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Skysona
elivaldogene autotemcel
Black Box Warnings .
Hematologic Malignancy
incl. life-threatening myelodysplastic syndrome, acute myeloid leukemia have occurred; pts diagnosed 14mo-7.5y after admin; likely due to lentiviral vector, Lenti-D, integration in proto-oncogenes; weigh risk/benefit and consider hematology consult before tx start; monitor closely w/ CBC at least q3mo and assessments for evidence of clonal expansion or predominance 2x in 1st year, then annually; consider bone marrow eval. as clinically indicated
Adult Dosing .
Adult dosing is currently unavailable or not applicable for this drug.
Peds Dosing .
- Dosage forms: INJ
Restricted Distribution in US
- [1-833-666-2583 or www.skysona.com for more info]
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, prophylactic regimens, and dosing
cerebral adrenoleukodystrophy, male
- [4-17 yo]
- Dose: 5x10^6 CD34+ cells/kg/dose IV x1; Start: >48h after myeloablative and lymphodepleting conditioning; Info: for pts w/ early, active dz; do not start myeloablative and lymphodepleting conditioning until confirming elivaldogene autotemcel infusion bag(s) at tx facility and back-up collection of CD34+ cells available; consider premed w/ antiemetic, antipyretic, and/or antihistamine
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- HIV status, positive or unknown
- infection, active
- antiretroviral use w/in at least 1mo before mobilization and until apheresis completed
- avoid: blood donation indefinitely
- avoid: organ donation indefinitely
- avoid: tissue donation indefinitely
- avoid: cell donation indefinitely
- avoid: PCR-based HIV testing after elivaldogene autotemcel tx
- caution: hypersensitivity to DMSO
- caution: pts of childbearing potential
- caution: male pts of reproductive potential
Drug Interactions .
Overview
elivaldogene autotemcel
gene therapy
- gene therapy
- immunosuppressive effects
- lowers seizure threshold
- myelosuppressive effects
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
- abacavir
- aldesleukin
- amifampridine
- atazanavir
- bictegravir
- cabotegravir
- chloramphenicol
- cladribine oral
- cobicistat
- darunavir
- deferiprone
- dolutegravir
- doravirine
- efavirenz
- elvitegravir
- emtricitabine
- enfuvirtide
- etrasimod
- etravirine
- fexinidazole
- fostemsavir
- ganciclovir
- human papillomavirus vaccine
- ibalizumab
- iohexol
- lamivudine
- lopinavir/ritonavir
- maraviroc
- natalizumab
- nevirapine
- penicillamine
- pimecrolimus topical
- poliovirus vaccine
- primaquine
- rabies vaccine
- radium Ra 223 dichloride
- raltegravir
- rilpivirine
- ritonavir
- ropeginterferon alfa-2b
- tenofovir alafenamide
- tenofovir disoproxil
- valganciclovir
- zidovudine
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- ado-trastuzumab emtansine
- afamitresgene autoleucel
- albendazole
- alemtuzumab
- allopurinol
- anthrax vaccine
- anti-thymocyte globulin
- arsenic trioxide
- asciminib
- asenapine
- atidarsagene autotemcel
- auranofin
- axicabtagene ciloleucel
- azacitidine
- azathioprine
- balsalazide
- baricitinib
- belantamab mafodotin
- belinostat
- bendamustine
- benznidazole
- betibeglogene autotemcel
- bevacizumab
- bexarotene
- blinatumomab
- bortezomib
- bosutinib
- brentuximab vedotin
- brexucabtagene autoleucel
- bupropion
- busulfan
- cabazitaxel
- capecitabine
- carboplatin
- carfilzomib
- carmustine
- chikungunya vaccine
- chlorambucil
- cidofovir
- ciltacabtagene autoleucel
- cisplatin
- cladribine injection
- clofarabine
- clozapine
- colchicine
- copanlisib
- COVID-19 vaccine
- crizotinib
- cyclophosphamide
