TREMFYA® (guselkumab)

ONE-PRESS
PATIENT-CONTROLLED INJECTOR

AVAILABLE IN 2 DOSAGE FORMS:

Prefilled syringe (NDC: 57894-640-01)
One-Press patient-controlled injector (NDC: 57894-640-11)

DEVICE FEATURES DESIGNED WITH PATIENTS IN MIND:

Can be used in physician’s office or at home after physician approval and proper training
Needle guard keeps needle out of view
Soft “click” indicates when the injection is complete
Not made with natural rubber latex

*Frequency of maintenance injections for TREMFYA® after the first year.

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.

In active psoriatic arthritis, TREMFYA® may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).

PATIENT SELF-INJECTION DEMONSTRATION VIDEOS

Watch these easy-to-follow injection demonstration videos for TREMFYA®.

The injection demonstration videos are not meant to replace the IFU that are supplied with TREMFYA®. Instruct patients to read the IFU before using their TREMFYA® prefilled syringe or One-Press injector and each time they get a refill.

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.

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

TREMFYA^®:
DOSING SCHEDULE¹

ONE-PRESS
PATIENT-CONTROLLED INJECTOR

AVAILABLE IN 2 DOSAGE FORMS:

DEVICE FEATURES DESIGNED WITH PATIENTS IN MIND:

PATIENT SELF-INJECTION DEMONSTRATION VIDEOS

IMPORTANT SAFETY INFORMATION

INDICATIONS

DOSAGE AND ADMINISTRATION

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TREMFYA®: DOSING SCHEDULE1

ONE-PRESSPATIENT-CONTROLLED INJECTOR

AVAILABLE IN 2 DOSAGE FORMS:

DEVICE FEATURES DESIGNED WITH PATIENTS IN MIND:

PATIENT SELF-INJECTION DEMONSTRATION VIDEOS

DOSAGE AND ADMINISTRATION

Do you want to continue to [extlink:external-url]?

TREMFYA^®:
DOSING SCHEDULE¹

ONE-PRESS
PATIENT-CONTROLLED INJECTOR