Starjemza

Starjemza (ustekinumab-hmny) is a biosimilar to Stelara used to treat certain types of plaque psoriasis, active psoriatic arthritis, Crohn's disease, and ulcerative colitis, which are all autoimmune conditions.

Starjemza's mechanism of action involves blocking certain inflammatory proteins in your body, called IL-12 (interleukin-12) and IL-23 (interleukin-23). These proteins are known as cytokines and they are responsible for the inflammation associated with certain autoimmune conditions. By blocking their activity, Starjemza reduces inflammation, pain, swelling, and skin symptoms.

Starjemza gained FDA approval in May 2025 as a biosimilar to Stelara. A biosimilar is a biological product that is like the reference biologic (in this case Stelara) and for which there are no clinically meaningful differences in terms of safety, purity, and potency.

Starjemza is used to treat:

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

It is not known if Starjemza is safe and effective in children less than 6 years of age.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Starjemza is intended for use under the guidance and supervision of your doctor. Prepare your injection only when you are ready to give it. Starjemza should look clear and colorless to light yellow. Do not use it if it is frozen, discolored, cloudy, or has particles in it. Call your pharmacist for new medicine.

• Crohn's disease and ulcerative colitis: The first dose of Starjemza is given through a vein in the arm (intravenous infusion) by your healthcare provider. It takes at least 1 hour to receive the infusion. Your next dose is given as an injection under the skin (subcutaneous injection) 8 weeks after the infusion, then every 8 weeks after that.
• Psoriasis or psoriatic arthritis: Starjemza is given as an injection under the skin (subcutaneous injection) as described below.

How to administer subcutaneous Starjemza

In children 6 years and older, it is recommended that Starjemza is administered by a healthcare provider. If your doctor decides that you or a caregiver may give your injections at home, you should receive training on the right way to prepare and inject Starjemza.

• Your doctor will determine the right dose for you, the amount for each injection, and how often you should receive it. Your dose needs may change if you gain or lose weight, because the dose is based on your weight at the time of dosing.
• Do not try to inject yourself unless you or your caregiver have been shown how to use it by your doctor or nurse.
• Inject Starjemza under the skin 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 this medicine.
• If you are using vials and your dose is 90 mg, you will receive two 45 mg vials and will need to give two injections, one right after the other.
• Do not shake the syringe or vial at any time. Shaking can damage the medicine.
• Do not use a vial more than once, even if there is medicine left in it. Once the rubber stopper is punctured, the medicine can become contaminated by bacteria that could cause an infection.
• Use a needle and syringe only once and then place them in a sharps disposal container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets. Throw away any unused portion of Starjemza.
• Be sure to keep all of your scheduled follow-up appointments.

You should not use Starjemza if you are allergic to ustekinumab products, or to any of the inactive ingredients in Starjemza. Ask your doctor if you are not sure.

Latex. The needle cover on the Starjemza prefilled syringe contains dry natural rubber, a derivative of latex, which may cause an allergic reaction in people who are sensitive to latex. Tell your doctor if you have a latex allergy, and do not handle the needle cover if you are sensitive to latex.

Before you start treatment with this injection, your doctor should evaluate you for tuberculosis. Starjemza should not be given to people with active tuberculosis, and treatment for latent tuberculosis should be started before Starjemza is given.

• Tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone with tuberculosis.

To make sure Starjemza is safe for you, tell your healthcare provider about all your medical conditions, including if you:

• have signs of infection (fever, sweats or chills, muscle aches, cough, shortness of breath, blood in phlegm, weight loss, warm, red or painful skin or sores, diarrhea or stomach pain, burning when you urinate, feeling 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 ever had an allergic reaction to an ustekinumab product
• are allergic to latex
• 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)
• have new or changing skin lesions within psoriasis areas or on normal skin
• have ever had any type of cancer
• receive or have received phototherapy (light therapy) for 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 Starjemza. Starjemza may also increase your risk of having an allergic reaction to an allergy shot
• 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 one year before receiving Starjemza or one year after you stop receiving Starjemza
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known whether Starjemza will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant, and you and your doctor should decide together whether you will receive Starjemza.

If you received Starjemza while you were pregnant, it is important that you tell your baby's healthcare provider before any vaccinations are given to your baby.

Breastfeeding

Starjemza can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you receive this medicine.

The most common Starjemza side effects are:

• nasal congestion, sore throat, and runny nose
• upper respiratory infections
• fever
• headache
• tiredness
• itching
• nausea and vomiting
• flu (influenza)
• redness at the injection site
• vaginal yeast infections
• urinary tract infections
• sinus infection
• bronchitis
• diarrhea
• stomach pain
• joint pain.