- cytarabine
- dacarbazine
- dactinomycin
- dapsone
- daratumumab
- dasatinib
- daunorubicin
- decitabine
- deferasirox
- deuruxolitinib
- dexrazoxane
- dinutuximab
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- docetaxel
- dostarlimab
- doxorubicin
- duvelisib
- ebola vaccine, live
- eflornithine
- elranatamab
- enfortumab vedotin
- entrectinib
- epcoritamab
- epirubicin
- eribulin
- etoposide
- everolimus
- fam-trastuzumab deruxtecan
- fedratinib
- floxuridine
- flucytosine
- fludarabine
- fluorouracil
- fluphenazine
- foscarnet
- fostamatinib
- gemcitabine
- gemtuzumab ozogamicin
- givinostat
- glasdegib
- glofitamab
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- hydroxychloroquine
- hydroxyurea
- ibritumomab tiuxetan
- ibrutinib
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- imatinib
- imetelstat
- influenza H5N1 vaccine
- influenza vaccine
- inotuzumab ozogamicin
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- iopamidol
- irinotecan
- isatuximab
- ivosidenib
- ixabepilone
- Japanese encephalitis vaccine
- leflunomide
- lenalidomide
- lifileucel
- linezolid
- linvoseltamab
- lisocabtagene maraleucel
- lomustine
- lonafarnib
- loncastuximab tesirine
- lovotibeglogene autotemcel
- lumateperone
- lurbinectedin
- lutetium Lu 177 dotatate
- lutetium Lu 177 vipivotide tetraxetan
- lymphocyte immune globulin, anti-thymocyte globulin
- melphalan
- meningococcal vaccine
- mercaptopurine
- mesalamine
- mesalamine rectal
- methotrexate
- midostaurin
- mitomycin
- mitotane
- mitoxantrone
- mogamulizumab
- momelotinib
- mosunetuzumab
- mycophenolate mofetil
- mycophenolic acid
- nelarabine
- nilotinib
- niraparib
- obecabtagene autoleucel
- obinutuzumab
- ofatumumab
- olaparib
- olsalazine
- oxaliplatin
- paclitaxel
- pacritinib
- palbociclib
- panobinostat
- peginterferon alfa 2a
- peginterferon beta 1a
- pemetrexed
- pentamidine
- pentostatin
- pirtobrutinib
- pneumococcal vaccine
- polatuzumab vedotin
- pomalidomide
- ponatinib
- pralatrexate
- procarbazine
- proguanil
- pyrimethamine
- quizartinib
- respiratory syncytial virus vaccine
- ribavirin
- ribociclib
- rifabutin
- rituximab
- romidepsin
- rucaparib
- ruxolitinib
- ruxolitinib topical
- sacituzumab govitecan
- sarilumab
- satralizumab
- selinexor
- sipuleucel-T
- sirolimus
- sirolimus albumin-bound
- smallpox/mpox vaccine, live
- stiripentol
- streptozocin
- succimer
- sulfasalazine
- tafasitamab
- tagraxofusp
- talazoparib
- talquetamab
- tarlatamab
- tazemetostat
- teclistamab
- temozolomide
- temsirolimus
- teriflunomide
- thalidomide
- thioguanine
- thiotepa
- tick-borne encephalitis vaccine
- tisagenlecleucel
- tocilizumab
- tofacitinib
- topotecan
- trabectedin
- trastuzumab
- treosulfan
- trifluridine
- trimethoprim
- typhoid vaccine
- upadacitinib
- valproic acid
- vancomycin
- venetoclax
- vinblastine
- vincristine
- vinorelbine
- zanubrutinib
- ziv-aflibercept
Caution Advised
- abatacept
- abrocitinib
- acetazolamide
- adalimumab
- anakinra
- anifrolumab
- avacopan
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- betamethasone
- bimekizumab
- brivaracetam
- brodalumab
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- canakinumab
- cannabidiol
- carbamazepine
- cenobamate
- certolizumab pegol
- clobazam
- clobetasol ophthalmic
- clomipramine
- clonazepam
- clorazepate
- corticotropin
- cortisone
- crovalimab
- cyclosporine
- danicopan
- deflazacort
- delgocitinib topical
- deucravacitinib
- dexamethasone
- dexamethasone ophthalmic
- diazepam
- difluprednate ophthalmic
- dimethyl fumarate
- diroximel fumarate
- dupilumab
- eculizumab
