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What is Ustekinumab: Uses, Dosage, Side Effects and More

Created at:1/13/2025

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Ustekinumab is a prescription medication that helps calm your immune system when it's overactive. It's specifically designed to treat certain autoimmune conditions where your body's defense system mistakenly attacks healthy tissue, causing inflammation and uncomfortable symptoms.

This medication belongs to a class called biologics, which are made from living cells rather than chemicals. Think of ustekinumab as a targeted therapy that blocks specific proteins in your immune system that trigger inflammation, helping restore balance to your body's natural processes.

What is Ustekinumab Used For?

Ustekinumab treats several autoimmune conditions where your immune system causes inflammation in different parts of your body. Your doctor might prescribe it when other treatments haven't provided enough relief or when you need more targeted therapy.

The medication is FDA-approved for treating moderate to severe plaque psoriasis, a skin condition that causes thick, scaly patches. It's also used for psoriatic arthritis, which affects both your skin and joints, causing pain and stiffness.

Additionally, ustekinumab helps manage Crohn's disease and ulcerative colitis, two forms of inflammatory bowel disease that cause digestive tract inflammation. These conditions can significantly impact your daily life, and ustekinumab offers hope for better symptom control.

In some cases, doctors prescribe ustekinumab for other inflammatory conditions when standard treatments aren't working well. Your healthcare provider will determine if this medication is right for your specific situation.

How Does Ustekinumab Work?

Ustekinumab works by blocking two specific proteins in your immune system called interleukin-12 and interleukin-23. These proteins normally help coordinate your immune response, but in autoimmune conditions, they can trigger excessive inflammation.

By blocking these proteins, ustekinumab helps reduce the inflammatory signals that cause your symptoms. This targeted approach allows your immune system to function more normally while still protecting you from infections and other threats.

The medication is considered a strong, targeted therapy that's more precise than older immunosuppressive drugs. It specifically targets the pathways involved in your condition rather than broadly suppressing your entire immune system.

Results typically don't happen overnight. Most people begin noticing improvements within 4 to 12 weeks of starting treatment, with continued improvement over several months as the medication builds up in your system.

How Should I Take Ustekinumab?

Ustekinumab is given as an injection under your skin, similar to how people with diabetes give themselves insulin shots. Your healthcare provider will teach you the proper injection technique or arrange for a healthcare professional to administer it.

The medication comes in pre-filled syringes or auto-injectors that make the process easier. You'll typically inject it into your thigh, upper arm, or abdomen, rotating injection sites to prevent skin irritation.

You don't need to take ustekinumab with food or avoid eating before your injection. However, make sure to store the medication in your refrigerator and let it reach room temperature before injecting, which takes about 15 to 30 minutes.

Keep track of your injection schedule and mark it on a calendar. Missing doses can affect how well the medication works, so consistency is important for optimal results.

How Long Should I Take Ustekinumab For?

Ustekinumab is typically a long-term treatment that you'll continue as long as it's helping your condition and you're tolerating it well. Most people need ongoing treatment to maintain their improvement and prevent symptoms from returning.

Your doctor will monitor your response regularly, usually every few months initially, then less frequently once your condition stabilizes. They'll assess whether the medication is working effectively and if you're experiencing any concerning side effects.

Some people may be able to reduce their dosing frequency or take breaks from treatment if they achieve sustained remission. However, stopping the medication often leads to symptom return, so any changes should be carefully discussed with your healthcare provider.

The decision about treatment duration depends on your specific condition, how well you respond, and your overall health status. Your doctor will work with you to find the right balance between symptom control and minimizing long-term risks.

What Are the Side Effects of Ustekinumab?

Like all medications, ustekinumab can cause side effects, though many people tolerate it well. Understanding what to expect can help you feel more prepared and know when to contact your healthcare provider.

The most common side effects you might experience include mild reactions at the injection site, such as redness, swelling, or tenderness. These usually resolve within a day or two and tend to become less noticeable as your body adjusts to the medication.

