Stelara

Stelara (ustekinumab) is a prescription medicine used to treat Crohn’s disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis in eligible adults and children. Stelara works by blocking immune system proteins called IL-12 (interleukin-12) and IL-23 (interleukin-23), which help reduce inflammation, ease pain, swelling, and improve skin symptoms. Stelara is a biologic medication from the drug class interleukin inhibitors.

Stelara is usually administered as an injection under the skin (subcutaneous injection), and Stelara infusion is used for the first dose (induction) for Crohn’s disease and ulcerative colitis. Stelara is given 4 weekly initially, then every 8 to 12 weeks for maintenance treatment, depending on the condition being treated.

Stelara injection was first FDA-approved on September 25, 2009, for adults with moderate to severe psoriasis, and since then, approval has been extended to include other conditions. Stelara's Crohn's disease FDA approval was on Sept. 26, 2016. Crohn’s disease is often written as Crohns disease.

Stelara is FDA-approved to treat:

• Crohn’s disease (moderately to severely active) in adults and children 2 years and older.
• Ulcerative colitis (moderately to severely active ) in adults and children 2 years and older.
• Plaque psoriasis (moderate to severe) in patients 6 years and older who are candidates for phototherapy or systemic therapy.
• Psoriatic arthritis (active) in patients 6 years and older.

Stelara's mechanism of action (MOA) is as an interleukin inhibitor (interleukin-12 and interleukin-23 antagonist). Stelara works by targeting immune system proteins called interleukin (IL)-12 and IL-23, which are thought to contribute to long-lasting inflammation in conditions like Crohn’s disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis. By blocking interleukin, Stelara injection helps reduce inflammation and relieve symptoms of these conditions.

Stelara is a medicine that affects your immune system. Stelara can increase your risk of having serious side effects, including:

• Serious infections. Stelara may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have serious infections during treatment with Stelara, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection. Your healthcare provider should check you for TB before starting Stelara. If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Stelara and during treatment with Stelara. Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with Stelara. You should not start Stelara if you have any kind of infection unless your healthcare provider says it is okay.

Before starting Stelara, tell your healthcare provider if you: think you have an infection or have symptoms of an infection such as fever, sweat, or chills; weight loss; muscle aches; warm, red, or painful skin or sores on your body; cough; diarrhea or stomach pain; shortness of breath; burning when you urinate or urinate more often than normal; blood in phlegm; feel very tired; are being treated for an infection or have any open cuts; get a lot of infections or have infections that keep coming back; have TB or have been in close contact with someone with TB.

After starting Stelara, call your healthcare provider right away if you get any symptoms of an infection (see above). These may be signs of infections such as chest infections, skin infections, or shingles that could have serious complications. Stelara can make you more likely to get infections or make an infection that you have worse.

• People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious infections. These infections can spread throughout the body and cause death. People who take Stelara may also be more likely to get these infections.
• Cancers. Stelara may decrease the activity of your immune system and increase your risk for certain types of cancers. Tell your healthcare provider if you have ever had any type of cancer. Some people who are receiving Stelara and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with Stelara, tell your healthcare provider if you develop any new skin growths.

Before you start treatment with this medicine, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Stelara is intended for use under the guidance and supervision of your doctor. Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Stelara for Crohn’s disease and ulcerative colitis. The first dose is given through a vein in the arm (intravenous infusion) in a healthcare facility by your healthcare provider. It takes at least 1 hour to receive the infusion. Your next doses will be given as an injection under the skin (subcutaneous injection).

Stelara for psoriasis or psoriatic arthritis. Stelara is given as an injection under the skin (subcutaneous injection) as described below.

Stelara injection instructions (subcutaneous)

• In pediatric patients, it is recommended that Stelara be administered by a healthcare provider.
• If your doctor decides that you or a caregiver may give your Stelara injections at home, you should receive training on the right way to prepare and inject this medicine.
• Your doctor will determine the right dose for you, the amount for each Stelara injection, and how often you should receive it. Your dose needs may change if you gain or lose weight.
• Do not try to inject yourself unless you or your caregiver has been shown how to use it by your doctor or nurse.
• Inject Stelara under the skin in your upper arms, buttocks, upper legs (thighs) or stomach area (abdomen).
• Do not give a Stelara injection in an area of the skin that is tender, bruised, red or hard.
• Use a different injection site each time you use this medicine.
• Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
• Be sure to keep all of your scheduled follow-up appointments.

