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Casgevy
exagamglogene autotemcel
Adult Dosing .
Dosage forms: INJ
Restricted Distribution in US
- [1-877-634-8789 or www.casgevy.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 regimens, and dosing
sickle cell dz
- [3 x10^6 CD34+ cells/kg/dose IV x1]
- Start: between 48h and 7 days after myeloablative conditioning w/ busulfan; Info: for pts w/ recurrent vaso-occlusive crises; maintain HgbS <30%, Hgb <11.1 for at least 8wk before mobilization until myeloablative conditioning; do not start myeloablative conditioning until confirming exagamglogene autotemcel infusion bag(s) at tx facility and back-up collection of CD34+ cells available
beta-thalassemia, transfusion-dependent
- [3 x10^6 CD34+ cells/kg/dose IV x1]
- Start: between 48h and 7 days after myeloablative conditioning w/ busulfan; Info: maintain Hgb >11 before mobilization and x60 days before myeloablative conditioning; do not start myeloablative conditioning until confirming exagamglogene autotemcel infusion bag(s) at tx facility and back-up collection of CD34+ cells available
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
- [1-877-634-8789 or www.casgevy.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 regimens, and dosing
sickle cell dz
- [12 yo and older]
- Dose: 3 x10^6 CD34+ cells/kg/dose IV x1;Start: between 48h and 7 days after myeloablative conditioning w/ busulfan; Info: for pts w/ recurrent vaso-occlusive crises; maintain HgbS <30%, Hgb <11.1 for at least 8wk before mobilization until myeloablative conditioning; do not start myeloablative conditioning until confirming exagamglogene autotemcel infusion bag(s) at tx facility and back-up collection of CD34+ cells available
beta-thalassemia, transfusion-dependent
- [12 yo and older]
- Dose: 3 x10^6 CD34+ cells/kg/dose IV x1; Start: between 48h and 7 days after myeloablative conditioning w/ busulfan; Info: maintain Hgb >11 before mobilization and x60 days before myeloablative conditioning; do not start myeloablative conditioning until confirming exagamglogene autotemcel infusion bag(s) at tx facility and back-up collection of CD34+ cells available
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- HIV infection, active
- HBV infection, active
- HCV infection, active
- HSCT hx
- pregnancy
- hydroxyurea use w/in 8wk before mobilization
- dz-modifying agent use w/in 8wk before mobilization
- G-CSF use before and during mobilization (sickle cell dz use)
- hydroxyurea use w/in 8wk before myeloablative conditioning
- dz-modifying agent use w/in 8wk before myeloablative conditioning
- iron chelator use w/in 7 days before myeloablative conditioning
- <48h post-myeloablative conditioning
- >7 days post-myeloablative conditioning
- avoid: non-myelosuppressive iron chelator use x3mo after exagamglogene autotemcel tx
- avoid: myelosuppressive iron chelator use x6mo after exagamglogene autotemcel tx
- avoid: G-CSF use x21 days after exagamglogene autotemcel tx
- avoid: blood donation indefinitely
- avoid: organ donation indefinitely
- avoid: tissue donation indefinitely
- avoid: cell donation indefinitely
- caution: hypersensitivity to DMSO
- caution: hypersensitivity to dextran 40
- caution: female pts of reproductive potential
- caution: male pts of reproductive potential
Drug Interactions .
