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Epkinly (epcoritamab-bysp)
epcoritamab
Black Box Warnings .
Cytokine Release Syndrome
incl. serious or life-threatening rxn occurred in 51% of pts; initiate tx according to step-up dosing schedule to decr. CRS risk; monitor pts x24h in hospital after first 48 mg dose (day 15 of cycle 1); manifestations may incl. fever, hypotension, hypoxia, dyspnea, chills, tachycardia; provide supportive care as needed; withhold tx until s/sx resolve or permanently D/C, based on severity
Immune Effector Cell-Associated Neurotoxicity Syndrome
which may be fatal or life-threatening, occurred in 6% of pts, incl. concurrently w/ CRS, after CRS resolution, or in the absence of CRS; monitor pts x24h in hospital after first 48 mg dose (day 15 of cycle 1); provide supportive care as needed; withhold tx until s/sx resolve or permanently D/C, based on severity
Adult Dosing .
Dosage forms: INJ
Special Note
- [formulation clarification]
- Info: nonproprietary name = epcoritamab-bysp
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, postmeds, prophylactic meds, and dosing incl. toxicity-related dose adjustments
large B-cell lymphoma, relapsed or refractory
- [0.16 mg SC x1 on day 1, then 0.8 mg SC x1 on day 8 as part of step-up dosing schedule, then 48 mg SC x1 on days 15, 22 of 28-day cycle for cycle 1, then 48 mg SC x1 on days 1, 8, 15, 22 of 28-cycle for cycles 2-3, then 48 mg SC x1 on days 1, 15 of 28-day cycle for cycles 4-9, then 48 mg SC x1 on day of 1 of 28-day cycle starting cycle 10]
- Info: for pts w/ diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma who have received at least 2 lines of tx
follicular lymphoma, relapsed or refractory
- [0.16 mg SC x1 on day 1, then 0.8 mg SC x1 on day 8, then 3 mg SC x1 on day 15 as part of step-up dosing schedule, then 48 mg SC x1 on day 22 of 28-day cycle for cycle 1, then 48 mg SC x1 on days 1, 8, 15, 22 of 28-cycle for cycles 2-3, then 48 mg SC x1 on days 1, 15 of 28-day cycle for cycles 4-9, then 48 mg SC x1 on day of 1 of 28-day cycle starting cycle 10]
- Info: for pts who have received at least 2 lines of tx
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1-1.5x ULN or AST >ULN: no adjustment; bilirubin >1.5x ULN: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- infection, active
- avoid: breastfeeding during tx and x4mo after D/C
- caution: pts of childbearing potential
Drug Interactions .
Overview
epcoritamab
bispecific T cell engager
- immunosuppressive oncologic agent
- myelosuppressive oncologic agent
- caution advised w/ narrow therapeutic index drugs metabolized by CYP450 liver enzymes, esp. at initiation and up to 14 days after first 48 mg dose on Day 15 of Cycle 1 or during/after CRS; epcoritamab may transiently increase cytokine release leading to suppression of CYP450 metabolic function, causing incr. levels of concomitant drugs, risk of adverse 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
- abrocitinib
- anifrolumab
- chloramphenicol
- cladribine oral
- deferiprone
- deuruxolitinib
- etrasimod
- fexinidazole
- ganciclovir
- palifermin
- penicillamine
- pimecrolimus topical
- primaquine
- rabies vaccine
- radium Ra 223 dichloride
- ritlecitinib
- ropeginterferon alfa-2b
- ruxolitinib topical
- sarilumab
- valganciclovir
Monitor/Modify Tx
- albendazole
- alemtuzumab
- allopurinol
- anthrax vaccine
- anti-thymocyte globulin
- asenapine
- atidarsagene autotemcel
- auranofin
- azathioprine
- balsalazide
- baricitinib
- benznidazole
- betibeglogene autotemcel
- chikungunya vaccine
- cidofovir
- clozapine
- colchicine
- COVID-19 vaccine
- cyclophosphamide
- dapsone
- deferasirox
- dexrazoxane
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- ebola vaccine, live
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- elivaldogene autotemcel
- everolimus
- exagamglogene autotemcel
- filgrastim (G-CSF)
