelines
Secondary malignancies may develop; monitor patient life-long for secondary malignancies
Hypersensitivity
Allergic reactions may occur during infusion; serious hypersensitivity reactions, including anaphylaxis
Monitor for 2 hr after infusion for signs and symptoms of severe reaction; treat promptly and manage patients appropriately according to severity of the hypersensitivity reaction
Recurrent cytopenias
Prolonged cytopenias may occur and last for several weeks following lymphodepleting chemotherapy and CAR-T cell infusion
Monitor blood cell counts before and after infusion
Manage cytopenias with growth factors and blood product transfusion support according to local institutional guidelines
Hemophagocytic/ macrophage activation syndrome
Manifestations of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) include hypotension, hypoxia with diffuse alveolar damage, coagulopathy, cytopenia, and multiorgan dysfunction, including renal dysfunction; HLH is a life-threatening condition with a high mortality rate if not recognized and treated early
Patients with HLH/MAS have been reported to have CRS symptoms and neurologic events after infusion
Treat HLH/MAS per institutional standards
Cytokine release syndrome
- Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment in many patients (see Black Box Warnings and Adverse Effects)
- Closely monitor patients who experience CRS for cardiac and other organ function until resolution of symptoms
- Monitor patients who experience Grade 2 or higher CRS (eg, hypotension not responsive to fluids, or hypoxia requiring supplemental oxygenation) with continuous telemetry and pulse oximetry
- For severe or life-threatening CRS, consider intensive care unit level monitoring and supportive therapy including tocilizumab, corticosteroids, and antiseizure prophylaxis with levetiracetam (see Dosage Modifications)
- Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time
Infection risk
- Serious infections, including life-threatening or fatal infections, reported; before administering, infection prophylaxis for neutropenia should follow local guidelines; monitor for signs and symptoms of infection after treatment and treat appropriately
- In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids and other supportive care, as medically indicated
- Viral reactivation can occur; hepatitis B virus (HBV) reactivation can result in fulminant hepatitis, hepatic failure, and death; perform screening for cytomegalovirus (CMV), HBV, hepatitis C virus, and HIV in accordance with clinical guidelines before collection of cells for manufacturing
Neurologic effects
- Neurological toxicities, which may be severe or life-threatening, can occur following treatment
- Neurotoxicities may include immune effector cell-associated neurotoxicity syndrome (ICANS), parkinsonism, Guillain-Barré syndrome (GBS), peripheral neuropathy, or cranial nerve palsies
- Counsel patients on the signs and symptoms of neurologic toxicities, and on delayed nature of onset; instruct patients to seek immediate medical attention for further assessment and management if signs or symptoms of any of these neurologic toxicities occur at any time
- Monitor patients at least daily for 10 days following infusion at REMS-certified healthcare facility for signs and symptoms of ICANS; rule out other causes of ICANS symptoms; monitor patients for signs or symptoms of ICANS for at least 4 weeks after infusion and treat promptly; neurologic toxicity should be managed with supportive care and/or corticosteroids as needed
- Monitor patients for signs and symptoms of parkinsonism that may be delayed in onset and managed with supportive care measures; there is limited efficacy information with medications used for the treatment of Parkinson disease for improvement or resolution of parkinsonism symptoms following treatment
- Monitor for GBS; evaluate patients presenting with peripheral neuropathy for GBS; consider treatment of GBS with supportive care measures and in conjunction with immunoglobulins and plasma exchange, depending on severity of GBS
- Occurrence of 3rd and 6th cranial nerve palsy, bilateral 7th cranial nerve palsy, worsening of cranial nerve palsy after improvement, and occurrence of peripheral neuropathy in patients with cranial nerve palsy also reported; monitor patients for signs and symptoms of cranial nerve palsies; consider management with systemic corticosteroids, depending on severity and progression of signs and symptoms
- 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
Drug interaction overview
-
Immunization with live viral vaccines
- Safety of immunization with live viral vaccines during or following treatment has not been studied
- Vaccination with live-virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during ciltacabtagene autoleucel treatment, and until immune recovery afterwards
-
HIV nucleic acid tests
- HIV and the lentivirus used to make ciltacabtagene autoleucel have limited, short spans of identical genetic material (RNA)
- Therefore, some commercial HIV nucleic acid tests may yield false-positive results
Pregnancy & Lactation
Pregnancy
Data are not available in pregnant females
