Stelara (ustekinumab) is an immunosuppressant that reduces the effects of a chemical substance in the body that can cause inflammation.
Stelara is used in adults to treat plaque psoriasis or psoriatic arthritis.
Stelara is sometimes given with another medicine called methotrexate.
Important information
You should not use Stelara if you have received a BCG (Bacillus Calmette and Guérin) vaccine within the past 12 months.
Serious infections may occur during treatment with Stelara. Call your doctor right away if you have signs of infection such as: fever, chills, muscle pain, shortness of breath, weight loss, diarrhea or stomach pain, burning when you urinate, feeling very tired, skin warmth or redness, painful skin sores, or coughing up blood.
Before using this medicine
You should not use Stelara if you are allergic to ustekinumab, or if you have:
Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.
To make sure Stelara is safe for you, tell your doctor if you have:
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signs of infection (fever, chills, cough, muscle aches, diarrhea, pain when you urinate, feeling very tired);
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a history of chronic infections;
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a latex allergy;
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new or changing lesions on your skin;
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if you are scheduled to receive any vaccine;
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if you have ever received phototherapy (light therapy); or
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if you have ever received allergy shots or used an Epi-Pen (for severe allergic reaction).
Some people using Stelara have developed skin cancer (non-melanoma). However, these people may have had a higher risk of skin cancer. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.
This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Stelara on the baby.
Ustekinumab can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
How should I use Stelara?
Before you start treatment with Stelara, your doctor may perform tests to make sure you do not have tuberculosis or other infections.
Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Stelara is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.
Stelara is usually given every 12 weeks, but your first two injections will be 4 weeks apart. Follow your doctor"s instructions.
Your care provider will show you the best places on your body to inject Stelara. Use a different place each time you give an injection. Do not inject into the same place two times in a row. Avoid injecting the medicine into skin that is red, bruised, swollen, or tender.
Call your doctor if you have any signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling constantly tired.
While using Stelara, you will need frequent blood tests at your doctor"s office.
You must remain under the care of a doctor while you are receiving Stelara.
Each prefilled syringe or single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
Store in the refrigerator, do not freeze. Protect from light. Store the Stelara vials in an upright position.
Stelara dosing information
Usual Adult Dose of Stelara for Psoriasis:
For use in the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy:
100 kg (220 lbs) or less:
Initial dose: 45 mg subcutaneously once initially and 4 weeks later
Maintenance dose: 45 mg subcutaneously once every 12 weeks
Greater than 100 kg (220 lbs):
Initial dose: 90 mg subcutaneously once initially and 4 weeks later
Maintenance dose: 90 mg subcutaneously once every 12 weeks
In subjects weighing greater than 100 kg, 45 mg was also shown to be effective. However, 90 mg resulted in greater efficacy.
The safety and efficacy of ustekinumab have not been evaluated beyond two years.
Usual Adult Dose of Stelara for Psoriatic Arthritis:
Initial dose: 45 mg subcutaneously once initially and 4 weeks later
Maintenance dose: 45 mg subcutaneously once every 12 weeks
For patients with co-existent moderate-to-severe plaque psoriasis weighing greater than 100 kg (220 lbs):
Initial dose: 90 mg subcutaneously once initially and 4 weeks later
Maintenance dose: 90 mg subcutaneously once every 12 weeks
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Stelara injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Stelara?
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
Do not receive a "live" vaccine while using Stelara, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
BCG vaccine should not be given for at least 1 year after you receive your last dose of Stelara.
Non-live vaccines (including flu shots) may not work as well during your treatment, and may not fully protect you from disease. Make sure you are current on all vaccines before you begin treatment with Stelara.
Stelara side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Stelara: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Serious infections may occur during treatment with Stelara. Call your doctor right away if you have signs of infection such as: fever, chills, muscle pain, shortness of breath, weight loss, diarrhea or stomach pain, burning when you urinate, feeling very tired, skin warmth or redness, painful skin sores, or coughing up blood.
Also call your doctor at once if you have:
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a mole that has changed in size or color;
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swelling, pain, warmth, or redness anywhere on your body;
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stomach pain that is sudden and severe or comes on slowly, changes in bowel habits (diarrhea or constipation);
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stabbing chest pain, wheezing, cough with yellow or green mucus; or
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severe headache, confusion, change in mental status, vision problems, and/or seizure (convulsions).
Common Stelara side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Stelara?
Other drugs may interact with ustekinumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
