Ustekinumab

Ustekinumab injection is used to treat plaque psoriasis, ulcerative colitis, Crohn’s disease, and psoriatic arthritis, which are autoimmune disorders. Ustekinumab injection works by targeting specific proteins in the immune system that drive inflammation. By blocking these proteins, ustekinumab helps reduce inflammation, pain, swelling, and skin symptoms.

Ustekinumab's mechanism of action (MOA) is an interleukin inhibitor that targets and blocks proteins IL-12 (interleukin-12) and IL-23 (interleukin-23) in the immune system, which improves symptoms in these conditions.

Ustekinumab is usually given as an injection under the skin (subcutaneous injection) for most doses except initial doses for Crohn’s disease and ulcerative colitis, which is given as an infusion into a vein (intravenous infusion). Ustekinumab maintenance dose is every 8 to 12 weeks, depending on the condition being treated.

Ustekinumab brand name Stelara, was first FDA approved on September 25, 2009. Since then, FDA approval has been received for ustekinumab biosimilars and interchangeable biosimilars.

Ustekinumab injection is used to treat:

• 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.
• 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.

It is not known if ustekinumab injection is safe and effective in children less than 6 years of age with psoriasis or psoriatic arthritis, or children less than 2 years of age with Crohn's disease or ulcerative colitis.

Ustekinumab brand names are Stelara, Wezlana, Selarsdi, Pyzchiva, Otulfi, Imuldosa, Yesintek, Steqeyma, and Starjemza.

The ustekinumab reference product is Stelara, the first brand of ustekinumab to become FDA-approved. Since then, other brands of ustekinumab have been approved.

You should not use this medicine if you have received a vaccine to prevent tuberculosis (BCG vaccine) within 1 year before using ustekinumab while using it, or 1 year after you have finished treatment. Before you start treatment with this medicine your doctor may perform tests to make sure you do not have tuberculosis.

When you are being treated with ustekinumab, it can make you more likely to get infections or make an infection that you have worse. Call your doctor right away if you have signs of infection, including fever, chills, muscle pain, shortness of breath, weight loss, diarrhea or stomach pain, burning when you urinate, feeling very tired, skin warmth or redness, painful skin sores, or coughing up blood.

Ustekinumab may also cause a rare but serious condition affecting the brain. Tell your doctor right away if you have a headache, confusion, vision problems, or a seizure

You should not use ustekinumab injection or infusion if you:

• are allergic to the active ingredient ustekinumab or any of the inactive ingredients contained in the medicine.
• have active tuberculosis; or
• have received a BCG (Bacillus Calmette and Guérin) vaccine within the past 12 months.

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.

To make sure ustekinumab 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
• a genetic problem where your body does not make the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23)
• new or changing skin lesions
• a latex allergy as the needle cover on the prefilled syringe contains latex
• phototherapy (light therapy)
• allergy shots
• 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
• 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).

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

It may not be safe to breastfeed while using this medicine. It is thought that ustekinumab passes into your breast milk in small amounts. Talk to your doctor about the best way to feed your baby if you receive this medicine.

Common ustekinumab side effects

• cough with mucus, shortness of breath, chest discomfort
• Infection
• fever, flu-like symptoms
• headache, tiredness
• Itching
• redness at the injection site
• vaginal itching or discharge
• pain or burning when you urinate
• stomach pain, nausea, vomiting, diarrhea.

Serious ustekinumab side effects

Serious hypersensitivity reactions have been reported with intravenous and subcutaneous administration of ustekinumab products. Discontinue ustekinumab and seek immediate medical attention if you experience any signs or symptoms of hypersensitivity reactions, such as hives; chest discomfort, difficulty breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Serious infections may occur during treatment with ustekinumab. Call your doctor right away if you have signs of infection, including fever, chills, muscle pain, shortness of breath, weight loss, diarrhea or stomach pain, burning when you urinate, feeling very tired, skin warmth or redness, painful skin sores, or coughing up blood.

Also, call your doctor at once if you have:

• a mole that has changed in size or color
• swelling, pain, warmth, or redness anywhere on your body
• stomach pain that is sudden and severe or comes on slowly, changes in bowel habits (diarrhea or constipation)
• new or worsening cough, sudden chest pain, feeling short of breath
• pain or burning when you urinate
• severe headache, confusion, change in mental status, vision problems, and/or seizure (convulsions).

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088

If you have psoriasis, you will be given ustekinumab as an injection under the skin (subcutaneous injection). Once you have had your first injection, you will have your next injection after 4 weeks, and from then on you will have an injection every 12 weeks.

If you have Crohn’s disease or ulcerative colitis, your first dose is given slowly as an infusion into a vein by your doctor or nurse. The next doses you have will be every 8 weeks as an injection under the skin (subcutaneous injection).

You will be able to inject yourself or have a caregiver give you your injection once you have been shown how to do this by your doctor or nurse.

The dose your healthcare provider will give you will depend on how much you weigh and whether you have psoriasis, Crohn’s disease or ulcerative colitis.

