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Lunsumio (mosunetuzumab-axgb)
mosunetuzumab
Black Box Warnings .
Cytokine Release Syndrome
including serious or life-threatening reaction occurred; initiate tx according to step-up dosing schedule to decr. CRS risk; manifestations may include fever, chills, hypotension, tachycardia, hypoxia, headache; withhold tx until signs/symptoms resolve or permanently D/C, based on severity; provide supportive care, including intensive care for severe or life-threatening CRS, as needed
Adult Dosing .
Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = mosunetuzumab-axgb
- [equivalency or interchangeability info]
- Info: not interchangeable with SC mosunetuzumab; do not substitute on a mg to mg basis
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, prophylactic antimicrobials, and dosing including toxicity-related dose adjustments
follicular lymphoma, relapsed or refractory
- [1 mg IV x1 on day 1, then 2 mg IV x1 on day 8 as part of step-up dosing schedule, then 60 mg IV x1 on day 15 of 21-day cycle for cycle 1, then 60 mg IV x1 on day 1 of 21-cycle for cycle 2, then 30 mg IV x1 on day 1 of 21-day cycle for cycles 3-8]
- Info: for patients who have received at least 2 prior tx; give additional 9 cycles for patients who achieve partial response or stable disease after 8 cycles
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
- infection, active
- avoid: breastfeeding during tx and x3mo after D/C
- caution: patients of childbearing potential
- caution: immunosuppressant agent use history, significant
- caution: infection history, chronic
- caution: infection history, recurring
- caution: infection risk
- caution: tumor, bulky
- caution: tumor proximity to airway
- caution: tumor proximity to vital organ
Drug Interactions .
Overview
mosunetuzumab
bispecific T cell engager
- CNS depression
- immunomodulatory effects
- myelosuppressive oncologic agent
- peripheral neuropathy
- caution advised with narrow therapeutic index drugs, especially at mosunetuzumab initiation/titration or during/after CRS; mosunetuzumab may incr. cytokine release leading to suppression of metabolic enzymes, causing incr. drug levels, 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
- butalbital
- chloramphenicol
- cladribine oral
- clonidine
- codeine
- deferiprone
- deuruxolitinib
- doxylamine
- ethanol (alcoholic beverage)
- ethanol injection
- etrasimod
- fexinidazole
- ganciclovir
- haloperidol
- hydrocodone
- 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
- ruxolitinib topical
- scopolamine
- thalidomide
- tradipitant
- tranylcypromine
- trimethobenzamide
- valganciclovir
- zuranolone
Monitor/Modify Tx
- albendazole
- aldesleukin
- alemtuzumab
- alfentanil
- allopurinol
- alprazolam
- anthrax vaccine
- anti-thymocyte globulin
- atidarsagene autotemcel
- auranofin
- avian influenza vaccine
- azathioprine
- baclofen intrathecal
- balsalazide
- baricitinib
- benznidazole
- betibeglogene autotemcel
- buprenorphine
- butorphanol
- carbamazepine
- chikungunya vaccine
- chlordiazepoxide
- chlorpromazine
- cidofovir
- clobazam
- clonazepam
- clorazepate
- clozapine
- colchicine
- copper histidinate
- COVID-19 vaccine
- cyclophosphamide
- dapsone
- daridorexant
- deferasirox
- desflurane
- dexmedetomidine
- dexmedetomidine injection
- dexrazoxane
- 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
- etuvetidigene autotemcel
- everolimus
- exagamglogene autotemcel
- fentanyl
- filgrastim (G-CSF)
- flucytosine
- fluphenazine
- flurazepam
- foscarnet
- fosfomycin injection
- fostamatinib
- gabapentin
- gabapentin enacarbil
- givinostat
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydromorphone
- hydroxychloroquine
- hydroxyurea
- hydroxyzine
- ifosfamide
- influenza vaccine
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- isoflurane
