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Zeposia
ozanimod
Adult Dosing .
Dosage forms: CAP: 0.92 mg; CAP (7-day starter pack): 0.23 mg x4 and 0.46 mg x3; CAP (28-day starter pack): 0.23 mg x4, 0.46 mg x3, and 0.92 mg x21
multiple sclerosis, relapsing forms
- [0.92 mg PO qd]
- Start: 0.23 mg PO qd x4 days, then 0.46 mg PO qd x3 days, then 0.92 mg PO qd; Info: for patients with clinically isolated syndrome, relapsing-remitting disease, or active secondary progressive disease; restart titration if dose missed within first 2wk of tx
ulcerative colitis, moderate-severe
- [0.92 mg PO qd]
- Start: 0.23 mg PO qd x4 days, then 0.46 mg PO qd x3 days, then 0.92 mg PO qd; Info: restart titration if dose missed within first 2wk of tx
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: 0.23 mg qd x4 days, then 0.46 mg qd x3 days, then 0.92 mg qod; Child-Pugh Class C: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- MAO inhibitor use within 14 days
- pregnancy
- hepatic impairment, Child-Pugh Class C
- infection, active
- phototherapy, concurrent
- MI within 6mo
- unstable angina within 6mo
- stroke within 6mo
- TIA within 6mo
- decompensated heart failure with hospitalization within 6mo
- NYHA Class III-IV CHF within 6mo
- AV block, 2nd-3rd degree (patients without pacemaker)
- sick sinus syndrome (patients without pacemaker)
- sino-atrial block (patients without pacemaker)
- sleep apnea, severe untreated
- caution: hepatic impairment, Child-Pugh Class A-B
- caution: AV block risk
- caution: bradycardia risk
- caution: QT prolongation
- caution: long QT syndrome, congenital
- caution: QT prolongation family history
- caution: torsades de pointes history
- caution: ventricular arrhythmia
- caution: electrolyte abnormalities
- caution: patients of childbearing potential
- caution: infection risk
- caution: diabetes mellitus
- caution: uveitis history
Drug Interactions .
Overview
ozanimod
S1P modulator
- CYP2C8 substrate
- MAO substrate
- bradycardia
- delays atrioventricular conduction
- hypertensive effects
- immunomodulatory effects
- prolongs QT interval (conditional)
Contraindicated
- adenovirus vaccine, live
- BCG live intravesical
- chikungunya vaccine, live
- cholera vaccine, live
- dengue vaccine, live
- influenza nasal vaccine, live
- isocarboxazid
- linezolid
- measles/mumps/rubella vaccine, live
- methylene blue oral
- phenelzine
- pimozide
- rasagiline
- rotavirus vaccine, live
- safinamide
- selegiline
- selegiline transdermal
- smallpox vaccine, live
- talimogene laherparepvec
- thioridazine
- tranylcypromine
- typhoid vaccine, live
- varicella vaccine, live
- viloxazine
- yellow fever vaccine, live
- yohimbe
Avoid/Use Alternative
- acebutolol
- adagrasib
- adenosine
- albuterol
- albuterol inhaled
- alectinib
- alemtuzumab
- alfentanil
- amiodarone
- anagrelide
- apalutamide
- apomorphine
- apraclonidine ophthalmic
- arsenic trioxide
- artemether/lumefantrine
- articaine
- asenapine
- atazanavir
- atenolol
- azithromycin
- bedaquiline
- benzphetamine
- betaxolol
- betaxolol ophthalmic
- bisoprolol
- brigatinib
- bupivacaine
- bupivacaine liposomal
- cabozantinib
- carbamazepine
- carteolol ophthalmic
- carvedilol
- ceritinib
- chloroprocaine
- chloroquine
- cisapride
- citalopram
- cladribine oral
- clarithromycin
- clofazimine
- clonidine
- clozapine
- crizotinib
- degarelix
- desflurane
- desipramine
- dexmedetomidine
- dexmedetomidine injection
- digoxin
- diltiazem
- disopyramide
- dobutamine
- dofetilide
- domperidone
