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Carvykti
ciltacabtagene autoleucel
Black Box Warnings .
Cytokine Release Syndrome
including fatal or life-threatening reaction, has occurred; do not administer if active infection or inflammatory disorders; confirm minimum 2 doses tocilizumab available prior to infusion; treat severe or life-threatening CRS with tocilizumab /- corticosteroids; monitor patients at least daily x7 days post-infusion, then monitor signs/symptoms for at least 2wk after tx within proximity of healthcare facility; counsel patients on signs/symptoms and to seek immediate medical attention if they occur at any time
Immune Effector Cell-Associated Neurotoxicity Syndrome
which may be fatal or life-threatening, occurred, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS; provide supportive care, and/or corticosteroids, levetiracetam as needed; monitor patients at least daily x7 days post-infusion, then monitor signs/symptoms for at least 2wk after tx within proximity of healthcare facility; counsel patients on signs/symptoms and to seek immediate medical attention if they occur at any time
Parkinsonism and Guillain-Barre Syndrome
and associated complications resulting in fatal or life-threatening reaction occurred; provide supportive care; consider immunoglobulins and plasma exchange for Guillain-Barre syndrome, depending on severity
Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome
including fatal or life-threatening reaction, has occurred; can occur with CRS or neurologic toxicities
Cytopenias
including prolonged and/or recurrent cytopenias with bleeding and infection, requiring stem cell transplantation for hematopoietic recovery
Immune Effector Cell-Associated Enterocolitis
which may be fatal or life-threatening, occurred weeks to months after tx; manifestations may include severe or prolonged diarrhea, abdominal pain, or weight loss requiring TPN
Secondary Hematological Malignancies
including myelodysplastic syndrome, AML, T-cell malignancies, have occurred; monitor life-long; contact Janssen Biotech at 1-800-526-7736 to report malignancy occurrence and obtain instructions on patients sample collection
Adult Dosing .
Dosage forms: INJ
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, prophylactic antimicrobials, and dosing
multiple myeloma, relapsed or refractory
- [0.5-1 x10^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg/dose IV x1]
- Max: 1 x10^8 CAR-positive viable T-cells/total dose; Start: 2-4 days after completing lymphodepleting combo chemo regimen cyclophosphamide + fludarabine; Info: for patients who have received at least 1 prior tx including a proteasome inhibitor and an immunomodulatory agent, and who are refractory to lenalidomide
renal dosing
- [see below]
- CrCl >60: no adjustment; CrCl <60: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- mild impairment: no adjustment; moderate-severe impairment: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy
- infection, active
- inflammatory disorder
- GVHD, active
- chemotherapy-associated serious reaction, unresolved
- avoid: blood donation indefinitely
- avoid: organ donation indefinitely
- avoid: tissue donation indefinitely
- avoid: cell donation indefinitely
- caution: hypersensitivity to DMSO
- caution: patients of childbearing potential
- caution: male patients of reproductive potential
- caution: CNS disease
- caution: HBV carriers
Drug Interactions .
Overview
ciltacabtagene autoleucel
CAR T cell immunotherapy
- immunomodulatory effects
- lowers seizure threshold
- myelosuppressive oncologic agent
- peripheral neuropathy
Contraindicated
- adenovirus vaccine, live
- BCG live intravesical
- chikungunya vaccine, live
- cholera vaccine, live
- dengue vaccine, live
- influenza nasal vaccine, live
- measles/mumps/rubella vaccine, live
- rotavirus vaccine, live
- smallpox vaccine, live
- talimogene laherparepvec
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Avoid/Use Alternative
- abrocitinib
- aldesleukin
- amifampridine
- anifrolumab
- anti-thymocyte globulin
- azathioprine
- basiliximab
- betamethasone
- budesonide
- chloramphenicol
- cladribine oral
- cortisone
- cyclosporine
- deferiprone
- deflazacort
- deuruxolitinib
- dexamethasone
- dexrazoxane
- etrasimod
- etuvetidigene autotemcel
- everolimus
- fexinidazole
- fludrocortisone
- ganciclovir
- hydrocortisone
- iohexol
- lymphocyte immune globulin, anti-thymocyte globulin
- methylprednisolone
- mycophenolate mofetil