- 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
- Japanese encephalitis vaccine
- leflunomide
- linezolid
- lonafarnib
- lovotibeglogene autotemcel
- lumateperone
- lymphocyte immune globulin, anti-thymocyte globulin
- meningococcal vaccine
- mercaptopurine
- mesalamine
- mesalamine rectal
- methotrexate
- mycophenolate mofetil
- mycophenolic acid
- 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)
- satralizumab
- sipuleucel-T
- sirolimus
- smallpox/mpox vaccine, live
- stiripentol
- succimer
- sulfasalazine
- teplizumab
- teriflunomide
- thalidomide
- tick-borne encephalitis vaccine
- tocilizumab
- tofacitinib
- trimethoprim
- typhoid vaccine
- upadacitinib
- valproic acid
- zidovudine
- zoster vaccine, recombinant
Caution Advised
- abatacept
- adalimumab
- anakinra
- avacopan
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- betamethasone
- bimekizumab
- brodalumab
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- canakinumab
- certolizumab pegol
- clobetasol ophthalmic
- corticotropin
- cortisone
- crovalimab
- cyclosporine
- danicopan
- deflazacort
- deucravacitinib
- dexamethasone
- dexamethasone ophthalmic
- difluprednate ophthalmic
- dimethyl fumarate
- diroximel fumarate
- dupilumab
- eculizumab
- efgartigimod alfa
- emapalumab
- etanercept
- fingolimod
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- golimumab
- guselkumab
- hydrocortisone
- hydrocortisone ophthalmic
- inebilizumab
- infliximab
- iptacopan
- ixekizumab
- lebrikizumab
- loteprednol ophthalmic
- methylprednisolone
- mirikizumab
- mitoxantrone
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- nadofaragene firadenovec intravesical
- natalizumab
- nipocalimab
- ocrelizumab
- ofatumumab
- ozanimod
- pegcetacoplan
- ponesimod
- pozelimab
- prednisolone
- prednisolone ophthalmic
- prednisone
- ravulizumab
- rilonacept
- risankizumab
- rozanolixizumab
- secukinumab
- siltuximab
- siponimod
- spesolimab
- sutimlimab
- tacrolimus
- tezepelumab
- tildrakizumab
- tralokinumab
- triamcinolone
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- vamorolone
- vedolizumab
- vilobelimab
- voclosporin
- zilucoplan
Adverse Reactions .
Serious Reactions
- cytokine release syndrome
- immune effector cell-assoc. neurotoxicity syndrome
- infection, serious
- opportunistic infection
- sepsis
- neutropenia
- febrile neutropenia
- anemia
- thrombocytopenia
- pleural effusion
- tumor lysis syndrome
Common Reactions
- cytokine release syndrome
- fatigue
- musculoskeletal pain
- injection site rxn
- fever
- abdominal pain
- diarrhea
- nausea
- rash
- infection
- edema
- headache
- vomiting
- appetite decr.
- arrhythmia
- immune effector cell-assoc. neurotoxicity syndrome
- febrile neutropenia
- lymphocytes decr.
- Hgb decr.
- sodium decr.
- phosphate decr.
- neutrophils decr.
- Plt decr.
- ALT or AST incr.
- potassium decr.
- magnesium decr.
- Cr incr.
- potassium incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; CBC; s/sx cytokine release syndrome, neurological toxicities x24h in hospital after first 48 mg injection and as clinically indicated
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human or animal data available; possible risk of fetal harm, incl. embryo-fetal death and B-cell lymphocytopenia, based on drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x4mo after D/C in pts of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x4mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: catabolism; CYP450: unknown
Excretion: unknown; Half-life: 22 days
Subclass: Immunotherapy, Bispecific CD3 T-Cell Engagers ; Immunotherapy, CD20 Inhibitors
Mechanism of Action
binds to CD20 receptors on B-cells, and CD3 receptors on T-cells, leading to T-cell activation and subsequent lysis of CD20-positive B-cells (bispecific T-cell engager)
Formulary .
No Formulary Selected
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