• Stelara is a brand (trade) name for ustekinumab, an immunosuppressant that helps to reduce inflammation and which may be used for the treatment of plaque psoriasis, psoriatic arthritis, or inflammatory bowel disease.
• Stelara binds to the p40 protein subunit that is used by two cytokines, IL-12 and IL-23. Cytokines are signaling substances that help control immunity, inflammation, and the manufacture of blood cells. By binding to this protein, Stelara disrupts the interaction of these two cytokines which have been identified as being important contributors to chronic inflammation that is a hallmark of Crohn’s disease and ulcerative colitis. These cytokines are also present in skin lesions associated with psoriasis and in the joints of people with psoriatic arthritis.
• Stelara belongs to the class of medicines known as interleukin inhibitors. It may also be called a monoclonal antibody or a biologic. Monoclonal antibodies are man-made proteins that act like human antibodies in the immune system. They are a type of “targeted” treatment. Targeted treatments attach only to specific proteins in the body.

• May be used to treat moderate-to-severe plaque psoriasis in adults and children who are at least 6 years old and for the treatment of psoriatic arthritis in adults, either with or without methotrexate. It may also be given to treat psoriatic arthritis in children aged 6 years and older.
• Approved for the treatment of moderate-to-severe Crohn's disease or ulcerative colitis in adults. The dosage varies depending on body weight.
• Stelara reduces inflammation.
• Administered by injection, under the skin (subcutaneous), at weeks 0 and 4 for psoriasis, then every 12 weeks thereafter. For Crohn's disease and ulcerative colitis, Stelara is usually administered every 8 weeks.
• Stelara is considered safe and effective to use in children aged 6 to 17 years with moderate to severe plaque psoriasis or psoriatic arthritis. The recommended dosage for children is based on body weight. The safety of Stelara in children under the age of 6 has not been established.

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:

• Nasopharyngitis, upper respiratory tract infections, headache, tiredness, diarrhea, back and muscle pain, dizziness, sore throat, itching, depression, and injection site redness are the most common side effects reported.
• Two cases of posterior reversible encephalopathy syndrome (PRES) have been reported in clinical trials with Stelara and postmarketing. Symptoms include headaches, seizures, confusion, visual disturbances, and imaging changes. If PRES occurs, discontinue Stelara and administer appropriate treatment.
• People being treated with Stelara are at a slightly higher risk of developing non-melanoma skin cancer.
• Baseline tests required before Stelara administration include a comprehensive metabolic panel, a complete blood count and a hepatitis panel; tuberculosis screening; and possibly antibody tests if vaccination status is unknown or uncertain.
• Ongoing monitoring tests depend on risk factors but may include a comprehensive metabolic panel and complete blood count every 3 to 6 months, and TB, hepatitis, or HIV screening in those with risk factors.
• Stelara blocks the effects of cytokines, IL-12 and IL-23, which reduces the immune response. Stelara can increase the risk of infection or precipitate symptoms of an infection that has been asymptomatic. Stelara 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 Stelara 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.
• Serious infections, caused by bacteria, fungi, or viruses, have been reported in people taking Stelara, for example, appendicitis, cellulitis, colds, flu, and other respiratory viral infections, diverticulitis, gastroenteritis, herpes zoster, listeria meningitis, osteomyelitis, pneumonia, sepsis, and urinary tract infections. Noninfectious pneumonia has also been reported.
• Live vaccines, such as BCG, MMR, and chickenpox should NOT be administered during Stelara treatment. Inactivated vaccines, such as the flu vaccine, may be given to people taking Stelara and a yearly flu vaccine is recommended for people taking biologics, such as Stelara.
• Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with Stelara and consider discontinuing Stelara for serious or clinically significant infections until the infection resolves or is adequately treated.
• Biologics, such as Stelara typically have long half-lives and there may be a delay from the time of discontinuation to the time of immune function recovery. Discontinuation of Stelara has been associated with immune reconstitution inflammatory syndrome. This is a condition caused by the immune system overreacting to the previously unrecognized antigens because it was suppressed. Many doctors just proceed with biological therapy during an infection and treat the infection with the appropriate medication, for example, antibiotics if it is bacterial, or antivirals if it is a viral infection. Corticosteroids may also be administered.
• Before starting treatment with Stelara, ensure all patients have received all their appropriate immunizations for their age as recommended by National guidelines. It is important people administered Stelara DO NOT receive live vaccines. This includes the BCG vaccine for tuberculosis. This should not be given during treatment or within ONE YEAR of initiating or discontinuing Stelara; measles, mumps rubella vaccine; varicella (chickenpox) vaccine. Caution should also be exercised when administering live vaccines to close contacts of people taking Stelara as viral shedding and subsequent transmission of the virus to Stelara patients may occur. In addition, non-live vaccines (such as influenza, hepatitis A, and pertussis [whooping cough]) that are administered during treatment with Stelara may not initiate an immune response that is sufficient to prevent disease. However, a yearly flu vaccine is currently recommended for people administered Stelara.
• Serious hypersensitivity reactions (such as tightness of the throat, shortness of breath, and flushing) have been reported in 0.1% of people administered Stelara. A health professional should always administer the first dose of Stelara and patients should be advised to seek urgent emergency help if they experience an allergic-type reaction.
• Stelara is only available as an injection that is administered under the skin. It takes one hour to receive the full dose of the medicine. Store Stelara in the refrigerator before use and remove it from the refrigerator 30 minutes before administration to reduce the risk of stinging during administration.
• Stelara is only intended for administration by a health professional; however, some patients and caregivers may be able to be taught how to inject Stelara. Administer the injection at a different anatomical site (such as the upper arms, gluteal regions, thighs, or abdomen) and not into the skin that is bruised, tender, or red.
• There is not enough data to know the effect Stelara has during pregnancy on the unborn child. There are no data on the effect of Stelara during lactation.

