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Aucatzyl
obecabtagene autoleucel
Black Box Warnings .
Cytokine Release Syndrome
do not administer if active infection or inflammatory disorders; ensure providers have immediate access to meds, resuscitative equipment to manage CRS before administration; monitor patients daily for at least 7 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
Neurological Toxicities
immune effector cell-associated neurotoxicity syndrome, including fatal or life-threatening, occurred, including concurrently with CRS or after CRS resolution; ensure providers have immediate access to meds, resuscitative equipment to manage neurologic toxicities before administration; provide supportive care and/or corticosteroids as needed; monitor patients daily for at least 7 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
Secondary Hematological Malignancies
including T-cell malignancies, have occurred; monitor life-long; contact Autolus Therapeutics at 1-855-288-5227 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
B-cell precursor ALL, relapsed or refractory
- [bone marrow blast <20%]
- Dose: 100 x10^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg/dose IV x1 on day 1, then 310 x10^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg/dose IV x1 on day 10; Start: 3 days after completing lymphodepleting combo chemo cyclophosphamide + fludarabine
- [bone marrow blast >20% or biopsy results inconclusive]
- Dose: 10 x10^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg/dose IV x1 on day 1, then 400 x10^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg/dose IV x1 on day 10; Start: 3 days after completing lymphodepleting combo chemo cyclophosphamide + fludarabine
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [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
- 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
Drug Interactions .
Overview
obecabtagene autoleucel
CAR T cell immunotherapy
- immunomodulatory effects
- lowers seizure threshold
- myelosuppressive oncologic agent
Contraindicated
- BCG live intravesical
- talimogene laherparepvec
Avoid/Use Alternative
- abrocitinib
- adenovirus vaccine, live
- aldesleukin
- amifampridine
- anifrolumab
- anti-thymocyte globulin
- azathioprine
- basiliximab
- belatacept
- betamethasone
- budesonide
- chikungunya vaccine, live
- chloramphenicol
- cholera vaccine, live
- cladribine oral
- cortisone
- cyclosporine
- deferiprone
- deflazacort
- dengue vaccine, live
- dexamethasone
- dexrazoxane
- etrasimod
- etuvetidigene autotemcel
- everolimus
- fexinidazole
- fludrocortisone
- ganciclovir
- hydrocortisone
- influenza nasal vaccine, live
- iohexol
- lymphocyte immune globulin, anti-thymocyte globulin
- measles/mumps/rubella vaccine, live
- methylprednisolone
- mycophenolate mofetil
- mycophenolic acid
- natalizumab
- palifermin
- penicillamine
- pimecrolimus topical
- prednisolone
- prednisone
- primaquine
- radium Ra 223 dichloride
- ritlecitinib
- ropeginterferon alfa-2b
- rotavirus vaccine, live
- ruxolitinib topical
- sirolimus
- smallpox vaccine, live
- tacrolimus
- triamcinolone
- typhoid vaccine, live
- valganciclovir
- vamorolone
- varicella vaccine, live
- voclosporin
- yellow fever vaccine, live
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
- deuruxolitinib
- 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
- rabies vaccine
- respiratory syncytial virus vaccine
- ribavirin
- rifabutin
- rituximab
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- sipuleucel-T
- smallpox/mpox vaccine, live
- stiripentol
- succimer
- sulfasalazine
- teplizumab
- teriflunomide
- thalidomide
- tick-borne encephalitis vaccine
- tocilizumab
- tofacitinib
- trimethoprim
- typhoid vaccine
- upadacitinib
- valproic acid
- vancomycin
- zidovudine
- zoster vaccine, recombinant
Caution Advised
- abatacept
- acetazolamide
- adalimumab
- anakinra
- avacopan
- beclomethasone inhaled
- beclomethasone nasal
- belimumab
