Stelara infusion: What to expect

In this article:

• How to prepare for your first Stelara (ustekinumab) infusion
• What to expect during your Stelara infusion
• What to expect after your Stelara infusion
• Serious Stelara infusion side effects
• Stelara vs. Wezlana
• Stelara maintenance injections

In this article

• How to prepare for your first Stelara (ustekinumab) infusion
• What to expect during your Stelara infusion
• What to expect after your Stelara infusion
• Serious Stelara infusion side effects
• Stelara vs. Wezlana
• Stelara maintenance injections

Stelara is an injectable prescription medication used to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It works on proteins that affect the immune system, which helps improve symptoms such as inflammation. Made by the pharmaceutical company Janssen Biotech, Inc., this medication is available as an intravenous (IV) solution and a subcutaneous (under the skin) injection. According to the prescribing information, people taking Stelara for moderately to severely active Crohn’s disease or ulcerative colitis will begin treatment with a one-time IV infusion (through a vein in the arm) over at least one hour, which is administered by a healthcare provider in a healthcare setting. 

How to prepare for your first Stelara (ustekinumab) infusion

Your healthcare provider will advise you when and where to arrive for your Stelara IV infusion. You can ask your healthcare provider how long the appointment will take. The medication is infused over at least one hour. However, you may be asked to arrive early to prepare for your infusion or stay later to be observed for side effects. 

In clinical trials, a small number of people experienced dizziness as a side effect of Stelara. You may want to have a family member, caregiver, or friend drive you to and from your appointment in case you experience dizziness or other side effects. 

As an immunosuppressive medicine, Stelara affects the immune system, which increases the risk of infections, including serious infections that require hospitalization. Before starting Stelara, your healthcare provider will check you for tuberculosis (TB). Before or during treatment, let them know if you have any symptoms of infection, such as:

• Fever or chills
• Muscle aches
• Cough
• Difficulty breathing
• Blood in the phlegm
• Weight loss
• Red, warm, or painful skin or sores on the body
• Diarrhea
• Stomach pain
• Fatigue
• Burning when you urinate
• Urinating more frequently

Before you start treatment with Stelara, tell your healthcare provider about your medical conditions and medical history, including if you are pregnant or breastfeeding. Tell your provider about all the medications you take, especially if you take blood thinners, corticosteroids, or any drugs that affect the immune system. 

What to expect during your Stelara infusion

At your appointment, a healthcare professional will administer your one-time Stelara infusion. This is called an induction dose. The first dose is given this way, and the following doses are given by injection under the skin, starting eight weeks after the infusion. 

The infusion is given through a vein in the arm. A healthcare professional will administer the appropriate dose based on your body weight, and they will make sure you are comfortable throughout the process. It will take at least one hour to receive the full dose of medication, so you may want to plan something to help pass the time, such as reading a book or watching a TV show on your phone.

You will not be put to sleep during the procedure, so you can stay awake (or choose to nod off on your own). 

While getting the infusion, tell your healthcare provider immediately if you have symptoms of an allergic reaction or hypersensitivity reaction such as itching, hives, shortness of breath, difficulty swallowing, feeling faint, or swelling of the face, lips, tongue, or throat. 

What to expect after your Stelara infusion

You may start to notice an improvement in symptoms as soon as three weeks after your infusion. 

By week six, 56% of people in clinical studies where Stelara was their first biologic medication experienced symptom relief. About 34% of people who had previously taken a different biologic drug without improvement experienced improvement with Stelara after six weeks.

Studies have shown that 53% of the people who responded to the initial IV infusion and continued with subcutaneous injections every eight weeks were in remission at the one-year mark. 

After your infusion, you may experience some side effects. Common possible side effects of Stelara include:

• Stuffy or runny nose
• Sore throat
• Upper respiratory infection
• Fever
• Headache
• Tiredness
• Itching
• Nausea
• Vomiting
• Diarrhea 
• Stomach pain
• Vaginal yeast infections
• Urinary tract infections
• Sinus infections
• Bronchitis

Before taking Stelara, you can talk with your healthcare provider about side effects and what to do if you experience them. For example, you’ll need to notify your healthcare provider right away if you have any symptoms of infection.

While you are on Stelara, you should not receive live vaccines, including MMR, varicella, rotavirus, nasal flu vaccine, or the Bacillus Calmette–Guérin (BCG) vaccine, which is used to prevent TB in high-risk people in some countries. 

