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Tzield (teplizumab-mzwv)
teplizumab
Adult Dosing .
Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = teplizumab-mzwv
diabetes mellitus prevention, type 1
- [65 mcg/m^2/dose IV x1 on day 1, then 125 mcg/m^2/dose IV x1 on day 2, then 250 mcg/m^2/dose IV x1 on day 3, then 500 mcg/m^2/dose IV x1 on day 4, then 1030 mcg/m^2/dose IV qd on days 5-14]
- Info: for patients w/ stage 2 type 1 diabetes mellitus to delay onset of stage 3 disease; premed w/ antipyretic, antihistamine, and/or antiemetic prior to 1st 5 doses, then as needed
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = teplizumab-mzwv
diabetes mellitus prevention, type 1
- [8 yo and older]
- Dose: 65 mcg/m^2/dose IV x1 on day 1, then 125 mcg/m^2/dose IV x1 on day 2, then 250 mcg/m^2/dose IV x1 on day 3, then 500 mcg/m^2/dose IV x1 on day 4, then 1030 mcg/m^2/dose IV qd on days 5-14; Info: for patients w/ stage 2 type 1 diabetes mellitus to delay onset of stage 3 disease; premed w/ antipyretic, antihistamine, and/or antiemetic prior to 1st 5 doses, then as needed
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy
- baseline lymphocytes <1000
- baseline Hgb <10
- baseline Plt <150,000
- baseline ANC <1500
- baseline ALT or AST >2x ULN
- baseline bilirubin >1.5x ULN
- infection, active serious
- infection, chronic
- CMV infection, acute
- EBV infection, acute
- caution: patients of childbearing potential
Drug Interactions .
Overview
teplizumab
CD3 directed antibody
- immunomodulatory effects
- myelosuppressive 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
- chloramphenicol
- cladribine oral
- deferiprone
- deuruxolitinib
- etrasimod
- fexinidazole
- ganciclovir
- infliximab
- natalizumab
- penicillamine
- pimecrolimus topical
- primaquine
- rabies vaccine
- radium Ra 223 dichloride
- ritlecitinib
- ropeginterferon alfa-2b
- ruxolitinib topical
- upadacitinib
- valganciclovir
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- ado-trastuzumab emtansine
- afamitresgene autoleucel
- albendazole
- aldesleukin
- alemtuzumab
- allopurinol
- anthrax vaccine
- anti-thymocyte globulin
- arsenic trioxide
- asciminib
- asenapine
- atidarsagene autotemcel
- auranofin
- axicabtagene ciloleucel
- azacitidine
- azathioprine
- balsalazide
- baricitinib
- belantamab mafodotin
- belinostat
- bendamustine
- benznidazole
- betibeglogene autotemcel
- bevacizumab
- bexarotene
- blinatumomab
- bortezomib
- bosutinib
- brentuximab vedotin
- brexucabtagene autoleucel
- busulfan
- cabazitaxel
- capecitabine
- carboplatin
- carfilzomib
- carmustine
- chikungunya vaccine
- chlorambucil
- cidofovir
- ciltacabtagene autoleucel
- cisplatin
- cladribine injection
- clofarabine
- clozapine
- colchicine
- copanlisib
- COVID-19 vaccine
- crizotinib
- cyclophosphamide
- cytarabine
- dacarbazine
- dactinomycin
- dapsone
- daratumumab
- dasatinib
- daunorubicin
- decitabine
- deferasirox
- dexrazoxane
- dinutuximab
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- docetaxel
- dostarlimab
- doxorubicin
- duvelisib
- ebola vaccine, live
- eflornithine
- elranatamab
- enfortumab vedotin
- entrectinib
- epcoritamab
- epirubicin
- eribulin
- etoposide
- everolimus
- exagamglogene autotemcel
- fam-trastuzumab deruxtecan
- fedratinib
- floxuridine
- flucytosine
- fludarabine
- fluorouracil
- fluphenazine
- foscarnet
- fostamatinib
- gemcitabine
- gemtuzumab ozogamicin
- givinostat
- glasdegib
- glofitamab
- 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
- ivosidenib
- ixabepilone
- Japanese encephalitis vaccine
- leflunomide
- lenalidomide
- lifileucel
- linezolid
- linvoseltamab
- lisocabtagene maraleucel
- lomustine
- lonafarnib
- loncastuximab tesirine
- lovotibeglogene autotemcel
- lumateperone
- 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
- mitomycin
- mitotane
- mitoxantrone
- mogamulizumab
- momelotinib
- mosunetuzumab
- mycophenolate mofetil
- mycophenolic acid
- nelarabine
- nilotinib
- niraparib
- obecabtagene autoleucel
- obinutuzumab
- ofatumumab
- 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
- quizartinib
