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Stelara Dosing For Ulcerative Colitis

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Stelara For Plaque Psoriasis

Phase 3 STELARA Study for Treatment to Ulcerative Colitis (UC)

Stelara is FDA-approved to treat moderate to severe plaque psoriasis in adults and children ages 6 years and older.

Its approved for use in people who could receive treatment with either:

  • systemic therapy ,
  • or

Plaque psoriasis is an autoimmune disease that causes plaques on your skin. Plaques are areas on your skin that are raised and may be red- or silver-colored. They may also feel itchy.

Effectiveness for plaque psoriasis

In clinical studies, Stelara was effective in treating adults and adolescents with moderate to severe plaque psoriasis.

After 12 weeks of treatment:

  • Up to 73% of adults taking Stelara had very few plaques to no plaques on their skin. Of those taking a placebo , 4% had the same results.
  • Almost 70% of adolescents taking Stelara had very few plaques to no plaques on their skin. Of those taking a placebo, 5.4% had the same results.

Also, 77.3% of children ages 6 to 11 years had very few to no plaques on their skin. No one in this age group took a placebo.

These studies also looked at how many people had fewer plaques on their skin after treatment. The studies found that:

  • Up to 76% of adults taking Stelara had at least a 75% improvement in their psoriasis symptoms. Of those taking a placebo, 4% of adults had the same results.
  • Up to 80.6% of adolescents taking Stelara had at least a 75% improvement in their psoriasis symptoms. Of those taking a placebo, about 11% of adolescents had the same results.

Drug Forms And Strengths

Stelara comes as a liquid solution that contains the active drug ustekinumab.

Its available as:

  • a single-dose, prefilled syringe that holds 0.5 mL of solution and contains 45 mg of ustekinumab
  • a single-dose, prefilled syringe that holds 1 mL of solution and contains 90 mg of ustekinumab
  • a single-dose vial that holds 0.5 mL of solution and contains 45 mg of ustekinumab

Stelara is given as a subcutaneous injection. It can be given in your upper arms, thighs, belly, or buttocks.

Your healthcare professional may give you Stelara injections at a medical clinic. They may also show you how to self-inject Stelara at home.

Note: Stelara also comes in a vial that contains 130 mg of ustekinumab. This vial is used for a one-time intravenous infusion of Stelara. Its used to give the first dose of the drug to people with Crohns disease or ulcerative colitis. This one-time infusion is called a loading dose or an induction dose. This IV infusion will take place over at least 1 hour. Each dose of Stelara after the IV infusion is given as a subcutaneous injection.

What Are The Forms Of Stelara

Stelara comes as a liquid solution in either in a single-dose prefilled syringe or in a single-dose vial. The drug can be given in two ways: as a subcutaneous injection or as an intravenous infusion.

If you receive Stelara by IV infusion, youll get your doses from a healthcare professional, such as at your doctors office or a clinic. Its also recommended that children receiving subcutaneous injections of Stelara get their doses in the doctors office or a clinic.

Adults using the subcutaneous injection form of Stelara may want to learn how to inject the drug themselves or have a caregiver administer their doses of Stelara. If your doctor determines that this is an option for you, theyll give you dosing instructions.

If youre interested in using Stelara at home, talk with your doctor.

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Who Are Our Experts

Pharmacists or Nurses who are specifically trained on all aspects of the Janssen products and the therapeutic areas they treat.

All third party trademarks used herein are trademarks of their respective owners.

This information is intended for healthcare providers in the United States only.This page was last modified on January 06, 2022.

What Should I Avoid While Using Stelara

Learn About STELARA® (ustekinumab) for ulcerative colitis ...

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a “live” vaccine while using Stelara, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella , rotavirus, typhoid, yellow fever, varicella , zoster , and nasal flu vaccine.

BCG vaccine should not be given for at least 1 year after you receive your last dose of Stelara.

Non-live vaccines may not work as well during your treatment, and may not fully protect you from disease. Make sure you are current on all vaccines before you begin treatment with this medicine.

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Report A Janssen Product Adverse Event

You may contact the Medical Information Center by calling 1-800-JANSSEN to speak to a clinical expert regarding your question or to report a possible adverse event.

Report a Janssen COVID-19 Vaccine Adverse Event

Report a Adverse Event to FDA VAERS at www.vaers.hhs.gov/reportevent.html or call the FDA at 1-800-822-7967.Report a Adverse Event to Janssen at 1-800-565-4008 or 1-908-455-8822 .

Side Effects In Children

In a clinical study, children ages 12 years and older with plaque psoriasis used Stelara for treatment. The side effects in these children were similar to the side effects in adults with plaque psoriasis during other clinical studies.

The Stelara dosage your doctor prescribes will depend on several factors. These include:

  • the condition, or conditions, youre using Stelara to treat
  • your age
  • your weight

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

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How Is Stelara Given

Stelara comes as a liquid solution that can be given as a subcutaneous injection or as an intravenous infusion. With an IV infusion, youll get the medication through your vein over a period of time. If you receive the IV infusion form of Stelara, youll get your doses at your doctors office.

