• Ilumya is a brand (trade) name for tildrakizumab-asmn which may be used to reduce inflammation associated with psoriasis.
• Ilumya blocks the inflammatory response by binding selectively to 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, Ilumya 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.
• Ilumya belongs to the class of medicines known as interleukin inhibitors. It may also be called a human monoclonal antibody.

• May be used to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic treatment or phototherapy (ultraviolet or UV light).
• Given as a 100 milligram (mg) subcutaneous (under the skin) injection. The first two injections are given 4 weeks apart, followed by an injection once every 12 weeks.
• Each single-dose prefilled syringe contains 100 mg of Ilumya.
• Because Ilumya only requires dosing every 12 weeks after administration of loading doses it represents a good option for optimizing compliance.
• May be given as monotherapy or in addition to other therapies.
• 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. Ilumya 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).
• After 12 weeks: 55% to 58% of people administered Ilumya had cleared or minimal disease according to their PGA (physicians global assessment) score compared to 4% to 7% of those administered placebo; 61% to 64% of those had experienced a 75% reduction.

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), injection site reactions (including itching, pain, redness, swelling, bruising, hematoma formation, and bleeding), and diarrhea are the most common side effects.
• 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.
• Ilumya, 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.
• Ilumya blocks the effects of cytokine IL-23, which reduces the immune response. Ilumya can increase the risk of infection or precipitate symptoms of an asymptomatic infection. Ilumya should NOT be initiated in any person with a current or suspected infection. This includes active tuberculosis. If a person has latent tuberculosis, treatment for tuberculosis should be initiated before Ilumya is started in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Anybody with a prior history of TB should be monitored closely for signs and symptoms of active tuberculosis during and after treatment. In clinical trials, the difference in the frequency of infections between the Ilumya group and the placebo group was less than 1%. Take into consideration the infection risk when planning for surgery.
• Needs to be administered by a healthcare professional. Must be kept refrigerated (at between 2°C to 8°C [36°F to 46°F]) and protected from light; do not freeze or shake. May be kept at room temperature at 25°C or less (77°F) for up to 30 days; but once stored at room temperature, do not place it back in the refrigerator and discard Ilumya if not used within 30 days.
• Before starting treatment with Ilumya, ensure all patients have received all their appropriate immunizations for their age as recommended by National guidelines. People administered Ilumya should NOT receive live vaccines.
• Serious hypersensitivity reactions (such as angioedema and urticaria) have been reported in people administered Ilumya. If a reaction occurs, discontinue Ilumya and initiate appropriate treatment. There is also the potential for immunogenicity and antibody formation. Up to week 64, approximately 6.5% of people treated with Ilumya developed antibodies to it; 40% had antibodies that were classified as neutralizing.
• The safety of Ilumya in children aged less than 18 years has not been established.
• There is not enough data to know the effect Ilumya has during pregnancy on the unborn child. There are no data on the effect of Ilumya during lactation.
• No generic form of Ilumya 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

• Ilumya needs to be administered by a healthcare professional. Ensure you keep your scheduled appointments so that your injection is given on time. If you miss an appointment reschedule it as soon as you can. Always read the medication guide about Ilumya that your healthcare professional gives you.
• Ilumya (tildrakizumab) affects the immune system by blocking the inflammatory response which changes how your body responds to autoimmune conditions, such as psoriasis, but also to infection. This may increase your risk of infection or cause the reactivation of some infections, such as tuberculosis.
• Seek urgent medical attention if you experience shortness of breath, or facial or throat tightness after being administered Ilumya. Tell your doctor if you experience any other side effects, such as signs of infection (such as shortness of breath, cough, burning when urinating), diarrhea, tiredness, or pain.
• Tell other health professionals that you are being administered Ilumya. Before you start Ilumya, all your vaccinations should be up to date. While you are receiving Ilumya, you should not receive any live vaccines (such as the MMR vaccine or the chickenpox vaccine).
• Ilumya is not recommended during pregnancy unless the benefits outweigh the risks but tell your doctor immediately if you become pregnant while being administered Ilumya.

• It takes approximately 12 weeks for Ilumya (tildrakizumab) to start working with nearly 60% of people experiencing a 75% reduction in the severity of their psoriasis within that time; however, it may take over a year for the full benefits to be seen.
• Research has shown that after 12 weeks: 55% to 58% of people administered Ilumya had cleared or minimal disease according to their PGA (physicians global assessment) score compared to 4% to 7% of those administered placebo; 61% to 64% had experienced a 75% reduction in their disease as defined by their PASI score; 35% to 39% had experienced a 90% reduction in their disease as defined by their PASI score; 12% to 14% had experienced a 100% reduction in their disease as defined by their PASI score.
• Longer-term studies have indicated that the percentage of people experiencing benefits increases with continued treatment. After 28 weeks of treatment, 74% of people administered Ilumya had experienced a 75% reduction in their disease as defined by their PASI score; After 64 weeks of treatment, 84% of people administered Ilumya had experienced a 75% reduction in their disease as defined by their PASI score.
• Some people who had previously been assigned Ilumya in the trial were then given a placebo. It took an average of 20 weeks for the benefits of Ilumya to be lost once it had been discontinued and the placebo started.
• Trials have shown that Ilumya has a similar number of side effects when compared to Stelara and Tremfya.

Medicines that interact with Ilumya may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Ilumya. 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 Ilumya include:

• etanercept
• herbals, such as brewer's yeast
• immunosuppressants (such as azathioprine, cyclosporine, or tacrolimus)
• live vaccines and some other vaccines, such as BCG, cholera, measles, or hepatitis b 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 Ilumya. 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 Ilumya 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 Ilumya. You should refer to the prescribing information for Ilumya for a complete list of interactions.