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Briumvi (ublituximab-xiiy)
ublituximab
Adult Dosing .
Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = ublituximab-xiiy
multiple sclerosis, relapsing forms
- [1st course]
- Dose: 150 mg IV x1; Info: for patients with clinically isolated syndrome, relapsing-remitting disease, or active secondary progressive disease; premed with corticosteroid 30min before and antihistamine 30-60min before infusion; consider premed with antipyretic
- [2nd course]
- Dose: 450 mg IV x1; Start: 2wk after 1st course; Info: for patients with clinically isolated syndrome, relapsing-remitting disease, or active secondary progressive disease; premed with corticosteroid 30min before and antihistamine 30-60min before infusion; consider premed with antipyretic
- [subsequent courses]
- Dose: 450 mg IV x1 q24wk; Start: 24wk after 1st course; Info: for patients with clinically isolated syndrome, relapsing-remitting disease, or active secondary progressive disease; premed with corticosteroid 30min before and antihistamine 30-60min before each infusion; consider premed with antipyretic
renal dosing
- [see below]
- mild impairment: no adjustment; moderate-severe impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- mild impairment: no adjustment; moderate-severe impairment: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- life-threatening infusion reaction with prior ublituximab use
- infection, active
- HBV infection, active
- caution: HBV infection history
- caution: HBV carriers
- caution: ALT or AST 3x ULN with bilirubin 2x ULN
- caution: patients of childbearing potential
Drug Interactions .
Overview
ublituximab
CD20 antigen inhibitor
- immunomodulatory 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
- cladribine oral
- deuruxolitinib
- etrasimod
- natalizumab
- pimecrolimus topical
- rabies vaccine
- ritlecitinib
- ruxolitinib topical
- sarilumab
- tocilizumab
Monitor/Modify Tx
- anthrax vaccine
- carfilzomib
- chikungunya vaccine
- COVID-19 vaccine
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- ebola vaccine, live
- everolimus
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- influenza H5N1 vaccine
- influenza vaccine
- Japanese encephalitis vaccine
- meningococcal vaccine
- mitomycin
- pneumococcal vaccine
- poliovirus vaccine
- respiratory syncytial virus vaccine
- sipuleucel-T
- smallpox/mpox vaccine, live
- tick-borne encephalitis vaccine
- typhoid vaccine
- zoster vaccine, recombinant
Caution Advised
- abatacept
- abemaciclib
- acalabrutinib
- adalimumab
- afamitresgene autoleucel
- aldesleukin
- alemtuzumab
- anakinra
- anti-thymocyte globulin
- atidarsagene autotemcel
- avacopan
- axicabtagene ciloleucel
- azacitidine
- azathioprine
- baricitinib
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- belinostat
- bendamustine
- betamethasone
- bimekizumab
- blinatumomab
- bortezomib
- brentuximab vedotin
- brexucabtagene autoleucel
- brodalumab
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- busulfan
- cabazitaxel
- canakinumab
- carboplatin
- carmustine
- certolizumab pegol
- chlorambucil
- ciltacabtagene autoleucel
- cisplatin
- cladribine injection
- clobetasol ophthalmic
- clofarabine
- coccidioides immitis skin test antigen
- copanlisib
- corticotropin
- cortisone
- crovalimab
- cyclophosphamide
- cyclosporine
- cytarabine
- dactinomycin
- danicopan
- daratumumab
- daunorubicin
- decitabine
- deflazacort
- delgocitinib topical
- deucravacitinib
- dexamethasone
- dexamethasone ophthalmic
- difluprednate ophthalmic
- dimethyl fumarate
- dinutuximab
- diroximel fumarate
- docetaxel
- doxorubicin
- dupilumab
- duvelisib
- eculizumab
- efgartigimod alfa
- elivaldogene autotemcel
- elotuzumab
- elranatamab
- emapalumab
- epcoritamab
- epirubicin
- eribulin
- etanercept
- etoposide
- etuvetidigene autotemcel
- fingolimod
- floxuridine
- fludarabine
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- fruquintinib
- gemtuzumab ozogamicin
- glofitamab
- golimumab
