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Cyltezo (adalimumab-adbm)
adalimumab
Black Box Warnings .
Serious Infection Risk
weigh tx benefit vs. risk in patients with chronic or recurrent infection; pulmonary and extrapulmonary tuberculosis (TB), invasive fungal infections, and other opportunistic infections including Legionella and Listeria observed; some infections have been fatal; most infections occur in combo with other immunosuppressants; evaluate for TB risk factors and screen for latent TB infection before and during adalimumab tx; initiate anti-TB tx before adalimumab tx; monitor for infection signs/symptoms during and after adalimumab tx; since active TB has developed in patients with negative tuberculin skin test, monitor all patients for active TB signs/symptoms; since histoplasmosis may be present in patients with negative antigen and antibody tests, consider empiric antifungal tx in patients with severe systemic illness if at risk for invasive fungal infection; D/C adalimumab tx if serious infection or sepsis occurs
Malignancy
lymphoma and other malignancies, some fatal, reported in children and adolescents treated with TNF blockers; post-marketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) reported mostly in Crohn disease 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 with other immunosuppressants
Adult Dosing .
Dosage forms: INJ (pen): 40 mg per 0.4 mL, 40 mg per 0.8 mL; INJ (Crohn disease, UC, HS pen 4-wk starter pack): 40 mg per 0.4 mL x6; INJ (Crohn disease, UC, HS pen 4-wk starter pack): 40 mg per 0.8 mL x6; INJ (psoriasis or uveitis pen 5-wk starter pack): 40 mg per 0.4 mL x4; INJ (psoriasis or uveitis pen 5-wk starter pack): 40 mg per 0.8 mL x4; INJ (pre-filled syringe): 10 mg per 0.2 mL, 20 mg per 0.4 mL, 40 mg per 0.4 mL, 40 mg per 0.8 mL
Special Note
- [drug name clarification]
- Info: nonproprietary name = adalimumab-adbm
rheumatoid arthritis, moderate-severe
- [40 mg SC q2wk]
- Info: may incr. dose to 40 mg SC qwk or 80 mg SC q2wk if not on methotrexate
psoriatic arthritis
- [40 mg SC q2wk]
ankylosing spondylitis
- [40 mg SC q2wk]
Crohn disease, moderate-severe
- [40 mg SC q2wk]
- Start: 160 mg SC x1 on day 1, then 80 mg SC x1 on day 15, then 40 mg SC q2wk on day 29; Alt: start 80 mg SC x1 on days 1, 2, 15, then 40 mg SC q2wk on day 29
ulcerative colitis, moderate-severe
- [40 mg SC q2wk]
- Start: 160 mg SC x1 on day 1, then 80 mg SC x1 on day 15, then 40 mg SC q2wk on day 29; Alt: start 80 mg SC x1 on days 1, 2, 15, then 40 mg SC q2wk on day 29; Info: D/C if no evidence of remission after 8wk
psoriasis, moderate-severe chronic plaque
- [40 mg SC q2wk]
- Start: 80 mg SC x1 on day 1, then 40 mg SC q2wk on day 8
hidradenitis suppurativa, moderate-severe
- [40 mg SC qwk or 80 mg SC q2wk]
- Start: 160 mg SC x1 on day 1, then 80 mg SC x1 on day 15, then 40 mg SC qwk or 80 mg SC q2wk on day 29; Alt: start 80 mg SC x1 on days 1, 2, 15, then 40 mg SC qwk or 80 mg SC q2wk on day 29
uveitis
- [40 mg SC q2wk]
- Start: 80 mg SC x1 on day 1, then 40 mg SC q2wk on day 8; Info: for non-infectious intermediate, posterior, and panuveitis
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ (pen): 40 mg per 0.4 mL, 40 mg per 0.8 mL; INJ (pre-filled syringe): 10 mg per 0.2 mL, 20 mg per 0.4 mL, 40 mg per 0.4 mL, 40 mg per 0.8 mL
Special Note
- [drug name clarification]
- Info: nonproprietary name = adalimumab-adbm
polyarticular juvenile idiopathic arthritis, moderate-severe
- [2 yo and older, 10-14 kg]
- Dose: 10 mg SC q2wk
- [2 yo and older, 15-29 kg]
- Dose: 20 mg SC q2wk
- [2 yo and older, >30 kg]
- Dose: 40 mg SC q2wk
Crohn disease, moderate-severe
- [6 yo and older, 17-39 kg]
- Dose: 20 mg SC q2wk; Start: 80 mg SC x1 on day 1, then 40 mg SC x1 on day 15, then 20 mg SC q2wk on day 29
- [6 yo and older, >40 kg]
- Dose: 40 mg SC q2wk; Start: 160 mg SC x1 on day 1, then 80 mg SC x1 on day 15, then 40 mg SC q2wk on day 29; Alt: start 80 mg SC x1 on days 1, 2, 15, then 40 mg SC q2wk on day 29
ulcerative colitis, moderate-severe (off-label)
- [5 yo and older, 20-39 kg]
