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Kymriah
tisagenlecleucel
Black Box Warnings .
Appropriate Use
restricted distribution program (Kymriah REMS) due to cytokine release syndrome (CRS) and neurological toxicity risk; admin. only at certified healthcare facility w/ on-site, immediate access to tocilizumab, and a minimum of 2 doses of tocilizumab for each pt w/in 2h after tx if needed; 1-844-459-6742 or www.kymriah-rems.com for more information
Cytokine Release Syndrome
incl. fatal or life-threatening rxn, occurred; do not admin. if active infection or inflammatory disorders; treat severe or life-threatening CRS w/ tocilizumab +/- corticosteroids; monitor pts 2-3x during 1st wk post-infusion at certified healthcare facility, then monitor s/sx for at least 4wk after tx w/in proximity of certified healthcare facility; counsel pts on s/sx and to seek immediate medical attention if they occur at any time
Neurological Toxicities
which may be severe or life-threatening, can occur after tx, incl. concurrently w/ CRS; provide supportive care as needed; monitor pts 2-3x during 1st wk post-infusion at certified healthcare facility, then monitor s/sx for at least 4wk after tx w/in proximity of certified healthcare facility
Secondary Hematological Malignancies
incl. T-cell malignancies, have occurred; monitor life-long; contact Novartis at 1-844-459-6742 to report malignancy occurrence and obtain instructions on pt sample collection
Adult Dosing .
Dosage forms: INJ
Restricted Distribution in US
- [1-844-459-6742 or www.kymriah-rems.com for more info]
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
- [25 yo and younger, <50 kg]
- Dose: 0.2-5 x10^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg/dose IV x1; Start: 2-14 days after completing lymphodepleting combo chemo cyclophosphamide + fludarabine
- [25 yo and younger, >50 kg]
- Dose: 0.1-2.5 x10^8 CAR-positive viable T-cells IV x1; Start: 2-14 days after completing lymphodepleting combo chemo cyclophosphamide + fludarabine
large B-cell lymphoma, relapsed or refractory
- [0.6-6 x10^8 CAR-positive viable T-cells IV x1]
- Start: 2-11 days after completing lymphodepleting combo chemo regimen cyclophosphamide + fludarabine; Info: for pts w/ diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma; may omit lymphodepleting regimen if WBC <1000 w/in 1wk before tisagenlecleucel tx; see pkg insert for alternative lymphodepleting regimen
follicular lymphoma, relapsed or refractory
- [0.6-6 x10^8 CAR-positive viable T-cells IV x1]
- Start: 2-6 days after completing lymphodepleting combo chemo regimen cyclophosphamide + fludarabine; Info: use as 3rd-line and subsequent tx; may omit lymphodepleting regimen if WBC <1000 w/in 1wk before tisagenlecleucel tx; see pkg insert for alternative lymphodepleting regimen
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ
Restricted Distribution in US
- [1-844-459-6742 or www.kymriah-rems.com for more info]
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, prophylactic antimicrobials, and dosing incl. toxicity-related dose adjustments
B-cell precursor ALL, relapsed or refractory
- [3 yo and older, <50 kg]
- Dose: 0.2-5 x10^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg/dose IV x1; Start: 2-14 days after completing lymphodepleting combo chemo cyclophosphamide + fludarabine
- [3 yo and older, >50 kg]
- Dose: 0.1-2.5 x10^8 CAR-positive viable T-cells IV x1; Start: 2-14 days after completing lymphodepleting combo chemo cyclophosphamide + fludarabine
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy
- infection, active
- inflammatory disorder
- GVHD, active
- chemotherapy-associated serious rxn, unresolved
- baseline bone marrow blasts >50%
- tumor burden refractory to lymphodepleting chemotherapy
- avoid: blood donation indefinitely
- avoid: organ donation indefinitely
- avoid: tissue donation indefinitely
- avoid: cell donation indefinitely
- caution: hypersensitivity to DMSO
- caution: pts of childbearing potential
- caution: HBV carriers
Drug Interactions .
