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Kesimpta
ofatumumab
Adult Dosing .
Dosage forms: INJ (Sensoready pen): 20 mg per injection; INJ (pre-filled syringe): 20 mg per 0.4 mL
multiple sclerosis, relapsing forms
- [20 mg SC q4wk]
- Start: 20 mg SC on wk 0, 1, 2, then q4wk starting wk 4; Info: for patients with clinically isolated syndrome, relapsing-remitting disease, or active secondary progressive disease
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
- infection, active
- HBV infection, active
- caution: HBV carriers
- caution: ALT or AST 3x ULN with bilirubin 2x ULN
- caution: patients of childbearing potential
Drug Interactions .
Overview
ofatumumab
CD20 antigen inhibitor
- immunomodulatory effects
- myelosuppressive oncologic agent
- myelosuppression associated with higher, more frequent doses used for cancer chemotherapy, lower risk with MS doses
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
- dexrazoxane
- etrasimod
- fexinidazole
- ganciclovir
- infliximab
- natalizumab
- palifermin
- penicillamine
- pimecrolimus topical
- primaquine
- rabies vaccine
- radium Ra 223 dichloride
- ritlecitinib
- ropeginterferon alfa-2b
- ruxolitinib topical
- sarilumab
- tocilizumab
- upadacitinib
- valganciclovir
Monitor/Modify Tx
- albendazole
- alemtuzumab
- allopurinol
- anthrax vaccine
- anti-thymocyte globulin
- atidarsagene autotemcel
- auranofin
- azathioprine
- balsalazide
- baricitinib
- benznidazole
- betibeglogene autotemcel
- carfilzomib
- chikungunya vaccine
- cidofovir
- clozapine
- colchicine
- copper histidinate
- COVID-19 vaccine
- cyclophosphamide
- dapsone
- deferasirox
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- ebola vaccine, live
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- elivaldogene autotemcel
- etuvetidigene autotemcel
- everolimus
- exagamglogene autotemcel
- filgrastim (G-CSF)
- flucytosine
- fluphenazine
- foscarnet
- fosfomycin injection
- fostamatinib
- givinostat
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydroxychloroquine
- hydroxyurea
- influenza H5N1 vaccine
- influenza vaccine
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- Japanese encephalitis vaccine
- leflunomide
- linezolid
- lonafarnib
- lovotibeglogene autotemcel
- lymphocyte immune globulin, anti-thymocyte globulin
- meningococcal vaccine
- mercaptopurine
- mesalamine
- mesalamine rectal
- methotrexate
- mitomycin
- 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)
- satralizumab
- sipuleucel-T
- sirolimus
- smallpox/mpox vaccine, live
- stiripentol
- succimer
- sulfasalazine
- teplizumab
- teriflunomide
- thalidomide
- tick-borne encephalitis vaccine
- tofacitinib
- trimethoprim
- typhoid vaccine
- valproic acid
- vancomycin
- zidovudine
- zoster vaccine, recombinant
Caution Advised
- abatacept
- abemaciclib
- acalabrutinib
- adalimumab
- afamitresgene autoleucel
- aldesleukin
- anakinra
- avacopan
- axicabtagene ciloleucel
- azacitidine
- 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
- 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
- elotuzumab
- elranatamab
- emapalumab
- epcoritamab
- epirubicin
- eribulin
- etanercept
- etoposide
- fingolimod
- floxuridine
- fludarabine
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- fruquintinib
- gemtuzumab ozogamicin
- glofitamab
- golimumab
- guselkumab
- hydrocortisone
- hydrocortisone ophthalmic
- ibritumomab tiuxetan
- ibrutinib
- icotrokinra
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- inebilizumab
- inotuzumab ozogamicin
- iptacopan
- irinotecan
- isatuximab
- ixabepilone
- ixekizumab
- lebrikizumab
- lenalidomide
- lifileucel
- linvoseltamab
- lisocabtagene maraleucel
- lomustine
- loncastuximab tesirine
- loteprednol ophthalmic
- melphalan
- methylprednisolone
- mirikizumab
- mitoxantrone
- mogamulizumab
- momelotinib
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- mosunetuzumab
- nadofaragene firadenovec intravesical
- narsoplimab
- nelarabine
- nipocalimab
- obecabtagene autoleucel
- obinutuzumab
- ocrelizumab
- oxaliplatin
- ozanimod
- paclitaxel
- pegcetacoplan
- pentostatin
- pirtobrutinib
- polatuzumab vedotin
- pomalidomide
- ponatinib
- ponesimod
- pozelimab
- prednisolone
- prednisolone ophthalmic
- prednisone
- procarbazine
- quizartinib
- ravulizumab
- regorafenib
- rilonacept
- rilzabrutinib
- risankizumab
- romidepsin
- rozanolixizumab
- ruxolitinib
- secukinumab
- selinexor
- sibeprenlimab
- siltuximab
- siponimod
- sirolimus albumin-bound
- spesolimab
- sutimlimab
- tacrolimus
- tafasitamab
- talquetamab
- tarlatamab
- teclistamab
- temozolomide
- temsirolimus
- tezepelumab
- thioguanine
- thiotepa
- tildrakizumab
- tisagenlecleucel
- topotecan
- trabectedin
- tralokinumab
- triamcinolone
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- vamorolone
- vedolizumab
- venetoclax
- vilobelimab
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- zanubrutinib
- zilucoplan
Adverse Reactions .
Serious Reactions
- hepatic failure
- hepatitis, fulminant
- hepatic injury
- infection, serious
- HBV reactivation
- PML
- injection-related reaction, severe
- hypersensitivity reaction
- Stevens-Johnson syndrome
Common Reactions
- infection
- URI
- injection-related reaction
- headache
- injection site reaction
- UTI
- back pain
- 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 hepatitis or HBV reactivation during tx and for several mo after D/C if current or prior HBV infection
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no 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 death, B-cell depletion, and impaired immune function based on animal data at >500x recommended human dose; for infants exposed to ofatumumab in utero, avoid live vaccines until B-cell recovery confirmed
Pregnancy Registry
enroll patients or encourage patients to enroll in MotherToBaby Pregnancy Study in Multiple Sclerosis at 1-877-311-8972 or www.mothertobaby.org/join-study
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 ofatumumab: proteolytic degradation; CYP450: none
Excretion: for ofatumumab: non-renal; Half-life: 16 days
Subclass: Multiple Sclerosis
Mechanism of Action
for ofatumumab: 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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