Stelara

ustekinumab

Stelara (ustekinumab) is an expensive drug used to treat plaque psoriasis, psoriatic arthritis and ulcerative colitis. This medicine is also used to treat Crohn's disease. It is not a cure. This drug is more popular than comparable drugs. There are currently no generic alternatives to Stelara.

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Avg. retail price

$49,410.30/mo

Lower your copay to

$15-$20/mo

What is Stelara (ustekinumab)?

Common Brands

Stelara

Drug Class

IL-12 and IL-23 antagonist

Controlled Substance Classification

Not a controlled medication

Manufacturer

Janssen Biotech, Inc.

Generic Status

No lower-cost generic available

Availability

Prescription only

How Stelara (ustekinumab) works

Stelara (ustekinumab) is an interleukin antagonist. It blocks proteins in your immune system called interleukin-12 (IL-12) and interleukin-23 (IL-23) from working. This helps to lower inflammation and treat symptoms caused by autoimmune conditions.

What is Stelara (ustekinumab) used for?

  • Moderate-to-severe plaque psoriasis (Ps) in adults and children ages 6 years and older.

  • Psoriatic arthritis (PsA) in adults and children ages 6 years and older.

  • Moderate-to-severe Crohn's disease (CD) in adults.

  • Moderate-to-severe ulcerative colitis (UC) in adults.

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Average copay is $15-$20/mo.

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What are the side effects of Stelara (ustekinumab)?

Contact your healthcare provider immediately if you experience any of the following.

Serious infection: fever, cough, weight loss, muscle aches, dark urine, chills, vomiting.

Severe allergic reaction: rash; trouble breathing; swelling of your face, eyes, lips, or mouth; hives.

Posterior reversible encephalopathy syndrome (PRES): headache, feeling sluggish or confused, vision changes, seizure.

Swelling in the lungs: trouble breathing, cough.

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

Plaque Psoriasis

Inflammation of the nasal passages (7-8%)

Upper respiratory tract infection (4-5%)

Headache (5%)

Psoriatic Arthritis

Joint pain (3%)

Nausea (3%)

Crohn's Disease

Inflammation of the nasal passages (11%)

Redness at the injection site (5%)

Yeast infection (5%)

Bronchitis (5%)

Ulcerative Colitis

Inflammation of the nasal passages (24%)

Headache (10%)

Stomach pain (7%)

Flu infection (6%)

Fever (5%)

Other Side Effects

Dizziness

Diarrhea

Back pain

Muscle pain

Depression

Sore throat

Itchiness

Vomiting

Urinary tract infection

Source: DailyMed

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Pros and cons of Stelara (ustekinumab)

Pros

Isn't injected as often as other similar medications.

Comes as a prefilled syringe for easier home administration.

Can be stored at room temperature up to 30 days.

Can be used in children as young as 6 years old.

Cons

Can weaken your immune system and raise your risk of infection.

Potential to cause serious allergic reactions.

For CD and UC, the first dose must be given as an IV infusion.

Can't receive live vaccines while taking this medication.

Need help paying for Stelara?

Average copay is $15-$20/mo.

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Pharmacist Tips for Stelara (ustekinumab)

  • Mark your injection dates on a calendar. Stelara (ustekinumab) isn't injected that often, so it can be hard to remember when your doses are scheduled.

  • Inject Stelara (ustekinumab) into your stomach area, buttocks, thighs, or outer area of the upper arm. Rotate the site of injection with each dose to avoid any irritation.

  • Let your provider know if you have a latex allergy. The needle cover of the Stelara (ustekinumab) prefilled syringe contains latex.

  • Make sure you know how to properly inject Stelara (ustekinumab). Read the instructions for use to help you. Ask your provider or pharmacist if you have further questions.

  • Because Stelara (ustekinumab) can potentially weaken your immune system, it raises your risk for an infection. Let your provider know right away if you experience symptoms such as fever, chills, muscle aches, diarrhea, or fatigue.

  • Store Stelara (ustekinumab) in its original container in the refrigerator. But it can also be left at room temperature up to 30°C (86°F) for up to 30 days as long as it remains in the original carton. After that, it should be thrown away. Once Stelara (ustekinumab) has warmed up to room temperature, don't put it back in the fridge.

Frequently asked questions about Stelara (ustekinumab)

Is Stelara (ustekinumab) a biologic?

Yes. Stelara (ustekinumab) is considered a biologic medication. Biologic medications are made from living sources, like cells or proteins.

Is Stelara (ustekinumab) an immunosuppressant?