- efgartigimod alfa
- elotuzumab
- emapalumab
- eslicarbazepine acetate
- etanercept
- ethosuximide
- felbamate
- fenfluramine
- fingolimod
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- fosphenytoin
- fruquintinib
- gabapentin
- ganaxolone
- golimumab
- guselkumab
- hydrocortisone
- hydrocortisone ophthalmic
- inebilizumab
- infliximab
- iptacopan
- ixekizumab
- lacosamide
- lamotrigine
- lebrikizumab
- levetiracetam
- lorazepam
- loteprednol ophthalmic
- magnesium citrate
- methsuximide
- methylprednisolone
- midazolam
- mirikizumab
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- nadofaragene firadenovec intravesical
- nipocalimab
- ocrelizumab
- oxcarbazepine
- ozanimod
- pegcetacoplan
- perampanel
- phenobarbital
- phenytoin
- polyethylene glycol
- polyethylene glycol/electrolytes
- ponesimod
- pozelimab
- prednisolone
- prednisolone ophthalmic
- prednisone
- pregabalin
- primidone
- promethazine
- ravulizumab
- regorafenib
- rilonacept
- risankizumab
- ritlecitinib
- rozanolixizumab
- rufinamide
- secukinumab
- siltuximab
- siponimod
- sodium picosulfate
- spesolimab
- sulfate bowel prep
- sutimlimab
- tacrolimus
- tiagabine
- tildrakizumab
- topiramate
- tralokinumab
- tramadol
- triamcinolone
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- vamorolone
- vedolizumab
- vigabatrin
- vilobelimab
- voclosporin
- zilucoplan
- zonisamide
Adverse Reactions .
Serious Reactions
- myelodysplastic syndrome
- AML
- lentiviral vector-mediated insertional oncogenesis
- infection, severe
- febrile neutropenia
- pancytopenia, incl. prolonged
- thrombocytopenia, incl. prolonged
- neutropenia, incl. prolonged
- lymphopenia, incl. prolonged
- Plt engraftment delay
- neutrophil engraftment failure risk
- hypersensitivity rxn
- anaphylaxis
- seizures
Common Reactions
- leukopenia
- lymphopenia
- thrombocytopenia
- neutropenia
- mucositis
- nausea
- anemia
- vomiting
- febrile neutropenia
- alopecia
- appetite decr.
- abdominal pain
- constipation
- hypokalemia
- fever
- headache
- diarrhea
- rash
- infection, severe
- pruritus
- epistaxis
- skin hyperpigmentation
- oropharyngeal pain
- anxiety
- tachycardia
- HTN
- blurred vision
- cough
- infusion rxn
Safety/Monitoring .
Monitoring Parameters
screening for HBV, HCV, HTLV-1/HTLV-2, HIV-1/HIV-2 before apheresis; CBC w/ diff frequently until normalization, then at least q3mo x15y; integration site analysis 2x/y x1y, then annually x15y; see pkg insert for additional hematologic malignancy monitoring considerations; s/sx infection, bleeding before and after infusion
Pregnancy/Lactation .
Pregnancy
Clinical Summary
N/A; drug unlikely to be used during pregnancy based on indication
Individuals of Reproductive Potential
avoid pregnancy by using effective contraception (IUD or combined hormonal and barrier contraceptive methods) from start of mobilization through at least 6mo after elivaldogene autotemcel tx in male pts and partners of childbearing potential; avoid semen donation indefinitely
Lactation
Clinical Summary
N/A; drug unlikely to be used while breastfeeding based on indication
Pharmacology .
Metabolism: other; CYP450: unknown
Excretion: unknown; Half-life: unknown
Subclass: Inherited Metabolic Disorders
Mechanism of Action
adds functional copies of ABCD1 cDNA into hematopoietic stem cells via autologous CD34+ cells transduced w/ Lenti-D lentiviral vector, promoting production of functional ALDP, leading to degradation of very long chain fatty acids, which slows or possibly prevents further inflammation and demyelination
Formulary .
No Formulary Selected
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