- guselkumab
- hydrocortisone
- hydrocortisone ophthalmic
- hydroxyurea
- ibritumomab tiuxetan
- ibrutinib
- icotrokinra
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- inebilizumab
- infliximab
- inotuzumab ozogamicin
- iptacopan
- irinotecan
- isatuximab
- ixabepilone
- ixekizumab
- lebrikizumab
- leflunomide
- lenalidomide
- lifileucel
- linvoseltamab
- lisocabtagene maraleucel
- lomustine
- loncastuximab tesirine
- loteprednol ophthalmic
- lymphocyte immune globulin, anti-thymocyte globulin
- melphalan
- mercaptopurine
- methotrexate
- methylprednisolone
- mirikizumab
- mitoxantrone
- mogamulizumab
- momelotinib
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- mosunetuzumab
- mycophenolate mofetil
- mycophenolic acid
- nadofaragene firadenovec intravesical
- narsoplimab
- nelarabine
- nipocalimab
- obecabtagene autoleucel
- obinutuzumab
- ocrelizumab
- ofatumumab
- oxaliplatin
- ozanimod
- paclitaxel
- pegcetacoplan
- pentostatin
- pirtobrutinib
- polatuzumab vedotin
- pomalidomide
- ponatinib
- ponesimod
- pozelimab
- prednisolone
- prednisolone ophthalmic
- prednisone
- procarbazine
- quizartinib
- ravulizumab
- regorafenib
- rilonacept
- rilzabrutinib
- risankizumab
- rituximab
- romidepsin
- ropeginterferon alfa-2b
- rozanolixizumab
- ruxolitinib
- satralizumab
- secukinumab
- selinexor
- sibeprenlimab
- siltuximab
- siponimod
- sirolimus
- sirolimus albumin-bound
- spesolimab
- sulfasalazine
- sutimlimab
- tacrolimus
- tafasitamab
- talquetamab
- tarlatamab
- teclistamab
- temozolomide
- temsirolimus
- teplizumab
- teriflunomide
- thioguanine
- thiotepa
- tildrakizumab
- tisagenlecleucel
- tofacitinib
- topotecan
- trabectedin
- tralokinumab
- triamcinolone
- tuberculin purified protein derivative
- upadacitinib
- ustekinumab
- vamorolone
- venetoclax
- vilobelimab
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- zanubrutinib
- zilucoplan
Adverse Reactions .
Serious Reactions
- infusion reaction, severe
- infection, serious
- pneumonia
- HBV reactivation
- hepatic injury
- PML
Common Reactions
- infection
- infusion reaction
- respiratory infection
- neutropenia
- UTI
- herpes viral infection
- extremity pain
- insomnia
- fatigue
- hypogammaglobulinemia
Safety/Monitoring .
Monitoring Parameters
HBV screening at baseline; AST/ALT, alk phos, bilirubin at baseline, then as clinically indicated; serum immunoglobulins at baseline, then periodically, especially in patients with opportunistic or recurrent infection, until B-cell repletion after D/C; signs/symptoms of infusion reaction during and for at least 1h post-infusion x2 infusions, then as clinically indicated; consider MRI for signs/symptoms of PML
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available, though risk of transient neonatal B-cell depletion and lymphocytopenia based on limited human data with other anti-CD20 antibodies and drug's mechanism of action; no known risk of teratogenicity, though risk of neonatal B-cell depletion based on animal data; for infants exposed to ublituximab in utero, avoid live vaccines until B-cell recovery confirmed
Pregnancy Registry
enroll patients or encourage patients who become pregnant during tx or within 6mo after D/C to enroll in Briumvi Pregnancy Registry at 1-877-411-4546 or www.briumvipregnancyregistry.com
Individuals of Reproductive Potential
avoid pregnancy by using effective contraception during tx and for at least 6mo after D/C in patients of childbearing potential
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm, though possible drug excretion into milk based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for ublituximab: proteolytic degradation; CYP450: unknown
Excretion: for ublituximab: unknown; Half-life: 22 days
Subclass: Multiple Sclerosis
Mechanism of Action
for ublituximab: exact mechanism of action unknown; binds to B-lymphocyte CD20 surface antigens, resulting in lysis (monoclonal antibody)
Formulary .
No Formulary Selected
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