Stelara (ustekinumab) (2023)

What is Stelara used for?

  • Moderate to severe plaque psoriasis in adults and adolescents aged 12 years and over.

    Stelara is used for people whose psoriasis has not responded to other systemic therapy including ciclosporin, methotrexate or PUVA, and for people who cannot have these types of treatments.

    • A form of arthritis called psoriatic arthritis that can occur in people with the skin condition psoriasis.

      Stelara is used for adults with active progressive disease that has not responded to treatment with other disease modifying antirheumatic drugs (DMARDs) such as sulfasalazine. It can be used either on its own or in combination with methotrexate.

      How does Stelara work?

      Stelara injection contains the active ingredient ustekinumab, which is a type of medicine called a human monoclonal antibody. It works by suppressing part of the immune system and modifying the process of inflammation.

      (Video) How to Inject Stelara (ustekinumab)

      Ustekinumab works in a similar way to the natural antibodies produced by our immune system. Our natural antibodies recognise foreign invaders and bind to them, helping our immune systems to attack them and protect us from infections. Monoclonal antibodies like ustekinumab are made in laboratories and are designed to recognise particular proteins in a similar way.

      Ustekinumab specifically recognises and binds to two proteins produced by the body called interleukin-12 and interleukin-23. These are involved in causing inflammation.

      By preventing the action of interleukin-12 and interleukin-23, ustekinumab helps reduce the inflammation and other symptoms of psoriasis, such as thickened scaly plaques of skin.

      Preventing the action of these interleukins can also reduce inflammation in the joints in people with a form of arthritis that can occur alongside psoriasis. This is called psoriatic arthritis. Ustekinumab improves the arthritic symptoms and physical function of the joints in this condition. When treating arthritis, ustekinumab is referred to as a disease-modifying antirheumatic drug (DMARD).

      (Video) Risankizumab vs. Ustekinumab for Psoriasis

      How is Stelara given?

      • Ustekinumab is only prescribed by specialists in these diseases.
      • The Stelara injection is given under the skin (subcutaneously). If possible the areas of the skin that are affected by psoriasis should be avoided.
      • Your doctor or consultant will administer your first Stelara injection. This will be repeated after four weeks and then every 12 weeks. You may be taught how to use the injection yourself, so that you can administer the next injections yourself and do not have to visit the clinic. If this applies to you it is important to make sure you understand what to do and ask questions if you don't.
      • The length of your treatment will be decided by your doctor; this will depend on the severity of the condition and the response to the treatment. Treatment should be stopped if no improvements in symptoms are seen after 28 weeks.

        Important information about Stelara

        • This medicine can compromise the body's ability to fight infections and can increase the risk of tuberculosis (TB) and other serious infections. You should be tested for TB before treatment is started. Tell your doctor immediately if you experience weight loss, fever or persistent coughing during treatment, as these can be symptoms of TB.
        • It is important to try and avoid exposure to infections during your treatment. Let your doctor know as soon as possible if you get any symptoms of any infection, so that it can be treated without delay. If you develop a serious infection, treatment with this medicine should be stopped until the infection is controlled. Your doctor may want to continue to monitor you for infections for a period of time after treatment with this medicine is stopped.
        • You should consult your doctor promptly if you notice increased redness, itching, scaling or shedding of your skin over a larger area of your body while you are having treatment with this medicine, because this may be a sign of an adverse reaction to the medicine.
        • If you are due to have any surgery or dental procedures, it is important to tell your doctor or dentist that you are having treatment with this medicine.
        • Women who could get pregnant should use an effective method of contraception to prevent pregnancy, both during treatment with this medicine and for at least 15 weeks after their last injection. Seek medical advice from your doctor.

          Stelara should be used with caution in

          • People with a dormant (currently inactive) tuberculosis infection.
          • People with a chronic infection or history of recurrent infections.
          • People at risk of infections.
          • People who are or who have recently been receiving treatment that suppresses the activity of the immune system, eg long-term oral corticosteroids, chemotherapy, radiotherapy, medicines to prevent transplant rejection.
          • People who have had PUVA treatment.
          • People with cancer or a history of cancer.
          • People who are allergic to latex (the syringe cover contains latex).
          • People over 65 years of age.

