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Kevzara
sarilumab
Black Box Warnings .
Serious Infection Risk
incr. risk of serious infection leading to hospitalization or death; pulmonary and extrapulmonary TB, invasive fungal infections, and other opportunistic infections observed; most infections occur in combo w/ other immunosuppressants; weigh risk/benefit in patients w/ chronic or recurrent infection; avoid use in patients w/ active infection; screen for latent TB infection before and during sarilumab tx; initiate anti-TB tx before sarilumab tx; monitor closely for infection signs/symptoms during tx, incl. TB development in patients w/ negative TB test; D/C sarilumab if serious infection develops
Adult Dosing .
Dosage forms: INJ (pen): 150 mg per injection, 200 mg per injection; INJ (pre-filled syringe): 150 mg per 1.14 mL, 200 mg per 1.14 mL
rheumatoid arthritis, moderate-severe
- [200 mg SC q2wk]
- Info: use as monotherapy or w/ methotrexate or other non-biologic DMARDs; see pkg insert for dose adjustments based on AST/ALT, ANC, and Plt
polymyalgia rheumatica
- [200 mg SC q2wk]
- Info: use w/ corticosteroid taper or as monotherapy following corticosteroid; D/C tx if AST or ALT >3x ULN, ANC <1000 at dosing interval end, or Plt <100,000
COVID-19 (off-label)
- [400 mg IV x1]
- Info: for hospitalized patients w/ severe COVID-19 and elevated systemic inflammatory markers; not 1st-line agent; use prefilled syringe to make IV infusion
renal dosing
- [SC route]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
- [IV route]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- active hepatic disease or baseline AST/ALT >1.5x ULN: avoid use
Peds Dosing .
- Dosage forms: INJ (pre-filled syringe): 200 mg per 1.14 mL
polyarticular juvenile idiopathic arthritis
- [2 yo and older, >63 kg]
- Dose: 200 mg SC q2wk; Max: 200 mg/dose; Info: use as monotherapy or w/ other non-biologic DMARDs; hold tx if ALT 3.1-5x ULN, ANC 500-999, or Plt 50,001-100,000; D/C tx if ALT >5x ULN, ANC <500 w/ infection, or Plt <50,000
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- active hepatic disease or baseline AST/ALT >1.5x ULN: avoid use
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- ANC <2000
- Plt <150,000
- ALT or AST >1.5x ULN
- hepatic disease, active
- infection, active
- TB infection, active
- caution: infection, chronic
- caution: infection, recurrent
- caution: infection risk
- caution: opportunistic infection history
- caution: TB infection, latent
- caution: TB infection risk
- caution: residents of area w/ endemic TB
- caution: residents of area w/ endemic mycosis
- caution: travelers in area w/ endemic TB
- caution: travelers in area w/ endemic mycosis
- caution: HBV infection
- caution: HBV infection history
- caution: malignancy risk
- caution: GI perforation risk
Drug Interactions .
Overview
sarilumab
IL-6 antagonist
- CYP3A4 inducer, weak
- immunomodulatory effects
- myelosuppressive effects
- caution advised w/ narrow therapeutic index drugs; chronic inflammatory conditions may alter metabolic enzyme formation; tx w/ immune modulators may reverse this effect, resulting in altered levels of concomitant drugs
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
- ranolazine
- rotavirus vaccine, live
- smallpox vaccine, live
- talimogene laherparepvec
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Avoid/Use Alternative
- abatacept
- abrocitinib
- adalimumab
- anakinra
- anifrolumab
- atazanavir
- baricitinib
- canakinumab
- certolizumab pegol
- chloramphenicol
- cladribine oral
- codeine
- deferiprone
- desogestrel (contraceptive)
- deuruxolitinib
- dienogest (contraceptive)
- dolutegravir
- drospirenone (contraceptive)
- epcoritamab
- estradiol (contraceptive)
- etanercept
- ethinyl estradiol (contraceptive)
- ethynodiol (contraceptive)
- etonogestrel (contraceptive)
- etrasimod
- fentanyl
- fexinidazole
- fosamprenavir
- ganciclovir
- glofitamab
- golimumab
- infliximab
- levonorgestrel (contraceptive)
- levonorgestrel (post-coital contraceptive)
- lopinavir/ritonavir
- lumateperone
- mavacamten
- medroxyprogesterone (contraceptive)
- meperidine
- natalizumab
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- obinutuzumab
- ocrelizumab
- ofatumumab
- oliceridine
- oxycodone
- penicillamine
- pimecrolimus topical
- primaquine
- rabies vaccine
- radium Ra 223 dichloride
- rilonacept
- ritlecitinib
- rituximab