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

• Before starting Stelara all your vaccinations should be up to date and you should be free of infection.
• If you develop an infection while on Stelara, your doctor may consider temporarily discontinuing Stelara until the infection resolves or treatment can be instigated. If your doctor decides to continue with Stelara, then antibiotics may be administered at the same time if the infection is bacterial in origin. Always monitor yourself for symptoms that suggest an infection, such as burning when urinating, diarrhea, difficulty breathing, fever or flu-like symptoms, red, painful, blistered, or swollen skin, sweats, or chills.
• Stelara is usually administered every 8 to 12 weeks by a health professional. Keep a note of this date on your calendar. If you forget your appointment, schedule another as soon as you can. Some people can be taught how to self-administer Stelara.
• Do not self-administer Stelara if you have not been already shown how to do so by a doctor or other health care provider. Take Stelara out of the fridge and check the expiry date. Do not shake the carton or syringe at any time. Visually inspect Stelara for discoloration or cloudiness. It should look colorless to light yellow and it may contain a few small translucent or white particles. Do not use if discolored or cloudy. Use an antiseptic wipe to clean your chosen injection site. Stelara may be injected into the stomach area (except for a 2-inch radius around the belly button), front of the thighs, or buttocks. If a caregiver is administering Stelara, it can also be injected into the upper arm. Avoid skin that is bruised, tender, red, or hard. Hold the body of the syringe and remove the needle cover without touching the plunger. Hold the syringe in one hand like a pen and use your other hand to pinch the skin up. Insert the needle at a 45° angle with a quick dart-like motion into the pinched-up area of skin. Use your thumb to push the plunger head all the way down between the needle guard wings. Once all the medicine has been injected, gently remove the needle from the skin. Take your thumb off the plunger head and you should hear a click which is the sound of the needle guard activating. Dispose of the syringe safely in a sharps container (call Janssen CarePath 877-227-3728 if you don’t have one). There may be a little bit of blood at the injection site. Apply light pressure with a cotton ball until it stops or cover with a plaster. Do not rub.
• Seek urgent medical attention if you experience shortness of breath, facial or throat tightness after being administered Stelara. Tell your doctor if you experience any other side effects, such as headache, tiredness, or pain.
• Tell other health professionals that you are being administered Stelara. Before you start Stelara, all your vaccinations should be up to date. While you are receiving Stelara, you should not receive any live vaccines (such as the MMR vaccine or the chickenpox vaccine).
• Stelara is not recommended during pregnancy unless the benefits outweigh the risks but tell your doctor immediately if you become pregnant while being administered Stelara.
• If you are traveling for an extended period and your dose of Stelara falls during your time away, then remove the injectable syringe from the refrigerator, and wrap it in bubble wrap or light insulation. Put it in a purse or briefcase, and bring the box label. Keep the injection away from sunlight and heat. Stelara can be kept at room temperature for up to 30 days. If you are traveling for longer than this, you may need to arrange a cool box or ask for it to be kept in a refrigerator on the plane.