            Stelara should not be used in

            • People with active tuberculosis.
            • People with other serious active infections.
            • Women who are pregnant or breastfeeding.
            • This medicine is not recommended for children and adolescents under 12 years of age.

              This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

              If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

              Pregnancy and breastfeeding

              Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

              • There is no information about the safety of this medicine if used during pregnancy. It is not recommended for use during pregnancy as it could potentially be harmful to a developing baby.
              • Women who could get pregnant should use an effective method of contraception to prevent pregnancy, both during treatment and for at least 15 weeks after their last injection. If you think you could be pregnant at any point during treatment you should tell your doctor straight away. Seek further medical advice from your doctor.
              • It is not known if this medicine passes into breast milk. Women should not breastfeed during treatment with this medicine, or for at least 15 weeks after their last dose. Seek further medical advice from your doctor.

                Possible side effects of Stelara

                Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

                (Video) How Stelara (ustekinumab) Works in Crohn’s Disease

                Common (affect between 1 in 10 and 1 in 100 people)

                • Inflammation of the nose and throat, causing a blocked or runny nose and sore throat (nasopharyngitis).
                • Upper respiratory tract infections, eg coughs and colds.
                • Headache.
                • Dizziness.
                • Tooth infections.
                • Pain in the throat, nose or mouth.
                • Diarrhoea.
                • Nausea.
                • Itching.
                • Back pain.
                • Pain in the muscles or joints (myalgia or arthralgia).
                • Feeling tired or weak.
                • Redness and pain at site of injection.

                  Uncommon (affect between 1 in 100 and 1 in 1000 people)

                  • Bacterial infections of the skin or soft tissue, eg cellulitis.
                  • Shingles (herpes zoster).
                  • Depression.
                  • Facial palsy (Bell's palsy).
                  • Blocked nose.
                  • Pustular psoriasis (psoriasis where blisters or pustules containing fluid appear on the skin).
                  • Skin scaling, flaking or peeling.
                  • Reaction at site of injection such as bleeding, swelling, bruising, hardness and itching.

                    Rare (affect between 1 in 1000 and 1 in 10,000 people)

                    • Serious allergic reactions, including anaphylaxis and swelling of the face, throat and tongue (angioedema).
                    • Severe skin reaction called exfoliative dermatitis, which involves widespread redness, scaling, itching and shedding of the skin. See important information above.

                      The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

                      If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it's necessary they'll report it for you.

                      You can also report side effects yourself using the yellow card website: www.mhra.gov.uk/yellowcard.

                      How can Stelara affect other medicines?

                      You should tell your doctor if you are taking any other medicines, including over-the-counter and herbal medicines, before you start treatment with this medicine. Similarly, always seek advice from your doctor or pharmacist before taking any new medicines while you are receiving treatment with this medicine, so they can check that the combination is safe.

                      (Video) STELARA® (ustekinumab) Mechanism of Action

                      This medicine suppresses part of the immune system. This means that vaccines may potentially be less effective if given during treatment, and live vaccines may cause serious infections. Live vaccines include: measles, mumps, rubella, MMR, BCG, oral polio, oral typhoid and yellow fever. It is recommended that live vaccines are not given to people being treated with this medicine, or for 15 weeks after treatment with this medicine is stopped.

                      Other medicines containing the same active ingredient

                      There are currently no other medicines available in the UK that contain ustekinumab as the active ingredient.

                      Further reading

                      For background information about our medicine factsheets, including the references used to produce them, click here.

                      Last updated

                      (Video) William Sandborn, MD: Ustekinumab for Ulcerative Colitis

                      Advertisement - Continue Reading Below

                      FAQs

                      What is Stelara used for? ›

                      STELARA® is a prescription medicine used to treat: adults and children 6 years and older with moderate to severe psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).

                      Is ustekinumab the same as Stelara? ›

                      Ustekinumab is a drug that reduces the signs and symptoms of active psoriatic arthritis, such as psoriasis and joint swelling. It is also approved for the treatment of plaque psoriasis and moderate to severe, active Crohn's disease. Ustekinumab is commonly known as Stelara®. It is a type of drug called a biologic.