- Japanese encephalitis vaccine
- ketamine
- leflunomide
- lemborexant
- levorphanol
- linezolid
- lonafarnib
- lorazepam
- lovotibeglogene autotemcel
- lymphocyte immune globulin, anti-thymocyte globulin
- marnetegragene autotemcel
- 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
- 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
- acalabrutinib
- adalimumab
- ado-trastuzumab emtansine
- afamitresgene autoleucel
- almotriptan
- amantadine
- amiodarone
- amitriptyline
- amoxapine
- anakinra
- apomorphine
- apraclonidine ophthalmic
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- asenapine
- avacopan
- axicabtagene ciloleucel
- azacitidine
- baclofen
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- belinostat
- bendamustine
- betamethasone
- bimekizumab
- blinatumomab
- bortezomib
- brentuximab vedotin
- brexpiprazole
- brexucabtagene autoleucel
- brimonidine ophthalmic
- brimonidine topical
- brivaracetam
- brodalumab
- bromocriptine
- brompheniramine
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- buspirone
- busulfan
- cabazitaxel
- canakinumab
- cannabidiol
- cannabis
- carbinoxamine
- carboplatin
- carfilzomib
- cariprazine
- carisoprodol
- carmustine
- cenobamate
- certolizumab pegol
- cetirizine
- chamomile, German
- chlophedianol
- chlorambucil
- chlorcyclizine
- chlorpheniramine
- chlorzoxazone
- ciclesonide
- ciltacabtagene autoleucel
- ciprofloxacin
- cisplatin
- citalopram
- cladribine injection
- clemastine
- clobetasol ophthalmic
- clofarabine
- clomipramine
- coccidioides immitis skin test antigen
- copanlisib
- corticotropin
- cortisone
- crovalimab
- cyclobenzaprine
- cyclosporine
- cyproheptadine
- cytarabine
- dacarbazine
- dactinomycin
- danicopan
- dantrolene
- daptomycin
- daratumumab
- darifenacin
- daunorubicin
- deflazacort
- delafloxacin
- delgocitinib topical
- desipramine
- desvenlafaxine
- deucravacitinib
- deutetrabenazine
- dexamethasone
- dexamethasone ophthalmic
- dexbrompheniramine
- dexchlorpheniramine
- dichlorphenamide
- difelikefalin
- difenoxin
- difluprednate ophthalmic
- dimenhydrinate
- dimethyl fumarate
- dinutuximab
- diphenhydramine
- diphenoxylate
- diroximel fumarate
- disulfiram
- docetaxel
- domperidone
- doxepin
- doxepin topical
- doxorubicin
- dronabinol
- duloxetine
- dupilumab
- duvelisib
- eculizumab
- efavirenz
- efgartigimod alfa
- eletriptan
- elinzanetant
- elotuzumab
- elranatamab
- emapalumab
- enfortumab vedotin
- entacapone
- entrectinib
- epcoritamab
- epirubicin
- eribulin
- escitalopram
- eslicarbazepine acetate
- etanercept
- ethosuximide
- etoposide
- felbamate
- fenfluramine
- fesoterodine
- fingolimod
- flibanserin
- floxuridine
- fludarabine
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluoxetine
- fluticasone furoate
- fluticasone propionate
- fluvoxamine
- foslevodopa
- fosphenytoin
- frovatriptan
- fruquintinib
- ganaxolone
- gemtuzumab ozogamicin
- glofitamab
- glycopyrrolate
- golimumab
- guanfacine
- guselkumab
- hydrocortisone
- hydrocortisone ophthalmic
- hyoscyamine
- ibritumomab tiuxetan
- ibrutinib
- icotrokinra
- idarubicin
- idecabtagene vicleucel
- idelalisib
- iloperidone
- imipramine
- inebilizumab
- infliximab
- inotuzumab ozogamicin
- iptacopan
- irinotecan
- isatuximab
- itraconazole
- ixabepilone
- ixazomib
- ixekizumab
- lacosamide
- lamotrigine
- lebrikizumab
- lenalidomide
- levetiracetam
- levocetirizine
- levodopa
- levofloxacin
- levomilnacipran
- lifileucel
- linvoseltamab
- lisocabtagene maraleucel
- lofexidine
- lomustine
- loncastuximab tesirine
- loteprednol ophthalmic
- loxapine
- lumateperone
- lurasidone
- meclizine
- melatonin
- melphalan
- meprobamate
- methocarbamol
- methsuximide
- methyldopa
- methylprednisolone
- metronidazole
- metyrapone
- metyrosine
- miglustat
- milnacipran
- milsaperidone