Most people prescribed Stelara receive it as a subcutaneous injection. Your doctor may be able to teach you or your caregiver how to give Stelara injections so you can receive your doses at home.

If you use Stelara at home, its important to rotate your injection sites. You can inject Stelara into your upper arms, buttocks, upper thighs, or abdomen . You shouldnt inject Stelara into skin that is red or discolored, hard, tender, or bruised.

For more information about how to inject Stelara, see the step-by-step instructions.

Dont use more Stelara than your doctor prescribes. Using more than this can lead to serious side effects.

Does Stelara Decrease My Immune System Function

STELARA® Phase 3 Data – Treatment for Ulcerative Colitis

Yes. Stelara reduces your immune systems ability to fight off infections.

Stelara is used to treat conditions that are partly caused by an overactive immune system. These conditions include plaque psoriasis, psoriatic arthritis, Crohns disease, and ulcerative colitis.

Having an overactive immune system can lead to inflammation, pain, and other health problems.

Stelara helps decrease the activity of your immune system, which helps stop it from attacking your joints and organs. This can improve your symptoms and your quality of life.

However, when your immune system activity is decreased, you have a greater risk of developing serious or rare infections. You may also have a greater risk of reactivation of infections, such as tuberculosis , that youve had in the past. Reduced immune system function caused by Stelara may also increase your risk of certain cancers, including skin cancer.

Talk with your doctor about infections that youve had in the past. Also, you should call your doctor right away if you think you have an infection during Stelara treatment. If you develop an infection while youre using Stelara, your doctor may have you stop using Stelara for a while. Theyll also inform you when its safe for you to restart treatment.

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How To Optimize Treatment With Ustekinumab In Inflammatory Bowel Disease: Lessons Learned From Clinical Trials And Real

  • 1Gastroenterology Department, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Hospital General Universitario de Alicante, Alicante, Spain
  • 2Gastroenterology Department, Hospital de Galdakao, Biocruces Bizkaia Health Research Institute, Galdakao, Spain

Ustekinumab is a fully human IgG1 monoclonal antibody that has been approved for the treatment of moderate to severe Crohn’s disease, and more recently moderate to severe ulcerative colitis. It binds with high affinity to the p40 subunit of human interleukin-12 and 23. This mechanism of action prevents the bioactivity of both interleukins, thus precluding their interaction with the cell surface receptor protein. The pivotal clinical trials demonstrated its clinical efficacy and safety, in naïve patients and also in those previously exposed to immunosuppressants and/or biologics. There is now an extensive experience with its use worldwide, corroborating its favorable profile even in patients with refractory disease. However, the number of medical treatment options available in inflammatory bowel disease are still limited. Hence, we should prioritize the treatments that have a greater probability of response in an individual patient. Our aim was to review and summarize all the available literature regarding the potential predictors of response to ustekinumab that can increase the success rate with this therapy in clinical practice.

Drug Forms And Administration

Stelara and Humira both come as a liquid solution thats given as a subcutaneous injection.

For people taking Stelara to treat Crohns disease or ulcerative colitis, their first dose is given by intravenous infusion . The infusion lasts for at least 1 hour. The rest of their doses are given by subcutaneous injection.

Stelara and Humira can both be given as injections at your doctors office or clinic. They can also be self-injected at home, after your healthcare professional has shown you how to inject the drugs.

Stelara can be injected under the skin of your upper arms, thighs, belly, or buttocks. Humira can be injected under the skin of your thighs or belly.

Stelara comes as a disposable prefilled syringe thats meant to be used once. It also comes as a single-dose vial that youll inject using a syringe and needle. Stelara also comes in a single-use vial thats used for injections given by healthcare professionals.

Humira comes as prefilled, single-dose pens and syringes. It also comes in a single-use vial thats used for injections given by healthcare professionals.

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What Strengths Does Stelara Come In

Stelara is available in either a single-dose prefilled syringe or a single-dose vial, both of which can be given by subcutaneous injection. The prefilled syringe and the vial both come in a strength of 45 milligrams per 0.5 milliliters of solution. In addition, the prefilled syringe is available in a strength of 90 mg/mL.

When given by IV infusion, Stelara comes in a single-dose vial thats available in one strength: 130 mg/26 mL.

How To Use Stelara Vial

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Read the Medication Guide and the Instructions for Use provided by your pharmacist before you start using ustekinumab and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Before starting this drug, you should take a tuberculosis skin test to check for a type of tuberculosis that may not be causing any symptoms . If you are diagnosed with TB, to prevent a serious TB infection you must first be treated for it before you start ustekinumab.

For the treatment of psoriasis or psoriatic arthritis, this medication is given by injection under your skin as directed by your doctor. You will receive one dose, followed by a second dose 4 weeks later. Then this medication is given every 3 months.