                      What type of drug is ustekinumab? ›

                      Ustekinumab injection is in a class of medications called monoclonal antibodies. It works by stopping the action of certain cells in the body that cause the symptoms of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

                      What does Stelara do for Crohn's disease? ›

                      Stelara binds to two small proteins (cytokines) that are meant to support the body's immune response. In people with Crohn's, levels of these cytokines are elevated, causing long-term inflammation. By blocking these cytokines, Stelara reduces inflammation in the gastrointestinal tract.

                      Is Stelara a high risk medication? ›

                      STELARA® is a prescription medicine that affects your immune system. It can increase your chance of having serious side effects including serious infections, cancer, serious allergic reactions, lung inflammation, and a rare condition called posterior reversible encephalopathy syndrome.

                      How much does a Stelara shot cost? ›

                      The cost for Stelara subcutaneous solution (45 mg/0.5 mL) is around $13,434 for a supply of 0.5 milliliters, depending on the pharmacy you visit. Quoted prices are for cash-paying customers and are not valid with insurance plans.

                      Is Humira a Stelara? ›

                      A main difference between these drugs is how often you use them. Once you're on a maintenance dose, you'll receive Stelara once every 8 or 12 weeks. Humira's maintenance dose is one injection every other week. Also, Stelara and Humira aren't in the same exact drug class.

                      How long can you stay on Stelara? ›

                      It is important that you tell your doctor about any new symptoms you notice. This will help prevent any potential complications or catch them at an early stage. Your IBD team should give you a check-up to see whether you should continue having Stelara after 12 months of treatment.

                      What to avoid on Stelara? ›

                      Infection with salmonella from eating undercooked meat, poultry and eggs may be more serious in some patients taking Stelara.

                      Does Stelara cause hair loss? ›

                      Is hair loss a side effect of Stelara? No, you shouldn't have hair loss from Stelara. Hair loss wasn't reported in studies of the drug. But some other medications that may be used to treat autoimmune conditions can cause hair loss.

                      How long do you stay on Stelara for Crohn's? ›

                      To treat Crohn's disease, Stelara is given as an initial induction dose, then administered again every 8 weeks. An induction dose is used to get enough medication in your body for the treatment to start working quickly.
                      ...
                      Dosage.
                      Body weightInduction dose
                      86 kg (about 187 lb) or more520 mg
                      2 more rows

                      Is Humira better than Stelara? ›

                      Around 61% of patients on the J&J drug hit corticosteroid-free remission versus 57.4% of Humira patients. Around 6% more patients on Stelara achieved clinical response than those on Humira, and self-reported symptom remission was around 1% higher in the Stelara arm.

                      What cancers can Stelara cause? ›

                      In clinical studies of people with plaque psoriasis, 1.5% of those taking Stelara reported a nonmelanoma skin cancer. Also in these studies, 1.7% of people taking Stelara developed cancer other than nonmelanoma skin cancer. These types of cancer included prostate cancer, breast cancer, and colorectal cancer.

                      Does Stelara make you immunocompromised? ›

                      by Drugs.com

                      Stelara (ustekinumab) is an immunosuppressant drug, which means that it weakens the immune system and can increase the risk of infections such as COVID-19. Additionally, having a weakened immune system can dampen the body's response to vaccination, potentially decreasing the efficacy.

                      Is Stelara a steroid? ›

                      No. STELARA® is not a steroid. STELARA® targets an underlying cause of plaque psoriasis and psoriatic arthritis—an overactive immune system. It blocks the action of IL-12 and IL-23, two proteins that may play a role in plaque psoriasis and active psoriatic arthritis.

                      Is Stelara hard on kidneys? ›

                      STELARA was effective and well tolerated in all 3 patients, while not causing any worsening in their renal function or comorbidity.

                      How can Stelara affect the brain? ›

                      Stelara may cause mild neurological side effects such as headache and dizziness. But Stelara can also cause a more serious brain condition called posterior reversible leukoencephalopathy syndrome (PRES). For more information about headache and PRES, see the “Stelara: Side effects explained” section below.

                      Can Stelara cause liver damage? ›

                      Conclusions: Ustekinumab-related liver injury is uncommon and mild. From a hepatic point of view, the drug appears safe, even in patients with pre-existing liver disease and those who have developed altered liver function previously with other drugs.