How to use ustekinumab injection

• Inject ustekinumab under the skin (subcutaneous injection) in your upper arms, buttocks, upper legs (thighs), or stomach area (abdomen).
• Do not 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.
• If you inject more ustekinumab than prescribed, call your doctor right away.
• Be sure to keep all of your scheduled follow-up appointments.

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.

Other drugs may interact with ustekinumab, 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. Not all possible interactions are listed here.

Stelara vials and prefilled syringes

• Refrigerate at 2°C to 8°C (36°F to 46°F).
• Store ustekinumab vials upright.
• Keep the product in the original carton to protect it from light until the time of use.
• Do not freeze.
• Do not shake.

Active ingredient: ustekinumab

Inactive ingredients:

Stelera:

Single-dose prefilled syringe for subcutaneous use: L-histidine, L-histidine monohydrochloride monohydrate, Polysorbate 80, and sucrose.

Single-dose vial for subcutaneous use contains L-histidine, L-histidine hydrochloride 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.

Selarsdi:

Inactive ingredients (single-dose prefilled syringe for SC use): histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and water for injection.

Inactive ingredients (single-dose vial for intravenous infusion): edetate disodium, histidine, L-histidine monohydrochloride monohydrate, methionine, polysorbate 80, sucrose, and water for injection.

Selarsdi is available as a 45 mg/0.5 mL single-dose prefilled syringe and a 90 mg/mL single-dose prefilled syringe.

Selarsdi is also available as a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion.

Imuldosa

Inactive ingredients (single-dose prefilled syringe for subcutaneous use): histidine, histidine hydrochloride monohydrate, polysorbate 80, and sucrose.

Inactive ingredients (single-dose vial for intravenous infusion): edetate disodium, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 80, and sucrose.

Imuldosa is available as a 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe for SC use.

Imuldosa is also available as a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion.

Otulfi

Inactive ingredients (single-dose prefilled syringe for subcutaneous use): histidine, polysorbate 80,sucrose and hydrochloric acid (to adjust pH).

Inactive ingredients (single-dose vial for intravenous infusion): edetate disodium, histidine, L-histidine hydrochloride monohydrate, methionine, polysorbate 80, and sucrose.

Otulfi is available as a 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe for SC use.

Otulfi is also available as a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion.

Pyzchiva

Inactive ingredients (single-dose prefilled syringe for subcutaneous use): histidine, histidine hydrochloride monohydrate, polysorbate 80, and sucrose.

Inactive ingredients (single-dose vial for intravenous infusion): edetate disodium, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 80, and sucrose.

Pyzchiva is available as a 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe for SC use.

Pyzchiva is available as a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion.

Wezlana

Inactive ingredients (single-dose prefilled syringe for subcutaneous use): histidine, histidine hydrochloridemonohydrate, Polysorbate 80, and sucrose.

Inactive ingredients (single-dose vial for subcutaneous use): histidine, histidine hydrochloride monohydrate, Polysorbate 80, and sucrose.

Inactive ingredients (single-dose vial for intravenous infusion) edetate disodium, histidine, histidine hydrochloride monohydrate, methionine, Polysorbate 80, and sucrose.

Yesintek

Inactive ingredients (single-dose prefilled syringe for subcutaneous use): histidine, L-histidine monohydrochloride monohydrate, Polysorbate 80, and sucrose. Hydrochloric acid and sodium hydroxide added to adjust the pH.

Inactive ingredients (single-dose vial for subcutaneous use): histidine, L-histidine hydrochloride monohydrate, Polysorbate 80, and sucrose. Hydrochloric acid and sodium hydroxide are added to adjust the pH.

Inactive ingredients (single-dose vial for intravenous infusion): edetate disodium, histidine, L-histidine hydrochloride monohydrate, methionine, Polysorbate 80, and sucrose. Hydrochloric acid and sodium hydroxide are added to adjust the pH.

Steqeyma

Inactive ingredients (single-dose prefilled syringe for subcutaneous use): histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection.

Inactive ingredients (single-dose vial for subcutaneous use): histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection.

Inactive ingredients (single-dose vial for intravenous infusion): edetate disodium, histidine, L-histidine monohydrochloride monohydrate, methionine, polysorbate 80, sucrose, and Water for Injection.

Stelara: Janssen Biotech, Inc.

Selarsdi: Alvotech and Teva Pharmaceutical Industries.

Steqeyma: Celltrion Inc.

Imuldosa: Dong-A ST and Meiji Seika Pharma.

Otulfi: Fresenius Kabi.

Pyzchiva: Samsung Bioepis Co., Ltd., makes Pyzchiva for Sandoz Inc.

Wezlana: Amgen, Inc.

Yesintek: Biocon Biologics Inc.

Starjemza: Hikma Pharmaceuticals USA Inc.

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 ustekinumab.

Stelara (ustekinumab) - Janssen Biotech, Inc.

View Stelara information in detail.

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.