Plaque psoriasis was originally thought to be a disorder driven primarily by dysregulated skin cell proliferation. However, years of research have revealed that plaque psoriasis is actually a disorder of the immune system, driven primarily by dysregulated T cells.

Today, biologic agents are one of the treatments used to treat plaque psoriasis. The first biologic agents focused on controlling broad inflammatory cytokines like tumor necrosis factor (TNF).

However, subsequent biologics began to target specific T cell pathways. These pathways include two main targets, regulatory cytokines, such as interleukin 23 and interleukin 12, and effector cytokines such as interleukin 17A and interleukin 17F. Recent findings suggest that the IL-23 Th17 axis is one of the key pathways involved in the pathogenesis of psoriasis.

Looking more closely at IL-23, interaction of this cytokine with its receptor triggers the differentiation, proliferation, and survival of these T cells. The cytokines produced by these T cells stimulate inflammation and keratinocyte proliferation. IL-23 has become an important target in developing biologic therapies for plaque psoriasis.

TREMFYA^® (guselkumab) is an interleukin 23 blocker indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as the treatment of adult patients with active psoriatic arthritis.

TREMFYA^® is a human monoclonal IgG1 lambda antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor, thereby inhibiting the release of pro inflammatory cytokines and chemokines.

In evaluated subjects with plaque psoriasis, TREMFYA^® reduced serum levels of IL-17A, IL-17F, and IL-22 relative to pre-treatment levels based on exploratory analysis of the pharmacodynamic markers. The relationship between these pharmacodynamic markers and the mechanisms by which TREMFYA^® exerts its clinical effects is unknown. TREMFYA^® was the first biologic to selectively target and bind with high specificity and affinity to IL-23.

INDICATIONS

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.

IMPORTANT SAFETY INFORMATION

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 post market 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 history of recurrent infection. Instruct patients receiving TREMFYA^® to seek medical help if signs or symptoms of clinically important chronic of 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 the 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.

Are you ready to inject TREMFYA^®, also known as guselkumab, using the One-Press patient-controlled injector? TREMFYA^® is given as a 100-mg injection under your skin that you only need to take once every eight weeks after two starter doses at Weeks 0 and 4.

Your first self injection may be performed at your healthcare provider’s office so he or she can show you the right way to give yourself injections under the skin. After this training, and with your healthcare provider’s approval, you may be able to inject at home.

If you do inject at home, remember that TREMFYA^® must be stored in the refrigerator at 36° to 46° Fahrenheit. Do not freeze your One-Press injector. Do not shake your One-Press injector. Keep your One-Press injector and all medicines out of reach of children and keep it in the original carton to protect it from light and physical damage.

What follows are instructions for how to inject TREMFYA^® using the One-Press injector. But first, carefully read the Instructions for Use and Medication Guide enclosed in the carton before you or your caregiver injects TREMFYA^® and each time you get a refill.

This video will help you get comfortable with using One-Press injector to self inject TREMFYA^® as prescribed by your healthcare provider. It’s important that you don’t try to inject yourself until your healthcare provider has walked you through the whole process.

Let’s get started.

Let’s first familiarize ourselves with the One-Press injector itself. On the left side of the screen is the One-Press injector before use. You see the handle, the teal body of the device, the window where you can inspect the liquid, the needle guard, and the bottom cap over the needle guard. Do not remove the bottom cap until you are ready to inject. On the right side of the screen is the One-Press injector after use. The One-Press injector is a patient-controlled device, so the medication injects as you push the handle. You can do this at a speed that is comfortable for you.

Now you’ll need a few supplies to prepare for your injection: one alcohol swab, one cotton ball or gauze pad, one adhesive bandage, and one sharps container. These items are not included with the One-Press injector.

Before you inject, remove the carton with your One-Press injector from the fridge. Leave the One-Press injector in the carton and let it sit on a flat surface at room temperature for at least 30 minutes before you inject. Do not attempt to warm the medicine any other way. Make sure you check the expiration date on the carton and do not use the One-Press injector if the date has passed. Do not use the One-Press injector if the seal on the carton is broken. If you find this or any other damage to the carton, call your healthcare provider or pharmacist to get a new One-Press injector.

