Guselkumab

Guselkumab is a human monoclonal IgG1λ antibody that selectively binds to the p19 subunit of interleukin 23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.

• TREMFYA is an interleukin-23 antagonist indicated for the treatment of: adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. ( 1.1 ) adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis.ICD-10: L40.50, L40.9

• TREMFYA is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients [see Warnings and Precautions (5.1) ] . History of serious hypersensitivity reactions to guselkumab or to any of the excipients.contraindicated

For the treatment of ulcerative colitis or Crohn's disease: Obtain liver enzymes and bilirubin levels prior to initiating treatment with TREMFYA. ( 2.1 , 5.4 ). For the treatment of plaque psoriasis or psoriatic arthritis, if clinically indicated, evaluate liver enzymes and bilirubin at baseline prior to initiating treatment with TREMFYA ( 2.1 , 5.4 ). Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment initiation. ( 2.1 ) Recommended Dosage Plaque Psoriasis Adults 100 mg administered by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter. ( 2.2 ) Pediatric Patients 6 Years of Age and Older Who Also Weigh at Least 40 kg 100 mg administered by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter. ( 2.2 ) Psoriatic Arthritis Adults 100 mg administered by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter. TREMFYA can be used alone or in combination with a conventional DMARD (e.g., methotrexate). ( 2.3 ) Pediatric Patients 6 Years of Age and Older Who Also Weigh at Least 40 kg 100 mg administered by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter. TREMFYA may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (e.g., methotrexate). ( 2.3 ) Ulcerative Colitis and Crohn's Disease Induction : 200 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8 or 400 mg administered by subcutaneous injection at Week 0, Week 4, and Week 8.

Hypersensitivity Reactions : Serious hypersensitivity reactions, including anaphylaxis, may occur. ( 5.1 ) Infections : TREMFYA may increase the risk of infections. Do not initiate treatment with TREMFYA in patients with clinically important active infection until the infection resolves or is adequately treated. If such an infection develops, discontinue TREMFYA until the infection resolves. ( 5.2 ) Tuberculosis (TB) : Evaluate for TB prior to initiating treatment with TREMFYA. Monitor patients for signs and symptoms of active TB during and after treatment with TREMFYA. ( 5.3 ) Hepatotoxicity : Drug-induced liver injury has been reported. For the treatment of ulcerative colitis or Crohn's disease, evaluate liver enzymes and bilirubin levels at baseline, for at least 16 weeks of treatment, and periodically thereafter according to routine patient management. For the treatment of plaque psoriasis or psoriatic arthritis, if clinically indicated, evaluate liver enzymes and bilirubin at baseline, and periodically thereafter according to routine patient management. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. ( 5.4 ) Immunizations : Avoid use of live vaccines. ( 5.5 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, have been reported with post market use of TREMFYA. Some cases required hospitalization. If a serious hypersensitivity reaction occurs, discontinue TREMFYA and initiate appropriate therapy.

The following adverse reactions are discussed in greater detail in other sections of labeling: Hypersensitivity Reactions [see Contraindications (4) and Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Tuberculosis [see Warnings and Precautions (5.3) ] Hepatotoxicity [see Warnings and Precautions (5.4) ] Most common adverse reactions associated with TREMFYA are: Plaque Psoriasis and Psoriatic Arthritis (≥1%): upper respiratory infections, headache, injection site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections. ( 6.1 ) Ulcerative Colitis (≥3%) : injection site reactions, arthralgia, upper respiratory tract infections, headache, gastroenteritis, fatigue, pyrexia, and rash. ( 6.1 ) Crohn's Disease (≥3%) : respiratory tract infections, abdominal pain, injection site reactions, headache, fatigue, arthralgia, diarrhea, and gastroenteritis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adults with Plaque Psoriasis In clinical trials, a total of 1823 adult subjects with moderate-to-severe plaque psoriasis received TREMFYA.

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to TREMFYA during pregnancy. Patients should be encouraged to enroll in the registry by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing MotherToBaby@health.ucsd.edu. Risk Summary Available data from literature, post-marketing reports, and ongoing pregnancy registry with TREMFYA use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Monoclonal antibodies are actively transported across the placenta (see Clinical Considerations ). In a combined embryofetal development and pre- and post-natal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of guselkumab during organogenesis through parturition at doses up to 18 times the exposure (AUC) in humans administered 200 mg intravenously and 16 times the exposure (AUC) to the 400 mg dose given subcutaneously. Neonatal deaths in monkeys were observed at 4 to 18 times the exposure (AUC) in humans administered 200 mg intravenously and 4 to 16 times the exposure (AUC) to the 400 mg dose given subcutaneously (see Data ) .

