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Lynozyfic (linvoseltamab-gcpt)
linvoseltamab
Black Box Warnings .
Appropriate Use
restricted distribution program (LYNOZYFIC 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; 1-855-212-6391 or lynozyficREMS.com for more information
Cytokine Release Syndrome
incl. serious or life-threatening rxns occurred in 46% of pts; initiate tx according to step-up dosing schedule and admin. premeds to decr. CRS risk; monitor pts x24h in hospital after 1st and 2nd dose of step-up dosing schedule for CRS s/sx, incl. fever, chills, hypoxia, tachycardia, hypotension; 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 54% of pts; may occur concurrently w/ CRS, after CRS resolution, or in the absence of CRS; monitor pts in hospital x24h after 1st and 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
- [1-855-212-6391 or lynozyficREMS.com for more information]
Special Note
- [drug name clarification]
- Info: nonproprietary name = linvoseltamab-gcpt
- [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
- [5 mg IV x1 on day 1 (1st step-up dose), then 25 mg IV x1 on day 8 (2nd step-up dose), then 200 mg IV x1 on day 15 (1st tx dose) as part of step-up dosing schedule, then 200 mg IV qwk x10wk starting wk 4, then 200 mg IV q2wk starting wk 14]
- Info: for pts refractory to at least 4 prior tx, incl. an anti-CD38 agent, a proteasome inhibitor, and an immunomodulatory agent; decr. frequency to q4wk after at least 17 doses of 200 mg if very good partial response or better achieved and maintained at or after wk 24
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.1-1.5x 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
- avoid: breastfeeding during tx and x3mo after D/C
- caution: pts of childbearing potential
Drug Interactions .
Overview
linvoseltamab
bispecific T cell engager
- CNS depression
- immunosuppressive effects
- myelosuppressive oncologic agent
- caution advised w/ narrow therapeutic index drugs metabolized by CYP450 liver enzymes, especially at initiation and up to 14 days after 1st 200 mg dose or during/after cytokine release syndrome; linvoseltamab 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
- butalbital
- chloramphenicol
- cladribine oral
- clonidine
- codeine
- deferiprone
- dexrazoxane
- doxylamine
- ethanol
- etrasimod
- fexinidazole
- ganciclovir
- isocarboxazid
- kava
- kratom
- metaxalone
- metoclopramide
- midazolam
- natalizumab
- oxybate
- palifermin
- penicillamine
- phenelzine
- pimecrolimus topical
- primaquine
- promethazine
- rabies vaccine
- radium Ra 223 dichloride
- ritlecitinib
- ropeginterferon alfa-2b
- thalidomide
- tranylcypromine
- trimethobenzamide
- valganciclovir
- zuranolone
Monitor/Modify Tx
- albendazole
- aldesleukin
- alemtuzumab
- alfentanil
- allopurinol
- alprazolam
- anthrax vaccine
- anti-thymocyte globulin
- asenapine
- atidarsagene autotemcel
- auranofin
- azathioprine
- baclofen intrathecal
- balsalazide
- baricitinib
- benznidazole
- betibeglogene autotemcel
- buprenorphine
- butorphanol
- carbamazepine
- chikungunya vaccine
- chlordiazepoxide
- chlorpromazine
- cidofovir
- clobazam
- clonazepam
- clorazepate
- clozapine
- colchicine
- COVID-19 vaccine
- cyclophosphamide
- dapsone
- daridorexant
- deferasirox
- desflurane
- deuruxolitinib
- dexmedetomidine
- dexmedetomidine injection
- diazepam
- dihydrocodeine
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- droperidol
- ebola vaccine, live
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- elivaldogene autotemcel
- esketamine
- estazolam
- eszopiclone
- ethanol (in some formulations)
- etomidate
- everolimus
- exagamglogene autotemcel
- fentanyl
- filgrastim (G-CSF)
- flucytosine