Next, choose one of these injection sites. We recommend the front of your thighs. But you can also choose an area on your lower stomach, but never within the two inches around your belly button. And if you have someone giving you the injection, the back of one of your upper arms is also an option. Remember, do not inject into skin that is tender, bruised, red, scaly, hard, thick, or is affected by psoriasis.

Wash your hands well with soap and warm water. Next, clean your chosen injection site by wiping with the alcohol swab, then allowing it to dry. Do not touch, fan, or blow on the injection site after you’ve cleaned it.

Take your One-Press injector out of the carton. Take a look at the liquid in the viewing window on the One-Press injector. It should be clear to slightly yellow and may contain tiny white or clear particles. You may also see one or more air bubbles. All of this is completely normal. Do not inject if the liquid is cloudy, discolored or has large particles. Call your healthcare provider or pharmacist and ask for a new One-Press injector.

So it’s been at least 30 minutes since you took the carton out of the fridge, right? Now, take the One-Press injector and pull off the bottom cap. Make sure you keep your hands away from the needle guard after the cap is removed. It is normal to see a few drops of liquid. Make sure you complete your injection within five minutes of removing the cap. Do not put the cap back on. This could damage the needle. Do not use the One-Press injector if it’s dropped after the cap has been removed. If this happens, call your healthcare provider or pharmacist to get a new prefilled One-Press injector.

Place the One-Press injector straight onto the skin at the injection site. Push the handle all the way down until the teal body is not visible. This is very important. Do not lift the One-Press injector during the injection. If you do, the needle guard will lock, showing a yellow band, and you will not get the full dose. You may hear a click when the injection begins. Keep pushing. If you feel resistance, keep pushing. This is normal. The medication injects as you push. Do this at a speed that is comfortable for you.

Confirm that your injection is complete. The injection is complete when the teal body is not visible and you cannot press the handle down anymore. You may hear a click. Then lift straight up from the injection site. The yellow band will tell you that the needle guard is locked.

Now, all you’ve got to do is a bit of cleanup. First, put your used One-Press injector in a sharps disposal container right away after use. Do not throw away or dispose of your One-Press injector in your household trash and do not recycle your used sharps disposal container. Make sure you dispose of the bin and its contents as instructed by your healthcare provider, nurse, or pharmacist. For more information, please read the section on disposing of TREMFYA^® One-Press injector in the Instructions for Use.

There may be a small amount of blood or liquid at the injection site. Hold pressure over your skin using a cotton ball or gauze pad until any bleeding stops, but do not rub the injection site. If needed, cover the injection site with a bandage.

Congrats! Your self injection with TREMFYA^® and One-Press is done. When it comes time for your next injection, this video can serve as a great refresher if you’re feeling a little rusty about the process. So definitely come back and watch it again. Remember to read the Instructions for Use before using your One-Press injector and each time you get a new one. There may be new information.

Please reach out to your healthcare provider for any questions you may have about your treatment. If you need additional injection support or would like information about a program to safely return your used devices at no cost to you, you can connect with a TREMFYA withMe Guide at 1-833-WITHME1. That’s 948-4631, Monday through Friday, from 8 AM to 11 PM Eastern time.

Thanks for clicking with TREMFYA^® and One-Press.

TREMFYA^® (guselkumab) is not for everyone; only your doctor can decide if it’s right for you. Do not use if you are allergic to TREMFYA^®. TREMFYA^® is a prescription medicine that may cause serious side effects, including serious allergic reactions and infections. TREMFYA^® affects your immune system. It may increase your risk of infections and lower your ability to fight them. Please read the Important Safety Information and the Medication Guide for TREMFYA^® to learn more about these and other risks for TREMFYA^®. Discuss any questions you have with your doctor.

Getting comfortable with taking TREMFYA^® (guselkumab)

Carefully read the Instructions for Use and Medication Guide enclosed with your prefilled syringe before you or a caregiver administer TREMFYA^® and each time you get a refill.

Hello there and welcome to your easy-to-follow overview of self injecting TREMFYA^®. If you’re watching this video, you’ve already received training from your healthcare professional and he or she has decided you’re ready to begin self administering TREMFYA^®. That’s great. This video can help you feel even more comfortable with self injection.

Remember, it’s important that you don’t try to inject yourself until your healthcare provider has shown you the correct way to give yourself an injection.

