Janssen Biotech Tremfya (guselkumab) Monograph

Published: February 17, 2026

Tremfya (guselkumab) is an interleukin-23 antagonist indicated for the treatment of moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis, and moderately to severely active Crohn’s disease. Tremfya was initially approved in 2017 for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Read on to learn more about Tremfya, including its warnings and precautions, dosage and administration information, how guselkumab appears in clinical guidelines, and more.

Medication Overview:

Brand Name: Tremfya
Generic Name: guselkumab
Treatment for: moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis, moderately to severely active Crohn’s disease
Manufacturer(s): Janssen Biotech
Initial FDA Approval: July 2017

Indicated Condition	Indication	Age	Date Approved
Moderate to Severe Plaque Psoriasis	Adults and pediatric patients six 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.	Adult and Pediatric Patients	July 2017
Active Psoriatic Arthritis	Adults and pediatric patients six years of age and older who also weigh at least 40 kg with active psoriatic arthritis.	Adult and Pediatric Patients	July 2020
Moderately to Severely Active Ulcerative Colitis	Adults with moderately to severely active ulcerative colitis.	Adults	September 2024
Moderately to Severly Active Crohn's Disease	Adults with moderately to severely active Crohn’s disease.	Adults	March 2025

Warnings and Precautions:

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur.
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.
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.
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.
Immunizations: Avoid use of live vaccines.

Dosage and Administration:

For the treatment of ulcerative colitis or Crohn’s disease: Obtain liver enzymes and bilirubin levels prior to initiating treatment with Tremfya.
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.
Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment initiation.

Recommended Dosage:

Plaque Psoriasis:
- Adults: 100 mg administered by subcutaneous injection at week zero, week four, and every eight weeks thereafter.
- Pediatric Patients 6 Years of Age and Older Who Also Weigh At Least 40 kg: 100 mg administered by subcutaneous injection at week zero, week four, and every eight weeks thereafter.

Psoriatic Arthritis:
- Adults: 100 mg administered by subcutaneous injection at week zero, week four, and every eight weeks thereafter. Tremfya can be used alone or in combination with a conventional DMARD (e.g., methotrexate).
- Pediatric Patients 6 Years of Age and Older Who Also Weigh At Least 40 kg: 100 mg administered by subcutaneous injection at week zero, week four, and every eight weeks thereafter. Tremfya may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (e.g., methotrexate).

Ulcerative Colitis and Crohn’s Disease:
- Induction: 200 mg administered by intravenous infusion over at least one hour at week zero, week four, and week eight, or 400 mg administered by subcutaneous injection at week zero, week four, and week eight.
- Maintenance: 100 mg administered by subcutaneous injection at week 16, and every eight weeks thereafter, or 200 mg administered by subcutaneous injection at week 12, and every four weeks thereafter. Use the lowest effective recommended dosage to maintain therapeutic response.

Contraindications:

Serious hypersensitivity reactions to guselkumab or to any of the excipients.

Drug Interactions:

CYP450 Substrates: Upon initiation of Tremfya in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect or drug concentration and consider dosage adjustment as needed.

Adverse Reactions:

Plaque Psoriasis and Psoriatic Arthritis (≤1%): upper respiratory infections, headache, injection site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.
Ulcerative Colitis (≤3%): injection site reactions, arthralgia, upper respiratory tract infections, headache, gastroenteritis, fatigue, pyrexia, and rash.
Crohn’s Disease (≤3%): respiratory tract infections, abdominal pain, injection site reactions, headache, fatigue, arthralgia, diarrhea, and gastroenteritis.

Examples of Guselkumab in Guidelines

Pharmacologic Management of Moderate-to-Severe Crohn’s Disease

American Gastroenterological Association (AGA), November 2025
In adult outpatients with moderate-to-severely active CD, AGA recommends the use of infliximab, adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab, or upadacitinib, over no treatment.

Pharmacological Management of Moderate to Severe Ulcerative Colitis

American Gastroenterological Association (AGA), November 2024
In adult outpatients with moderate-to-severe UC, AGA recommends the use of infliximab, golimumab, vedolizumab, tofacitinib, upadacitinib, ustekinumab, ozanimod, etrasimod, risankizumab and guselkumab over no treatment.

Management and Treatment of Psoriasis with Biologics

American Academy of Dermatology, February 2019
Guselkumab is recommended as a monotherapy treatment option for use in adult patients with moderate-to-severe plaque psoriasis.

Please note: This article is current as of February 16, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.