Generic Name: ustekinumab, Parenteral Solution

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SECTION 1 of 4

Highlights for ustekinumab

Parenteral Solution
1

Ustekinumab is an injected drug used to treat plaque psoriasis and psoriatic arthritis in adults.

2

This drug can decrease how well your immune system works and lower your body’s ability to fight infection. Some people have developed cancer and serious infections while taking it.

3

You shouldn’t receive live vaccines while taking ustekinumab. You may not be fully protected by the vaccine and it may cause an infection.

4

Common side effects include upper respiratory infections, headaches, and tiredness.

IMPORTANT INFORMATION

Risk of serious infections

Ustekinumab may lower the ability of your immune system to fight infections. It may increase your risk for getting an infection or make an infection that you have worse. Some people have developed serious infections while taking this drug. These include tuberculosis (TB) and infections caused by bacteria, fungi, or viruses. You shouldn’t take ustekinumab if you have an active infection. Tell your doctor if you have symptoms of an infection before starting and during treatment with this drug, such as:

  • fever, sweating, or chills
  • muscle aches
  • cough
  • shortness of breath
  • blood in your phlegm
  • unexplained weight loss
  • warm, red, or painful skin or sores on your body
  • diarrhea or stomach pain
  • burning when you urinate or urinating more often than normal
  • feeling very tired

Also let your doctor know if you:

  • are being treated for an infection
  • get a lot of infections or have infections that keep coming back 

Cancer (malignancy) risk

Ustekinumab may lower your immune system and increase your risk for some types of cancers. Let your doctor know if you’ve ever had cancer. Some people with risk factors for skin cancer develop skin cancer while taking this drug. Tell your doctor if you develop symptoms, such as:

  • wart-like growths
  • scaly red patches that may bleed
  • open sores

RPLS risk

Reversible posterior leukoencephalopathy syndrome (RPLS) is a rare condition that affects the brain and can be fatal. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you start experiencing:

  • headache
  • seizures
  • confusion
  • vision problems

Drug Features

Ustekinumab is a prescription drug. It’s available as a solution for subcutaneous injection (under the skin). You may receive the injection from your doctor or you may inject it yourself.

This drug may be used alone or as part of a combination therapy. That means you may need to take it with other drugs. For psoriatic arthritis, this drug may be used with the medication methotrexate.

Why It's Used

Ustekinumab is used to treat moderate or severe plaque psoriasis and active psoriatic arthritis in adults.

More Details

How It Works

Ustekinumab belongs to a class of drugs called monoclonal antibodies.

More Details

Why It's Used

Ustekinumab is used to treat moderate or severe plaque psoriasis and active psoriatic arthritis in adults.

For plaque psoriasis, it’s used to treat the condition when it involves large areas or many areas of your body. It’s used in adults who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light).

For psoriatic arthritis, it can be used alone or with the drug methotrexate.

How It Works

Ustekinumab belongs to a class of drugs called monoclonal antibodies. It works by stopping your immune system from attacking your body and by reducing inflammation.

Plaque psoriasis and psoriatic arthritis are thought to occur when your immune system attacks your own body. This leads to inflammation, pain and swelling of your joints, and skin lesions and scaly rashes.

Proteins in your body called cytokines play a big role in regulating your immune system and inflammation. This drug attaches to these proteins, which helps to stop your immune system from attacking your body. This also reduces inflammation.

SECTION 2 of 4

ustekinumab Side Effects

Parenteral Solution

Most Common Side Effects

The most common side effects that occur with ustekinumab include:

  • upper respiratory tract infections

  • headache

  • tiredness

Serious Side Effects

If you experience any of these serious side effects, call your doctor right away. If your symptoms are potentially life threatening, or if you think you’re experiencing a medical emergency, call 9-1-1.

  • serious allergic reactions. Symptoms may include:

    • feeling faint
    • swelling of your face, eyelids, tongue, or throat (anaphylactic reaction)
    • trouble breathing or tightness in your throat
    • chest tightness
    • skin rash
  • serious infections. Symptoms may include:

    • fever, sweating, or chills
    • muscle aches
    • cough
    • shortness of breath
    • blood in your phlegm
    • weight loss
    • warm, red, or painful skin; or sores on your body
    • diarrhea or stomach pain
    • burning when you urinate or urinating more often than normal
    • feeling very tired
  • cancer, including skin cancer. Symptoms may include:

    • wart-like growths
    • scaly red patches that may bleed
    • open sores
  • Reversible posterior leukoencephalopathy syndrome. Symptoms may include:

    • headache
    • seizures
    • confusion
    • vision problems
Pharmacist's Advice
Healthline Pharmacist Editorial Team

Ustekinumab does not cause drowsiness.