- donepezil
- dordaviprone
- doxapram
- dronedarone
- droperidol
- dulaglutide
- eliglustat
- encorafenib
- ensartinib
- ephedra
- ephedrine oral
- epinephrine
- epinephrine inhaled
- epirubicin
- eribulin
- erythromycin
- esmolol
- etrasimod
- etripamil nasal
- fentanyl
- fexinidazole
- fingolimod
- flecainide
- fluorouracil
- fosfomycin injection
- fosphenytoin
- gadobenate dimeglumine
- galantamine
- gemfibrozil
- gilteritinib
- glasdegib
- goserelin
- guanfacine
- haloperidol
- hydroxychloroquine
- hydroxyzine
- ibutilide
- inotuzumab ozogamicin
- isoflurane
- isoniazid
- ivabradine
- ivosidenib
- labetalol
- lacosamide
- lamotrigine
- landiolol
- lanreotide
- lefamulin
- leuprolide
- levalbuterol inhaled
- levobunolol ophthalmic
- levofloxacin
- levoketoconazole
- lidocaine
- lofexidine
- lonafarnib
- lopinavir/ritonavir
- lorlatinib
- macimorelin
- mefloquine
- mepivacaine
- methadone
- metoprolol
- midodrine
- mobocertinib
- moxifloxacin
- nadolol
- natalizumab
- nebivolol
- neostigmine
- nilotinib
- norepinephrine
- octreotide
- oliceridine
- ondansetron
- osimertinib
- pacritinib
- paliperidone
- palonosetron
- paltusotine
- pasireotide
- pentamidine
- phenylephrine
- phenytoin
- pimecrolimus topical
- pindolol
- ponesimod
- praziquantel
- procainamide
- procarbazine
- propafenone
- propofol
- propranolol
- pseudoephedrine
- pyridostigmine
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- quizartinib
- rabies vaccine
- regadenoson
- remifentanil
- remimazolam
- revumenib
- ribociclib
- rifampin
- ritonavir
- rivastigmine
- romidepsin
- ropivacaine
- rucaparib
- selpercatinib
- sevoflurane
- siponimod
- sotalol
- succinylcholine
- sufentanil
- sugammadex
- taletrectinib
- telavancin
- tetrabenazine
- thalidomide
- ticagrelor
- timolol
- timolol ophthalmic
- toremifene
- tramadol
- triclabendazole
- trifluridine
- triptorelin
- vandetanib
- vemurafenib
- verapamil
- ziftomenib
- ziprasidone
Monitor/Modify Tx
- abiraterone acetate
- aliskiren
- almotriptan
- amiloride
- amlodipine
- amphetamine
- angiotensin II
- anthrax vaccine
- aprocitentan
- arformoterol inhaled
- armodafinil
- asciminib
- atogepant
- atomoxetine
- atropine ophthalmic
- axitinib
- azilsartan medoxomil
- benazepril
- betamethasone
- bevacizumab
- bismuth subsalicylate
- budesonide
- bumetanide
- bupropion
- caffeine
- caffeine citrate
- candesartan cilexetil
- cannabis
- captopril
- carfilzomib
- celecoxib
- chikungunya vaccine
- chlorothiazide
- chlorthalidone
- clevidipine
- clopidogrel
- cocaine
- copanlisib
- corticotropin
- cortisone
- COVID-19 vaccine
- cyclosporine
- danazol
- darbepoetin alfa
- deferasirox
- deflazacort
- desmopressin
- desvenlafaxine
- dexamethasone
- dexmethylphenidate
- dextroamphetamine
- diclofenac
- diclofenac topical
- diethylpropion
- diflunisal
- dihydroergotamine
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- dopamine
- doxazosin
- dronabinol
- droxidopa
- ebola vaccine, live
- eletriptan
- enalapril
- enalaprilat
- ephedrine injection
- eplerenone
- epoetin alfa
- eptinezumab
- erenumab
- ergotamine
- esketamine
- estetrol (contraceptive)
- estradiol (contraceptive)
- ethacrynic acid
- ethanol (alcoholic beverage)
- ethinyl estradiol (contraceptive)
- etodolac
- everolimus
- felodipine
- fenfluramine
- fenoldopam
- fenoprofen
- fludrocortisone
- flurbiprofen
- formoterol inhaled
- fosinopril
- fostamatinib
- fremanezumab
- frovatriptan
- fruquintinib
- furosemide
- galcanezumab
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- histrelin