• Depending on the condition being treated, some improvement is usually within 3 weeks of a Stelara dose. It may take up to 8 weeks to see a response in some people. Stelara reduces disease activity in most people; however, less achieve remission.
• Crohn’s disease improvement is measured using the Crohn’s Disease Activity Index (CDAI). This looks at various signs, symptoms, and other variables present over the past seven days and assigns a severity score. Clinical response in two published trials was defined as a reduction in CDAI score of greater than or equal to 100 points or a CDAI score of less than 150 at week 6 and clinical remission as a CDAI score of less than 150 at week 8. By week 3, 41 to 51% had experienced a CDAI score of at least 70. This improved to 44 to 65% by week 6. 34 to 56% of patients achieved a CDAI100 at week 6 with Stelara and by week 8, 21 to 40% had achieved clinical remission (CDAI150). By week 8 response rates had improved to 38-58%. At week 44, 47% of patients receiving Stelara were in clinical remission and corticosteroid free compared with only 30% receiving placebo.
• Trials of Stelara in patients with ulcerative colitis (UC) used the Mayo score to determine the effectiveness of treatment. The Mayo score is a combined endoscopic (a tool that looks into the small bowel) and clinical scale to assess the severity of UC. 19% of patients given Stelara (6mg/kg/dose) achieved clinical remission (defined as a Mayo score of 0 or 1 by week 8) compared with only 7% of those receiving placebo ( a pretend pill) in a study of 961 patients with ulcerative colitis. The patients had to have failed previous treatment with corticosteroids, immunomodulators, or at least one biologic. A clinical response (defined as at least a 30% difference in Mayo score or an improvement of at least 2 points) was experienced in 58% of those receiving Stelara compared with 31% receiving placebo. In another study, 45% of patients achieved clinical remission (defined as a Mayo score of 0 or 1 after 44 weeks) compared with only 26% receiving placebo. 74% experience a clinical response after 44 weeks.
• For psoriasis, the response is measured using the Psoriasis Area and Severity Index (PASI) score. The PASI 75 is a 75% reduction in the PASI score from baseline, after 12 weeks of therapy. A PASI75 was experienced in 66% to 76% of participants in two studies (Ps Study 1 and Ps study 2) 59% to 73% were reported to have cleared or minimal psoriatic plaques remaining.
• For psoriatic arthritis, the American College of Rheumatology (ACR) responder criteria is used. This assesses several variables, such as the number of tender and number of swollen joints, patient global assessment, physician global assessment, functional ability measure visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). The percentage (20, 50, or 70) is an indication of the amount of improvement. An ACR of 20% was reported in 44%-50% of patients given 90mg Stelara and 42% to 44% of patients given Stelara 45mg after 24 weeks of treatment. An ACR of 50% was reported in 23%-28% of patients given 90mg Stelara and 17% to 25% of patients given Stelara 45mg after 24 weeks of treatment. An ACR of 70% was reported in 9%-14% of patients given 90mg Stelara and 7% to 12% of patients given Stelara 45mg after 24 weeks of treatment.
• A few studies have identified problems with storing biologics, such as Stelara. One study showed that only 11.6% of injections were stored correctly; 33.2% were stored for over a week above 46.4° F (8°C) and 11.4% were stored for more than 30 minutes below 32° F (0°C). Unfortunately, it is unknown how much these missteps in storage impact the effectiveness and absorption of these biologics. Some experts suggest changes in the protein structure of biologics brought about by freeze-thawing or prolonged storage at elevated temperatures may lead to a breakdown in protein structure, the irreversible formation of protein complexes, and a loss of biological activity.

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

• aminophylline
• anticonvulsants, such as phenobarbital,
• benzodiazepines, such as alprazolam or clonazepam
• chemotherapy agents, such as cyclophosphamide, methotrexate, or bleomycin
• corticosteroids (such as prednisone or dexamethasone)
• cyclosporine
• heart medications such as amiodarone or flecainide
• herbals, such as echinacea
• hormones such as levonorgestrel or norgestrel
• 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
• opioids, such as fentanyl or oxycodone
• other biologics, such as adalimumab, golimumab, or infliximab
• probiotics, such as lactobacillus
• statins, such as atorvastatin or simvastatin
• theophylline
• warfarin
• 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 Stelara. This is because the formation of CYP450 enzymes can be altered by increased levels of certain cytokines (such as IL-12 and IL-23) during chronic inflammation. Because Stelara stops IL-12 and 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 Stelara. You should refer to the prescribing information for Stelara for a complete list of interactions.