What Is Stelara?
Stelara (ustekinumab) is a prescription medication used for the treatment of moderate to severe psoriasis (an inflammatory skin disease that causes itchy, red, scaly patches) and inflammatory bowel diseases (IBD, which includes Crohn’s disease and ulcerative colitis). It contains ustekinumab, which is both an immunosuppressant drug (suppresses the immune system) and a monoclonal antibody (a type of cell that finds and fights diseases).
Ustekinumab reduces the activity of inflammation-causing proteins that cause symptoms of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It does this by attaching to specific proteins called interleukin-12 (IL-12) and interleukin-23 (IL-23). This results in less inflammation, fewer symptoms, and improvement in your condition.
Stelara is a prescription medicine available as an injectable solution.
Generic Name: Ustekinumab
Brand Name(s): Stelara
Drug Availability: Prescription
Therapeutic Classification: Immunosuppressant, Monoclonal antibodies
Available Generically: No
Controlled Substance: N/A
Administration Route: Subcutaneous or intravenous
Active Ingredient: Ustekinumab
Dosage Form(s): Solution
What Is Stelara Used For?
The Food and Drug Administration (FDA) approved Stelara (ustekinumab) to treat:
- Moderate to severe plaque psoriasis in adults and children aged six years and older who may benefit from phototherapy (light therapy) or systemic therapy (drugs).
- Psoriatic arthritis as a monotherapy (one drug used by itself) or in combination with methotrexate.
- Moderate to severe Crohn’s disease (an IBD that affects all layers of the bowel wall anywhere in the digestive tract) in adults whose treatment with immunomodulators or corticosteroids wasn’t successful, but whose treatment with tumor necrosis factor (TNF) blockers has been successful. It’s also used in people who can’t tolerate TNF blockers or whose treatment with TNF blockers hasn’t been successful.
- Ulcerative colitis (an IBD affecting the inner lining of the large intestine and rectum)
How to Take Stelara?
Read the prescription label carefully before using Stelara. If you don’t understand anything, ask your pharmacist or healthcare provider.
Stelara comes as a solution. It can be injected subcutaneously (under your skin) or intravenously (into your veins).
For plaque psoriasis and psoriatic arthritis: The first two doses are injected subcutaneously (under your skin) every four weeks and then every 12 weeks for as long as your treatment continues.
For Crohn’s disease and ulcerative colitis: The first dose is injected intravenously and then administered subcutaneously every eight weeks for the rest of your treatment.
Your healthcare provider may give the first dose in their office to assure that it’s safe and to teach you how to give yourself injections. After that, you or someone else can give you injections at home. Always read the manufacturer’s label and follow the guidelines.
Points to keep in mind when taking this medicine:
- Take Stelara doses regularly to get the most benefit from the treatment.
- If using a prefilled syringe or vial, use each syringe or vial only once and inject all the solution in the syringe.
- Always check the solution for clarity before use. The drug solution should be clear or slightly yellow and contain few visible white particles.
- Clean the area of your skin where you plan to inject your medication (for example, with rubbing alcohol).
- Dispose of the injector in a puncture-resistant container.
- Inject Stelara subcutaneously on the front of your thighs, upper outer arms, buttocks, or abdomen (stomach area).
- Don’t inject Stelara in your navel or 2 inches around it.
- Don’t use a damaged or expired product.
- Don’t reuse the syringe even if there is still some solution left in the syringe.
- Don’t inject if the solution is very cloudy or has large particles.
- Don’t inject at the same site (which helps prevent bruising).
- Don’t inject on tender, bruised, red, or hard skin or skin with scars or stretch marks.
- Don’t shake a prefilled Stelara syringe or vial.
- Don’t discontinue your injections without discussing with your healthcare provider first.
Store Stelara in a refrigerator (between 36 and 46 degrees Fahrenheit). Do not freeze. Keep the vials and prefilled syringes in their original cartons to protect them from light. Keep all medications out of sight and reach of children and pets. Always lock safety caps to avoid accidental poisoning.
