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Zymfentra (infliximab-dyyb)
infliximab
Black Box Warnings .
Serious Infection Risk
weigh tx benefit vs. risk in patients w/ chronic or recurrent infection; pulmonary and extrapulmonary tuberculosis (TB), invasive fungal infections, and other opportunistic infections incl. Legionella and Listeria observed; some infections have been fatal; most infections occur in combo w/ other immunosuppressants; evaluate for TB risk factors and screen for latent TB infection before and during infliximab tx; initiate anti-TB tx before infliximab tx; monitor for infection s/sx during and after infliximab tx; since active TB has developed in patients w/ negative tuberculin skin test, monitor all patients for active TB s/sx; since histoplasmosis may be present in patients w/ negative antigen and antibody tests, consider empiric antifungal tx in patients w/ severe systemic illness if at risk for invasive fungal infection; D/C infliximab tx if serious infection or sepsis occurs
Malignancy
lymphoma and other malignancies, some fatal, reported in children and adolescents treated w/ TNF blockers; post-marketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) reported mostly in Crohn dz or ulcerative colitis patients, mostly adolescent and young adult males receiving concomitant azathioprine or mercaptopurine; uncertain whether HSTCL related to TNF-blocker monotherapy or in combo w/ other immunosuppressants
Adult Dosing .
Dosage forms: INJ (pen): 120 mg per injection; INJ (pre-filled syringe): 120 mg per mL
Special Note
- [drug name clarification]
- Info: nonproprietary name = infliximab-dyyb
Crohn dz, moderate-severe
- [conversion from infliximab IV induction tx]
- Dose: 120 mg SC q2wk; Start: at wk 10 after induction tx w/ IV form (5 mg/kg/dose IV x1 on wk 0, 2, 6); Info: not for initial tx
- [conversion from infliximab IV maintenance tx]
- Dose: 120 mg SC q2wk; Start: in place of next scheduled dose of IV maint. tx; Info: not for initial tx
ulcerative colitis, moderate-severe
- [conversion from infliximab IV induction tx]
- Dose: 120 mg SC q2wk; Start: at wk 10 after induction tx w/ IV form (5 mg/kg/dose IV x1 on wk 0, 2, 6); Info: not for initial tx
- [conversion from infliximab IV maintenance tx]
- Dose: 120 mg SC q2wk; Start: in place of next scheduled dose of IV maint. tx; Info: not for initial tx
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
- hypersensitivity to murine protein
- infection, active
- COPD, moderate-severe
- CHF
- demyelinating dz
- myelosuppression
- myelosuppression history
- malignancy history
- caution: malignancy risk
- caution: patients >65 yo
- caution: infection risk
- caution: infection, chronic
- caution: infection, recurrent
- caution: diabetes mellitus, uncontrolled
- 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
Drug Interactions .
Overview
infliximab
TNF blocker
- cardiotoxic effects
- immunomodulatory 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
- chikungunya vaccine, live
- dengue vaccine, live
- influenza nasal vaccine, live
- rotavirus vaccine, live
- smallpox vaccine, live
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Avoid/Use Alternative
- abatacept
- abrocitinib
- alemtuzumab
- anifrolumab
- baricitinib
- belimumab
- brodalumab
- canakinumab
- cladribine oral
- deuruxolitinib
- eculizumab
- efgartigimod alfa
- epirubicin
- etrasimod
- golimumab
- idarubicin
- infliximab
- ixekizumab
- mirikizumab
- natalizumab
- ocrelizumab
- ofatumumab
- pimecrolimus topical
- rabies vaccine
- ravulizumab
- rilonacept
- risankizumab
- rituximab
- ruxolitinib topical
- secukinumab
- siltuximab
- teplizumab
- tildrakizumab
- tofacitinib
- tralokinumab
- upadacitinib
- ustekinumab
- vedolizumab
- vilobelimab
Monitor/Modify Tx
- ado-trastuzumab emtansine
- aldesleukin
- anagrelide
- anthrax vaccine
- avelumab
- axitinib
- bevacizumab
- bezlotoxumab
- binimetinib
- bortezomib
- bosutinib
- capecitabine
- chikungunya vaccine
- cilostazol
- cobimetinib
- COVID-19 vaccine
- dabrafenib
- daunorubicin
- diphtheria/tetanus/pertussis vaccine
- doxorubicin
- ebola vaccine, live
- encorafenib
- entrectinib
- everolimus
- fam-trastuzumab deruxtecan
- fluorouracil
- Haemophilus b vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- ibrutinib
- ifosfamide
- influenza H5N1 vaccine
- influenza vaccine
- interferon beta 1b
- interferon gamma 1b
- Japanese encephalitis vaccine
- lapatinib
- lenvatinib
- linagliptin
- margetuximab
- mavacamten
- meningococcal vaccine
- mirdametinib
- mitomycin
- mitoxantrone
- mobocertinib
- pazopanib
- peginterferon beta 1a
- pertuzumab
- pioglitazone
- pneumococcal vaccine
- poliovirus vaccine
- ponatinib
- propafenone
- ripretinib
- ropeginterferon alfa-2b
- rosiglitazone