- hoodia
- human papillomavirus vaccine
- hydralazine
- hydrochlorothiazide
- hydrocortisone
- hydroxocobalamin IV
- ibrutinib
- ibuprofen
- indapamide
- indomethacin
- influenza H5N1 vaccine
- influenza vaccine
- irbesartan
- isradipine
- Japanese encephalitis vaccine
- ketamine
- ketoprofen
- ketorolac
- leflunomide
- lenvatinib
- levomilnacipran
- licorice
- lisdexamfetamine
- lisinopril
- losartan
- lumacaftor/ivacaftor
- luspatercept
- magnesium salicylate
- meclofenamate
- mefenamic acid
- meloxicam
- meningococcal vaccine
- methamphetamine
- methoxy polyethylene glycol-epoetin beta
- methyldopa
- methylene blue injection
- methylergonovine
- methylphenidate
- methylprednisolone
- methyltestosterone
- metoclopramide
- metolazone
- milnacipran
- minoxidil
- mirabegron
- mitomycin
- modafinil
- moexipril
- nabumetone
- naphazoline ophthalmic
- naproxen
- naratriptan
- naxitamab
- nicardipine
- nifedipine
- nimodipine
- niraparib
- nisoldipine
- obinutuzumab
- olmesartan medoxomil
- olodaterol inhaled
- osilodrostat
- oxaprozin
- oxymetazoline nasal
- oxymetazoline ophthalmic
- oxymetazoline topical
- oxytocin
- pazopanib
- perindopril
- pexidartinib
- phendimetrazine
- phenoxybenzamine
- phentermine
- phentolamine
- phenylephrine injection
- phenylephrine nasal
- phenylephrine ophthalmic
- phenylephrine rectal
- piroxicam
- pirtobrutinib
- pneumococcal vaccine
- poliovirus vaccine
- ponatinib
- pralsetinib
- prazosin
- prednisolone
- prednisone
- quetiapine
- quinapril
- ramipril
- ramucirumab
- regorafenib
- respiratory syncytial virus vaccine
- rimegepant
- ripretinib
- rizatriptan
- ropinirole
- rotigotine transdermal
- salmeterol inhaled
- salsalate
- sipuleucel-T
- smallpox/mpox vaccine, live
- solriamfetol
- sorafenib
- spironolactone
- sulindac
- sumatriptan
- sunitinib
- tacrolimus
- tagraxofusp
- telmisartan
- terazosin
- terbutaline
- teriflunomide
- testosterone
- tetrahydrozoline ophthalmic
- tick-borne encephalitis vaccine
- tivozanib
- tolmetin
- torsemide
- trametinib
- trandolapril
- triamcinolone
- triamterene
- typhoid vaccine
- ubrogepant
- vadadustat
- valsartan
- vamorolone
- vasopressin
- venlafaxine
- vilanterol inhaled
- voclosporin
- zavegepant
- ziv-aflibercept
- zolmitriptan
Caution Advised
- abatacept
- abemaciclib
- abrocitinib
- acalabrutinib
- adalimumab
- afamitresgene autoleucel
- aldesleukin
- anakinra
- anifrolumab
- anti-thymocyte globulin
- atidarsagene autotemcel
- avacopan
- axicabtagene ciloleucel
- azacitidine
- azathioprine
- baricitinib
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- belinostat
- bendamustine
- bimekizumab
- blinatumomab
- bortezomib
- brentuximab vedotin
- brexucabtagene autoleucel
- brodalumab
- 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
- crovalimab
- cyclophosphamide
- cytarabine
- dactinomycin
- danicopan
- daratumumab
- daunorubicin
- decitabine
- delgocitinib topical
- deucravacitinib
- deuruxolitinib
- dexamethasone ophthalmic
- difluprednate ophthalmic
- dimethyl fumarate
- dinutuximab
- diroximel fumarate
- docetaxel
- doxorubicin
- dupilumab
- duvelisib
- eculizumab
- efgartigimod alfa
- elivaldogene autotemcel
- elotuzumab
- elranatamab
- emapalumab
- epcoritamab
- etanercept
- etoposide
- etuvetidigene autotemcel
- floxuridine
- fludarabine
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- gemtuzumab ozogamicin
- glofitamab
- golimumab
- guselkumab
- hydrocortisone ophthalmic
- hydroxyurea
- ibritumomab tiuxetan
- icotrokinra