You should not use Stelara injection or infusion if you:

• are allergic to the active ingredient ustekinumab or any of the inactive ingredients contained in the medicine. See the full list of Stelara ingredients at the bottom of this page.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, if you have recently traveled to an area where tuberculosis is common, or have received a BCG (Bacillus Calmette and Guérin) vaccine within the past 12 months.

To make sure Stelara injection or infusion is safe for you, tell your doctor if you have:

• signs of infection (fever, chills, cough, muscle aches, painful skin sores, diarrhea, pain when you urinate, feeling very tired)
• chronic infections
• have any new or changing lesions within psoriasis areas or on normal skin
• a latex allergy as the needle cover on the prefilled syringe contains latex
• receive or have received phototherapy for your psoriasis
• are receiving or have received allergy shots, especially for serious allergic reactions. Allergy shots may not work as well for you during treatment with Stelara. Stelara may also increase your risk of having an allergic reaction to an allergy shot
• have an allergy to alpha-gal or have been diagnosed with alpha-gal syndrome (a type of food allergy to certain meats or meat products that may be triggered by some tick bites)
• if you recently received or are scheduled to receive any vaccine, people who take this medicine should not receive live vaccines. Tell your doctor if anyone in your house needs a live vaccine. The viruses used in some types of live vaccines can spread to people with a weakened immune system, and can cause serious problems. You should avoid receiving the BCG vaccine during the 1 year before receiving Stelara or 1 year after you stop receiving Stelara.
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Some people using this medicine have developed skin cancer (non-melanoma). 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.

Pregnancy

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ustekinumab on the baby.

Breastfeeding

Stelara can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive Stelara.

Serious side effects

Stelara may cause serious side effects, including:

• See "What is the most important information I should know about Stelara?"
• Serious allergic reactions. Serious allergic reactions including death can occur with Stelara. Stop using Stelara and get medical help right away if you get any of the following symptoms of a serious allergic reaction: feeling faint; trouble breathing; swelling of your face, eyelids, tongue, or throat; skin rash; chest discomfort.
• Posterior Reversible Encephalopathy Syndrome (PRES). PRES is a rare condition that affects the brain and can cause death. Tell your healthcare provider right away if you get any symptoms of PRES during treatment with Stelara, including: headache; confusion; seizures; vision problems.
• Lung inflammation. Cases of lung inflammation have happened in some people who receive Stelara and may be serious. These lung problems may need to be treated in a hospital. Tell your healthcare provider right away if you develop shortness of breath or a cough that doesn't go away during treatment with Stelara.

Noninfectious Pneumonia. Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of this medicine. If diagnosis is confirmed, discontinue Stelara and treat as appropriate.

Live immunizations should not be used in patients being treated with this medicine.

BCG (Bacillus Calmette and Guérin) vaccine. Avoid BCG during treatment, for one year before initiating treatment, and for one year following discontinuation.

Common Stelara side effects

Common Stelara side effects in plaque psoriasis

• Itching (2%)
• Muscle pain (1%)
• Tiredness - fatigue (3%)
• Headache (5%)
• Back pain (1%)
• Dizziness (1%)
• Depression (1%)
• Pharyngolaryngeal pain (1%)
• Injection site redness (1%)
• Flu or cold-like symptoms - nasopharyngitis (8%)
• Upper respiratory tract infection URTI (5%).

The common side effects listed above were experienced by 1% or more of patients treated with Stelara injection (45 mg every 12 weeks) for plaque psoriasis during clinical trials PS STUDY 1 and PS STUDY 2.

Common Stelara side effects in Crohn’s disease

• Flu or cold-like symptoms - nasopharyngitis 11%
• Injection site redness (5%)
• Vaginal yeast infections (5%)
• Bronchitis (5%)
• Itchy skin (4%)
• Urinary tract infection - UTI (4%)
• Sinusitis (3%).

The side effects of Stelara injection for Crohn’s disease occurred in 3% or more of patients receiving a maintenance dose of 90 mg (given as a subcutaneous injection every 8 weeks) during clinical trial CD-3.

Common Stelara side effects in ulcerative colitis

• Flu or cold-like symptoms - nasopharyngitis (24%)
• Headache (10%)
• Stomach pain (7%)
• Influenza (6%)
• Fever (5%)
• Diarrhea (4%)
• Sinusitis (4%)
• Tiredness - fatigue (4%)
• Nausea (3%).

Side effects of Stelara for ulcerative colitis occurred in 3% or more of patients receiving a weight-based maintenance dose during clinical trial UC-2.