- saxagliptin
- selumetinib
- sipuleucel-T
- sitagliptin
- smallpox/mpox vaccine, live
- sorafenib
- sunitinib
- temsirolimus
- tick-borne encephalitis vaccine
- tivozanib
- trabectedin
- trametinib
- trastuzumab
- typhoid vaccine
- vandetanib
- zanidatamab
- zenocutuzumab
- zongertinib
Caution Advised
- abemaciclib
- acalabrutinib
- afamitresgene autoleucel
- anti-thymocyte globulin
- atidarsagene autotemcel
- avacopan
- axicabtagene ciloleucel
- azacitidine
- azathioprine
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belinostat
- bendamustine
- betamethasone
- bimekizumab
- blinatumomab
- brentuximab vedotin
- brexucabtagene autoleucel
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- busulfan
- cabazitaxel
- carboplatin
- carmustine
- chlorambucil
- ciltacabtagene autoleucel
- cisplatin
- cladribine injection
- clobetasol ophthalmic
- clofarabine
- copanlisib
- corticotropin
- cortisone
- crovalimab
- cyclosporine
- cytarabine
- dactinomycin
- danicopan
- daratumumab
- decitabine
- deflazacort
- delgocitinib topical
- deucravacitinib
- dexamethasone
- dexamethasone ophthalmic
- difluprednate ophthalmic
- dimethyl fumarate
- dinutuximab
- diroximel fumarate
- docetaxel
- duvelisib
- elivaldogene autotemcel
- elotuzumab
- elranatamab
- emapalumab
- epcoritamab
- eribulin
- etoposide
- fingolimod
- floxuridine
- fludarabine
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- fruquintinib
- gemtuzumab ozogamicin
- glofitamab
- hydrocortisone
- hydrocortisone ophthalmic
- hydroxyurea
- ibritumomab tiuxetan
- idecabtagene vicleucel
- idelalisib
- inebilizumab
- inotuzumab ozogamicin
- iptacopan
- irinotecan
- isatuximab
- ixabepilone
- lebrikizumab
- leflunomide
- lenalidomide
- lifileucel
- linvoseltamab
- lisocabtagene maraleucel
- lomustine
- loncastuximab tesirine
- loteprednol ophthalmic
- lymphocyte immune globulin, anti-thymocyte globulin
- melphalan
- mercaptopurine
- methotrexate
- methylprednisolone
- mogamulizumab
- momelotinib
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- mosunetuzumab
- mycophenolate mofetil
- mycophenolic acid
- nelarabine
- nipocalimab
- obecabtagene autoleucel
- obinutuzumab
- oxaliplatin
- ozanimod
- paclitaxel
- panobinostat
- pegcetacoplan
- pentostatin
- pirtobrutinib
- polatuzumab vedotin
- pomalidomide
- ponesimod
- pozelimab
- prednisolone
- prednisolone ophthalmic
- prednisone
- procarbazine
- quizartinib
- regorafenib
- romidepsin
- rozanolixizumab
- ruxolitinib
- satralizumab
- selinexor
- siponimod
- sirolimus
- sirolimus albumin-bound
- sulfasalazine
- sutimlimab
- tacrolimus
- tafasitamab
- talquetamab
- tarlatamab
- teclistamab
- temozolomide
- teriflunomide
- thioguanine
- thiotepa
- tisagenlecleucel
- topotecan
- triamcinolone
- tuberculin purified protein derivative
- ublituximab
- vamorolone
- venetoclax
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- zanubrutinib
- zilucoplan
Adverse Reactions .
Serious Reactions
- infection, serious
- opportunistic infection
- tuberculosis
- HBV reactivation
- malignancy
- lymphoma
- leukemia
- skin CA
- cervical CA
- myelosuppression
- hypersensitivity rxn
- anaphylaxis
- serum sickness
- toxic epidermal necrolysis
- Stevens-Johnson syndrome
- MI
- arrhythmia
- CHF
- CVA
- neurologic disorders
- optic neuritis
- lupus-like syndrome
- vasculitis
- sarcoidosis
- interstitial lung dz
- hepatotoxicity
Common Reactions
- URI
- headache
- injection site rxn
- anemia
- diarrhea
- CPK incr.
- arthralgia
- ALT incr.
- abdominal pain
- HTN
- UTI
- neutropenia
- dizziness
- leukopenia
- infection, serious
Safety/Monitoring .
Monitoring Parameters
hepatitis B serology incl. HBsAg at baseline; TB test at baseline, then periodically; LFTs, incl. ALT/AST, q3-4mo; active TB s/sx; dermatologic exams, especially if incr. skin CA risk
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available w/ SC route, though no known risk of teratogenicity based on human data w/ IV route; possible risk of neonatal agranulocytosis based on limited human data w/ IV route; possible risk of neonatal immunosuppression based on drug's mechanism of action; for infants exposed to infliximab in utero, avoid live vaccines for at least 6mo after birth
Lactation
Clinical Summary
may use while breastfeeding; no human data available w/ SC route, though no known risk of infant harm based on limited human data w/ IV route and drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: proteolytic degradation; CYP450: unknown
Excretion: unknown; Half-life: 13.8 days
Subclass: Inflammatory Bowel Disease (IBD)
Mechanism of Action
binds and inhibits tumor necrosis factor alpha, reducing inflammation and altering immune response
Formulary .
No Formulary Selected
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