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- inebilizumab
- infliximab
- iptacopan
- irinotecan
- isatuximab
- ixabepilone
- ixekizumab
- lebrikizumab
- lenalidomide
- lifileucel
- linvoseltamab
- lisocabtagene maraleucel
- lomustine
- loncastuximab tesirine
- loteprednol ophthalmic
- lymphocyte immune globulin, anti-thymocyte globulin
- melphalan
- mercaptopurine
- methotrexate
- 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
- ocrelizumab
- ofatumumab
- oxaliplatin
- paclitaxel
- pegcetacoplan
- pentostatin
- polatuzumab vedotin
- pomalidomide
- pozelimab
- prednisolone ophthalmic
- ravulizumab
- rilonacept
- rilzabrutinib
- risankizumab
- ritlecitinib
- rituximab
- ropeginterferon alfa-2b
- rozanolixizumab
- ruxolitinib
- ruxolitinib topical
- sarilumab
- satralizumab
- secukinumab
- selinexor
- sibeprenlimab
- siltuximab
- sirolimus
- sirolimus albumin-bound
- spesolimab
- sulfasalazine
- sutimlimab
- tafasitamab
- talquetamab
- tarlatamab
- teclistamab
- temozolomide
- temsirolimus
- teplizumab
- thioguanine
- thiotepa
- tildrakizumab
- tisagenlecleucel
- tocilizumab
- tofacitinib
- topotecan
- trabectedin
- tralokinumab
- tuberculin purified protein derivative
- ublituximab
- upadacitinib
- ustekinumab
- vedolizumab
- venetoclax
- vilobelimab
- vinblastine
- vincristine
- vinorelbine
- zanubrutinib
- zilucoplan
Adverse Reactions .
Serious Reactions
- bradyarrhythmia
- AV block
- infection, serious
- PML
- PML-associated immune reconstitution syndrome after D/C
- posterior reversible encephalopathy syndrome
- macular edema
- hepatic injury
- hypertensive crisis
- malignancy
- disability incr. after D/C, severe (MS use)
- skin CA
Common Reactions
- infection
- LFTs elevated
- headache
- hypotension, orthostatic
- back pain
- HTN
- lymphopenia
- fever
- nausea
- arthralgia
- peripheral edema
- upper abdominal pain
- pulmonary function decr.
Safety/Monitoring .
Monitoring Parameters
CBC with diff at baseline if none within 6mo of tx start; LFTs at baseline if none within 6mo of tx start, then periodically until 2mo after D/C; ECG at baseline; ophthalmic exam at baseline, then periodically or if change in vision; dermatologic exam at baseline, then periodically, especially if incr. skin CA risk; BP; signs/symptoms of infection during tx and x3mo after D/C; VZV antibody testing at baseline if no varicella or vaccination history; consider MRI for signs/symptoms of PML
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; inadequate human data available; risk of teratogenicity and embryo-fetal death based on animal data at >2x MRHD
Pregnancy Registry
enroll or encourage patients with multiple sclerosis to enroll in Zeposia Pregnancy Registry at 1-877-301-9314 or www.zeposiapregnancyregistry.com
Individuals of Reproductive Potential
avoid pregnancy by using effective contraception during tx and x3mo 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 or effects on milk production
Pharmacology .
Metabolism: for ozanimod: liver; CYP450: 2C8 (primary), 3A4 substrate; Info: active metabolites
Excretion: for ozanimod: feces 37%, urine 26%; Half-life: 21h (parent drug), 11 days (active metabolites)
Subclass: Inflammatory Bowel Disease (IBD) ; Multiple Sclerosis
Mechanism of Action
for ozanimod: exact mechanism of action unknown; binds to sphingosine 1-phosphate receptors 1 and 5; reduces lymphocyte egress from lymph nodes and migration into CNS and intestine
Formulary .
No Formulary Selected
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