Guselkumab
TREMFYA
Pronunciation: gyoo-sel-KOO-mab (trem-FYE-a)
“Trim for ya’, Goose-elk mab”
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
- Plaque psoriasis (2017)
- psoriatic arthritis (2017)
- ulcerative colitis (2017)
- Crohn disease (2017)
FDA label
Read the full label on DailyMed ↗
| 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
Instructions
- 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
Available strengths
- inj 100 mg/mL
Contraindications
- History of serious hypersensitivity reaction to guselkumab or to any of the excipients
Cautions
- Serious hypersensitivity reactions including anaphylaxis
- Increased risk of infections
- Tuberculosis — evaluate before treatment
- Hepatotoxicity (drug-induced liver injury reported)
- Avoid live vaccines
Adverse reactions
- Upper respiratory infections
- Headache
- Injection site reactions
- Arthralgia
- Bronchitis
- Diarrhea
- Gastroenteritis
- Fatigue
- Abdominal pain
Pregnancy Insufficient human data; monoclonal antibody actively transported across placenta
Lactation No data on presence in human milk; not detected in lactating monkey milk
Cost
| Strength | #/mo | generic $/unit | brand $/unit | CostPlus | |
|---|---|---|---|---|---|
| 100 mg/mL | inj | per unit | — | $14728.91/mL | not offered |
NO BOXED WARNINGS
Principal riskScreen for tuberculosis before starting
Classes and tags
Clinical profile
Legacy pregnancy categoryN/A (post-2015 labeling)
Defining liabilityInfection, hypersensitivity and liver injury monitoring