Overview
exagamglogene autotemcel
gene therapy
- gene therapy
- myelosuppressive effects
Avoid/Use Alternative
- chloramphenicol
- cladribine oral
- deferasirox
- deferiprone
- deferoxamine
- fexinidazole
- ganciclovir
- penicillamine
- primaquine
- radium Ra 223 dichloride
- ropeginterferon alfa-2b
- valganciclovir
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- ado-trastuzumab emtansine
- afamitresgene autoleucel
- albendazole
- aldesleukin
- alemtuzumab
- allopurinol
- anti-thymocyte globulin
- arsenic trioxide
- asciminib
- asenapine
- atidarsagene autotemcel
- auranofin
- axicabtagene ciloleucel
- azacitidine
- azathioprine
- balsalazide
- baricitinib
- belantamab mafodotin
- belinostat
- bendamustine
- benznidazole
- bevacizumab
- bexarotene
- blinatumomab
- bortezomib
- bosutinib
- brentuximab vedotin
- brexucabtagene autoleucel
- busulfan
- cabazitaxel
- capecitabine
- carboplatin
- carfilzomib
- carmustine
- chlorambucil
- cidofovir
- ciltacabtagene autoleucel
- cisplatin
- cladribine injection
- clofarabine
- clozapine
- colchicine
- copanlisib
- crizanlizumab
- crizotinib
- cyclophosphamide
- cytarabine
- dacarbazine
- dactinomycin
- dapsone
- daratumumab
- dasatinib
- daunorubicin
- decitabine
- deuruxolitinib
- dexrazoxane
- dinutuximab
- docetaxel
- dostarlimab
- doxorubicin
- duvelisib
- 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
- hydroxychloroquine
- hydroxyurea
- ibritumomab tiuxetan
- ibrutinib
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- iloperidone
- imatinib
- imetelstat
- inotuzumab ozogamicin
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- irinotecan
- isatuximab
- ivosidenib
- ixabepilone
- leflunomide
- lenalidomide
- lifileucel
- linezolid
- lisocabtagene maraleucel
- lomustine
- lonafarnib
- loncastuximab tesirine
- lumateperone
- lurbinectedin
- lutetium Lu 177 dotatate
- lutetium Lu 177 vipivotide tetraxetan
- lymphocyte immune globulin, anti-thymocyte globulin
- melphalan
- 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
- omacetaxine mepesuccinate
- oxaliplatin
- paclitaxel
- pacritinib
- palbociclib
- panobinostat
- peginterferon alfa 2a
- peginterferon beta 1a
- pemetrexed
- pentamidine
- pentostatin
- pirtobrutinib
- polatuzumab vedotin
- pomalidomide
- ponatinib
- pralatrexate
- procarbazine
- proguanil
- pyrimethamine
- quizartinib
- ribavirin
- ribociclib
- rifabutin
- rituximab
- romidepsin
- rucaparib
- ruxolitinib
- ruxolitinib topical
- sacituzumab govitecan
- sarilumab
- satralizumab
- selinexor
- sirolimus
- sirolimus albumin-bound
- stiripentol
- streptozocin
- succimer
- sulfasalazine
- tafasitamab
- tagraxofusp
- talazoparib
- talquetamab
- tarlatamab
- tazemetostat
- teclistamab
- temozolomide
- temsirolimus
- teplizumab
- teriflunomide
- thalidomide
- thioguanine
- thiotepa
- tisagenlecleucel
- tocilizumab
- tofacitinib
- topotecan
- trabectedin
- trastuzumab
- treosulfan
- trifluridine
- trimethoprim
- upadacitinib
- valproic acid
- venetoclax
- vinblastine
- vincristine
- vinorelbine
- voxelotor
- zanubrutinib
- ziv-aflibercept
Adverse Reactions .
Serious Reactions
- neutrophil engraftment failure risk
- febrile neutropenia
- Plt engraftment delay
- hypersensitivity rxn
- anaphylaxis
- off-target genome editing risk
Common Reactions
- mucositis
- febrile neutropenia
- appetite decr.
- infusion rxn
- epistaxis
- musculoskeletal pain
- hepatic veno-occlusive dz
- abdominal pain
- cholelithiasis
- pruritus
- pneumonia
- hypoxia
- infection
- neutropenia
- thrombocytopenia
- anemia
- lymphopenia
Safety/Monitoring .
Monitoring Parameters
pregnancy test before start of mobilization, then before myeloablative conditioning; screening for HIV-1/HIV-2, HBV, HCV before apheresis; CBC w/ diff until engraftment achieved; s/sx hypersensitivity rxn during and after infusion; s/sx bleeding
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; no human or animal data available
Individuals of Reproductive Potential
obtain negative pregnancy test before start of mobilization, then before myeloablative conditioning; avoid pregnancy by using effective contraception from start of mobilization through at least 6mo after exagamglogene autotemcel tx in female and male 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: unknown
Subclass: Gene Therapy, Hemoglobin Disorders ; Sickle Cell Disease ; Thalassemia
Mechanism of Action
reduces BCL11A expression in erythroid lineage cells via CD34+ cells edited by CRISPR/Cas9 at the erythroid specific enhancer region of BCL11A gene, leading to incr. gamma-globin expression and fetal Hgb F formation, thereby eliminating RBC transfusion dependence and preventing sickling of RBCs
Formulary .
No Formulary Selected
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