• Tremfya is a brand (trade) name for guselkumab which may be used to treat plaque psoriasis.
• Tremfya blocks the inflammatory response by binding selectively to the p19 subunit of interleukin-23 (IL-23) which is a naturally occurring cytokine. Cytokines are substances released by cells of the immune system that influence other cells. IL-23 plays a key role in promoting inflammation and regulating other cytokines (such as IL-17) and inflammatory substances, such as TNF-α3-7. IL-23 is thought to be crucial in regulating inflammation that stems from infection or chronic autoimmune conditions, such as psoriasis, inflammatory bowel disease, rheumatoid arthritis, and multiple sclerosis. In these conditions, IL-23 maintains immune cells in an inflammatory state.
• By blocking the effects of IL-23, Tremfya helps control the release of IL-17 and TNF-α, which reduces inflammation. It also decreases how many inflammatory cells are present within psoriatic lesions and helps prevent plaque formation and resolves tissue damage.
• Tremfya belongs to the class of medicines known as interleukin inhibitors. It may also be called a human monoclonal antibody.

• Tremfya may be used to reduce symptoms of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
• Tremfya may also be used to treat psoriatic arthritis in adults.
• Maintenance doses of Tremfya are given every 8 weeks by subcutaneous injection after the first two doses at week 0 and week 4.
• People prescribed Tremfya can be taught by a healthcare professional how to self-administer.
• Usually well tolerated with few side effects.
• May be given as monotherapy or in addition to other therapies (such as methotrexate) for psoriatic arthritis.
• Because it precisely targets the inflammatory pathway at IL-23, it does not modify the effects of another cytokine, IL-12 which helps to protect against infection and cancer. Tremfya can still increase a person’s risk of infection or cause reactivation of tuberculosis; however, the risk for serious infection is low (0.3%) and similar to a placebo (a medicine with no active ingredient in it).
• Tremfya is available as the Tremfya One-Press Injector and the Tremfya prefilled syringe.
• Research has shown Tremfya to be more effective than adalimumab

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Upper respiratory infections (eg, nasopharyngitis, upper respiratory tract infection, viral upper respiratory tract infection, and pharyngitis), headache, fatigue, injection site reactions (including itching, pain, redness, swelling, bruising, hematoma formation, and bleeding), and tinea infections are the most common side effects reported.
• May also cause serious side effects such as allergic reactions with angioedema (swelling in the lower layers of the skin, often in the face, tongue, throat, arms, or legs), urticaria (hives), and infections.
• Tremfya, like other biologics, should be monitored for effectiveness and side effects. A lack of response, loss of response, or severe side effects may warrant switching to a different biologic or the addition of other treatments.
• Research has shown infections, such as upper respiratory tract infections, gastroenteritis, herpes simplex, and tinea infections are more likely to occur with Tremfya (incidence 23% with Tremfya compared with 21% with placebo) because it affects the immune system, reducing its ability to respond to pathogens. Some of these infections can become serious. Tremfya should not be started in people who have symptoms of an infection, and your doctor may decide to discontinue Tremfya, either temporarily or permanently, if you develop an infection while being administered Tremfya.
• Before starting Tremfya, your doctor will ask you if you have been exposed to tuberculosis (TB) in the past. They may need to do some further tests and may require you to undertake a course of antibiotics if their investigations show you have been exposed to TB. If you develop symptoms of TB (such as a persistent cough lasting longer than three weeks, chest pain, coughing up blood, or sputum), tell your doctor immediately.
• Serious hypersensitivity reactions (such as angioedema and urticaria) have been reported rarely in people administered Tremfya. A health professional should always administer the first dose of Tremfya and patients should be advised to seek urgent emergency help if they experience an allergic-type reaction. There is also the potential for immunogenicity and antibody formation.
• Tremfya is only available as an injection that is administered under the skin. It must be stored in the refrigerator before use. You should remove Tremfya from the refrigerator 30 minutes before you intend to administer it to ensure that it has reached room temperature, which reduces the risk of it stinging when you administer it. There is currently no information on how long Tremfya can remain out of the refrigerator.
• Before starting treatment with Tremfya, ensure all patients have received all their appropriate immunizations for their age as recommended by National guidelines. People administered Tremfya mustn't receive live vaccines.
• The safety of Tremfya in children aged less than 18 years has not been established.
• It is unknown what effect Tremfya has during pregnancy on the unborn child. There are no data on the effect of Tremfya during lactation.
• No generic form of Tremfya is available.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• If you have been shown how to self-inject Tremfya, administer yourself a dose once every eight weeks, otherwise see your healthcare provider for your regular. If you forget a dose, schedule it as soon as you can, then continue with your regular dosing schedule.
• Immediately before administration take one Tremfya prefilled syringe or One-Press injector out of the refrigerator and leave it on a flat surface, away from children and pets, to warm up to room temperature for at least 30 minutes. Do not warm it in any other way (such as by putting it in hot water). Tremfya at room temperature reduces the risk of stinging. The liquid in Tremfya should be clear, colorless, or slightly yellow, and may contain tiny white or clear particles. You may see one or more air bubbles that are considered normal. Check the expiry date on the side of the injection and do not use Tremfya if it has expired, contains large particles, or is cloudy. Do not shake Tremfya. Do not use the injection if it has been frozen or dropped.
• Tremfya is best administered into the front of your thighs or the lower part of your abdomen, avoiding the area around your belly button (stay an inch away from your belly button). If somebody else is giving you your injection they can also administer it into the outer area of your upper arm. Change your injection site each month so that you are not injecting into the same spot each time.
• Only inject into clear, healthy skin. Do not inject into any areas that are bruised, tender, red, scaly, or hard. You should also not inject any scars, stretch marks, or areas of psoriasis.
• If you feel pain when you inject Tremfya, placing an ice pack on the area of the skin where you inject Tremfya for a few minutes before and after the injection can help reduce this pain. Wash your hands before you start, then clean the 2 injection sites with an alcohol wipe and let the areas dry.
• Do not shake the Tremfya One-Press injector before use. Wash your hands then clean the injection site with an alcohol wipe and let the area dry. Twist and pull off the bottom cap, keeping your hands away from the needle guard. Inject Tremfya within 5 minutes of removing the cap. Position the One-Press injector straight up and down on the skin (at a 90-degree angle). Push the handle straight down, the medication will inject as you push. The injection is complete when the handle is pushed all the way down and you hear a click and the teal body is no longer visible. Lift the injection straight up off the skin, the yellow band indicates the needle guard is locked. Dispose of the used Tremfya One-Press injector in an approved sharps container.
• For the Tremfya pre-filled syringe, remove the needle cover from the Tremfya prefilled syringe and throw it away. Hold the prefilled syringe in one hand then with the other hand gently pinch the skin at the injection site to form a small bump of skin. Then insert the needle at a 45-degree angle into the small bump, making sure you push the needle in. Push down the plunger as far as it can go and all the liquid is injected and the syringe is empty. Pull the needle out of the skin, then release the plunger rod and the entire needle should then be covered by the needle guard. Throw away the used Tremfya prefilled syringe into your sharps disposal container.
• Store Tremfya in the refrigerator. Do not put Tremfya back in the refrigerator if it has been out of the refrigerator for more than a few minutes. Do not freeze Tremfya. Protect Tremfya from light.
• Seek urgent medical attention if you experience shortness of breath, or facial or throat tightness after administering Tremfya. If you feel unwell or experience other signs of infection, tell your doctor immediately. Also remember to tell your doctor about any other side effects that you may be experiencing, such as dizziness or fainting.
• Tell other health professionals that you are being administered Tremfya. Before you start Tremfya, all your vaccinations should be up to date. While you are receiving Tremfya, you should not receive any live vaccines (such as the MMR vaccine or the chickenpox vaccine).
• Tremfya is not recommended during pregnancy unless the benefits outweigh the risks but tell your doctor immediately if you become pregnant while being administered Tremfya.
• Talk to your doctor or pharmacist before taking any other medicines with Tremfya.