Mild side effects may disappear within a few days or a couple of weeks. Talk to your doctor or pharmacist if they’re more severe or don’t go away.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
SECTION 3 of 4

ustekinumab May Interact with Other Medications

Parenteral Solution

Ustekinumab may interact with other medications, herbs, or vitamins you might be taking. That’s why your doctor should manage all of your medications carefully. If you’re curious about how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Note: You can reduce your chances of drug interactions by having all of your prescriptions filled at the same pharmacy. That way, a pharmacist can check for possible drug interactions.

Medications That Might Interact with This Drug

Live vaccines

Examples are:

  • varicella (chickenpox)
  • measles, mumps, and rubella
  • tuberculosis (TB)

Ustekinumab works by lowering your immune system. You shouldn’t receive live vaccines. You may not be fully protected by the vaccine. It may lead to an infection.

Tell your doctor if anyone in your household needs a vaccine. The viruses used in some vaccines can spread to people with a weakened immune system and can cause serious problems.

You shouldn’t receive the TB vaccine one year before taking ustekinumab and for one year after stopping the drug.

Inactivated vaccines

Examples are:

  • flu shot
  • pertussis (whooping cough)
  • polio

If you receive an inactivated (non-live) vaccine while taking this drug, your body may not respond to it properly. This means you won’t be protected against the disease that the vaccine is used to prevent. 

Allergy shots

Allergy shots may not work as well when used with ustekinumab. The drug may also increase your risk of having an allergic reaction to an allergy shot. Let your doctor know if you’re receiving or have received allergy shots.

Anticoagulant, blood thinner
  • warfarin

Ustekinumab can affect the level of warfarin in your body. If you take this medication, your doctor may need to adjust your dose.

Arthritis and psoriasis drug
  • cyclosporine

Ustekinumab can affect the level of warfarin in your body. If you take this medication, your doctor may need to adjust your dose.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

People with latex allergy

The needle cover on the prefilled syringe contains latex. Tell your doctor if you’re allergic to latex.

People receiving phototherapy

Let your doctor know if you receive or have received phototherapy for your psoriasis. You may be at higher risk for developing skin cancer.

People with serious infection

If you have a serious infection, including tuberculosis (TB), taking ustekinumab may make it worse. It may also cause TB to come back if you’ve had it before. Let your doctor know if you’ve ever had TB. Also tell your doctor about any symptoms of an infection, such as fever, chills, or body aches. You shouldn’t take this drug if you currently have a serious infection.

People with genetic problems

If you have a genetic problem in which your body doesn’t make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23), you’re at a higher risk for serious infections. These infections can spread throughout your body and be fatal. It isn’t known if people who take this drug will get these infections. Your doctor will watch you more closely and do testing if you have symptoms of an infection.

People with cancer risk

Ustekinumab may increase your risk for cancer, especially if you have risk factors for skin cancer. Tell your doctor if you’ve ever had cancer. Let your doctor know if you develop any new skin growths.

Pregnant women

Ustekinumab is pregnancy Category B drug. That means two things:

  1. Studies of the drug in pregnant animals have not shown risk to the fetus.
  2. There aren’t enough studies done in pregnant women to show the drug poses a risk to the fetus.

Tell your doctor if you’re pregnant or plan to become pregnant. Ustekinumab should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Women who are nursing

It isn’t known whether ustekinumab is passed through breast milk. You and your doctor should decide if you’ll take this drug or breastfeed.

For Seniors

The risk of developing skin cancer while taking this drug may be higher for adults over the age of 60 years. Your doctor will monitor you closely for signs of skin cancer.

For Children

The safety and effectiveness of ustekinumab haven’t been established in people under the age of 18 years.

Syringes and needles are used to inject this medicine. Make sure to keep them out of the reach of children and dispose of them properly. Don’t throw out individual needles into trashcans or recycling bins. Never flush them down the toilet. Ask your pharmacist for a needle clipper and a safe container for throwing out used needles and syringes. Your community may have a program for disposing needles and syringes. If you throw out the container in the trash, label it “do not recycle.”

Allergies

Ustekinumab can cause a severe allergic reaction. Symptoms may include:

  • feeling faint
  • swelling of your face, eyelids, tongue, or throat (anaphylactic reaction)
  • trouble breathing or tightness in your throat
  • chest tightness
  • skin rash

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal.

SECTION 4 of 4

How to Take ustekinumab (Dosage)

Parenteral Solution

All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

What Are You Taking This Medication For?

Plaque psoriasis
Form: Subcutaneous injection: single-use prefilled syringe or single-use vial
Strengths: 45 mg/0.5 mL and 90 mg/mL
Adult Dosage (ages 18 years and older)
  • If you weigh 220 pounds (100 kg) or less, the recommended dose is 45 mg for the first dose and 45 mg again 4 weeks later.
  • After that, the dose is 45 mg taken every 12 weeks.
  • If you weigh more than 220 pounds (100 kg), the recommended dose is 90 mg for the first dose and 90 mg again 4 weeks later.
  • After that, the dose is 90 mg taken every 12 weeks
Child Dosage (ages 0-17 years)

A safe and effective dose hasn’t been established for people younger than 18 years.