- mycophenolic acid
- natalizumab
- palifermin
- penicillamine
- pimecrolimus topical
- prednisolone
- prednisone
- primaquine
- rabies vaccine
- radium Ra 223 dichloride
- ritlecitinib
- ropeginterferon alfa-2b
- ruxolitinib topical
- sirolimus
- tacrolimus
- triamcinolone
- valganciclovir
- vamorolone
- voclosporin
Monitor/Modify Tx
- albendazole
- alemtuzumab
- allopurinol
- anthrax vaccine
- atidarsagene autotemcel
- auranofin
- balsalazide
- baricitinib
- benznidazole
- betibeglogene autotemcel
- bupropion
- chikungunya vaccine
- cidofovir
- clozapine
- colchicine
- copper histidinate
- COVID-19 vaccine
- cyclophosphamide
- dapsone
- deferasirox
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- ebola vaccine, live
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- elivaldogene autotemcel
- exagamglogene autotemcel
- filgrastim (G-CSF)
- flucytosine
- fluphenazine
- foscarnet
- fosfomycin injection
- fostamatinib
- givinostat
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydroxychloroquine
- hydroxyurea
- influenza H5N1 vaccine
- influenza vaccine
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- iopamidol
- Japanese encephalitis vaccine
- leflunomide
- linezolid
- lonafarnib
- lovotibeglogene autotemcel
- meningococcal vaccine
- mercaptopurine
- mesalamine
- mesalamine rectal
- methotrexate
- mitomycin
- olsalazine
- pegfilgrastim (G-CSF)
- peginterferon alfa 2a
- peginterferon beta 1a
- pentamidine
- pneumococcal vaccine
- poliovirus vaccine
- proguanil
- pyrimethamine
- respiratory syncytial virus vaccine
- ribavirin
- rifabutin
- rituximab
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- smallpox/mpox vaccine, live
- stiripentol
- succimer
- sulfasalazine
- teplizumab
- teriflunomide
- thalidomide
- tick-borne encephalitis vaccine
- tocilizumab
- tofacitinib
- trimethoprim
- typhoid vaccine
- upadacitinib
- valproic acid
- vancomycin
- zidovudine
Caution Advised
- abatacept
- acetazolamide
- adalimumab
- ado-trastuzumab emtansine
- anakinra
- avacopan
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- bimekizumab
- bortezomib
- brentuximab vedotin
- brivaracetam
- brodalumab
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- busulfan
- canakinumab
- cannabidiol
- carbamazepine
- carboplatin
- cenobamate
- certolizumab pegol
- chlorambucil
- ciprofloxacin
- clobazam
- clobetasol ophthalmic
- clomipramine
- clonazepam
- clorazepate
- coccidioides immitis skin test antigen
- corticotropin
- crovalimab
- cytarabine
- danicopan
- daptomycin
- daunorubicin
- delafloxacin
- delgocitinib topical
- deucravacitinib
- dexamethasone ophthalmic
- diazepam
- difluprednate ophthalmic
- dimethyl fumarate
- dinutuximab
- diroximel fumarate
- disulfiram
- docetaxel
- dupilumab
- eculizumab
- efgartigimod alfa
- emapalumab
- eslicarbazepine acetate
- etanercept
- ethanol (alcoholic beverage)
- ethosuximide
- etoposide
- felbamate
- fenfluramine
- fingolimod
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- fosphenytoin
- gabapentin
- ganaxolone
- golimumab
- guselkumab
- hydrocortisone ophthalmic
- icotrokinra
- inebilizumab
- infliximab
- iptacopan
- ixekizumab
- lacosamide
- lamotrigine
- lebrikizumab
- levetiracetam
- levofloxacin
- linvoseltamab
- lomustine
- lorazepam
- loteprednol ophthalmic
- magnesium citrate
- methsuximide
- metronidazole
- midazolam
- miglustat
- mirikizumab
- mirvetuximab soravtansine
- mitoxantrone
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- mosunetuzumab
- moxifloxacin
- nadofaragene firadenovec intravesical
- narsoplimab
- naxitamab
- nipocalimab
- obinutuzumab
- ocrelizumab
- ofatumumab
- ofloxacin
- oxaliplatin
- oxcarbazepine
- ozanimod
- paclitaxel
- pegcetacoplan
- pentostatin
- perampanel
- phenobarbital
- phenytoin
- pirtobrutinib
- polatuzumab vedotin
- polyethylene glycol
- polyethylene glycol/electrolytes
- ponesimod
- pozelimab
- prednisolone ophthalmic
- pregabalin
- primidone
- promethazine
- ravulizumab
- rilonacept
- rilzabrutinib
- risankizumab
- rozanolixizumab
- rufinamide
- secukinumab
- selinexor
- sibeprenlimab
- siltuximab
- siponimod
- sipuleucel-T
- sodium picosulfate
- spesolimab
- sulfate bowel prep
- sutimlimab
- telisotuzumab vedotin
- temsirolimus
- tezepelumab
- thioguanine
- tiagabine
- tildrakizumab
- tinidazole
- topiramate
- trabectedin
- tralokinumab
- tramadol
- treosulfan
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- vedolizumab
- vigabatrin
- vilobelimab
- zilucoplan
- zonisamide
Adverse Reactions .
