Guselkumab

TREMFYA

What it isIL-23 p19 monoclonal antibody; plaque psoriasis, psoriatic arthritis and inflammatory bowel disease.

Why this oneIt is target-selective, unlike the broader interleukin blockade of ustekinumab.

What limits itScreen for tuberculosis before starting. Infection and injection-site reactions can interrupt treatment.

FDA-approved for

FDA dosing	Population	Start	Target	Max
Moderate-to-severe plaque psoriasis	Adults and pediatric ≥6 yr and ≥40 kg	100 mg SC at Week 0 and Week 4	100 mg SC every 8 weeks	100 mg every 8 weeks
Active psoriatic arthritis (alone or with cDMARD)	Adults and pediatric ≥6 yr and ≥40 kg	100 mg SC at Week 0 and Week 4	100 mg SC every 8 weeks	100 mg every 8 weeks
Moderately-to-severely active ulcerative colitis	Adults	Induction 200 mg IV or 400 mg SC at Weeks 0, 4, 8	100 mg SC every 8 weeks (from Wk 16) or 200 mg SC every 4 weeks (from Wk 12)	200 mg every 4 weeks
Moderately-to-severely active Crohn's disease	Adults	Induction 200 mg IV or 400 mg SC at Weeks 0, 4, 8	100 mg SC every 8 weeks (from Wk 16) or 200 mg SC every 4 weeks (from Wk 12)	200 mg every 4 weeks

Renal Undefined

Hepatic Undefined

Use lowest effective maintenance dosage for UC/CD

Administer by subcutaneous injection (or IV infusion over ≥1 hour for UC/CD induction)
Evaluate for TB before initiating; obtain liver enzymes and bilirubin before treatment (UC/CD; if clinically indicated for PsO/PsA)
Complete age-appropriate vaccinations before initiation; avoid live vaccines
Pediatric self-administration is not recommended

History of serious hypersensitivity reaction to guselkumab or to any of the excipients

Pregnancy Insufficient human data; monoclonal antibody actively transported across placenta

Lactation No data on presence in human milk; not detected in lactating monkey milk

NO BOXED WARNINGS

Principal riskScreen for tuberculosis before starting

Direct muscarinic antagonism0 / 4