Yes, Stelara (ustekinumab) can be considered an immunosuppressant since it can weaken your immune system. This medication works by blocking certain proteins in your immune system, which treats certain autoimmune conditions by lowering inflammation. But doing so also weakens your immune system and can raise your risk for infections.

Does Stelara (ustekinumab) cause weight gain?

Stelara (ustekinumab) doesn't appear to cause weight gain. In clinical studies, people taking Stelara (ustekinumab) didn't report weight gain. Speak with your provider if you experience unusual weight changes while you're taking this medication.

How long can you stay on Stelara (ustekinumab)?

This will be different for everyone. Keep in mind that Stelara (ustekinumab) doesn't cure certain autoimmune conditions, it only treats the symptoms. While there's no set time limit for how long you can use Stelara (ustekinumab), it's important to have regular discussions with your provider to make sure that this medication is still right for you.

How long does it take for Stelara (ustekinumab) to work?

It depends on the condition you're taking Stelara (ustekinumab) for. For example, studies show that some people saw improvement in their symptoms within 3 weeks for Crohn's disease and within 2 weeks for ulcerative colitis. But the full effect for all conditions can take a few months. Keep in mind that everyone responds differently. So make sure to follow up with your provider about how well Stelara (ustekinumab) is working for you.

Where do you inject Stelara (ustekinumab)?

Stelara (ustekinumab) is typically given as an injection under the skin into the stomach, buttock, or thigh if you're giving the medication to yourself. It can also be given in the upper back of the arm if another person is giving you the injection. Be sure to choose an injection site that's different from the one you used for the previous dose. And never inject Stelara (ustekinumab) into a muscle or vein.

Does Stelara (ustekinumab) cause hair loss?

Hair loss wasn't a reported side effect by people using Stelara (ustekinumab) during clinical trials. Contact your provider if you notice hair loss while you're taking this medication. Your provider can look into possible causes.

What are the risks and warnings for Stelara (ustekinumab)?

Stelara (ustekinumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

  • Infections

Risk factors:

Active, chronic, or recurrent infection | Taking other medications that weaken your immune system | Having certain conditions that raise risk of infection

Stelara (ustekinumab) can raise your risk of infections. Serious infections are more common in people taking other immunosuppressant medications and people with certain conditions. Let your provider know your past medical history before starting Stelara (ustekinumab), especially if you've ever had tuberculosis (TB) or certain viral infections. Also tell your provider if you have symptoms of an infection including fever, chills, muscle aches, diarrhea, or feeling very tired. If you develop a serious infection while taking Stelara (ustekinumab) you might have to stop the medication.

  • Cancers

Risk factors:

Lighter skin color | Older adults | Certain medical conditions | History of skin cancer

Stelara (ustekinumab) weakens your immune system and can raise your risk of certain cancers, especially skin cancer. Some cases of skin cancer were seen in people who already had a higher risk of developing skin cancer. Let your provider know if you have a history of skin cancer. Monitor your body for new skin growths and changes to your skin.

  • Posterior Reversible Encephalopathy Syndrome (PRES)

Posterior reversible encephalopathy syndrome (PRES) is a very rare side effect of Stelara (ustekinumab). Symptoms can appear anytime during treatment, ranging from within a few days and even up to a year or longer after your first dose. Let your provider know if you have any symptoms like headache, confusion, visual changes, and seizures.

  • Vaccines

You can receive non-live or inactivated vaccines while you're taking Stelara (ustekinumab), but your body might respond differently. Avoid getting live vaccines while you're taking Stelara (ustekinumab). Doing so might cause you to become sick. Make sure your shots are up to date before starting this medication.

  • Swelling in the lungs

There have been reports of people experiencing swelling in the lungs while taking Stelara (ustekinumab). Symptoms like coughing and trouble breathing were seen after one to three doses of the medication. In some cases, it can become serious and lead to hospitalization. Let your provider know if you're having symptoms so you can be treated right away.

Need help paying for Stelara?

Average copay is $15-$20/mo.

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Stelara (ustekinumab) dosage forms

  • Syringe

1ml of 90mg/ml

0.5ml of 45mg/0.5ml

  • Vial

26ml of 5mg/ml

Typical dosing for Stelara (ustekinumab)

Plaque Psoriasis

Adults:

Weight 220 lbs or less: The typical dose is 45 mg injected under the skin once, then another 45 mg four weeks later. After the second dose, 45 mg is injected every 12 weeks.

Weight more than 220 lbs: The typical dose is 90 mg injected under the skin once, then another 90 mg four weeks later. After the second dose, 90 mg is injected every 12 weeks.

