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Wezlana (ustekinumab-auub)
ustekinumab
Adult Dosing .
Dosage forms: INJ (ConfiPen SC auto-injector): 45 mg, 90 mg; INJ (SC pre-filled syringe): 45 mg per 0.5 mL, 90 mg per mL; INJ (SC vial): 45 mg per 0.5 mL; INJ (IV vial): various
Special Note
- [drug name clarification]
- Info: nonproprietary name = ustekinumab-auub
psoriasis, moderate-severe plaque
- [<100 kg]
- Dose: 45 mg SC q12wk; Start: 45 mg SC x1 on wk 0, 4, then q12wk
- [>100 kg]
- Dose: 90 mg SC q12wk; Start: 90 mg SC x1 on wk 0, 4, then q12wk; Info: may decr. dose to 45 mg if full dose intolerable
psoriatic arthritis
- [45 mg SC q12wk]
- Start: 45 mg SC x1 on wk 0, 4, then q12wk; Info: give 90 mg SC x1 on wk 0, 4, then q12wk if >100 kg with coexisting plaque psoriasis
Crohn disease, moderate-severe
- [induction tx, <56kg]
- Dose: 260 mg IV x1
- [induction tx, 56-85kg]
- Dose: 390 mg IV x1
- [induction tx, >85kg]
- Dose: 520 mg IV x1
- [maintenance tx]
- Dose: 90 mg SC q8wk; Start: 8wk after induction dose
ulcerative colitis, moderate-severe
- [induction tx, <56kg]
- Dose: 260 mg IV x1
- [induction tx, 56-85kg]
- Dose: 390 mg IV x1
- [induction tx, >85kg]
- Dose: 520 mg IV x1
- [maintenance tx]
- Dose: 90 mg SC q8wk; Start: 8wk after induction dose
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ (ConfiPen SC auto-injector): 45 mg, 90 mg; INJ (SC pre-filled syringe): 45 mg per 0.5 mL, 90 mg per mL; INJ (SC vial): 45 mg per 0.5 mL; INJ (IV vial): various
Special Note
- [drug name clarification]
- Info: nonproprietary name = ustekinumab-auub
psoriasis, moderate-severe plaque
- [6 yo and older, <60 kg]
- Dose: 0.75 mg/kg/dose SC q12wk; Start: 0.75 mg/kg/dose SC x1 on wk 0, 4, then q12wk
- [6 yo and older, 60-100 kg]
- Dose: 45 mg SC q12wk; Start: 45 mg SC x1 on wk 0, 4, then q12wk
- [6 yo and older, >100 kg]
- Dose: 90 mg SC q12wk; Start: 90 mg SC x1 on wk 0, 4, then q12wk
psoriatic arthritis
- [6 yo and older, <60 kg]
- Dose: 0.75 mg/kg/dose SC q12wk; Start: 0.75 mg/kg/dose SC x1 on wk 0, 4, then q12wk
- [6 yo and older, >60 kg]
- Dose: 45 mg SC q12wk; Start: 45 mg SC x1 on wk 0, 4, then q12wk; Info: give 90 mg SC x1 on wk 0, 4, then q12wk if >100 kg with coexisting plaque psoriasis
Crohn disease, moderate-severe (off-label)
- [induction tx, 2 yo and older, 10-25 kg]
- Dose: 10 mg/kg/dose IV x1
- [induction tx, 2 yo and older, 26-55 kg]
- Dose: 260 mg IV x1
- [induction tx, 2 yo and older, 56-85 kg]
- Dose: 390 mg IV x1
- [induction tx, 2 yo and older, >85 kg]
- Dose: 520 mg IV x1
- [maintenance tx, 2 yo and older, 10-35 kg]
- Dose: 2.5 mg/kg/dose SC q8wk; Start: 8wk after induction dose
- [maintenance tx, 2 yo and older, >35 kg]
- Dose: 90 mg SC q8wk; Start: 8wk after induction dose
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
- TB infection, active
- caution: patients >60 yo
- caution: infection, chronic
- caution: infection, recurrent
- caution: infection risk
- caution: TB infection, latent
- caution: TB infection risk
- caution: malignancy
- caution: malignancy history
- caution: malignancy risk
- caution: PUVA tx
- caution: PUVA tx history
- caution: immunosuppressant use, prolonged
- caution: allergen immunotherapy use, concurrent
- caution: allergen immunotherapy use history
Drug Interactions .
Overview
ustekinumab
IL-12/IL-23 antagonist
- 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
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- infection, severe
- infection exacerbation
- infection reactivation
- malignancy
- hypersensitivity reaction, serious
- anaphylaxis
- angioedema
- hypersensitivity vasculitis
- posterior reversible encephalopathy syndrome
- pneumonia, interstitial
- pneumonia, eosinophilic
- pneumonia, cryptogenic organizing
Common Reactions
- infection
- URI
- headache
- abdominal pain
- injection site erythema
- diarrhea
- pruritus
- fatigue
- vomiting
- arthralgia
- nausea
- back pain
- dizziness
- pharyngolaryngeal pain
Safety/Monitoring .
Monitoring Parameters
TB test at baseline, then active TB signs/symptoms during and after tx D/C; dermatologic exams
Pregnancy/Lactation .
Pregnancy
Clinical Summary
may use during pregnancy; risk of fetal harm not expected based on human data; no known risk of teratogenicity based on animal data at >100x MRHD; for infants exposed to ustekinumab in utero, weigh risk/benefit before administering live vaccines
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 ustekinumab: unknown; CYP450: unknown
Excretion: for ustekinumab: unknown; Half-life: 14.9-45.6 days (plaque psoriasis use), 19 days (Crohn disease or ulcerative colitis use)
Subclass: Inflammatory Bowel Disease (IBD) ; Interleukin-12/23 (IL-12/23) Antagonists ; Psoriasis, Systemic Agents ; Spondyloarthropathies
Mechanism of Action
for ustekinumab: binds to and interferes with interleukin-12 and interleukin-23 cytokines, reducing inflammation and altering immune response (monoclonal antibody)
Formulary .
No Formulary Selected
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