Important Safety Information
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  • TREMFYA® (guselkumab)

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

    TREMFYA® is indicated for the treatment of adults with active psoriatic arthritis.

     

    CONTRAINDICATIONS
    TREMFYA® is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients.

    WARNINGS AND PRECAUTIONS

    Hypersensitivity Reactions
    Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of TREMFYA®. Some cases required hospitalization. If a serious hypersensitivity reaction occurs, discontinue TREMFYA® and initiate appropriate therapy.

    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, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.

    The overall safety profile observed in patients with psoriatic arthritis is generally consistent with the safety profile in patients with plaque psoriasis, with the addition of bronchitis and neutrophil count decreased.

     

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

    cp-82625v3

     

    INDICATIONS
Click on the left to see the Important Safety Information

INDICATIONS

IMPORTANT SAFETY INFORMATION

Prescribing Information
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  • https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf
    https://www.janssenlabels.com/package-insert/product-patient-information/TREMFYA-medication-guide.pdf

Benefits Investigation Support

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Benefits Investigation Support

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  3. Insurance Coverage

We give you information to help your patients get on therapy. Our dedicated Care Coordinators can:

  • Look into patients’ insurance benefits and coverage
  • Review coverage with you and your patients
  • Provide prior authorization support and status monitoring
  • Help you understand the appeals process
  • Help you find a specialty pharmacy or distributor to access medication

Provider Portal

Register Today for the Provider Portal for 24-hour Online Access to Support Your Patients

With a Provider Portal account, you can:

  • Upload signed Patient Authorization forms
  • Get Benefits Investigation (BI) and Prior Authorization (PA) support when you need it
  • See the status of BIs
  • Complete and submit PAs with or without doing a BI
  • Create medical necessity and exception letters
  • Request exceptions and appeals information
  • Enroll your eligible patients in the TREMFYA withMe Savings Program
  • Manage your patients’ Savings Program benefits
  • See Patient Dashboard at a glance
  • Get timely notifications

Faxable Forms

Complete Benefits Investigations and Request Prior Authorizations Right in the Provider Portal

Or You Can Download Faxable Forms Below
Business Associate Agreement
Complete a Business Associate Agreement for your practice only once. No individual patient authorizations are required.

Important Safety Information For

  • TREMFYA®

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

    TREMFYA® is indicated for the treatment of adults with active psoriatic arthritis.

     

    CONTRAINDICATIONS
    TREMFYA® is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients.

    WARNINGS AND PRECAUTIONS

    Hypersensitivity Reactions
    Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of TREMFYA®. Some cases required hospitalization. If a serious hypersensitivity reaction occurs, discontinue TREMFYA® and initiate appropriate therapy.

    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, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.

    The overall safety profile observed in patients with psoriatic arthritis is generally consistent with the safety profile in patients with plaque psoriasis, with the addition of bronchitis and neutrophil count decreased.

     

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

    cp-82625v3

     

    INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS
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INDICATIONS

IMPORTANT SAFETY INFORMATION