Stelara psoriasis and psoriatic arthritis dose: Given as a subcutaneous injection initially, then 4 weeks later, and then a maintenance dose every 12 weeks.

Stelara Crohn’s disease and ulcerative colitis dose. The first dose is given as an infusion, then it is given as a subcutaneous injection every 8 weeks thereafter.

The dose is dependent on the patient's weight.

Subcutaneous Injection

• single-dose prefilled syringe 45 mg/0.5 mL or 90 mg/mL
• single-dose vial 45 mg/0.5 mL

Intravenous Infusion

• single-dose vial 130 mg/26 mL (5 mg/mL)

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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 this medicine, 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 (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

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

Non-live vaccines (including flu shots) 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.

Stelara is a biologic medicine and was the first brand of ustekinumab to be FDA-approved, so it is called the reference product. There are 8 Stelara biosimilars:

• Pyzchiva, Selarsdi, Otulfi, Yesintek, Steqeyma, Starjemza, and Imuldosa are interchangeable, which means they may be dispensed when the prescription has been written for Stelara without consulting the prescriber, subject to state laws.
• Wezlana has some presentations that are interchangeable with Stelara and others that are not.

Other drugs may interact with Stelara, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

It is important to tell your doctor if you are taking any of the following:

• anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven)
• medications that suppress the immune system, such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), methotrexate (Otrexup, Rasuvo, Trexall, Xatmep), sirolimus (Rapamune), and tacrolimus (Astagraf, Envarsus, Prograf)
• oral steroids such as dexamethasone (Hemady), methylprednisolone (Medrol), and prednisone (Rayos).

Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Not all possible interactions are listed here.

The Stelara Package Insert contains more detailed information about this medicine, including Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies, Drug Interactions, and more. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Stelara Prescribing Information (PI) or the FDA label.

• Store Stelara vials and prefilled syringes in a refrigerator between 36 °F and 46 °F (2 °C and 8 °C).
• Store Stelara vials standing up straight (upright).
• Store Stelara in the original carton to protect it from light until time to use it.
• Do not freeze Stelara.
• Do not shake Stelara.
• If needed, individual Stelara prefilled syringes may also be stored at room temperature up to 86 °F (30 °C) for a maximum single period of up to 30 days in the original carton to protect from light.
• Record the date when the prefilled syringe is first removed from the refrigerator on the carton in the space provided.
• After a prefilled syringe has been stored at room temperature, do not return it to the refrigerator.
• Throw away (discard) the prefilled syringe if it is not used within 30 days at room temperature storage.
• Do not use Stelara after the expiration date on the carton or on the prefilled syringe.

Keep Stelara and all medicines out of the reach of children.

Active ingredient: ustekinumab

Inactive ingredients: Single-dose prefilled syringe and single-dose vial for subcutaneous use contain L-histidine, L-histidine monohydrochloride monohydrate, Polysorbate 80, and Sucrose. Single-dose vial for intravenous infusion contains EDTA disodium salt dihydrate, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, Polysorbate 80, and Sucrose.

Stelara is manufactured by Janssen Biotech, Inc., Horsham, PA 19044, USA. U.S. License No. 1864.

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Stelara.

Stelara (ustekinumab) - Janssen Biotech, Inc.

Stelara interchangeable products

Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.

Pharmacy laws for biosimilar prescribing may vary by state.

Imuldosa (ustekinumab-srlf) - Accord BioPharma Inc.

View Imuldosa information in detail.

Otulfi (ustekinumab-aauz) - Fresenius Kabi USA, LLC

View Otulfi information in detail.

Pyzchiva (ustekinumab-ttwe) - Samsung Bioepis Co., Ltd.

View Pyzchiva information in detail.

Selarsdi (ustekinumab-aekn) - Alvotech USA Inc.

View Selarsdi information in detail.

Starjemza (ustekinumab-hmny) - Bio-Thera Solutions, Ltd.

View Starjemza information in detail.

Steqeyma (ustekinumab-stba) - CELLTRION, Inc.

View Steqeyma information in detail.

Wezlana (ustekinumab-auub) - Amgen Inc.

View Wezlana information in detail.

Yesintek (ustekinumab-kfce) - Biocon Biologics Inc.

View Yesintek information in detail.

Stelara biosimilar products

Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state

Wezlana (ustekinumab-auub) - Amgen Inc.

View Wezlana information in detail.

Yesintek (ustekinumab-kfce) - Biocon Biologics Inc.

View Yesintek information in detail.