Serious Stelara infusion side effects

There are also potential serious side effects associated with the use of Stelara, including:

• Severe infections – Stelara can increase your risk of infections, including bacterial, fungal, or viral infections. While taking Stelara, notify your healthcare provider of any signs or symptoms of infection. They may also test you for infections during the course of your treatment. 
• Malignancies – Stelara may increase the risk of certain types of cancer, such as skin cancer. Consult your healthcare provider right away if you notice any skin changes or skin growths.
• Allergic reactions – Get emergency medical help if you have hives, trouble breathing or swallowing, or swelling of the face, lips, tongue, or throat.
• Posterior reversible encephalopathy syndrome – PRES is a rare brain condition that can cause death. However, if PRES is discovered early and treated, most people will recover. Immediately let your healthcare provider know if you have headaches, confusion, vision problems, or seizures.

Stelara vs. Wezlana

In October 2023, the Food and Drug Administration (FDA) approved Wezlana, which is an interchangeable biosimilar to Stelara. To explain further:

• As a biologic drug, Stelara is made from natural sources and the use of biotechnology. The way brand name drugs have generic equivalents, biologic drugs may have biosimilars. According to the FDA, “a biosimilar is a biologic drug that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product).” 
• An interchangeable biosimilar is a drug that meets not only the requirements of a biosimilar but also additional requirements that allow pharmacies to substitute it for its reference product, as allowed by state law. So, if your healthcare provider writes a prescription for Stelara, the pharmacy may give you Wezlana because it is an interchangeable biosimilar.

Wezlana is expected to be available no later than Jan. 1, 2025. The table below contains information about Stelara and Wezlana.

 

Stelara vs. Wezlana comparison
	Stelara	Wezlana
Drug class	Interleukin 12 and interleukin 23 antagonist; monoclonal antibody	Interleukin 12 and interleukin 23 antagonist; monoclonal antibody
FDA-approved uses	Moderate to severe plaque psoriasis in adults and children 6 years and older, who are candidates for phototherapy or systemic therapy Active psoriatic arthritis in adults and children 6 years and older Adults with moderate to severe Crohn’s disease  Adults with moderately to severely active ulcerative colitis	Moderate to severe plaque psoriasis in adults and children 6 years and older, who are candidates for phototherapy or systemic therapy Active psoriatic arthritis in adults and children 6 years and older Adults with moderate to severe Crohn’s disease  Adults with moderately to severely active ulcerative colitis
Brand/generic/biosimilar status	Brand (reference product)	Biosimilar
What form(s) does the drug come in?	Vials for IV infusion Prefilled syringes for injection	Vials for IV infusion Prefilled syringes for injection
What is the standard dosage?	Varies by indication, age, and weight	Varies by indication, age, and weight
How long is the typical treatment?	Varies; at least one year	Varies; at least one year
Who typically uses the medication?	Crohn’s disease or ulcerative colitis: adults Plaque psoriasis or psoriatic arthritis: Adults and children 6 years and older	Crohn’s disease or ulcerative colitis: adults Plaque psoriasis or psoriatic arthritis: Adults and children 6 years and older
Average cost	Varies by dosage: One 90 ml syringe costs $36,060 without insurance	Pricing not yet available

 

Stelara maintenance injections

Although the first dose of Stelara for Crohn’s disease or ulcerative colitis will be by IV infusion in a healthcare setting, the maintenance doses that follow are administered by subcutaneous injection (a shot under the skin). 

After the one-time infusion, you will inject Stelara every eight weeks. Although the first infusion will take at least one hour, the subcutaneous injections are quick shots injected into either the stomach, thigh, buttock, or upper arms. Your healthcare provider can administer the injections for you in the office or train you or your caregiver on how to self-inject the shot at home. There are a total of six injections in one year. 

Here is an example schedule:

• January 10: First dose—IV infusion in a healthcare setting (induction dose)
• March 10: Second dose—subcutaneous injection (maintenance dose)
• May 10: Third dose—subcutaneous injection (maintenance dose)
• July 10: Fourth dose—subcutaneous injection (maintenance dose)
• September 10: Fifth dose—subcutaneous injection (maintenance dose)
• November 10: Sixth dose—subcutaneous injection (maintenance dose)

The side effects of the maintenance injections will likely be similar to the side effects of the IV infusion. Some people have injection site reactions, such as redness, pain, swelling, itching, bleeding, bruising, or irritation.