Overview
tisagenlecleucel
CAR T cell immunotherapy
- immunomodulatory effects (other)
- immunosuppressive oncologic agent
- 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
- anifrolumab
- anti-thymocyte globulin
- azathioprine
- basiliximab
- belatacept
- betamethasone
- budesonide
- budesonide rectal
- chloramphenicol
- cladribine oral
- cortisone
- cyclosporine
- deferiprone
- deflazacort
- deuruxolitinib
- dexamethasone
- dexrazoxane
- etrasimod
- 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
- aliskiren
- allopurinol
- anthrax vaccine
- asenapine
- atidarsagene autotemcel
- auranofin
- balsalazide
- baricitinib
- benznidazole
- betibeglogene autotemcel
- bupropion
- chikungunya vaccine
- cidofovir
- clozapine
- colchicine
- COVID-19 vaccine
- cyclophosphamide
- dapsone
- deferasirox
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- dipyridamole
- ebola vaccine, live
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- elivaldogene autotemcel
- exagamglogene autotemcel
- felodipine
- fentanyl
- filgrastim (G-CSF)
- flaxseed
- flucytosine
- fluphenazine
- foscarnet
- fostamatinib
- givinostat
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydroxychloroquine
- hydroxyurea
- iloperidone
- influenza H5N1 vaccine
- influenza vaccine
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- iopamidol
- Japanese encephalitis vaccine
- leflunomide
- linezolid
- lonafarnib
- lovotibeglogene autotemcel
- lumateperone
- meclofenamate
- mefenamic acid
- meningococcal vaccine
- mercaptopurine
- mesalamine
- mesalamine rectal
- methotrexate
- olsalazine
- pegfilgrastim (G-CSF)
- peginterferon alfa 2a
- peginterferon beta 1a
- pentamidine
- pneumococcal vaccine
- poliovirus vaccine
- pyrimethamine
- remimazolam
- respiratory syncytial virus vaccine
- ribavirin
- rifabutin
- rituximab
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- smallpox/mpox vaccine, live
- stiripentol
- succimer
- sulfasalazine
- sulindac
- tafasitamab
- teplizumab
- teriflunomide
- thalidomide
- tick-borne encephalitis vaccine
- tocilizumab
- tofacitinib
- tolmetin
- trimethoprim
- typhoid vaccine
- upadacitinib
- valproic acid
- vardenafil
- zidovudine
Caution Advised
- abatacept
- adalimumab
- anakinra
- avacopan
- beclomethasone inhaled
- beclomethasone nasal
- belimumab
- bimekizumab
- bortezomib
- brentuximab vedotin
- brivaracetam
- brodalumab
- budesonide inhaled
- budesonide nasal
- canakinumab
- cannabidiol
- carbamazepine
- cenobamate
- certolizumab pegol
- clobetasol ophthalmic
- clonazepam
- corticotropin
- crovalimab
- danicopan
- deucravacitinib
- dexamethasone ophthalmic
- diazepam
- difluprednate ophthalmic
- dimethyl fumarate
- diroximel fumarate
- docetaxel
- dupilumab
- eculizumab
- efgartigimod alfa
- emapalumab
- eslicarbazepine acetate
- etanercept
- fenfluramine
- fingolimod
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- gabapentin
- ganaxolone
- golimumab
- guselkumab
- hydrocortisone ophthalmic
- inebilizumab
- infliximab
- iptacopan
- ixekizumab
- lacosamide
- lamotrigine
- lebrikizumab
- levetiracetam
- lorazepam
- loteprednol ophthalmic
- magnesium citrate
- methsuximide
- metronidazole
- midazolam
- miglustat
- mirikizumab
- mirvetuximab soravtansine
- mitoxantrone
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- nadofaragene firadenovec intravesical
- naxitamab
- nipocalimab
- ocrelizumab
- ofatumumab
