Dosing

TREMFYA^® is the first and only anti–IL-23 with a patient-controlled, self-injection device.

Please see the full Instructions for Use (IFU) for TREMFYA® One-Press Patient-Controlled Injector.

Device features:

Can be used in a physician’s office or at home after physician approval and proper training
Soft “click” indicates when the injection is complete

ONE-PRESS: TESTED FOR PATIENT USABILITY AND ACCEPTABILITY

Tested for Patient Usability

98.7% of patients had a successful first injection with One-Press

Favorable Through 28 Weeks

Through Week 28, SIAQ* post-dose scores were favorable (overall means ranging from 7.63 to 9.84) in all treated patients at all timepoints across all 6 domains²:

Feelings about injections
Self-image
Self-confidence
Pain and skin reactions during or after the injection
Ease of use of the self-injection device
Satisfaction with self-injection

DOWNLOAD INSTRUCTIONS FOR USE

^*SIAQ=Self-Injection Assessment Questionnaire; a score of 0 corresponds to the subject’s worst experience (eg, not at all confident, extremely bothered, very dissatisfied) and a score of 10 corresponds to the subject’s best experience (eg, extremely confident, not at all bothered, very satisfied).

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
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.

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

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.

cp-82625v1