• Skyrizi is a brand (trade) name for risankizumab-rzaa which may be used to treat adults with plaque psoriasis, active psoriatic arthritis, or Crohn's disease.
• Skyrizi 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 (such as Crohn's 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, Skyrizi 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.
• Skyrizi 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).
• May also be used to treat active psoriatic arthritis (PA) in adults.
• Was the first specific IL-23 inhibitor to be approved for moderately to severely active Crohn's disease in adults.
• The recommended dose is 150mg, which is given as two 75mg injections subcutaneously (under the skin). The dose is administered at week 0, week 4, then every 12 weeks thereafter.
• Good for optimizing compliance because after the initial loading doses Skyrizi only requires dosing every 12 weeks.
• 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. Skyrizi 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 placebo (a medicine with no active ingredient in it).
• 75% of people experienced a reduction of 90% in their psoriasis after 16 weeks which increased to 82% at week 52.

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.
• Skyrizi, 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.
• Two injections are needed to make one dose for most people because each injection only contains 75mg Skyrizi.
• Skyrizi blocks the effects of cytokine IL-23, which reduces the immune response. Skyrizi can increase the risk of infection or precipitate symptoms of an infection that has been asymptomatic and 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 Skyrizi 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, infections occurred in 22.1% of patients treated with Skyrizi compared to 14.7% given placebo. Take into consideration this infection risk when planning for surgery.
• Before starting treatment with Skyrizi, ensure all patients have received all their appropriate immunizations for their age as recommended by National guidelines. It is important people administered Skyrizi DO NOT receive live vaccines.
• Serious hypersensitivity reactions (such as angioedema and urticaria) have been reported in people administered Skyrizi. If a reaction occurs, discontinue Skyrizi and initiate appropriate treatment. There is also the potential for immunogenicity and antibody formation. By week 52, 24% of people treated with Skyrizi developed antibodies to it; 57% had antibodies that were classified as neutralizing.
• The safety of Skyrizi in children aged less than 18 years has not been established.
• There is not enough data to know the effect Skyrizi has during pregnancy on the unborn child. There are no data on the effect of Skyrizi during lactation.
• No generic form of Skyrizi 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

• Ask your healthcare provider to show you how to self-administer Skyrizi before attempting to do so yourself.
• Skyrizi is usually given every 12 weeks for psoriasis and psoriatic arthritis, and for most people, the dosage is two 75mg injections that are given under the skin. Do not change the dosage of Skyrizi before talking to your healthcare provider.
• For people with Crohn's disease, Skyrizi can be self-administered once every 8 weeks after an initial course of 3 starter doses has been given 4 weeks apart. Only one injection needs to be given.
• Take the Skyrizi prefilled syringe carton out of the refrigerator about 15 minutes to 30 minutes before injection time, this way it will warm up to room temperature and will be more comfortable to inject. Do not shake the Skyrizi Prefilled Syringe.
• The Skyrizi dose is TWO injections for psoriasis and psoriatic arthritis, and one injection for Crohn's disease. If you are giving yourself two injections, then the second injection should be given straight after the first injection, but NOT injected into the same site. You can inject into the front of your thighs, the lower part of the abdomen (at least 2 inches away from your belly button), or the outer area of the upper arm if a caregiver is administering it. Only inject into clear, healthy skin. Do not inject into any areas that are bruised, tender, red, scaly, or hard.
• Wash your hands before you start, then clean the injection site(s) with an alcohol wipe and let the areas dry.
• Check the liquid inside the prefilled syringe; it should be clear to slightly yellow to clear and may contain tiny white or clear particles. If the liquid is cloudy or you can see flakes or large particles then DO NOT USE IT. It is normal to have air bubbles in the syringe. Do not use the injection if it has been frozen. Remove the needle cap from the Skyrizi 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 Skyrizi prefilled syringe into your sharps disposal container. Once you have finished the first injection you need to use the second injection to get your full dose. Choose your second site for injection if needed and repeat as above.
• Skyrizi 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, facial or throat tightness after being administered Skyrizi. 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 Skyrizi. Before you start Skyrizi, all your vaccinations should be up to date. While you are receiving Skyrizi, you should not receive any live vaccines (such as the MMR vaccine or the chickenpox vaccine).
• Skyrizi is not recommended during pregnancy unless the benefits outweigh the risks but tell your doctor immediately if you become pregnant while being administered Skyrizi.

• Trials investigating the effectiveness of Skyrizi use the PASI score (PASI stands for Psoriasis Area and Severity Index). It scores psoriasis on redness, thickness, amount of scaling, and how much of the body is affected. If the PASI score has a 90% reduction it is called PASI 90. Results from UltlMMa-1 and UltlMMa-2 trials reported the percentage of patients achieving 90% improvement in their PASI score (PASI 90) as 44% at week 4, 75% at week 16, and 82% at week 52. The percentage of patients who achieved PASI 100 was 42% at week 16 and 57% at week 52.
• Evidence for the benefit of Skrizi for Crohn's disease comes from two induction trials and one maintenance trial (ADVANCE, MOTIVATE and FORTIFY). As early as week 4 in the induction studies, clinical response and clinical remission were achieved by significantly more subjects treated with Skyrizi versus placebo, as were co-primary endpoints of endoscopic response and clinical remission at week 12 and week 52.

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

• etanercept
• herbals, such as brewers 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 Skyrizi. 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 Skyrizi 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 Skyrizi. You should refer to the prescribing information for Skyrizi for a complete list of interactions.