What is Stelara used for?
Stelara (ustekinumab) is a biologic medication that lowers your immune system response to treat several inflammatory conditions. It is given as a subcutaneous injection in your upper arms, buttocks, thighs, or abdomen. For certain conditions, your healthcare provider may administer the first dose by intravenous infusion. Stelara is FDA-approved to treat adults with:
- Moderate to severe plaque psoriasis (Ps) in candidates for phototherapy or systemic therapy. Plaque psoriasis appears as raised, red patches covered by silvery-white scales, typically on the scalp, trunk, knees, and elbows.
- Active psoriatic arthritis (PsA), causing joint pain and swelling at tendon and ligament attachments. Stelara may be used alone or with methotrexate.
- Moderate to severe active Crohn’s disease (CD), an inflammatory bowel disease causing digestive tract inflammation, pain, diarrhea, weight loss, and malnutrition.
- Moderate to severe active ulcerative colitis (UC), an inflammatory bowel disease with inflammation and ulcers in the large intestine lining.
Stelara is also approved for pediatric patients aged 6 years and older with moderate to severe plaque psoriasis or active psoriatic arthritis.
Stelara FAQs
How Does Stelara Work?
Stelara is a monoclonal antibody that binds to interleukin‑12 (IL‑12) and interleukin‑23 (IL‑23), proteins that drive inflammation. By blocking these cytokines, Stelara reduces inflammation and calms the immune system.
How Do You Use Stelara?
Your healthcare provider determines your dose. Adults with Crohn’s disease or ulcerative colitis receive the first dose by IV infusion, then subcutaneous injections every eight weeks. Adults and children (6 years and older) with psoriasis or psoriatic arthritis administer subcutaneous injections in the buttocks, upper arms, thighs, or abdomen. Injection training is provided by your healthcare team. Rotate sites and avoid red, bruised, tender, or hardened skin.
What Drug Interactions Are There?
Stelara may alter how other medications work or increase side effects. Inform your provider of all prescription drugs, OTC medications, vitamins, and supplements. Notable interactions include warfarin, cyclosporine, and live vaccines (e.g., BCG vaccine).
What Are the Possible Side Effects?
Common side effects seen in trials include:
- Runny or stuffy nose, sore throat
- Sinus infection, upper respiratory tract infection, bronchitis
- Headache, tiredness, itchiness, vomiting, nausea
- Injection site reactions
- Vaginal yeast infections, urinary tract infections
Other possible side effects:
- Diarrhea, dizziness, back pain, depression, muscle pain
Rare serious side effects may include:
- Severe allergic reactions (hives, facial or throat swelling, shortness of breath)
- Increased risk of serious infections (e.g., tuberculosis)
- Increased risk of certain cancers, including skin cancer
- Neurological effects such as posterior reversible encephalopathy syndrome (PRES)
Contact your healthcare provider for medical advice and report adverse effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Who Should Not Take Stelara?
Avoid Stelara if you have an allergy to ustekinumab or any inactive ingredients in its formulation.
What Should You Tell Your Healthcare Provider?
Before starting Stelara, inform your provider if you have:
- A latex allergy (the syringe cover contains latex)
- Upcoming or recent vaccinations (avoid live vaccines while on Stelara)
- New or changing psoriatic lesions
- Ongoing allergy shots (may be less effective and higher risk of reaction)
- Received phototherapy
- Pregnancy or plans to become pregnant
- Breastfeeding or plans to breastfeed
How Long Does Stelara Take to Work?
For Crohn’s disease, symptom relief often occurs by 6 weeks after one IV dose, with some noticing improvement by 3 weeks. Many patients maintain remission at 1 year. For ulcerative colitis, most achieve relief by 8 weeks, 20% reach complete remission, and 40% remain in remission at 1 year; 70% have no rectal bleeding by 2 years. In plaque psoriasis, 70% achieve 75% clearer skin by 12 weeks, 60% have minimal plaques by 12 weeks, and 80% maintain results at 2 years. In psoriatic arthritis, about 50% see a 20% improvement in joint symptoms after 24 weeks. Individual results may vary.
Does Stelara Lower Your Immune System?
Yes. Stelara can increase infection risk. Practice good hygiene and avoid contact with sick individuals. Notify your provider if you develop infection signs.
How Do You Store Stelara?
Store prefilled syringes and vials refrigerated at 36°F to 46°F (2°C to 8°C) in their original carton, upright. Do not freeze or shake. You may store syringes at room temperature (up to 86°F/30°C) for up to 30 days; record the date removed. Discard if returned to the refrigerator or after 30 days. Keep out of reach of children.
Related Medications
- Humira (adalimumab)
- Cosentyx (secukinumab)
- Dupixent (dupilumab)
- Fasenra (benralizumab)
- Nucala (mepolizumab)