Discard unwanted or expired medications. However, don’t dispose of medicines by flushing them down the toilet or throwing them in the trash. The best way to discard unwanted medication is through a medicine take-back program. Talk to your pharmacist or contact your local waste disposal department to learn more.
Stelara has been used off-label for various conditions, such as:
- Hidradenitis suppurativa (a condition causing small, painful lumps to form under the skin)
- Takayasu arteritis (a form of vasculitis characterized by inflammation of vessels)
- Giant cell arteritis (inflammation of the lining of arteries)
- Behcet’s disease (a disease causing inflammation of blood vessels throughout the body)
- Myelodysplastic syndrome (a type of cancer with decreased number of healthy blood cells)
- Pyoderma grangrenosum (a disease causing sores on the skin, usually on the legs)
- Pityriasis rubra pilaris (a rare disease causing inflammation of the skin)
- SAPHO syndrome (synovitis, synovial membrane inflammation; acne pustulosis, an inflammatory skin condition; hyperostosis, bone tissue thickening; and osteitis, bone inflammation)
- Lichen planus (inflammation on the inside of the mouth)
- Atopic dermatitis (causing red, itchy skin)
- Systemic lupus erythematosus (SLE, the most common type of lupus, an autoimmune disease that can cause pain, rashes, mouth sores, and fatigue)
Ask your healthcare provider before taking Stelara for any condition. Do not use it for conditions other than those prescribed by your healthcare provider.
How Long Does Stelara Take to Work?
Stelara works in different ways for different people. Some people start to feel an improvement within three weeks. In others, it could take six weeks to show full effects.
What Are the Side Effects of Stelara?
This is not a complete list of side effects, and others may occur. A medical professional can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 800-FDA-1088.
Common Side Effects
Stelara may cause the following side effects:
- Runny, stuffy nose, or sneezing
- Vomiting after first starting treatment for IBD
- Injection site erythema (swelling and redness at the site of your Stelara injection)
- Abdominal pain, fever, influenza, and diarrhea while used for maintenance therapy in IBD
- Back pain
- Joint pain
These side effects usually go away and don’t require medical attention. If symptoms worsen, call your healthcare provider.
Severe Side Effects
Some side effects can be severe and require immediate medical attention. Stelara may weaken your immune system and increase your risk of infections due to a possible decreased ability in your body to fight against bacterial and fungal infections. Possible infections include:
Stelara may also cause other adverse reactions such as:
- Nonmelanoma skin cancer (types of skin cancer that aren’t melanoma)
- Hypersensitivity reactions (chest tightness, difficulty breathing, itching, rash, redness, and swelling)
- Reversible posterior leukoencephalopathy syndrome (brain disease with vision changes, confusion, and seizures)
- Pustular psoriasis (psoriasis with pus-filled blisters) and erythrodermic psoriasis (a rare form of psoriasis that causes a peeling rash over the entire body)
If you have these symptoms, immediately contact your healthcare provider or seek medical help.
Report Side Effects
Stelara may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
Dosage: How Much Stelara Should I Take?
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The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For injection dosage form (prefilled syringe):
For Crohn’s disease and ulcerative colitis:
- Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 260 to 520 milligrams (mg) injected into your vein as a single dose (vial). After 8 weeks, a maintenance dose of 90 mg is injected under your skin as a single dose, then every 8 weeks after (prefilled syringe).
- Children—Use and dose must be determined by your doctor.
For plaque psoriasis:
Adults—Dose is based on body weight and must be determined by your doctor.:
- Weighing more than 100 kilograms (kg)—At first, 90 milligrams (mg) injected under your skin as a single dose, and then one dose (90 mg) after 4 weeks, followed by 90 mg every 12 weeks.
- Weighing 100 kg or less—At first, 45 mg injected under your skin as a single dose, and then one dose (45 mg) after 4 weeks, followed by 45 mg every 12 weeks.
Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor:
- Weighs more than 100 kilograms (kg)—90 milligrams (mg) at Weeks 0 and 4, then every 12 weeks after.
- Weighs 60 kg to 100 kg—45 mg at Weeks 0 and 4, then every 12 weeks after.
- Weighs less than 60 kg—0.75 mg per kg body weight at Weeks 0 and 4, then every 12 weeks after.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- Adults—Dose is based on body weight and must be determined by your doctor.:
For psoriatic arthritis:
- Adults—At first, 45 milligrams (mg) injected under your skin as a single dose, and then one dose (45 mg) after 4 weeks, followed by 45 mg every 12 weeks.
- Children—Use and dose must be determined by your doctor.
- For Crohn’s disease and ulcerative colitis:
- Children under 6 years of age with plaque psoriasis: Not enough is known about the safety and effectiveness of Stelara in children under 6 years of age with plaque psoriasis.
- Children with Crohn’s disease or ulcerative colitis: Not enough is known about the safety and effectiveness of Stelara in children with Crohn’s disease or ulcerative colitis.
- Pregnancy and breastfeeding: The safety of Stelara in pregnant and breastfeeding people is not known. More clinical research is needed to confirm safe use during pregnancy. This drug should be used only if the benefits to the pregnant parent outweigh the risks to the pregnant parent and unborn fetus.
- Adults over 65 years of age: In clinical studies, people above 65 years of age haven’t responded differently to Stelara than younger adults.
Take Stelara as scheduled by your healthcare provider. Call your healthcare provider for a new dosing schedule if you miss a dose. Do not take an additional dose to make up for the missed one.
Overdose: What Happens If I Take Too Much Stelara?
In case of an overdose of Stelara, seek immediate medical help.
What Happens If I Overdose on Stelara?
If you think you or someone else may have overdosed on Stelara, call a healthcare provider or the Poison Control Center (800-222-1222).
If someone collapses or isn’t breathing after taking Stelara, call 911 immediately.
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It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious infections (eg, bacteria, fungus, virus). Check with your doctor right away if you have stomach pain, fever, itching, pain or redness of the skin, indigestion, nausea, vomiting, chills, confusion, dizziness, fast heartbeat, bone pain, diarrhea, loss of appetite, weakness, bleeding in the eye, blurred vision, trouble breathing, tightness in the chest, sneezing, or cough.
You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test or been exposed to tuberculosis.
This medicine may increase your risk of getting some forms of cancer (eg, non-melanoma skin cancer). This is more likely to occur if you are over 60 years of age or if you are receiving PUVA therapy (psoralen and ultraviolet A treatment) or medicines that weaken the immune system (eg, steroids) in the past. Talk to your doctor about this risk if you have concerns.
This medicine may cause serious types of allergic reactions, including anaphylaxis and angioedema. These can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after receiving the medicine.
Check with your doctor if you have headache, seizures, confusion, or blurred vision or other visual problems. These may be symptoms of a rare and serious condition called posterior reversible encephalopathy syndrome (PRES) or reversible posterior leukoencephalopathy syndrome (RPLS).
This medicine may cause non-infectious pneumonia (eg, interstitial pneumonia, eosinophilic pneumonia, cryptogenic organizing pneumonia). Check with your doctor right away if you have chest pain, cough, fever or chills, sneezing, sore throat, trouble breathing, or tightness in the chest.
The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start receiving this medicine.
While you are being treated with ustekinumab and after you stop treatment with it, do not have any immunizations (especially live vaccines) without your doctor’s approval. Ustekinumab may lower your body’s resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, the other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also avoid persons who have recently taken oral polio vaccine. Do not get close to them or stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective mask that covers the nose and mouth. Tell your doctor if you have received a BCG vaccine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
What Are The Reasons I Should Not Take Stelara?
It’s not safe to use Stelara if:
- You’re hypersensitive to the ingredient ustekinumab or any of Stelara’s other ingredients.