For the treatment of Crohn’s disease or ulcerative colitis, the first dose of this medication is given by injection into a vein by a health care professional. The medication is then given by injection under your skin every 8 weeks as directed by your doctor.

The dosage is based on your weight, medical condition, and response to treatment.

When given under the skin, this medication should be injected in either the upper arms, buttock, thighs, or abdomen. It is important to change the location of the injection site with each dose to avoid problem areas under the skin. Choose a different injection site with each dose. Do not inject into skin that is irritated, sore, or infected.

Tell your doctor if your condition does not improve or if it worsens.

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What Is Stelara

Stelara is an immunosuppressant that reduces the effects of a chemical substance in the body that can cause inflammation.

Stelara is used to treat plaque psoriasis in adults and children who are at least 6 years old. It is also used to treat psoriatic arthritis in adults, and is sometimes given with another medicine called methotrexate.

Stelara is used in adults to treat moderately to severely active Crohn’s disease after other medicines have been tried without success.

Stelara is also used in adults to treat moderately to severely active ulcerative colitis.

How Much To Use

  • Your doctor will determine the correct dose of STELARA for you and how often you should receive it. Make sure to discuss with your doctor when you will receive injections and to come in for all your scheduled follow-up appointments.
  • For children and adolescents aged 6 years or older with psoriasis:- The doctor will work out the right dose for you, including the amount of Stelara to be injected to give the right dose. The right dose for you will depend on your body weight at the time each dose is given. If you weigh less than 60 kg, the recommended dose is 0.75 mg of Stelara per kg body weight.- If you weigh 60 kg to 100 kg, the recommended dose is 45 mg Stelara.- If you weigh more than 100 kg, the recommended dose is 90 mg Stelara.- After the starting dose, you will have the next dose 4 weeks later, and then every 12 weeks.

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What Is The Most Important Information I Should Know About Stelara

You should not use ustekinumab if you are allergic to it.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

Tell your doctor if you have ever had:

  • signs of infection
  • chronic infections
  • new or changing skin lesions
  • a latex allergy
  • allergy shots or
  • if you recently received or are scheduled to receive any vaccine.

Some people using ustekinumab have developed skin cancer . However, these people may have had a higher risk of skin cancer. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ustekinumab on the baby.

How To Inject Stelara From A Vial

STELARA® Phase 3 UNIFI Study – Ulcerative Colitis
  • Check Vials and Assemble materials:
  • Take the vial out of the refrigerator. Make sure that it is the right dose. If your dose is 45 mg you will receive one 45 mg vial. If your dose is 90mg, you will receive two 45 mg vials. If you receive two 45 mg vials for a 90 mg dose, you will need to give yourself two injections one right after the other. Check with your healthcare provider.Children weighing less than 60 kg require a dose lower than 45 mg. Make sure you know the proper amount and type of syringe needed for dosing. If you dont know the amount or type of syringe needed, contact your healthcare provider for further instructions.Check Expiration DateOpen the box and remove the vial. Check the expiration date on the vial and the label of the box. If the expiration date has passed, dont use it.Check Solution in VialMake sure the vial is not damaged. Look at the solution or liquid in the vial to make sure that it is not cloudy and not frozen.Assemble Additional SuppliesAssemble the additional supplies you will need for your injection. These include a syringe with a 27 gauge, 1/2 inch needle, an alcohol swab, a cotton ball or gauze, and a sharps container for syringe disposal.

  • Choose the Injection Site:
  • Good sites are the top of the thigh and around the tummy but about 2 inches away from the belly button . Avoid, if possible, skin involved with psoriasis. If your caregiver is giving you the injection, they may use the upper arms or buttocks as well.

  • Preparing the dose:
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    Does Stelara Have A Black Box Warning

    No, Stelara doesnt have a black box warning, which is also called a boxed warning. These warnings are used to alert healthcare professionals and patients about very serious side effects that can happen with some drugs.

    Stelara can cause serious side effects. But the Food and Drug Administration hasnt required the manufacturers of Stelara to include a black box warning with this medication.

    What Vaccines Can I Get During Stelara Treatment

    Stelara makes your immune system less able to function. Certain vaccines are made from weakened forms of a virus. Because your immune system cant fight off the virus very well, you shouldnt get live vaccines during Stelara treatment. Doing so can put you at risk for developing the infection that the vaccine is meant to prevent.

    Your doctor may recommend that you have all of the vaccines you need before you start Stelara treatment. This includes both live and non-live vaccines, with the exception of the Bacillus Calmette-Guérin vaccine.

    The BCG vaccine is meant to prevent tuberculosis . Its more commonly given to people who live outside of the United States. You shouldnt start taking Stelara for at least 1 year after youve received a BCG vaccine.

    If you receive any non-live vaccines while youre taking Stelara, its possible that your immune system wont have the right response to the vaccine. This means that the vaccine might not be able to prevent the infection that its meant to prevent.

    Talk with your doctor to make sure you are up to date on all of your vaccinations before you start using Stelara.

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