Before we do any actual injecting, let’s first familiarize ourselves with the syringe itself. When you first take it out of the package, it’ll look like this, complete with plunger, safety guard, finger flange, body, viewing window, and the needle cover. Do not hold or pull the plunger at any time and do not remove the needle cover until you are ready to inject TREMFYA^®. After you inject TREMFYA^®, it’ll look like this. The safety guard will cover the needle and lock into place.

Next, you’ll need to gather a few basic supplies: an alcohol swab, a cotton ball or gauze pad, an adhesive bandage, and a sharps container to put your syringe in when you’re done. Now, take your carton of TREMFYA^® out of the fridge. Keep the prefilled syringe in the carton and let it sit on a flat surface at room temperature for at least 30 minutes before use. Do not warm the prefilled syringe any other way.

Next, check the expiration date located right here on the back of the carton. If it’s expired, don’t use it. While you’re at it, check the carton to make sure it hasn’t been opened or tampered with. If it has, do not inject and call your healthcare provider or pharmacist for a refill.

TREMFYA^® prefilled syringe is given as an injection under the skin. As far as injection sites go, you can use areas of the body like the front of your thigh or your lower stomach area. Just remember the two inch radius around your belly button must be avoided. If you’ve got someone there to help you out, the back of your upper arm is also an option. Make sure you don’t inject into skin that is tender, bruised, red, hard, thick, scaly, or affected by psoriasis.

Take a moment to wash your hands well with soap and warm water. Wipe your chosen injection site with an alcohol swab and allow it to dry. Now that you’ve got it clean and ready to go, do not touch, fan, or blow on the injection site after cleaning it.

Now take your TREMFYA^® prefilled syringe out of the carton. Inspect the TREMFYA^® prefilled syringe liquid in the viewing window. It should be clear to slightly yellow and may contain tiny white or clear particles. You may also see one or more air bubbles. This is normal. Do not inject if the liquid is cloudy or discolored or has large particles. Call your healthcare provider or pharmacist for a refill.

Now, let’s get started. Hold your prefilled syringe by the body and pull the needle cover straight off. It is normal to see a drop of liquid. Inject TREMFYA^® within five minutes of removing the needle cover. Do not put the needle cover back on, as this may damage the needle or cause a needle stick injury. Do not touch the needle or let it touch any surface. And do not use a TREMFYA^® prefilled syringe if it is dropped. Call your healthcare provider or pharmacist for a refill.

Place your thumb, index, and middle fingers directly under the finger flange as shown here. Do not touch the plunger or the area above the finger flange, as this may cause the needle safety device to activate. Use your other hand to pinch skin at the injection site. Position the syringe at about a 45 degree angle to the skin. It’s important to pinch enough skin to inject under the skin and not into the muscle.

Insert needle with a quick dart-like motion. See? Like this. Release the pinched skin and now use that hand to grasp the body of the prefilled syringe. Place your thumb from the opposite hand on the plunger and press the plunger all the way down until it stops. Release pressure from the plunger. The safety guard will cover the needle and lock into place, removing the needle from your skin.

Put your used TREMFYA^® prefilled syringe in your FDA-cleared sharps disposal container right away after use. Do not throw away your TREMFYA^® prefilled syringe in your household trash. And do not recycle your used sharps disposal container. For more information, see “How Should I Dispose of the Used Prefilled Syringe?” in the Instructions for Use for TREMFYA^®.

Check the injection site. There may be a little blood or liquid where you gave yourself the injection. Just use the cotton ball or gauze pad to apply light pressure until bleeding stops. Do not rub the injection site. If needed, cover the injection site with a bandage.

Your injection is now complete.

Set a reminder in your calendar for your next injection. Call your healthcare provider to talk about any questions you may have. For additional assistance or to share your feedback, call 800-Janssen (800-526-7736).

Now that we’ve taken care of your injection, it’s time to hear some selected important safety information.

SELECTED IMPORTANT SAFETY INFORMATION

TREMFYA^® is not for everyone; only your doctor can decide if it’s right for you. Do not use if you are allergic to TREMFYA^®. TREMFYA^® is a prescription medicine that may cause serious side effects, including serious allergic reactions and infections. TREMFYA^® affects your immune system. It may increase your risk of infections and lower your ability to fight them. Please read the Important Safety Information located on this website and the Medication Guide for TREMFYA^® to learn more about these and other risks for TREMFYA^®. Discuss any questions you have with your doctor.