- You’re allergic to rubber or latex. Talk to your pharmacist or read the medication guide.
- You’ve had a severe infection like tuberculosis (TB). Stelara can increase your disease risk. You may need a TB test before starting your treatment. Don’t use Stelara if you have an active case or a latent (very low amount of bacteria in the body) case of TB.
What Other Drugs Interact With Stelara?
Stelara may interact with some drugs.
Avoid the use of live vaccines to avoid serious infections. These include:
If you’re taking Stelara with other medicines, you and your healthcare provider will carefully monitor how you’re doing. Your healthcare provider may also change your dose to avoid side effects. Mention to your healthcare provider if you’re taking the following:
Stelara may increase the risk of developing an allergic reaction to a dose of allergen immunotherapy, a type of allergy treatment. Use caution when using Stelara while receiving allergen immunotherapy.
What Medications Are Similar?
Current psoriasis treatment options include topical, phototherapy (light therapy), oral immunosuppressive agents (medicines that decrease your body’s immune response), and biologic agents (medicines made from a biological source).
Newer drugs like monoclonal antibodies have been effective for treating psoriasis symptoms. Monoclonal antibody drugs – other than Stelara – that treat different kinds of psoriasis are:
The clinical benefits of these drugs for psoriasis are well-established. However, you and your healthcare provider will determine the best medicine for you. Don’t switch brands, and always discuss your priorities with your healthcare provider.
Frequently Asked Questions
What is Stelara?
Stelara contains ustekinumab (an immunosuppressant monoclonal antibody). The FDA has approved Stelara to treat plaque psoriasis in adults and children aged 6 years and older, as well as psoriatic arthritis, Crohn’s disease, and ulcerative colitis in adults.
How does Stelara work?
Stelara is an immunosuppressant drug that decreases the activity of the immune system and results in less inflammation. It blocks the action of inflammation-causing proteins by attaching to specific receptors (interleukin-12 (IL-12) and interleukin-23 (IL-23)).
Why should I not take live vaccines during treatment with Stelara?
Stelara weakens the immune system. Taking live vaccines during Stelara treatment can put you at risk of developing an infection. It is important to have all of the vaccines you need before starting Stelara treatment. This includes both live and non-live vaccines.
Can Stelara weaken the immune system?
Stelara may weaken the immune system and increase the risk of developing an infection, meaning possibly getting sinus, lung, joint, bowel, and skin infections more easily. Stelara is meant to treat diseases caused by an overactive immune system. Since it decreases the immune response, it reduces the immune system’s ability to fight off infections.
How Can I Stay Healthy While Taking Stelara?
The management of psoriasis and inflammatory bowel disease is complex and can be expensive. The use of monoclonal antibodies like Stelara (ustekinumab) can be a part of treating these disorders. However, monoclonal antibodies are immunosuppressants, meaning they decrease the immune system’s response which can increase your risk of infections (like human immunodeficiency virus, or HIV; TB; hepatitis, and others).
Take all age-recommended vaccines before starting Stelara treatment to avoid side effects. One exception, however, is the bacille Calmette-Guerin (BCG) vaccine for TB, which must not be used one year before or after the therapy with Stelara.
People treated with Stelara should maintain a regular clinical checkup routine or clinical follow-up tests such as complete blood count, liver function tests, inflammatory markers, and TB screening tests. Always follow the prescription and maintain a regular dosing schedule to get the desired therapeutic effects from the medicine.
There is limited data on the use of Stelara in pregnant or breastfeeding people and people over age 65. Talk with your healthcare provider about your treatment options and any questions that you may have.
Individuals with inflammatory bowel disease may also benefit from working with a registered dietitian (RD) or registered dietitian nutritionist (RDN). Dietitians can help you explore possible food triggers, and support building healthier habits through food, movement, medication and more. Speak with your healthcare provider about connecting with a dietitian.
Verywell Health’s drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare professional. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.