- Dose: 20 mg SC qwk or 40 mg SC q2wk; Start: 80 mg SC x1 on day 1, then 40 mg SC x1 on days 8 and 15, then 20 mg SC qwk or 40 mg SC q2wk on day 29
- [5 yo and older, >40 kg]
- Dose: 40 mg SC qwk or 80 mg SC q2wk; Start: 160 mg SC x1 on day 1, then 80 mg SC x1 on days 8 and 15, then 40 mg SC qwk or 80 mg SC q2wk on day 29; Alt: start 80 mg SC x1 on days 1, 2, 8, 15, then 40 mg SC qwk or 80 mg SC q2wk on day 29
hidradenitis suppurativa, moderate-severe
- [12 yo and older, 30-59 kg]
- Dose: 40 mg SC q2wk; Start: 80 mg SC x1 on day 1, then 40 mg SC q2wk on day 8
- [12 yo and older, >60 kg]
- Dose: 40 mg SC qwk or 80 mg SC q2wk; Start: 160 mg SC x1 on day 1, then 80 mg SC x1 on day 15, then 40 mg SC qwk or 80 mg SC q2wk on day 29; Alt: start 80 mg SC x1 on days 1, 2, 15, then 40 mg SC qwk or 80 mg SC q2wk on day 29
uveitis
- [2 yo and older, 10-14 kg]
- Dose: 10 mg SC q2wk Info: for non-infectious intermediate, posterior, and panuveitis
- [2 yo and older, 15-29 kg]
- Dose: 20 mg SC q2wk; Info: for non-infectious intermediate, posterior, and panuveitis
- [2 yo and older, >30 kg]
- Dose: 40 mg SC q2wk; Info: for non-infectious intermediate, posterior, and panuveitis
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- infection, active
- caution: infection, chronic
- caution: infection, recurrent
- caution: infection risk
- caution: patients >65 yo
- caution: diabetes mellitus, uncontrolled
- caution: opportunistic infection history
- caution: TB infection, latent
- caution: TB infection risk
- caution: residents of area with endemic TB
- caution: residents of area with endemic mycosis
- caution: travelers in area with endemic TB
- caution: travelers in area with endemic mycosis
- caution: HBV infection
- caution: HBV infection history
- caution: malignancy history
- caution: malignancy risk
- caution: CHF
- caution: demyelinating disease
- caution: myelosuppression
- caution: myelosuppression history
- caution: hypersensitivity to latex
Drug Interactions .
Overview
adalimumab
TNF blocker
- cardiotoxic effects
- immunomodulatory effects
- caution advised with narrow therapeutic index drugs; chronic inflammatory conditions may alter metabolic enzyme formation; tx with 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
- 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
- baricitinib
- belimumab
- bimekizumab
- brodalumab
- canakinumab
- certolizumab pegol
- cladribine oral
- deuruxolitinib
- epirubicin
- etanercept
- etrasimod
- golimumab
- guselkumab
- idarubicin
- infliximab
- ixekizumab
- natalizumab
- pimecrolimus topical
- rabies vaccine
- rilonacept
- risankizumab
- ritlecitinib
- rituximab
- ruxolitinib topical
- sarilumab
- secukinumab
- tildrakizumab
- tocilizumab
- tofacitinib
- upadacitinib
- ustekinumab
- vedolizumab
Monitor/Modify Tx
- ado-trastuzumab emtansine
- aficamten
- aldesleukin
- alogliptin
- anagrelide
- anthrax vaccine
- asciminib
- avelumab
- axitinib
- bevacizumab
- bezlotoxumab
- binimetinib
- bortezomib
- bosutinib
- capecitabine
- carfilzomib
- chikungunya vaccine
- cilostazol
- clozapine
- cobimetinib
- COVID-19 vaccine
- cyclophosphamide
- dabrafenib
- daunorubicin
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- doxorubicin
- dronedarone
- ebola vaccine, live
- encorafenib
- entrectinib
- everolimus
- fam-trastuzumab deruxtecan
- fluorouracil
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydroxychloroquine
- ibrutinib
- ifosfamide
- imatinib
- influenza H5N1 vaccine
- influenza vaccine
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- itraconazole
- Japanese encephalitis vaccine
- lapatinib
- lenvatinib
- linagliptin
- margetuximab
- mavacamten
- meningococcal vaccine
- mirdametinib
- mitomycin
- mitoxantrone
- mobocertinib
- osimertinib
- pazopanib
- peginterferon beta 1a
- pertuzumab
- pioglitazone
- pneumococcal vaccine
- poliovirus vaccine
- ponatinib
- propafenone
- respiratory syncytial virus vaccine
- ripretinib
- ropeginterferon alfa-2b
- rosiglitazone
- saxagliptin
- selumetinib
- sipuleucel-T
- sitagliptin
- smallpox/mpox vaccine, live
- sorafenib
- sunitinib
- tick-borne encephalitis vaccine
- tivozanib
- trabectedin