Metabolism

Guselkumab exhibited linear pharmacokinetics in healthy adult subjects and adult subjects with plaque psoriasis following subcutaneous injections. In subjects with plaque psoriasis, following subcutaneous administration of 100 mg of TREMFYA at Weeks 0 and 4, and every 8 weeks thereafter, mean steady-state trough serum guselkumab concentration was approximately 1.2 mcg/mL.

• Jul 13, 2017BLABLA761061Janssen Biotech

1. 1Product Dose Omission Issue10,62532%
2. 2Accidental Exposure To Product3,31510%
3. 3Drug Ineffective2,3287.0%
4. 4Needle Issue2,1646.5%
5. 5Psoriasis2,1406.5%
6. 6Device Issue1,8365.6%
7. 7Device Malfunction1,5504.7%
8. 8Off Label Use1,4204.3%
9. 9Product Storage Error1,2093.7%
10. 10Device Deployment Issue1,1943.6%
11. 11Inappropriate Schedule Of Product Administration9422.8%
12. 12Arthralgia8892.7%
13. 13Device Leakage8562.6%
14. 14Pneumonia8072.4%
15. 15Device Defective7882.4%

The 10 most recently updated of 134 ClinicalTrials.gov registrations naming Guselkumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study of Persistence to Guselkumab Treatment in Participants With Moderate-to-Severe Plaque Psoriasis in Romania
  Recruiting · Observational · 200 enrolled · Janssen Research & Development, LLC
  NCT07582783updated 2026-06-12
• A Study to Assess Real-world Outcomes for Long-Term Use of Guselkumab
  Recruiting · Observational · 50 enrolled · Janssen-Cilag A.G., Switzerland
  NCT07532213updated 2026-06-12
• A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
  Recruiting · Phase 3 · Interventional · 196 enrolled · Janssen Research & Development, LLC
  NCT06663332updated 2026-06-11
• Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy
  Recruiting · Interventional · 20 enrolled · University of California, San Diego
  NCT06586281updated 2026-06-10
• Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
  Active not recruiting · Phase 2 · Phase 3 · Interventional · 45 enrolled · Wei-Che Ko
  NCT05535738updated 2026-06-09
• A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
  Recruiting · Phase 3 · Interventional · 644 enrolled · Janssen Research & Development, LLC
  NCT07577856updated 2026-06-08
• A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
  Active not recruiting · Phase 2 · Interventional · 577 enrolled · Janssen Research & Development, LLC
  NCT05242484updated 2026-06-08
• A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
  Active not recruiting · Phase 3 · Interventional · 418 enrolled · Janssen Research & Development, LLC
  NCT05528510updated 2026-06-08
• A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
  Active not recruiting · Phase 3 · Interventional · 120 enrolled · Janssen Research & Development, LLC
  NCT03451851updated 2026-06-08
• A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
  Active not recruiting · Phase 2 · Phase 3 · Interventional · 1,409 enrolled · Janssen Research & Development, LLC
  NCT03466411updated 2026-06-08

Frequently asked questions

How does Guselkumab work?

Guselkumab is a human monoclonal IgG1λ antibody that selectively binds to the p19 subunit of interleukin 23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.

What is Guselkumab used for?

According to FDA labeling, Guselkumab carries indications including: TREMFYA is an interleukin-23 antagonist indicated for the treatment of: adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. ( 1.1 ) adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Guselkumab?

Guselkumab is classified as Interleukin inhibitors, Interleukin-23 Antagonist, Antibody-Receptor Interactions, Interleukin-23 Antagonists.

What are the brand names for Guselkumab?

Guselkumab is marketed under brand names including Tremfya.

What are the contraindications for Guselkumab?

Guselkumab labeling lists contraindications including: TREMFYA is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients [see Warnings and Precautions (5.1) ] . History of serious hypersensitivity reactions to guselkumab or to any of the excipients.. Always consult the full prescribing information and a clinician.