- ropeginterferon alfa-2b
- ruxolitinib topical
- segesterone (contraceptive)
- tocilizumab
- tofacitinib
- tramadol
- ublituximab
- ulipristal (post-coital contraceptive)
- upadacitinib
- valganciclovir
- zuranolone
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- ado-trastuzumab emtansine
- afamitresgene autoleucel
- albendazole
- aldesleukin
- alemtuzumab
- allopurinol
- amlodipine
- anthrax vaccine
- anti-thymocyte globulin
- arsenic trioxide
- asciminib
- atidarsagene autotemcel
- atogepant
- auranofin
- axicabtagene ciloleucel
- azacitidine
- azathioprine
- balsalazide
- belantamab mafodotin
- belinostat
- bendamustine
- benznidazole
- betibeglogene autotemcel
- bevacizumab
- bexarotene
- blinatumomab
- bortezomib
- bosutinib
- brentuximab vedotin
- brexucabtagene autoleucel
- buprenorphine
- busulfan
- cabazitaxel
- capecitabine
- carbamazepine
- carboplatin
- carfilzomib
- carmustine
- chikungunya vaccine
- chlorambucil
- cidofovir
- ciltacabtagene autoleucel
- cisplatin
- cladribine injection
- clofarabine
- clozapine
- colchicine
- copanlisib
- COVID-19 vaccine
- crizotinib
- cyclophosphamide
- cyclosporine
- cytarabine
- dacarbazine
- dactinomycin
- dapsone
- daratumumab
- dasatinib
- daunorubicin
- decitabine
- deferasirox
- dexrazoxane
- diltiazem
- dinutuximab
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- disopyramide
- docetaxel
- dostarlimab
- doxorubicin
- duvelisib
- ebola vaccine, live
- eflornithine
- elivaldogene autotemcel
- elranatamab
- enfortumab vedotin
- entrectinib
- epirubicin
- eribulin
- etoposide
- everolimus
- exagamglogene autotemcel
- fam-trastuzumab deruxtecan
- fedratinib
- floxuridine
- flucytosine
- fludarabine
- fluorouracil
- fluphenazine
- foscarnet
- fostamatinib
- gemcitabine
- gemtuzumab ozogamicin
- givinostat
- glasdegib
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydroxychloroquine
- hydroxyurea
- ibritumomab tiuxetan
- ibrutinib
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- imatinib
- imetelstat
- influenza H5N1 vaccine
- influenza vaccine
- inotuzumab ozogamicin
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- irinotecan
- isatuximab
- isradipine
- ivosidenib
- ixabepilone
- Japanese encephalitis vaccine
- ketoconazole
- leflunomide
- lenalidomide
- lifileucel
- linezolid
- linvoseltamab
- lisocabtagene maraleucel
- lomustine
- lonafarnib
- loncastuximab tesirine
- lovotibeglogene autotemcel
- lurbinectedin
- lutetium Lu 177 dotatate
- lutetium Lu 177 vipivotide tetraxetan
- lymphocyte immune globulin, anti-thymocyte globulin
- melphalan
- meningococcal vaccine
- mercaptopurine
- mesalamine
- mesalamine rectal
- methotrexate
- midostaurin
- mitapivat
- mitomycin
- mitotane
- mitoxantrone
- mogamulizumab
- momelotinib
- mosunetuzumab
- mycophenolate mofetil
- mycophenolic acid
- nelarabine
- nicardipine
- nilotinib
- nimodipine
- niraparib
- nisoldipine
- obecabtagene autoleucel
- olaparib
- olsalazine
- oxaliplatin
- paclitaxel
- pacritinib
- palbociclib
- panobinostat
- peginterferon alfa 2a
- peginterferon beta 1a
- pemetrexed
- pentamidine
- pentostatin
- pirtobrutinib
- pneumococcal vaccine
- polatuzumab vedotin
- poliovirus vaccine
- pomalidomide
- ponatinib
- pralatrexate
- procarbazine
- proguanil
- pyrimethamine
- quinidine (antiarrhythmic)
- quizartinib
- respiratory syncytial virus vaccine
- ribavirin
- ribociclib
- rifabutin
- romidepsin
- rucaparib
- ruxolitinib
- sacituzumab govitecan
- satralizumab
- selinexor
- sipuleucel-T
- sirolimus
- sirolimus albumin-bound
- smallpox/mpox vaccine, live
- stiripentol
- streptozocin
- succimer
- sulfasalazine
- tacrolimus
- tafasitamab
- tagraxofusp
- talazoparib
- talquetamab
- tarlatamab
- tazemetostat
- teclistamab
- temozolomide
- temsirolimus
- teplizumab
- teriflunomide
- thalidomide
- thioguanine
- thiotepa
- tiagabine
- tick-borne encephalitis vaccine
- tisagenlecleucel
- topotecan
- trabectedin
- trastuzumab
- treosulfan
- trifluridine
- trimethoprim
- typhoid vaccine
- ubrogepant
- valproic acid
- vancomycin
- venetoclax
- vinblastine
- vincristine
- vinorelbine
- voriconazole
- warfarin
- zanubrutinib
- zidovudine
- ziv-aflibercept
Caution Advised
- alfentanil
- alprazolam
- amiodarone
- aprepitant
- artemether/lumefantrine
- atorvastatin
- avacopan
- avapritinib
- axitinib
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- betamethasone
- bictegravir
- bimekizumab
- brigatinib