No animal reproductive and developmental toxicity studies have been conducted
Unknown if ciltacabtagene autoleucel may potentially transfer to fetus; based on the mechanism of action, if transduced cells cross placenta, fetal toxicity, including B-cell lymphocytopenia, may occur; not recommended for females who are pregnant, and consult with treating physician on pregnancy after infusion
Treated patients may have hypogammaglobulinemia; assess immunoglobulin levels in newborns of treated mothers
Verify pregnancy status of females with reproductive potential before initiating treatment
There are no data on effects on fertility
Contraception
- See prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive lymphodepleting chemotherapy
- Insufficient exposure data are available to provide recommendations on duration of contraception following treatment
Lactation
There is no information regarding presence in human milk, effects on breastfed infants, and effects on milk production
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
B-cell maturation antigen (BCMA)-directed, genetically modified autologous chimeric antigen receptor T-cell (CAR-T) therapy
Patient’s own T-cells are reprogrammed with a transgene encoding CAR that identifies and eliminates cells that express BCMA
BCMA is a protein that is highly expressed on myeloma cells
Absorption
Peak plasma concentration: 47,806 copies/mcg
Peak plasma time: 12.7 days
AUC Day2 0-28: 371,569 copies⋅days/mcg
Elimination
Half-life: 15.3 days
Administration
IV Preparation
Confirm infusion time in advance, and adjust start time for thaw so that is available for infusion when recipient is ready; do not thaw until ready to be used
Confirm patient identity before preparing, and match patient's identity with the patient identifiers on ciltacabtagene autoleucel infusion bag; ciltacabtagene autoleucel is for autologous use only
Inspect infusion bag for any breaks or cracks before thawing; if bag is compromised, do not infuse the contents; contact Janssen Biotech at 1-800-526-7736
Place infusion bag inside a sealable plastic bag (preferably sterile) before thawing
Thaw infusion bag at 37ºC using either a water bath or dry thaw method until there is no visible ice in the infusion bag; total time for completion of thawing should not exceed 15 minutes
Remove infusion bag from sealable plastic bag and wipe dry; gently mix contents of bag to disperse clumps of cellular material; if visible cell clumps remain, continue to gently mix contents of bag
Do not prefilter into a different container, wash, spin down, and/or resuspend in new media before infusion
Once thawed, infusion must be completed within 2.5 hr at room/ambient temperature (20-25ºC); do not refreeze or refrigerate thawed product
Premedication
30-60 minutes before CAR-T cell infusion H4
Acetaminophen 650-1000 mg PO/IV
Diphenhydramine 25-50 mg (or equivalent) PO/IV
Avoid prophylactic systemic corticosteroids; use may interfere with activity of CAR-T cell therapy
IV Administration
Administer at a REMS-certified healthcare facility
For IV use only
For autologous use only
Do NOT use a leukocyte-depleting filter
Ensure minimum of 2 doses of tocilizumab and emergency equipment are present before infusion and during recovery period
Central venous access may be utilized for infusion and is encouraged in patients with poor peripheral access
Confirm patient’s identity with patient identifiers on infusion bag; do not infuse if information does not match intended patient
Prime infusion set tubing with 0.9% NaCl
Once thawed, administer entire contents of ciltacabtagene autoleucel bag by IV infusion within 2.5 hr using infusion sets fitted with an in-line filter
Gently mix contents of bag during infusion to disperse cell clumps
After entire contents are infused, flush administration line, inclusive of in-line filter, with 0.9% NaCl with volume equal or greater than total hold up volume of primary administration set used inclusive of the drip tube, to ensure that all product is delivered
Postinfusion monitoring
- Monitor for 2 hr after infusion for signs and symptoms of severe hypersensitivity
- Monitor at least daily for 10 days following infusion at certified healthcare facility for signs and symptoms of CRS and neurologic toxicities
- Monitor periodically for 4 weeks for signs and symptoms of delayed neurologic toxicity
- Instruct patients to remain within proximity of certified healthcare facility for ≥4 weeks after infusion
- Instruct patients to refrain from driving or hazardous activities for at least 8 weeks following infusion
Storage
Store and transport below -120ºC
All sites approved for infusion will support required storage conditions for vapor phase of liquid nitrogen
Shipped directly to the cell laboratory or clinical pharmacy associated with the infusion center in the vapor phase of a liquid nitrogen shipper
Handling
- Contains human blood cells that are genetically modified with replication incompetent, self-inactivating, lentiviral vector
- Follow universal precautions and local biosafety guidelines for handling and disposal to avoid potential transmission of infectious diseases
Images
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