Serious Reactions
- early mortality incr.
- cytokine release syndrome
- hypotension, severe
- fever
- hypoxia
- respiratory failure
- acute kidney injury
- DIC
- angina
- tachycardia
- ALT or AST elevated
- hyperbilirubinemia
- neurotoxicity, severe
- immune effector cell-associated neurotoxicity syndrome
- encephalopathy
- aphasia
- parkinsonism
- Guillain-Barre syndrome
- myelitis
- peripheral neuropathy
- cranial nerve palsy
- PML, JC virus-associated
- immune effector cell-associated enterocolitis
- diarrhea, severe or prolonged
- GI perforation
- sepsis
- hemophagocytic lymphohistiocytosis
- macrophage activation syndrome
- neutropenia, including prolonged
- thrombocytopenia, including prolonged
- lymphopenia, including prolonged
- hypogammaglobulinemia
- anemia
- infection, severe
- febrile neutropenia
- HBV reactivation
- hypersensitivity reaction, severe
- infusion reaction
- secondary malignancy
- myelodysplastic syndrome
- AML
- T-cell malignancy
- chimeric antigen receptor (CAR)-positive lymphoma
Common Reactions
- fever
- cytokine release syndrome
- hypogammaglobulinemia
- infection, severe
- hypotension
- musculoskeletal pain
- fatigue
- thrombocytopenia, including prolonged
- cough
- diarrhea
- rigors
- nausea
- lymphopenia, including prolonged
- anemia
- encephalopathy
- neutropenia, including prolonged
- appetite decr.
- URI
- tachycardia
- headache
- neurotoxicity
- edema
- dizziness
- dyspnea
- immune effector cell-associated neurotoxicity syndrome
- coagulopathy
- constipation
- vomiting
- HTN
- motor dysfunction
- nasal congestion
- hemorrhage
- insomnia
- pneumonia
- hypoxia
- febrile neutropenia
- sepsis
- hematologic malignancy
- aphasia
- ataxia
- rash
- chest pain
- renal failure
- tremor
- peripheral neuropathy
- hypersensitivity reaction
- delirium
- thrombosis
- parkinsonism
- UTI
- paresis
- depression
- micrographia
- dysgraphia
- cranial nerve palsy
- bradykinesia
- ALT or AST incr.
Safety/Monitoring .
Monitoring Parameters
screening for CMV, HBV, HCV, HIV before leukapheresis; pregnancy test at baseline; CBC, signs/symptoms of infection before and after infusion; signs/symptoms of infusion reaction during and x2h after infusion; IgG levels after infusion; signs/symptoms of parkinsonism, Guillain-Barre syndrome, peripheral neuropathy, cranial nerve palsies; signs/symptoms of cytokine release syndrome, neurological toxicities at least daily x7 days post-infusion, then for at least 2wk after tx within proximity of healthcare facility; signs/symptoms of secondary hematologic malignancy life-long
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; no human or animal data available; possible risk of B-cell lymphocytopenia and hypogammaglobulinemia based on drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for ciltacabtagene autoleucel: other; CYP450: unknown
Excretion: for ciltacabtagene autoleucel: unknown; Half-life: 3-95 days
Subclass: Immunotherapy, BCMA Inhibitors ; Immunotherapy, CAR T-Cells
Mechanism of Action
for ciltacabtagene autoleucel: binds to B-cell maturation antigen (BCMA)-expressing cells via chimeric antigen receptor (CAR)-positive autologous T-cells, inducing T-cell expansion, activation, and proliferation, and eliminating BCMA-expressing cells
Formulary .
No Formulary Selected
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