Frequently Asked Questions
Here you can find answers to the most common questions about STEQEYMA.
What is STEQEYMA?
STEQEYMA is a biosimilar of Stelara® (ustekinumab). Like Stelara, it is used to reduce inflammation from certain conditions, such as plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis, and moderately to severely active Crohn's disease. However, STEQEYMA may be more cost‑effective than Stelara.
What is a biosimilar?
STEQEYMA is a prescription biosimilar.
STEQEYMA is a biosimilar of Stelara®. Biosimilar means that:
- The biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product (known as a reference product)
- There are no clinically meaningful differences in how it works or in how safe it is compared to the reference product
A biosimilar is typically more affordable than the reference product.
Since STEQEYMA is a biosimilar of Stelara, it can be used instead of Stelara.
How is STEQEYMA for subcutaneous use provided?
STEQEYMA is provided as a single-dose, prefilled syringe with passive needle guard.
What should I know about injecting STEQEYMA?
STEQEYMA is administered as an injection under your skin (subcutaneously). Your healthcare provider will instruct you on how often to take your dose based on your condition. You or your caregiver will be shown how to prepare and inject STEQEYMA. Do not inject STEQEYMA without first receiving training from a healthcare provider and reviewing the instructions for use.
STEQEYMA is injected under your skin, in your upper arms, stomach area (abdomen), or upper legs (thighs). Do not give an injection in an area of the skin that is tender, bruised, red, or hard. Use a different injection site each time you use STEQEYMA.
What is the most important information I should know about STEQEYMA?
STEQEYMA is a medicine that affects your immune system. STEQEYMA can increase your risk of having serious side effects, including:
Serious infections. STEQEYMA may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have serious infections while taking ustekinumab products, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection.
- Your doctor should check you for TB before starting STEQEYMA
- If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with STEQEYMA and during treatment with STEQEYMA
- Your doctor should watch you closely for signs and symptoms of TB while you are being treated with STEQEYMA. You should not start taking STEQEYMA if you have any kind of infection unless your doctor says it is okay
Before starting STEQEYMA, tell your doctor if you:
- think you have an infection or have symptoms of an infection such as:
- fever, sweat, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning sensation when you urinate or urinating more than normal
- feeling very tired
- are being treated for an infection or have any open cuts.
- get a lot of infections or have infections that keep coming back.
- have TB, or have been in close contact with someone with TB.
After starting STEQEYMA, call your doctor right away if you have any symptoms of an infection.
Cancers. STEQEYMA may decrease the activity of your immune system and increase your risk for certain types of cancers. Tell your doctor if you have ever had any type of cancer. Some people who are receiving ustekinumab products and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with STEQEYMA, tell your doctor if you develop any new skin growths.
Posterior Reversible Encephalopathy Syndrome (PRES). PRES is a rare condition that affects the brain and can cause death. The cause of PRES is not known. If PRES is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including:
- headache
- confusion
- seizures
- vision problems
Be sure to review the Medication Guide carefully before starting STEQEYMA.
Speak with your doctor before you start your STEQEYMA injections. Use STEQEYMA exactly as your doctor tells you to.
It's also important to know do's and dont's of handling the device:
Do
Let the prefilled syringe stand outside the box for about 30 minutes at room temperature (68°F to 77°F) to allow it to warm up.
Check the expiration date on the carton and the label of the prefilled syringe.
Make sure you have the correct medicine and dosage.
Check the prefilled syringe to make sure it is not cracked or damaged.
Look at the medicine and confirm that the liquid is clear to slightly opalescent and colorless to pale yellow.
Don't
Do not warm the prefilled syringe using heat sources such as hot water or a microwave.
Do not use the injection if the expiration date has passed.
Do not use the injection if you are allergic to ustekinumab or any of the other ingredients of STEQEYMA.
Do not use the injection if you have an active infection which your doctor thinks is important.
Do not shake the prefilled syringes or use the injection if the medicine has been shaken strongly.
What happens if I miss a dose of STEQEYMA?
If you cannot inject STEQEYMA at your scheduled time or miss a dose, inject it as soon as possible. Then adjust your dosing schedule by the number of days you were late, keeping the same frequency your healthcare provider instructed. If you are unsure when to inject STEQEYMA, contact your healthcare provider.
What are the benefits of treatment with STEQEYMA?
In a clinical study of patients with plaque psoriasis, STEQEYMA was shown to be as effective as Stelara in reducing the severity of symptoms and decreasing the area affected.
STEQEYMA was studied in patients with plaque psoriasis, but STEQEYMA may be prescribed for all the same conditions Stelara is approved to treat.
What are the side effects of STEQEYMA?
STEQEYMA may cause serious side effects, including:
Serious allergic reactions. Serious allergic reactions can occur with STEQEYMA. Stop using STEQEYMA and get medical help right away if you have any of the following symptoms of a serious allergic reaction:
- feeling faint
- swelling of your face, eyelids, tongue, or throat
- chest tightness
- skin rash
Lung inflammation. Cases of lung inflammation have happened in some people who receive ustekinumab products, and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn’t go away during treatment with STEQEYMA.
Common side effects of STEQEYMA include:
- nasal congestion, sore throat, and runny nose
- redness at the injection site
- upper respiratory infections
- vaginal yeast infections
- fever
- urinary tract infections
- headache
- sinus infection
- tiredness
- bronchitis
- itching
- diarrhea
- nausea and vomiting
- stomach pain
These are not all of the possible side effects of STEQEYMA.
You should also review "What is the most important information I should know about STEQEYMA?" in the Medication Guide.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Celltrion USA, Inc. at 1-800-560-9414.
FDA, Food and Drug Administration.
How should I store STEQEYMA?
Store STEQEYMA prefilled syringes in a refrigerator at 36°F to 46°F. If needed, you may store STEQEYMA at room temperature at 86°F for up to 15 days. Once STEQEYMA has been stored at room temperature, it should not be placed back into the refrigerator. Throw away (discard) STEQEYMA if not used within the 15 days. Store STEQEYMA vials standing up straight. Do not freeze STEQEYMA. Be sure not to shake STEQEYMA. Keep STEQEYMA in the original carton until ready to use in order to protect it from light. Keep STEQEYMA and all medicines out of the reach of children.