- mirikizumab
- mirvetuximab soravtansine
- mitomycin
- mitotane
- mitoxantrone
- mogamulizumab
- molindone
- momelotinib
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- moxifloxacin
- nadofaragene firadenovec intravesical
- naltrexone
- naratriptan
- narsoplimab
- naxitamab
- nefazodone
- nipocalimab
- nortriptyline
- obecabtagene autoleucel
- obinutuzumab
- ocrelizumab
- ofatumumab
- ofloxacin
- orphenadrine
- oxaliplatin
- oxcarbazepine
- ozanimod
- paclitaxel
- pacritinib
- paliperidone
- paroxetine
- passion flower
- pegcetacoplan
- pentostatin
- perampanel
- pheniramine
- phenytoin
- pimozide
- pirtobrutinib
- polatuzumab vedotin
- pomalidomide
- ponatinib
- ponesimod
- pozelimab
- pramipexole
- prednisolone
- prednisolone ophthalmic
- prednisone
- procarbazine
- prochlorperazine
- protriptyline
- pyrilamine
- quetiapine
- ramelteon
- rasagiline
- ravulizumab
- regorafenib
- relacorilant
- repotrectinib
- rilonacept
- rilzabrutinib
- risankizumab
- risperidone
- rizatriptan
- romidepsin
- ropinirole
- rotigotine transdermal
- rozanolixizumab
- rufinamide
- ruxolitinib
- safinamide
- secukinumab
- selegiline
- selegiline transdermal
- selinexor
- sertraline
- sibeprenlimab
- siltuximab
- siponimod
- sirolimus albumin-bound
- solifenacin
- spesolimab
- sumatriptan
- sutimlimab
- tacrolimus
- tafasitamab
- talquetamab
- tarlatamab
- tasimelteon
- teclistamab
- telisotuzumab vedotin
- temozolomide
- temsirolimus
- tetrabenazine
- tezepelumab
- thioguanine
- thiotepa
- tiagabine
- tildrakizumab
- tinidazole
- tisagenlecleucel
- tisotumab vedotin
- tizanidine
- tolcapone
- tolterodine
- topiramate
- topotecan
- trabectedin
- tralokinumab
- trazodone
- triamcinolone
- trifluoperazine
- trihexyphenidyl
- trimipramine
- triprolidine
- trospium
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- valbenazine
- valerian
- vamorolone
- vedolizumab
- venetoclax
- venlafaxine
- vigabatrin
- vilazodone
- vilobelimab
- viloxazine
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- zanubrutinib
- zilucoplan
- ziprasidone
- zolmitriptan
- zonisamide
Adverse Reactions .
Serious Reactions
- cytokine release syndrome
- fever
- hypotension
- tachycardia
- hypoxia
- neurotoxicity, severe
- immune effector cell-associated neurotoxicity syndrome
- infection, serious
- opportunistic infection
- neutropenia
- febrile neutropenia
- anemia
- thrombocytopenia
- lymphopenia
- hemophagocytic lymphohistiocytosis
- tumor flare, severe
- tumor lysis syndrome
- hypogammaglobulinemia
Common Reactions
- injection site reaction (SC use)
- cytokine release syndrome
- fatigue
- rash
- headache
- fever
- musculoskeletal pain
- cough
- pruritus
- peripheral neuropathy
- edema
- diarrhea
- nausea
- constipation
- xeroderma
- URI
- rigors
- dizziness
- abdominal pain
- pneumonia
- insomnia
- arthralgia
- dyspnea
- UTI
- lymphocytes decr.
- phosphate decr.
- Hgb decr.
- neutrophils decr.
- Plt decr.
- glucose incr.
- ALT or AST incr.
- GGT incr.
- magnesium decr.
- potassium decr.
- uric acid incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; CBC with diff, signs/symptoms of infection at baseline and during tx; signs/symptoms of cytokine release syndrome, neurological toxicities
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human or animal data available; possible risk of fetal harm, including 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 x3mo after D/C in patients 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: for mosunetuzumab: other; CYP450: unknown
Excretion: for mosunetuzumab: unknown; Half-life: 16 days (IV), 17 days (SC)
Subclass: Immunotherapy, Bispecific CD3 T-Cell Engagers ; Immunotherapy, CD20 Inhibitors
Mechanism of Action
for mosunetuzumab: 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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