- brodalumab
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- buspirone
- cabozantinib
- capivasertib
- capmatinib
- clarithromycin
- clobetasol ophthalmic
- cobicistat
- cobimetinib
- coccidioides immitis skin test antigen
- corticotropin
- cortisone
- crovalimab
- danicopan
- daridorexant
- darunavir
- defactinib
- deflazacort
- delgocitinib topical
- deucravacitinib
- dexamethasone
- dexamethasone ophthalmic
- difluprednate ophthalmic
- dimethyl fumarate
- diroximel fumarate
- doravirine
- dordaviprone
- dronedarone
- drospirenone (hormone replacement)
- dupilumab
- eculizumab
- efgartigimod alfa
- elacestrant
- elbasvir
- elexacaftor/tezacaftor/ivacaftor
- eliglustat
- elotuzumab
- elvitegravir
- emapalumab
- erdafitinib
- erlotinib
- felodipine
- finerenone
- fingolimod
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- fosaprepitant
- fruquintinib
- gepirone
- gilteritinib
- glecaprevir
- grazoprevir
- guanfacine
- guselkumab
- haloperidol
- hydrocortisone
- hydrocortisone ophthalmic
- inebilizumab
- iptacopan
- isavuconazonium
- itraconazole
- ivacaftor
- ixekizumab
- lapatinib
- larotrectinib
- lazertinib
- lebrikizumab
- lefamulin
- lenacapavir
- leniolisib
- letermovir
- levoketoconazole
- levonorgestrel intrauterine device (contraceptive)
- lorlatinib
- loteprednol ophthalmic
- lurasidone
- macitentan
- maraviroc
- methadone
- methylprednisolone
- midazolam
- mirikizumab
- mobocertinib
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- nadofaragene firadenovec intravesical
- naldemedine
- naloxegol
- nefazodone
- nelfinavir
- neratinib
- netupitant
- nevirapine
- nifedipine
- nipocalimab
- nirmatrelvir
- nirogacestat
- olutasidenib
- ozanimod
- pegcetacoplan
- pemigatinib
- perampanel
- pimavanserin
- ponesimod
- pozelimab
- praziquantel
- prednisolone
- prednisolone ophthalmic
- prednisone
- pretomanid
- quetiapine
- quinine
- ravulizumab
- regorafenib
- repotrectinib
- rilpivirine
- rilzabrutinib
- ripretinib
- risankizumab
- ritonavir
- roflumilast
- rolapitant
- rozanolixizumab
- samidorphan
- sebetralstat
- secukinumab
- selpercatinib
- selumetinib
- sildenafil
- siltuximab
- simvastatin
- siponimod
- sonidegib
- spesolimab
- sutimlimab
- suzetrigine
- tadalafil
- taletrectinib
- tamoxifen
- tasimelteon
- tezacaftor/ivacaftor
- ticagrelor
- tildrakizumab
- tipranavir
- tolvaptan
- toremifene
- tralokinumab
- triamcinolone
- tuberculin purified protein derivative
- ustekinumab
- vamorolone
- vanzacaftor/tezacaftor/deutivacaftor
- vedolizumab
- velpatasvir
- verapamil
- vilobelimab
- voclosporin
- vonoprazan
- voxilaprevir
- zilucoplan
Adverse Reactions .
Serious Reactions
- infection, serious
- pneumonia
- cellulitis
- opportunistic infection
- tuberculosis
- herpes zoster
- HBV reactivation
- malignancy
- GI perforation
- hypersensitivity reaction
- neutropenia
- thrombocytopenia
Common Reactions
- neutropenia
- ALT or AST elevated
- injection site erythema
- injection site pruritus
- nasopharyngitis
- URI
- UTI
- constipation
- rash
- myalgia (polymyalgia rheumatica use)
- fatigue (polymyalgia rheumatica use)
- hyperlipidemia
- leukopenia
Safety/Monitoring .
Monitoring Parameters
hepatitis B serology incl. HBsAg at baseline; TB test at baseline, then active TB signs/symptoms; CBC w/ diff, LFTs at baseline, at 4-8wk, then q3mo; lipid panel at baseline, 4-8wk after tx start, then q6mo
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available, though likely to cross placenta based on human data w/ other monoclonal antibodies; no known risk of teratogenicity based on animal data up to 84x MRHD; possible risk of impaired immune function based on animal data up to 80x MRHD; for infants exposed to sarilumab in utero, weigh risk/benefit before admin. live vaccines; risk of interference w/ cervical ripening/dilatation and uterine contractility based on drug's mechanism of action
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available, though risk of infant harm not expected based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: unknown; CYP450: unknown
Excretion: unknown; Half-life: 8-10 days
Subclass: DMARDs, Interleukin (IL) Antagonists ; Interleukin-6 (IL-6) Antagonists
Mechanism of Action
binds to and inhibits IL-6 receptors, reducing inflammation and altering immune response (monoclonal antibody)
Formulary .
No Formulary Selected
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