- trametinib
- trastuzumab
- typhoid vaccine
- vandetanib
- zanidatamab
- zenocutuzumab
- zongertinib
Caution Advised
- abemaciclib
- acalabrutinib
- afamitresgene autoleucel
- alemtuzumab
- anti-thymocyte globulin
- atidarsagene autotemcel
- avacopan
- axicabtagene ciloleucel
- azacitidine
- azathioprine
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belinostat
- bendamustine
- betamethasone
- 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
- coccidioides immitis skin test antigen
- 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
- dupilumab
- duvelisib
- eculizumab
- efgartigimod alfa
- elivaldogene autotemcel
- elotuzumab
- elranatamab
- emapalumab
- epcoritamab
- eribulin
- etoposide
- etuvetidigene autotemcel
- fingolimod
- floxuridine
- fludarabine
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- fruquintinib
- gemtuzumab ozogamicin
- glofitamab
- hydrocortisone
- hydrocortisone ophthalmic
- hydroxyurea
- ibritumomab tiuxetan
- icotrokinra
- 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
- mirikizumab
- mogamulizumab
- momelotinib
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- mosunetuzumab
- mycophenolate mofetil
- mycophenolic acid
- nadofaragene firadenovec intravesical
- narsoplimab
- nelarabine
- nipocalimab
- obecabtagene autoleucel
- obinutuzumab
- ocrelizumab
- ofatumumab
- oxaliplatin
- ozanimod
- paclitaxel
- pegcetacoplan
- pentostatin
- pirtobrutinib
- polatuzumab vedotin
- pomalidomide
- ponesimod
- pozelimab
- prednisolone
- prednisolone ophthalmic
- prednisone
- procarbazine
- quizartinib
- ravulizumab
- regorafenib
- rilzabrutinib
- romidepsin
- rozanolixizumab
- ruxolitinib
- satralizumab
- selinexor
- sibeprenlimab
- siltuximab
- siponimod
- sirolimus
- sirolimus albumin-bound
- spesolimab
- sulfasalazine
- sutimlimab
- tacrolimus
- tafasitamab
- talquetamab
- tarlatamab
- teclistamab
- temozolomide
- temsirolimus
- teplizumab
- teriflunomide
- thioguanine
- thiotepa
- tisagenlecleucel
- topotecan
- tralokinumab
- triamcinolone
- tuberculin purified protein derivative
- ublituximab
- vamorolone
- venetoclax
- vilobelimab
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- zanubrutinib
- zilucoplan
Adverse Reactions .
Serious Reactions
- infection, serious
- opportunistic infection
- tuberculosis
- HBV reactivation
- malignancy
- lymphoma
- leukemia
- skin CA
- hypersensitivity reaction
- anaphylaxis
- Stevens-Johnson syndrome
- erythema multiforme
- CHF
- neurologic disorders
- optic neuritis
- myelosuppression
- lupus-like syndrome
- vasculitis
- sarcoidosis
- interstitial lung disease
- hepatotoxicity
Common Reactions
- injection site reaction
- URI
- headache
- rash
- nausea
- UTI
- hyperlipidemia
- flu syndrome
- abdominal pain
- back pain
- HTN
- hematuria
- hypersensitivity reaction
- alk phos incr.
- ALT elevated
- CK elevated, transient (peds patients)
- arthralgia (plaque psoriasis use)
Safety/Monitoring .
Monitoring Parameters
hepatitis B serology including HBsAg at baseline; TB test at baseline, then periodically; active TB signs/symptoms; dermatologic exams, especially if incr. skin CA risk
Pregnancy/Lactation .
Pregnancy
Clinical Summary
benefits outweigh risks in 1st and 2nd trimester, weigh risk/benefit in 3rd trimester; no known risk of teratogenicity based on human data; possible risk of neonatal immunosuppression based on drug's mechanism of action; for infants exposed to adalimumab in utero, avoid live vaccines for at least 6mo after birth
Lactation
Clinical Summary
may use while breastfeeding; no known risk of infant harm based on limited human data and drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for adalimumab: unknown; CYP450: unknown
Excretion: for adalimumab: unknown; Half-life: 2wk
Subclass: DMARDs, Tumor Necrosis Factor (TNF) Inhibitors ; Inflammatory Bowel Disease (IBD) ; Psoriasis, Systemic Agents ; Spondyloarthropathies
Mechanism of Action
for adalimumab: binds and inhibits tumor necrosis factor alpha, reducing inflammation and altering immune response
Formulary .
No Formulary Selected
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