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TREMFYA® (guselkumab)

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For US Healthcare Professionals

Full Prescribing Information

TREMFYA® (guselkumab)

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  • Efficacy
    • VOYAGE 1
    • VOYAGE 2
    • Patient Photos
    • VOYAGE 1: 100-week Open-label Extension
  • Safety Profile
  • Dosing
  • Mechanism of Action
  • Support and Resources
    • Patient Support
    • Resources
  • Important Safety Information
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REGISTER FOR UPDATES ABOUT TREMFYA®!

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IMPORTANT SAFETY INFORMATION

Infections
TREMFYA® may increase the risk of infection. Treatment with TREMFYA® should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated.

Consider the risks and benefits of treatment prior to prescribing TREMFYA® in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving TREMFYA® to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and discontinue TREMFYA® until the infection resolves.

Pre-Treatment Evaluation for Tuberculosis (TB)
Evaluate patients for TB infection prior to initiating treatment with TREMFYA®. Initiate treatment of latent TB prior to administering TREMFYA®. Monitor patients for signs and symptoms of active TB during and after TREMFYA® treatment. Do not administer TREMFYA® to patients with active TB infection.

Immunizations
Prior to initiating TREMFYA®, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with TREMFYA®.

Adverse Reactions
Most common (≥1%) adverse reactions associated with TREMFYA® include upper respiratory infections, headache, injection site reactions, arthralgia, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.

Please read the full Prescribing Information and Medication Guide for TREMFYA®. Provide the Medication Guide to your patients and encourage discussion.

067010-170208

 

INDICATION

TREMFYA® is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

TREMFYA® is administered as a 100 mg subcutaneous injection once every 8 weeks, after starter doses at weeks 0 and 4. TREMFYA® is intended for use under the guidance and supervision of a physician. Patients may self-inject with TREMFYA® after physician approval and proper training.

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© Janssen Biotech, Inc. 2018. All rights reserved.

This site is published by Janssen Biotech, Inc., which is solely responsible for its contents. This site is intended for use by healthcare professionals of the United States and Puerto Rico. Janssen Biotech, Inc., recognizes that the Internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico.

Third party trademarks used herein are trademarks of their respective owners.

Legal Notice | Privacy Policy | Medical Information Center  

Last Updated February 14, 2018

Janssen

Janssen

  • Privacy Policy
  • Legal Notice
  • Register for Updates
  • Medical Information Center

© Janssen Biotech, Inc. 2018. All rights reserved.

This site is published by Janssen Biotech, Inc., which is solely responsible for its contents. This site is intended for use by healthcare professionals of the United States and Puerto Rico. Janssen Biotech, Inc., recognizes that the Internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico.

Third party trademarks used herein are trademarks of their respective owners.

Legal Notice | Privacy Policy | Medical Information Center  

Last Updated February 14, 2018

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VOYAGE 1: Phase III Multicenter, Double-blind Trial (n=837)1,2

Patient Eligibility
  • ≥18 years of age
  • Moderate to severe plaque psoriasis (IGA score ≥3; PASI score ≥12; BSA involvement ≥10%) for at least 6 months
  • Candidates for phototherapy and/or systemic treatment

Patients who discontinued study agent because of lack of efficacy or an adverse event (AE) of psoriasis worsening or who started a protocol-prohibited psoriasis treatment were considered nonresponders (binary endpoints). Other patients with missing data were considered nonresponders for binary endpoints and nonresponder imputation (NRI) was applied.

OVERALL STUDY POPULATION

X

VOYAGE 2: Phase III Multicenter, Double-blind Trial (n=992)1,4

Patient Eligibility
  • ≥18 years of age
  • Moderate to severe plaque psoriasis (IGA score ≥3; PASI score ≥12; BSA involvement ≥10%) for at least 6 months
  • Candidates for phototherapy and/or systemic treatment

Analyses were nonresponder imputation (NRI).

*At Week 28, patients treated with TREMFYA® achieving PASI 90 (responders) were re-randomized in a 1:1 ratio to continue TREMFYA® 100 mg every 8 weeks (q8w) or placebo. Patients treated with placebo were re-treated with TREMFYA® and received another dose 4 weeks later, then q8w thereafter upon loss of 50% or more of Week 28 PASI response. TREMFYA® nonresponders continued TREMFYA® treatment.

† Placebo→TREMFYA®  responders received placebo q8w beginning at Week 28. Upon loss of  ≥50% Week 28 PASI response, patients were re-treated with TREMFYA®, another dose 4 weeks later, then q8w thereafter. Placebo→TREMFYA®  nonresponders at Week 28 continued TREMFYA® q8w.

‡ Humira® responders received placebo and upon loss of 50% or more of Week 28 PASI response, initiated TREMFYA®, then received another dose 4 weeks later, then q8w thereafter. Humira® nonresponders initiated TREMFYA® at Week 28, then received another dose 4 weeks later, then q8w thereafter.

OVERALL STUDY POPULATION

TREMFYA™ (guselkumab) VOYAGE 2 Study Population

X

IN MODERATE TO SEVERE PLAQUE PSORIASIS

STAND FOR LONG-TERM TRIAL DESIGN
CLINICAL TRIAL RESULTS THROUGH WEEK 1001,2

VOYAGE 1: OPEN-LABEL EXTENSION TRIAL (WEEK 48 TO WEEK 100)*

*After Week 48, an open-label treatment period began where patients initially randomized to TREMFYA® or placebo at Week 0 continued to receive TREMFYA® 100 mg q8w at Week 52 through the extension period. Patients initially randomized to Humira® entered a washout period after their final dose of Humira® at Week 47 and initiated TREMFYA® 100 mg at Week 52 and then q8w thereafter.

†After Week 48, subjects who discontinued study agent due to lack of efficacy or an adverse event of worsening of psoriasis, or who started a protocol-prohibited medication including conventional and biologic systemic therapy, phototherapy, and/or ultra-high–potency corticosteroids were considered treatment failures. Other topical agents for psoriasis were permitted.