- respiratory syncytial virus vaccine
- ribavirin
- ribociclib
- rifabutin
- rituximab
- romidepsin
- rucaparib
- ruxolitinib
- sacituzumab govitecan
- sarilumab
- satralizumab
- selinexor
- sipuleucel-T
- sirolimus
- sirolimus albumin-bound
- smallpox/mpox vaccine, live
- stiripentol
- streptozocin
- succimer
- sulfasalazine
- tafasitamab
- tagraxofusp
- talazoparib
- talquetamab
- tarlatamab
- tazemetostat
- teclistamab
- temozolomide
- temsirolimus
- teriflunomide
- thalidomide
- thioguanine
- thiotepa
- tick-borne encephalitis vaccine
- tisagenlecleucel
- tocilizumab
- tofacitinib
- topotecan
- trabectedin
- trastuzumab
- treosulfan
- trifluridine
- trimethoprim
- typhoid vaccine
- valproic acid
- vancomycin
- venetoclax
- vinblastine
- vincristine
- vinorelbine
- zanubrutinib
- zidovudine
- ziv-aflibercept
Caution Advised
- abatacept
- adalimumab
- anakinra
- anifrolumab
- avacopan
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- betamethasone
- bimekizumab
- brodalumab
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- canakinumab
- certolizumab pegol
- clobetasol ophthalmic
- coccidioides immitis skin test antigen
- corticotropin
- cortisone
- crovalimab
- cyclosporine
- danicopan
- deflazacort
- delgocitinib topical
- deucravacitinib
- dexamethasone
- dexamethasone ophthalmic
- difluprednate ophthalmic
- dimethyl fumarate
- diroximel fumarate
- dupilumab
- eculizumab
- efgartigimod alfa
- elotuzumab
- emapalumab
- etanercept
- fingolimod
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- fruquintinib
- golimumab
- guselkumab
- hydrocortisone
- hydrocortisone ophthalmic
- inebilizumab
- iptacopan
- ixekizumab
- lebrikizumab
- loteprednol ophthalmic
- methylprednisolone
- mirikizumab
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- nadofaragene firadenovec intravesical
- nipocalimab
- ocrelizumab
- ozanimod
- pegcetacoplan
- ponesimod
- pozelimab
- prednisolone
- prednisolone ophthalmic
- prednisone
- ravulizumab
- regorafenib
- rilonacept
- rilzabrutinib
- risankizumab
- rozanolixizumab
- secukinumab
- siltuximab
- siponimod
- spesolimab
- sutimlimab
- tacrolimus
- tildrakizumab
- tralokinumab
- triamcinolone
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- vamorolone
- vedolizumab
- vilobelimab
- voclosporin
- zilucoplan
Adverse Reactions .
Serious Reactions
- cytokine release syndrome
- infection, serious
- lymphopenia, incl. prolonged
- anemia
- thrombocytopenia
- hypersensitivity rxn
- anaphylaxis
- angioedema
Common Reactions
- lymphopenia
- rash
- anemia
- ALT or AST elevated
- leukopenia
- calcium decr.
- serum bicarbonate decr.
- thrombocytopenia
- headache
- infection, serious
- neutropenia
- cytokine release syndrome
- nausea
- diarrhea
- nasopharyngitis
- serum sickness
Safety/Monitoring .
Monitoring Parameters
CBC, LFTs at baseline, then periodically; signs/symptoms of infection during and after tx
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; no human data available, though likely to cross placenta based on human data w/ other monoclonal antibodies; possible risk of neonatal immunosuppression based on drug's mechanism of action; for infants exposed to teplizumab in utero, weigh risk/benefit before admin. live vaccines
Pregnancy Reporting
report any suspected fetal exposure to Provention Bio, Inc. at 1-844-778-2246
Individuals of Reproductive Potential
avoid pregnancy by using effective contraception during tx and x30 days after D/C in patients of childbearing potential
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding, consider holding breastfeeding during tx and x20 days after D/C; 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: proteolytic degradation; CYP450: unknown
Excretion: unknown; Half-life: 4.5 days
Subclass: Diabetes: Anti-CD3 Antibodies
Mechanism of Action
exact mechanism of action unknown; binds to CD3, may produce partial agonism and deactivation of pancreatic beta cell autoreactive T cells, increasing proportion of regulatory T cells and exhausted CD8+ T cells (monoclonal antibody)
Formulary .
No Formulary Selected
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