- fluphenazine
- flurazepam
- foscarnet
- fostamatinib
- gabapentin
- gabapentin enacarbil
- givinostat
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydrocodone
- hydromorphone
- hydroxychloroquine
- hydroxyurea
- hydroxyzine
- ifosfamide
- iloperidone
- influenza H5N1 vaccine
- influenza vaccine
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- isoflurane
- Japanese encephalitis vaccine
- ketamine
- leflunomide
- lemborexant
- levorphanol
- linezolid
- lonafarnib
- lorazepam
- lovotibeglogene autotemcel
- lumateperone
- lymphocyte immune globulin, anti-thymocyte globulin
- meningococcal vaccine
- meperidine
- mercaptopurine
- mesalamine
- mesalamine rectal
- methadone
- methohexital
- methotrexate
- mirtazapine
- morphine
- mycophenolate mofetil
- mycophenolic acid
- nalbuphine
- nelarabine
- olanzapine
- oliceridine
- olsalazine
- opicapone
- opium
- oxazepam
- oxybutynin
- oxycodone
- oxymorphone
- pegfilgrastim (G-CSF)
- peginterferon alfa 2a
- peginterferon beta 1a
- pentamidine
- pentazocine
- pentobarbital
- perphenazine
- phenobarbital
- pneumococcal vaccine
- poliovirus vaccine
- pregabalin
- primidone
- proguanil
- propofol
- pyrimethamine
- quazepam
- remifentanil
- remimazolam
- respiratory syncytial virus vaccine
- ribavirin
- rifabutin
- rituximab
- ruxolitinib topical
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- sevoflurane
- sipuleucel-T
- sirolimus
- smallpox/mpox vaccine, live
- stiripentol
- succimer
- sufentanil
- sulfasalazine
- suvorexant
- tapentadol
- temazepam
- teplizumab
- teriflunomide
- thioridazine
- thiothixene
- tick-borne encephalitis vaccine
- tocilizumab
- tofacitinib
- tramadol
- triazolam
- trimethoprim
- typhoid vaccine
- upadacitinib
- valproic acid
- vancomycin
- zaleplon
- ziconotide
- zidovudine
- zolpidem
- zoster vaccine, recombinant
Caution Advised
- 5-HTP
- abatacept
- adalimumab
- afamitresgene autoleucel
- almotriptan
- amantadine
- amitriptyline
- amoxapine
- anakinra
- anifrolumab
- apomorphine
- apraclonidine ophthalmic
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- avacopan
- axicabtagene ciloleucel
- baclofen
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- betamethasone
- bimekizumab
- brexpiprazole
- brexucabtagene autoleucel
- brimonidine ophthalmic
- brimonidine topical
- brivaracetam
- brodalumab
- bromocriptine
- brompheniramine
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- buspirone
- canakinumab
- cannabidiol
- cannabis
- carbinoxamine
- cariprazine
- carisoprodol
- cenobamate
- certolizumab pegol
- cetirizine
- chamomile, German
- chlophedianol
- chlorpheniramine
- chlorzoxazone
- ciltacabtagene autoleucel
- citalopram
- clemastine
- clobetasol ophthalmic
- clomipramine
- corticotropin
- cortisone
- crovalimab
- cyclobenzaprine
- cyclosporine
- cyproheptadine
- danicopan
- dantrolene
- darifenacin
- deflazacort
- delgocitinib topical
- desipramine
- desvenlafaxine
- deucravacitinib
- deutetrabenazine
- dexamethasone
- dexamethasone ophthalmic
- dexbrompheniramine
- dexchlorpheniramine
- dichlorphenamide
- difelikefalin
- difenoxin
- difluprednate ophthalmic
- dimenhydrinate
- dimethyl fumarate
- diphenhydramine
- diphenoxylate
- diroximel fumarate
- domperidone
- doxepin
- doxepin topical
- dronabinol
- duloxetine
- dupilumab
- eculizumab
- efavirenz
- efgartigimod alfa
- eletriptan
- emapalumab
- entacapone
- entrectinib
- escitalopram
- eslicarbazepine acetate
- etanercept
- ethosuximide
- felbamate
- fenfluramine
- fesoterodine
- fingolimod
- flibanserin
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluoxetine
- fluticasone furoate
- fluticasone propionate
- fluvoxamine
- foslevodopa
- fosphenytoin
- frovatriptan
- ganaxolone
- glofitamab
