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Uplizna (inebilizumab-cdon)
inebilizumab
Adult Dosing .
Dosage forms: INJ
Special Note
- [formulation clarification]
- Info: nonproprietary name = inebilizumab-cdon
neuromyelitis optica spectrum disorder
- [300 mg IV q6mo]
- Start: 300 mg IV x1, then 300 mg IV x1 after 2wk, then 300 mg IV q6mo starting 6mo after 1st dose; Info: for anti-aquaporin-4 antibody positive pts; premed w/ corticosteroid 30min before infusion, antihistamine and antipyretic 30-60min before infusion
immunoglobulin G4-related dz
- [300 mg IV q6mo]
- Start: 300 mg IV x1, then 300 mg IV x1 after 2wk, then 300 mg IV q6mo starting 6mo after 1st dose; Info: premed w/ corticosteroid 30min before infusion, antihistamine and antipyretic 30-60min before infusion
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [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 rxn w/ prior inebilizumab use
- infection, active
- TB infection, active
- TB infection, latent untreated
- HBV infection, active
- caution: HBV carriers
- caution: female pts of reproductive potential
Drug Interactions .
Overview
inebilizumab
CD19 antigen inhibitor
- immunosuppressive 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
- upadacitinib
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
- pneumococcal vaccine
- poliovirus vaccine
- respiratory syncytial virus vaccine
- sipuleucel-T
- smallpox/mpox vaccine, live
- temsirolimus
- 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
- copanlisib
- corticotropin
- cortisone
- crovalimab
- cyclophosphamide
- cyclosporine
- cytarabine
- dactinomycin
- danicopan
- daratumumab
- daunorubicin
- decitabine
- deflazacort
- 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
- fingolimod
- floxuridine
- fludarabine
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluorouracil
- fluticasone furoate
- fluticasone propionate
- fruquintinib
- gemcitabine
- gemtuzumab ozogamicin
- glofitamab
- golimumab
- guselkumab
- hydrocortisone
- hydrocortisone ophthalmic
- hydroxyurea
- ibritumomab tiuxetan
- ibrutinib
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- infliximab
- inotuzumab ozogamicin
- iptacopan
- irinotecan
- isatuximab
- ixabepilone
- ixekizumab
- lebrikizumab
- leflunomide
- lenalidomide
- lifileucel
- 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
- nelarabine
- obecabtagene autoleucel
- obinutuzumab
- ocrelizumab
- ofatumumab
- omacetaxine mepesuccinate
- oxaliplatin
- ozanimod
- paclitaxel
- panobinostat
- pegcetacoplan
- pentostatin
- pirtobrutinib
- polatuzumab vedotin
- pomalidomide
- ponatinib
- ponesimod
- pozelimab
- prednisolone
- prednisolone ophthalmic
- prednisone
- procarbazine
- quizartinib
- ravulizumab
- regorafenib
- rilonacept
- risankizumab
- rituximab
- romidepsin
- ropeginterferon alfa-2b
- rozanolixizumab
- ruxolitinib
- sarilumab
- satralizumab
- secukinumab
- selinexor
- siltuximab
- siponimod
- sirolimus
- sirolimus albumin-bound
- spesolimab
- sulfasalazine
- sutimlimab
- tacrolimus
- tafasitamab
- talquetamab
- tarlatamab
- teclistamab
- temozolomide
- teplizumab
- teriflunomide
- thioguanine
- thiotepa
- tildrakizumab
- tisagenlecleucel
- tocilizumab
- tofacitinib
- topotecan
- tralokinumab
- triamcinolone
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- vamorolone
- vedolizumab
- venetoclax
- vilobelimab
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- zanubrutinib
- zilucoplan
Adverse Reactions .
Serious Reactions
- anaphylaxis
- infusion rxn
- infection
- PML
Common Reactions
- hypogammaglobulinemia
- lymphopenia
- UTI
- nasopharyngitis
- infusion rxn
- neutropenia
- arthralgia
- fever
- headache
- URI
- influenza
- back pain
- myalgia
Safety/Monitoring .
Monitoring Parameters
HBV screening, TB test at baseline; serum immunoglobulins at baseline, then periodically, especially in pts w/ opportunistic or recurrent infection, until B-cell repletion after D/C; s/sx infusion rxn during and for at least 1h after infusion
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available, though likely to cross placenta based on human data w/ other monoclonal antibodies; possible risk of B-cell depletion and lymphopenia based on animal data; for infants exposed to inebilizumab in utero, avoid live vaccines until B-cell recovery confirmed
Pregnancy Registry
encourage pts to enroll in Uplizna Pregnancy Registry at 1-303-724-4644 or www.upliznapregnancyregistry.com
Individuals of Reproductive Potential
avoid pregnancy by using effective contraception during tx and for 6mo after D/C in female pts
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: unknown; CYP450: unknown
Excretion: unknown; Half-life: 18 days
Subclass: CD19 Inhibitors ; Neuromyelitis Optica Spectrum Disorder
Mechanism of Action
exact mechanism of action unknown; binds to B-lymphocyte CD19 surface antigens, resulting in cellular cytolysis (monoclonal antibody)
Formulary .
No Formulary Selected
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