                      How much do insurance companies pay for STELARA? ›

                      It is not a cure. This drug is more popular than comparable drugs. There are currently no generic alternatives to Stelara. While 96% of insurance plans cover the most common version of Stelara at a co-pay of $32.50-$80.00, many of them have restrictions.

                      Does Medicare pay for STELARA? ›

                      Since 2016, total Medicare Part B payments to physicians for Stelara-an expensive drug used to treat certain autoimmune diseases that is often self-injected by patients in their home-have increased substantially.

                      What is the success rate of STELARA? ›

                      45% of the overall population receiving STELARA ® were in clinical remission after 1 year of treatment.

                      Is STELARA a strong immunosuppressant? ›

                      Official answer. Yes, Stelara (ustekinumab) is an immunosuppressant. It is approved to treat certain forms of psoriasis, psoriatic arthritis and moderate to severe Crohn's disease and ulcerative colitis. It works by blocking the effects of two different cytokines, interleukin-12 and interleukin-23.

                      What drug is similar to STELARA? ›

                      • Methotrexate.
                      • Triamcinolone topical.
                      • Cosentyx.
                      • Taltz.
                      • Skyrizi.
                      • Remicade.

                      What is the best biologic for Crohn's disease? ›

                      Adalimumab (Humira®) is a prescription medicine shown to induce and maintain clinical remission in patients with moderate to severe Crohn's disease (in adults and children) and ulcerative colitis (in adults). Adalimumab is given as a subcutaneous injection under the skin of the abdomen or thigh.

                      Can you drink alcohol with Stelara? ›

                      There aren't any known interactions between Stelara and alcohol.

                      How do you feel after first Stelara infusion? ›

                      Bruising, itching, pain, redness, swelling, or hardening of the skin at the injection site may occur. Injection site reactions usually go away after 1 or 2 days. Headache, back pain, or sinus/throat pain may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

                      Can you drive after a Stelara infusion? ›

                      Stelara has no or negligible influence on the ability to drive and use machines. Stelara contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'. However, before Stelara is given to you, it is mixed with a solution that contains sodium.

                      Does Stelara raise blood pressure? ›

                      However, patients on existing treatments can experience several adverse events, including stomach trouble, tiredness, high blood pressure, fever, physical and mental fatigue, dactylitis, night sweats, weight loss, increased bruising and bleeding, jaundice, dark urine, loss of appetite, rapid heart rate, light- ...

                      Does Stelara affect your teeth? ›

                      Common (affect between 1 in 10 and 1 in 100 people)

                      Tooth infections. Pain in the throat, nose or mouth. Diarrhoea. Nausea.

                      Can Stelara cause mood changes? ›

                      Ustekinumab may cause a rare (sometimes fatal) condition called PRES (posterior reversible encephalopathy syndrome). Get medical help right away if you develop headache that doesn't go away, seizures, sudden vision changes, mental/mood changes (such as confusion).

                      Does Stelara make you sleepy? ›

                      Common side effects of STELARA® include: nasal congestion, sore throat, and runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, stomach pain, and ...

                      What is the new drug for Crohn's? ›

                      On June 17, the FDA expanded the approval of Skyrizi for the treatment of Crohn's disease. June 24, 2022 - The FDA recently approved Skyrizi as a treatment for moderate to severely active Crohn's disease.

                      Is Stelara better than Remicade? ›

                      Remicade has an average rating of 7.1 out of 10 from a total of 183 ratings on Drugs.com. 61% of reviewers reported a positive effect, while 21% reported a negative effect. Stelara has an average rating of 7.4 out of 10 from a total of 225 ratings on Drugs.com.

                      How often is Stelara shot? ›

                      STELARA® is a 45 mg or 90 mg injection given under the skin, as directed by your doctor. To start, you'll get doses at weeks 0, 4, and then every 12 weeks after that. Your doctor can administer it, or you (or a caregiver) can inject at your home after proper training.