Psoriatic arthritis
Form: Subcutaneous injection: single-use prefilled syringe or single-use vial
Strengths: 45 mg/0.5 mL and 90 mg/mL
Adult Dosage (ages 18 years and older)
  • The recommended dose is 45 mg for the first dose and 45 mg again 4 weeks later.
  • After that, the dose is 45 mg taken every 12 weeks.
  • If you also have moderate to severe plaque psoriasis and weigh more than 220 pounds (100 kg), the recommended dose is 90 mg for the first dose and 90 mg again 4 weeks later.
  • After that, the dose is 90 mg taken every 12 weeks.
Child Dosage (ages 0-17 years)

A safe and effective dose hasn’t been established for people younger than 18 years.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you.
Pharmacist's Advice
Healthline Pharmacist Editorial Team

Ustekinumab comes with serious risks if you don't take it as prescribed.

If You Don’t Take It

If you stop taking ustekinumab, miss doses, or don’t receive it on schedule, your symptoms of plaque psoriasis or psoriatic arthritis may get worse.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you can. If it’s almost time for your next dose, don’t double up or take two doses. Call your doctor to figure out your new dosing schedule.

How to Tell If the Drug Is Working

You may be able to tell the drug is working for plaque psoriasis if you experience fewer thick, raised, red, and white scaly patches.

You may be able to tell it’s working for psoriatic arthritis if you experience less tiredness, nail changes, and joint problems.

Ustekinumab is a long-term drug treatment.

Store ustekinumab in a refrigerator

Keep it in temperatures from 36–46ºF (2.2–7.8ºC). Make sure you don’t freeze ustekinumab. Protect it from light.

Don’t shake the drug. Store ustekinumab vials upright. Store it in its original carton until it’s used.

Throw away any unused ustekinumab. Throw away vials and bottles after the expiration date printed on the label.

Travel

When traveling with your medication:

  • Be sure you have enough medication before you leave on your trip. It may be difficult to fill this prescription at a pharmacy since they may not have it in stock.
  • Don’t worry about airport X-ray machines. They can’t hurt this medication.
  • You may need to show your pharmacy’s preprinted label to identify the medication. Keep the original pharmacy prescription label with you when traveling.
  • This medication needs to be refrigerated. You can use an insulated bag with a cold pack to maintain the temperature when traveling.
  • Always carry your medication with you in your carry-on bag with ice packs and a temperature-control thermometer.
  • Needles and syringes need to be used to take this medicine. Check for special rules about traveling with medicine, needles, and syringes.

Self-Management

Your doctor should show you how to prepare, measure, and give injections to yourself before your first dose of ustekinumab. Don’t try to inject the drug yourself until your doctor has shown you or your caretaker how to do it correctly.

Administration:

  • Ustekinumab is given by injection under the skin (subcutaneous injection), in your upper arms, buttocks, thighs, or stomach area (abdomen).
  • Don’t 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 ustekinumab.
  • Before you inject yourself, always check the drug for any particles or discoloration. Ustekinumab should look clear and colorless to light yellow with a few white particles. Don’t use it if it’s frozen, discolored, cloudy, or has large particles in it.
  • Don’t shake ustekinumab. This may damage it. If your prefilled syringe or vial has been shaken, don’t use it. Get a new prefilled syringe or vial.
  • Read the detailed instructions for use at the end of ustekinumab’s medication guide. You’ll learn how to prepare and inject a dose of ustekinumab. You’ll also learn how to properly throw away used needles and syringes.

Clinical Monitoring

Your doctor may monitor you for signs of serious infections.

You’ll be tested for tuberculosis (TB) before and during treatment with this medication. If your doctor feels that you’re at risk for TB, you may be treated for TB before starting treatment with ustekinumab.

Hidden Costs

In addition to this medicine, you’ll need sterile alcohol wipes and cotton balls or gauze pads.

If you’re using the vials, you’ll also need a syringe and a needle. You may need a needle clipper and a container for safe disposal of needles and syringes.

Insurance

Many insurance companies will require a prior authorization before they approve the prescription and pay for ustekinumab.

Are There Any Alternatives?

There are other drugs available to treat your condition. Some may be more suitable for you than others. Talk to your doctor about possible alternatives.


Show Sources

Content developed in collaboration with University of Illinois-Chicago, Drug Information Group

Medically reviewed by Creighton University, Center for Drug Information and Evidence-Based Practice on May 28, 2015

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Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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