• Trials have used the Investigator's Global Assessment (IGA) score and/or the Psoriasis Area and Severity Index to determine the effect of Tremfya on plaque psoriasis.
• 84% to 85% of adults achieved an IGA response of 0/1 after 16 weeks of treatment and 70% to 73% achieved a PASI 90 (Psoriasis Area and Severity Index [PASI] score with at least a 90% reduction in symptoms from baseline) score of ≥90.
• For people with psoriatic arthritis, 52% of participants achieved an ACR20 (20% improvement in tender and swollen joint counts) by week 16 which persisted till week 24. 23% of participants achieved an ACR50 (50% improvement) by week 16 and 30% achieved an ACR50 by week 24. 8% of participants achieved an ACR70 (70% improvement) by week 16 and 12% achieved an ACR70 by week 24.

Medicines that interact with Tremfya may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Tremfya. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Tremfya include:

• benzodiazepines such as clobazam and clonazepam
• buprenorphine
• cyclosporine
• etanercept
• herbals, such as brewer's yeast or echinacea
• immunosuppressants (such as azathioprine, cyclosporine, or tacrolimus)
• live vaccines and some other vaccines, such as BCG, cholera, measles, hepatitis b vaccines, or the SARS-cov-2 (covid-19) vaccines
• medications used to treat multiple sclerosis, such as fingolimod
• other biologics, such as adalimumab, golimumab, or infliximab
• probiotics, such as bifidobacterium lactobacillus
• zinc.

There is a potential for any medication that is metabolized by CYP450 enzymes, particularly those with a narrow therapeutic index (such as cyclosporine or warfarin) to interact with Tremfya. This is because the formation of CYP450 enzymes can be altered by increased levels of certain cytokines (such as IL-23) during chronic inflammation. Because Tremfya stops IL-23 from interacting with their receptors, this could normalize the formation of CYP450 enzymes. Monitor for any change in effect and consider any dosage modification.

Note that this list is not all-inclusive and includes only common medications that may interact with Tremfya. You should refer to the prescribing information for Tremfya for a complete list of interactions.