- bimekizumab
- brivaracetam
- brodalumab
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- busulfan
- canakinumab
- cannabidiol
- carbamazepine
- cenobamate
- certolizumab pegol
- chlorambucil
- clobazam
- clobetasol ophthalmic
- clomipramine
- clonazepam
- clorazepate
- coccidioides immitis skin test antigen
- corticotropin
- crovalimab
- cytarabine
- danicopan
- daunorubicin
- delgocitinib topical
- deucravacitinib
- dexamethasone ophthalmic
- diazepam
- difluprednate ophthalmic
- dimethyl fumarate
- dinutuximab
- diroximel fumarate
- dupilumab
- eculizumab
- efgartigimod alfa
- emapalumab
- eslicarbazepine acetate
- etanercept
- 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
- linvoseltamab
- lomustine
- lorazepam
- loteprednol ophthalmic
- magnesium citrate
- methsuximide
- midazolam
- mirikizumab
- mitoxantrone
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- mosunetuzumab
- nadofaragene firadenovec intravesical
- narsoplimab
- nipocalimab
- obinutuzumab
- ocrelizumab
- ofatumumab
- oxcarbazepine
- ozanimod
- pegcetacoplan
- pentostatin
- perampanel
- phenobarbital
- phenytoin
- pirtobrutinib
- polyethylene glycol
- polyethylene glycol/electrolytes
- ponesimod
- pozelimab
- prednisolone ophthalmic
- pregabalin
- primidone
- promethazine
- ravulizumab
- rilonacept
- rilzabrutinib
- risankizumab
- rozanolixizumab
- rufinamide
- secukinumab
- selinexor
- sibeprenlimab
- siltuximab
- siponimod
- sodium picosulfate
- spesolimab
- sulfate bowel prep
- sutimlimab
- temsirolimus
- tezepelumab
- thioguanine
- tiagabine
- tildrakizumab
- topiramate
- trabectedin
- tralokinumab
- tramadol
- treosulfan
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- vedolizumab
- vigabatrin
- vilobelimab
- zilucoplan
- zonisamide
Adverse Reactions .
Serious Reactions
- cytokine release syndrome
- hypotension, severe
- fever
- hypoxia
- cardiac failure
- arrhythmia
- respiratory failure
- ARDS
- neurotoxicity, severe
- immune effector cell-associated neurotoxicity syndrome
- encephalopathy
- seizures
- hypersensitivity reaction, severe
- anaphylaxis
- infection, serious
- febrile neutropenia
- viral reactivation
- neutropenia, including prolonged
- thrombocytopenia, including prolonged
- anemia
- lymphopenia
- hypogammaglobulinemia
- hemophagocytic lymphohistiocytosis
- macrophage activation syndrome
- thrombosis
- hemorrhage
- coagulopathy
- ascites
- secondary malignancy
- T-cell malignancy
- chimeric antigen receptor (CAR)-positive lymphoma
Common Reactions
- cytokine release syndrome
- fever
- neutropenia, including prolonged
- neurotoxicity
- thrombocytopenia, including prolonged
- infection
- musculoskeletal pain
- nausea
- febrile neutropenia
- diarrhea
- hypotension
- immune effector cell-associated neurotoxicity syndrome
- pain
- headache
- fatigue
- encephalopathy
- hemorrhage
- vomiting
- rash
- abdominal pain
- dizziness
- cough
- hypoxia
- appetite decr.
- tachycardia
- edema
- constipation
- rigors
- weight decr.
- coagulopathy
- hypogammaglobulinemia
- lymphocytopenia
- anemia
Safety/Monitoring .
Monitoring Parameters
screening for HBV, HCV, HIV before leukapheresis; pregnancy test at baseline; signs/symptoms of infection before and after infusion; CBC, IgG levels after infusion; signs/symptoms of cytokine release syndrome, neurological toxicities daily for at least 7 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 negative 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 obecabtagene autoleucel: other; CYP450: unknown
Excretion: for obecabtagene autoleucel: unknown; Half-life: unknown
Subclass: Immunotherapy, CAR T-Cells ; Immunotherapy, CD19 Inhibitors
Mechanism of Action
for obecabtagene autoleucel: binds to CD19-expressing cells via chimeric antigen receptor (CAR)-positive autologous T-cells, inducing T-cell expansion, activation, and proliferation, and eliminating CD19-expressing cells
Formulary .
No Formulary Selected
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