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Elrexfio (elranatamab-bcmm)
elranatamab
Black Box Warnings .
Appropriate Use
restricted distribution program (ELREXFIO REMS) due to cytokine release syndrome (CRS) and neurological toxicity risk; admin. only at certified healthcare facility w/ trained healthcare providers to manage CRS and neurological toxicities; 1-844-923-7845 or www.ELREXFIOREMS.com for more information
Cytokine Release Syndrome
incl. fatal or life-threatening rxn occurred in 58% of pts; initiate tx according to step-up dosing schedule to decr. CRS risk; monitor pts in hospital x48h after 1st step-up dose and x24h after 2nd step-up dose; manifestations may incl. fever, hypoxia, chills, hypotension, tachycardia, headache, elevated liver enzymes; provide supportive care as needed; withhold tx until s/sx resolve or permanently D/C, based on severity
Neurological Toxicities
serious and life-threatening rxn, incl. immune effector cell-assoc. neurotoxicity syndrome (ICANS) occurred in 59% of pts; may occur concurrently w/ CRS, after CRS resolution, or in the absence of CRS; monitor pts in hospital x48h after 1st step-up dose and x24h after 2nd step-up dose; provide supportive care as needed; withhold tx until s/sx resolve or permanently D/C, based on severity
Adult Dosing .
Dosage forms: INJ
Restricted Distribution in US
- [1-844-923-7845 or www.ELREXFIOREMS.com for more information]
Special Note
- [formulation clarification]
- Info: nonproprietary name = elranatamab-bcmm
- [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
multiple myeloma, relapsed or refractory
- [12 mg SC x1 on day 1, then 32 mg SC x1 on day 4, then 76 mg SC x1 on day 8 as part of step-up dosing schedule, then 76 mg SC qwk x22wk starting wk 3, then 76 mg SC q2wk starting wk 25 if partial or better response achieved and maintained for at least 2mo]
- Info: for pts refractory to at least 4 prior tx, incl. an anti-CD38 agent, a proteasome inhibitor, and an immunomodulatory agent
renal dosing
- [see below]
- eGFR >30: no adjustment; eGFR <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 (tx initiation use)
- avoid: breastfeeding during tx and x4mo after D/C
- caution: female pts of reproductive potential
Drug Interactions .
Overview
elranatamab
bispecific T cell engager
- immunosuppressive oncologic agent
- myelosuppressive oncologic agent
- peripheral neuropathy
- caution advised w/ narrow therapeutic index drugs metabolized by CYP450 liver enzymes, esp. at initiation and up to 14 days after 32 mg dose on Day 4 or during/after CRS; elranatamab 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
- 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)
- sarilumab
- 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
- bortezomib
- brentuximab vedotin
- 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
- docetaxel
- 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
- metronidazole
- miglustat
- mirikizumab
- mirvetuximab soravtansine
- mitoxantrone
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- nadofaragene firadenovec intravesical
- natalizumab
- naxitamab
- ocrelizumab
- ofatumumab
- oxaliplatin
- ozanimod
- paclitaxel
- pegcetacoplan
- polatuzumab vedotin
- ponesimod
- pozelimab
- prednisolone
- prednisolone ophthalmic
- prednisone
- ravulizumab
- rilonacept
- risankizumab
- rozanolixizumab
- secukinumab
- siltuximab
- siponimod
- spesolimab
- sutimlimab
- tacrolimus
- tezepelumab
- tildrakizumab
- tinidazole
- tralokinumab
- triamcinolone
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- vamorolone
- vedolizumab
- vigabatrin
- vilobelimab
- voclosporin
- zilucoplan
Adverse Reactions .
Serious Reactions
- cytokine release syndrome
- fever
- hypoxia
- hypotension
- tachycardia
- neurotoxicity, severe
- immune effector cell-assoc. neurotoxicity syndrome
- infection, serious
- opportunistic infection
- sepsis
- neutropenia
- febrile neutropenia
- hepatotoxicity
Common Reactions
- cytokine release syndrome
- fatigue
- injection site rxn
- diarrhea
- URI
- musculoskeletal pain
- pneumonia
- appetite decr.
- rash
- cough
- nausea
- fever
- edema
- headache
- arrhythmia
- constipation
- sepsis
- dyspnea
- encephalopathy
- vomiting
- hypogammaglobulinemia
- xerosis
- sensory neuropathy
- motor dysfxn
- hemorrhage
- insomnia
- UTI
- febrile neutropenia
- lymphocytes decr.
- Hgb decr.
- neutrophils decr.
- Plt decr.
- albumin decr.
- ALT or AST incr.
- Cr incr.
- potassium decr.
- alk phos incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; hepatic panel, CBC w/ diff, s/sx infection at baseline, then as clinically indicated; s/sx cytokine release syndrome, neurological toxicities x48h in hospital after 1st step-up dose, x24h in hospital after 2nd step-up dose, 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 female pts
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, BCMA Inhibitors ; Immunotherapy, Bispecific CD3 T-Cell Engagers
Mechanism of Action
binds to B-cell maturation antigen (BCMA) on multiple myeloma cells, recruiting T-cells via the anti-CD3 domain, leading to T-cell activation, cytokine release, and direct lysis of tumor cells (bispecific T-cell engager)
Formulary .
No Formulary Selected
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