- glycopyrrolate
- golimumab
- guanfacine
- guselkumab
- haloperidol
- hydrocortisone
- hydrocortisone ophthalmic
- hyoscyamine
- idecabtagene vicleucel
- imipramine
- inebilizumab
- infliximab
- iptacopan
- ixekizumab
- lacosamide
- lamotrigine
- lasmiditan
- lebrikizumab
- levetiracetam
- levocetirizine
- levodopa
- levomilnacipran
- lifileucel
- lisocabtagene maraleucel
- lithium
- lofexidine
- loteprednol ophthalmic
- loxapine
- lurasidone
- meclizine
- melatonin
- meprobamate
- methocarbamol
- methsuximide
- methyldopa
- methylprednisolone
- metyrapone
- metyrosine
- milnacipran
- mirikizumab
- mitotane
- mitoxantrone
- molindone
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- mosunetuzumab
- nadofaragene firadenovec intravesical
- naltrexone
- naratriptan
- nefazodone
- nipocalimab
- nortriptyline
- obecabtagene autoleucel
- ocrelizumab
- ofatumumab
- orphenadrine
- oxcarbazepine
- ozanimod
- paliperidone
- paroxetine
- passion flower
- pegcetacoplan
- perampanel
- pheniramine
- phenytoin
- pimozide
- ponesimod
- pozelimab
- pramipexole
- prednisolone
- prednisolone ophthalmic
- prednisone
- procarbazine
- prochlorperazine
- protriptyline
- pyrilamine
- quetiapine
- ramelteon
- rasagiline
- ravulizumab
- repotrectinib
- rilonacept
- risankizumab
- risperidone
- rizatriptan
- ropinirole
- rotigotine transdermal
- rozanolixizumab
- rufinamide
- safinamide
- scopolamine
- secukinumab
- selegiline
- selegiline transdermal
- selinexor
- sertraline
- siltuximab
- siponimod
- solifenacin
- spesolimab
- sumatriptan
- sutimlimab
- tacrolimus
- tasimelteon
- tetrabenazine
- thiotepa
- tiagabine
- tildrakizumab
- tisagenlecleucel
- tizanidine
- tolcapone
- tolterodine
- topiramate
- tralokinumab
- trazodone
- triamcinolone
- trifluoperazine
- trihexyphenidyl
- trimipramine
- triprolidine
- trospium
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- valbenazine
- valerian
- vamorolone
- vedolizumab
- venlafaxine
- vigabatrin
- vilazodone
- vilobelimab
- viloxazine
- voclosporin
- zilucoplan
- ziprasidone
- zolmitriptan
- zonisamide
Adverse Reactions .
Serious Reactions
- cytokine release syndrome
- fever
- rigors
- hypoxia
- tachycardia
- hypotension
- infusion rxn, severe
- neurotoxicity, severe
- immune effector cell-assoc. neurotoxicity syndrome
- encephalopathy
- infection, serious
- opportunistic infection
- pneumonia
- sepsis
- PML
- neutropenia
- febrile neutropenia
- hepatotoxicity
- tumor lysis syndrome
- acute kidney injury
Common Reactions
- neurotoxicity
- musculoskeletal pain
- cytokine release syndrome
- infection
- cough
- diarrhea
- fatigue
- pneumonia
- nausea
- headache
- dyspnea
- vomiting
- edema
- encephalopathy
- constipation
- fever
- appetite decr.
- rash
- hypogammaglobulinemia
- sensory neuropathy
- insomnia
- sepsis
- HTN
- infusion rxn
- immune effector cell-assoc. neurotoxicity syndrome
- febrile neutropenia
- acute kidney injury
- lymphocytes decr.
- Hgb decr.
- Plt decr.
- neutrophils decr.
- ALT or AST incr.
- phosphate decr.
- Cr incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; hepatic panel at baseline, then as clinically indicated; CBC w/ diff, IgG levels, s/sx infection at baseline, then periodically during tx; s/sx cytokine release syndrome, neurological toxicities, incl. x24h in hospital after 1st and 2nd dose w/in step-up dosing schedule
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 hypogammaglobulinemia, 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 x3mo after D/C in pts of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x3mo 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: unknown
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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