Here are the more frequently reported side effects that affect your whole body:

  • Upper respiratory tract infections like colds or sinus infections
  • Headaches that are usually mild to moderate
  • Fatigue or feeling more tired than usual
  • Mild nausea or stomach discomfort
  • Muscle or joint aches
  • Diarrhea or changes in bowel movements

These common side effects are generally manageable and often improve as your body adapts to the treatment. Most people find they can continue their normal activities while taking ustekinumab.

However, there are some more serious side effects that require immediate medical attention, though they're much less common. Because ustekinumab affects your immune system, you might be more susceptible to certain infections.

Here are the rare but serious side effects to watch for:

  • Serious infections that don't respond to usual treatment
  • Signs of tuberculosis like persistent cough, fever, or night sweats
  • Unusual skin changes or new growths
  • Severe allergic reactions with difficulty breathing or swelling
  • Persistent fever or flu-like symptoms
  • Unusual bleeding or bruising

If you experience any of these serious symptoms, contact your healthcare provider immediately or seek emergency care. Early recognition and treatment of these rare complications can prevent more serious problems.

Who Should Not Take Ustekinumab?

Ustekinumab isn't suitable for everyone, and your doctor will carefully review your medical history before prescribing it. Certain conditions or situations make this medication potentially risky or less effective.

You shouldn't take ustekinumab if you have an active, serious infection that hasn't been treated successfully. This includes bacterial, viral, or fungal infections that could become more severe when your immune system is modified.

People with a history of tuberculosis need special evaluation before starting ustekinumab. Your doctor will test for both active and latent tuberculosis, as this medication can increase the risk of tuberculosis reactivation.

Here are other conditions that may make ustekinumab inappropriate for you:

  • Current or recent cancer treatment (within the past 5 years)
  • Live vaccines received within the past month
  • Known allergy to ustekinumab or its components
  • Active hepatitis B or C infection
  • Severe kidney or liver disease
  • Pregnancy or breastfeeding (discuss risks and benefits with your doctor)

Your healthcare provider will also consider your age, other medications you're taking, and your overall health status. They might recommend additional monitoring or alternative treatments if ustekinumab poses too many risks for your situation.

Ustekinumab Brand Names

Ustekinumab is sold under the brand name Stelara in the United States and most other countries. This is the original brand developed by Janssen Pharmaceuticals and is the only version currently available.

Unlike some medications that have multiple brand names or generic versions, ustekinumab is exclusively available as Stelara. This biologic medication is complex to manufacture, so generic versions aren't yet available.

When you receive your prescription, you'll see "Stelara" on the packaging and documentation. The medication comes in different strengths depending on your condition and prescribed dose.

Always verify with your pharmacist that you're receiving the correct medication and strength. The packaging should clearly show "Stelara" and "ustekinumab" to ensure you have the right product.

Ustekinumab Alternatives

Several other medications can treat similar conditions to ustekinumab, though the best choice depends on your specific diagnosis and individual circumstances. Your doctor might consider alternatives if ustekinumab isn't suitable or effective for you.

For psoriasis and psoriatic arthritis, other biologic medications include adalimumab (Humira), etanercept (Enbrel), and secukinumab (Cosentyx). These work through different mechanisms but can be similarly effective for many people.

If you have inflammatory bowel disease, alternatives might include infliximab (Remicade), adalimumab (Humira), or vedolizumab (Entyvio). Each of these targets different aspects of the inflammatory process.

Non-biologic options are also available, including traditional immunosuppressive drugs like methotrexate, azathioprine, or corticosteroids. These might be considered if biologics aren't appropriate or as combination therapy.

Your healthcare provider will help you weigh the benefits and risks of different treatment options based on your condition severity, medical history, and personal preferences.

Is Ustekinumab Better Than Humira?

Both ustekinumab (Stelara) and adalimumab (Humira) are effective biologic medications, but they work through different mechanisms and may be better suited for different people. Direct comparisons show that both can be highly effective for treating autoimmune conditions.

Ustekinumab targets specific proteins (IL-12 and IL-23) involved in inflammation, while Humira blocks tumor necrosis factor (TNF), another inflammatory protein. This difference means they might work better for different individuals based on their specific inflammatory pathways.

