ciltacabtagene autoleucel (Rx)

Brand and Other Names:Carvykti
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and ciltacabtagene autoleucel

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              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)

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                  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%)
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                  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
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                  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.

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                  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

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                  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
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                  Images

                  No images available for this drug.
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                  Patient Handout

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

                  FormularyPatient Discounts

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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.