                      Can Stelara cause heart failure? ›

                      In clinical trials of STELARA in adult patients with plaque psoriasis (PsO): Through year 5 (week 264) of follow-up in the PHOENIX 1 trial, there were 3 serious adverse events (SAEs) of congestive heart failure (CHF; 0.4%; N=753); 1 case was reported in the 45-mg group and 2 cases were reported in the 90-mg group.

                      What happens when you stop taking Stelara? ›

                      No, you won't have withdrawal symptoms if you stop taking Stelara. But keep in mind that the symptoms of your condition may come back if you stop treatment.

                      Is Stelara an immunotherapy? ›

                      STELARA® is an immunosuppressant and may increase the risk of malignancy.

                      Are Stelara and Humira the same? ›

                      A main difference between these drugs is how often you use them. Once you're on a maintenance dose, you'll receive Stelara once every 8 or 12 weeks. Humira's maintenance dose is one injection every other week. Also, Stelara and Humira aren't in the same exact drug class.

                      Is stelara an autoimmune drug? ›

                      Stelara is the brand name for the biological medicine ustekinumab. Like Humira, doctors use this medicine to treat autoimmune conditions, which are diseases that affect the immune system. Stelara works by targeting two proteins in the body, interleukin-12 (IL-12) and interleukin-23 (IL-23).

                      What are the long-term effects of Stelara? ›

                      More common side effects in people receiving the long-term dosage† of Stelara for Crohn's disease include: infections, such as the common cold, sinus infection, or bronchitis* injection site reactions* itching.

                      Does Stelara cause weight loss? ›

                      No, Stelara doesn't affect your weight. On the other hand, if you're taking Stelara for Crohn's disease, the condition itself may cause weight loss. If you're losing or gaining weight while taking Stelara, talk with your doctor.

                      What is the success rate of Stelara? ›

                      45% of the overall population receiving STELARA ® were in clinical remission after 1 year of treatment.

                      Does Stelara cause neurological problems? ›

                      Stelara may cause mild neurological side effects such as headache and dizziness. But Stelara can also cause a more serious brain condition called posterior reversible leukoencephalopathy syndrome (PRES). For more information about headache and PRES, see the “Stelara: Side effects explained” section below.

                      Is Stelara a strong immunosuppressant? ›

                      Official answer. Yes, Stelara (ustekinumab) is an immunosuppressant. It is approved to treat certain forms of psoriasis, psoriatic arthritis and moderate to severe Crohn's disease and ulcerative colitis. It works by blocking the effects of two different cytokines, interleukin-12 and interleukin-23.

                      Does Stelara stop inflammation? ›

                      STELARA® targets an overactive immune system and is the only biologic that works by blocking two proteins, IL-23 and IL-12, which may play a role in psoriatic arthritis. By blocking these proteins, STELARA® may help reduce the inflammation that causes both the joint and skin symptoms.

                      Videos

                      1. Ustekinumab as a treatment for Crohn’s disease: Efficacy and safety
                      (HMP Education)
                      2. Maria Abreu, MD: Ustekinumab as a First Line Treatment for Ulcerative Colitis
                      (HCPLive)
                      3. Ustekinumab as the New Frontline Treatment
                      (HCPLive)
                      4. Stelara (Ustekinumab) Update- 1.5 YEARS ON! Kristy J
                      (Kristy J)
                      5. Crohn’s Disease: Clinical Experience With Ustekinumab
                      (HCPLive)
                      6. How to Self-Inject Stelara (Ustekinumab) | Kristy J
                      (Kristy J)
                      Top Articles
                      Latest Posts
                      Article information

                      Author: Cheryll Lueilwitz

                      Last Updated: 01/23/2023

                      Views: 6146

                      Rating: 4.3 / 5 (54 voted)

                      Reviews: 93% of readers found this page helpful

                      Author information

                      Name: Cheryll Lueilwitz

                      Birthday: 1997-12-23

                      Address: 4653 O'Kon Hill, Lake Juanstad, AR 65469

                      Phone: +494124489301

                      Job: Marketing Representative

                      Hobby: Reading, Ice skating, Foraging, BASE jumping, Hiking, Skateboarding, Kayaking

                      Introduction: My name is Cheryll Lueilwitz, I am a sparkling, clean, super, lucky, joyous, outstanding, lucky person who loves writing and wants to share my knowledge and understanding with you.