- oxaliplatin
- oxcarbazepine
- ozanimod
- paclitaxel
- pegcetacoplan
- perampanel
- phenobarbital
- phenytoin
- polatuzumab vedotin
- polyethylene glycol
- polyethylene glycol/electrolytes
- ponesimod
- pozelimab
- prednisolone ophthalmic
- pregabalin
- primidone
- promethazine
- ravulizumab
- rilonacept
- risankizumab
- rozanolixizumab
- rufinamide
- secukinumab
- siltuximab
- siponimod
- sodium picosulfate
- spesolimab
- sulfate bowel prep
- sutimlimab
- tezepelumab
- tiagabine
- tildrakizumab
- tinidazole
- topiramate
- 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 arrest
- cardiac failure
- respiratory failure
- pulmonary edema
- capillary leak syndrome
- HTN
- arrhythmia
- neurotoxicity, severe
- encephalopathy
- seizures
- aphasia
- hypersensitivity rxn, severe
- anaphylaxis
- infection, serious
- febrile neutropenia
- HBV reactivation
- neutropenia, incl. prolonged
- thrombocytopenia, incl. prolonged
- anemia
- hypogammaglobulinemia, incl. prolonged
- lymphopenia
- histiocytosis lymphocytic hemophagocytosis
- thrombosis
- hypofibrinogenemia
- intracranial hemorrhage
- DIC
- tumor lysis syndrome
- renal failure
- abdominal compartment syndrome
- graft vs. host dz
- multi-organ dysfxn syndrome
- secondary malignancy
- T-cell malignancy
- chimeric antigen receptor (CAR)-positive lymphoma
Common Reactions
- cytokine release syndrome
- neutropenia, incl. prolonged
- infection
- fever
- diarrhea
- hypotension
- headache
- nausea
- thrombocytopenia, incl. prolonged
- fatigue
- hypogammaglobulinemia
- febrile neutropenia
- encephalopathy
- edema
- appetite decr.
- cough
- acute kidney injury
- tachycardia
- dyspnea
- constipation
- pain
- vomiting
- hypoxia
- delirium
- rigors
- abdominal pain
- rash
- arthralgia
- anxiety
- myalgia
- sleep disorder
- dizziness
- HTN
- pulmonary edema
- tremor
- back pain
- oropharyngeal pain
- pleural effusion
- weight decr.
- hypofibrinogenemia
- thrombosis
- visual impairment
- DIC
- INR incr.
- peripheral neuropathy
- tachypnea
- motor dysfxn
- nasal congestion
- arrhythmia
- histiocytosis lymphocytic hemophagocytosis
- multi-organ dysfxn syndrome
- seizures
- speech disorder
- tumor lysis syndrome
- cardiac failure
- dermatitis
- prolonged aPTT
- coagulopathy
- respiratory failure
- lymphopenia
- anemia
- hypophosphatemia
- hypokalemia
Safety/Monitoring .
Monitoring Parameters
screening for HBV, HCV, HIV before leukapheresis; pregnancy test at baseline; s/sx infection before and after infusion; CBC, IgG levels after infusion; s/sx cytokine release syndrome, neurological toxicities 2-3x during 1st wk post-infusion at certified healthcare facility, then for at least 4wk after tx w/in proximity of certified healthcare facility
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
Pregnancy Reporting
report pregnancy to Novartis Pharmaceuticals Corp. at 1-888-669-6682
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during and after tx in female pts
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: other; CYP450: unknown
Excretion: unknown; Half-life: 2.5 days (non-responding peds pts), 13.6 days (non-responding adult pts), 16.8 days (responding peds pts), 45.3 days (responding adult pts)
Subclass: Immunotherapy, CAR T-Cells ; Immunotherapy, CD19 Inhibitors
Mechanism of Action
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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