One potential advantage of ustekinumab is its dosing schedule. Most people take it every 8 to 12 weeks after the initial doses, while Humira typically requires injections every two weeks. This less frequent dosing can be more convenient for many patients.

However, Humira has been available longer and has more extensive research data. Some people may respond better to one medication over the other, and switching between them is sometimes necessary to find the most effective treatment.

Your doctor will consider your specific condition, treatment history, and personal factors when recommending which medication might work best for you. Neither is universally "better" than the other.

Frequently asked questions about Ustekinumab (injection route)

Ustekinumab can generally be used safely in people with diabetes, though your doctor will monitor you more closely. Diabetes doesn't automatically prevent you from taking this medication, but it does require additional attention to prevent complications.

People with diabetes may have a slightly higher risk of infections, and since ustekinumab can also increase infection risk, your healthcare provider will be extra vigilant about monitoring for signs of infection. They might recommend more frequent check-ups or blood tests.

Your blood sugar control is important while taking ustekinumab. Well-controlled diabetes poses fewer risks than poorly controlled diabetes, so your doctor might work with you to optimize your blood sugar levels before starting treatment.

If you have diabetes, make sure to inform your healthcare provider about your blood sugar levels, any recent infections, and how well your diabetes is controlled. This information helps them make the best treatment decisions for your situation.

If you accidentally inject more ustekinumab than prescribed, contact your healthcare provider immediately, even if you feel fine. While serious overdose effects are rare, medical professionals need to monitor you for potential complications.

Don't try to "skip" your next dose to compensate for the extra medication. Your doctor will advise you on how to proceed with your regular dosing schedule and whether any additional monitoring is needed.

Bring the medication packaging with you if you seek medical attention, as this helps healthcare providers understand exactly how much extra medication you received. They can then determine the appropriate response.

In most cases, accidental overdoses don't cause serious immediate problems, but increased monitoring for side effects or infections might be recommended. Your healthcare provider will guide you through any necessary precautions.

If you miss a scheduled dose of ustekinumab, take it as soon as you remember, then return to your regular dosing schedule. Don't wait until your next scheduled dose if you're only a few days late.

Contact your healthcare provider's office to discuss the missed dose and get guidance on when to take your next injection. They might adjust your schedule slightly to maintain the proper timing between doses.

Never double up on doses or take two injections close together to "catch up." This could increase your risk of side effects without providing additional benefits.

If you frequently forget doses, consider setting reminders on your phone or calendar. Consistent dosing is important for maintaining the medication's effectiveness in controlling your condition.

You should never stop taking ustekinumab without discussing it with your healthcare provider first. Stopping suddenly can cause your symptoms to return, sometimes more severely than before you started treatment.

Your doctor might consider stopping or reducing ustekinumab if you achieve sustained remission, experience intolerable side effects, or develop complications that make continued treatment risky.

If you and your doctor decide to stop treatment, they'll likely monitor you closely for several months to watch for returning symptoms. Some people can maintain remission after stopping, while others need to restart treatment.

The decision to stop ustekinumab should be based on careful evaluation of your current condition, treatment response, and overall health status. Your healthcare provider will help you weigh the benefits and risks of continuing versus stopping treatment.

You can receive most vaccinations while taking ustekinumab, but you should avoid live vaccines during treatment. Your healthcare provider will help you plan appropriate vaccinations to protect your health.

Inactive vaccines like the flu shot, pneumonia vaccine, and COVID-19 vaccines are generally safe and recommended while taking ustekinumab. These vaccines might be slightly less effective than in people with normal immune systems, but they still provide important protection.

Live vaccines such as the measles-mumps-rubella (MMR) vaccine, varicella (chickenpox) vaccine, and live flu vaccine should be avoided while taking ustekinumab. These could potentially cause infections in people with suppressed immune systems.

Ideally, you should receive any needed vaccinations before starting ustekinumab treatment. If you need vaccinations during treatment, discuss the timing and type with your healthcare provider to ensure your safety.

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