Children ages 6 to under 18 years:

Weight less than 132 lbs: The typical dose is 0.75 mg/kg of body weight injected under the skin once, then another 0.75 mg/kg four weeks later. After the second dose, 0.75 mg/kg is injected every 12 weeks.

Weight of 132 lbs to 220 lbs: The typical dose is 45 mg injected under the skin once, then another 45 mg four weeks later. After the second dose, 45 mg is injected every 12 weeks.

Weight more than 220 lbs: The typical dose is 90 mg injected under the skin once, then another 90 mg four weeks later. After the second dose, 90 mg is injected every 12 weeks.

Psoriatic Arthritis

Adults:

Psoriatic arthritis only: The typical dose is 45 mg injected under the skin once, then another 45 mg four weeks later. After the second dose, 45 mg is injected every 12 weeks.

Psoriatic arthritis with plaque psoriasis and weighing more than 220 lbs: The typical dose is 90 mg injected under the skin once, then another 90 mg four weeks later. After the second dose, 90 mg is injected every 12 weeks.

Children ages 6 to under 18 years:

Weight less than 132 lbs: The typical dose is 0.75 mg/kg of body weight injected under the skin once, then another 0.75 mg/kg four weeks later. After the second dose, 0.75 mg/kg is injected every 12 weeks.

Weight of 132 lbs or more: The typical dose is 45 mg injected under the skin once, then another 45 mg four weeks later. After the second dose, 45 mg is injected every 12 weeks.

Psoriatic arthritis with plaque psoriasis and weighing more than 220 lbs: The typical dose is 90 mg injected under the skin once, then another 90 mg four weeks later. After the second dose, 90 mg is injected every 12 weeks.

Crohn's Disease and Ulcerative Colitis

Adults: The typical dose is 260 mg to 520 mg infusion into the veins (intravenous, IV) once, then 90 mg under the skin every 8 weeks.

Interactions between Stelara (ustekinumab) and other drugs

Stelara (ustekinumab) may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking. The list below does not include all possible drug interactions with Stelara (ustekinumab). Please note that only the generic name of each medication is listed below.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abatacept

  • Adenovirus Vaccine Type 4, Live

  • Adenovirus Vaccine Type 7, Live

  • Bacillus of Calmette and Guerin Vaccine, Live

  • Dengue Tetravalent Vaccine, Live

  • Infliximab

  • Influenza Virus Vaccine, Live

  • Measles Virus Vaccine, Live

  • Mumps Virus Vaccine, Live

  • Poliovirus Vaccine, Live

  • Rotavirus Vaccine, Live

  • Rubella Virus Vaccine, Live

  • Smallpox Vaccine

  • Tofacitinib

  • Typhoid Vaccine, Live

  • Varicella Virus Vaccine, Live

  • Yellow Fever Vaccine

  • Zoster Vaccine, Live

How much does Stelara (ustekinumab) cost?

  • Syringe

1ml of 90mg/ml ~ $26,000-$28,000 / 8-week dose

0.5ml of 45mg/0.5ml ~ $12,500-$14,000 / 8-week dose

  • Vial

26ml of 5mg/ml ~ $2,000 / dose*

*Healthcare provider administered. Added costs for administration may vary.

Need help paying for Stelara?

Average copay is $15-$20/mo.

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What are alternatives to Stelara (ustekinumab)?

There are a number of medications that your doctor can prescribe in place of Stelara (ustekinumab). Compare a few possible alternatives below.

Stelara (ustekinumab)

Used for:

Moderate-to-severe plaque psoriasis (Ps) in adults and children ages 6 years and older.

Psoriatic arthritis (PsA) in adults and children ages 6 years and older

Moderate-to-severe Crohn's disease (CD) in adults.

Moderate-to-severe ulcerative colitis (UC) in adults.

Price

~$26,000/mo.

Skyrizi (risankizumab-rzaa)

Used for:

Moderate-to-severe plaque psoriasis

Psoriatic arthritis.

Moderate-to-severe Crohn's disease.

Price

~$19,000/mo.

Humira (adalimumab)

Used for:

Rheumatoid arthritis (RA) - adults only

Juvenile idiopathic arthritis (JIA) - people age 2 and older

Psoriatic arthritis (PsA) - adults only

Ankylosing spondylitis (AS) - adults only

Crohn's disease (CD) - people age 6 and older

Ulcerative colitis (UC) - people age 5 and older

Plaque psoriasis - adults only

Hidradenitis suppurativa (HS) - people age 12 and older

Uveitis - people age 2 and older

Price

~$7300/mo.+

Need help paying for Stelara?

Average copay is $15/mo.

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