Serious Starjemza side effects and warnings

Starjemza can cause the following serious side effects.

Serious infections. Starjemza may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have serious infections while taking ustekinumab products, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection.

• Your doctor should check you for TB before starting Starjemza.
• If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Starjemza and during treatment with Starjemza.
• Your doctor should watch you closely for signs and symptoms of TB while you are being treated with Starjemza.

You should not start taking Starjemza if you have any kind of infection unless your doctor says it is okay.

After starting Starjemza, call your doctor right away if you have any symptoms of an infection such as fever, sweats or chills, muscle aches, cough, shortness of breath, blood in 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, or feeling very tired. These may be signs of infections such as chest infections, or skin infections or shingles, that could have serious complications.

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 Starjemza may also be more likely to get these infections.

Cancers. Starjemza may decrease the activity of your immune system and increase your risk for certain types of cancers. Tell your doctor if you have ever had any type of cancer. Some people who are receiving ustekinumab products and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with Starjemza, tell your doctor if you develop any new skin growths. Your doctor may monitor you more closely if you are over 60 years of age, have taken medicines that suppress the immune system for a long time, or have had PUVA treatment.

Serious allergic reactions. Serious allergic reactions, including anaphylaxis and angioedema (swelling under the skin), have been reported with ustekinumab products after these medicines were approved. Other allergic reactions, including rash and hives, have also been reported.

In the Crohn's disease clinical trials, two people had allergic reactions. One developed symptoms consistent with anaphylaxis, including tightness of the throat, shortness of breath, and flushing, after a single injection under the skin. The other developed chest discomfort, flushing, hives, and a raised temperature after their first intravenous dose. Both were treated with antihistamines or corticosteroids, and in both cases the symptoms settled within an hour.

The first dose for Crohn's disease and ulcerative colitis is given as an infusion in a healthcare setting, where staff can treat a reaction straight away.

Stop using Starjemza and get medical help right away if you have any symptoms of a serious allergic reaction, such as:

• feeling faint or light-headed
• swelling of your face, eyelids, tongue, or throat
• chest tightness or chest discomfort
• trouble breathing or shortness of breath
• hives, a skin rash, or flushing.

Do not take another dose of Starjemza unless your doctor tells you it is safe to do so.

Posterior Reversible Encephalopathy Syndrome (PRES). PRES is a rare condition that affects the brain and can cause death. The cause of PRES is not known. If PRES is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including headache, confusion, seizures, or vision problems.

Lung inflammation. Cases of lung inflammation, including interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia, have happened in some people who receive ustekinumab products such as Starjemza, and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn't go away during treatment with Starjemza.

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 or
• 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 or to Hikma Pharmaceuticals USA Inc. at 1-877-845-0689.

Your healthcare provider will work out the right dose for you based on your condition and, where relevant, your weight at the time of dosing.

Starjemza dosage for plaque psoriasis

Adults:

• 100 kg or less: 45 mg
• More than 100 kg: 90 mg.

Children 6 to 17 years:

• Less than 60 kg: 0.75 mg/kg
• 60 kg to 100 kg: 45 mg
• More than 100 kg: 90 mg.

For both adults and children, Starjemza is given as a subcutaneous injection initially and 4 weeks later, then every 12 weeks.

Starjemza dosage for psoriatic arthritis

Adults:

• 45 mg, regardless of weight
• 90 mg for people who also have moderate to severe plaque psoriasis and weigh more than 100 kg.

Children 6 to 17 years:

• Less than 60 kg: 0.75 mg/kg
• 60 kg or more: 45 mg
• More than 100 kg with co-existing moderate to severe plaque psoriasis: 90 mg.

For both adults and children, Starjemza is given as a subcutaneous injection initially and 4 weeks later, then every 12 weeks.

Starjemza dosage for Crohn's disease and ulcerative colitis

Adults receive a single intravenous infusion first, based on weight:

• Up to 55 kg: 260 mg (2 vials)
• More than 55 kg to 85 kg: 390 mg (3 vials)
• More than 85 kg: 520 mg (4 vials).

A 90 mg subcutaneous injection is then given 8 weeks after the initial intravenous dose, and every 8 weeks after that.

Starjemza is available as

Subcutaneous injection:

• Starjemza 45 mg/0.5 mL single-dose prefilled syringe
• Starjemza 90 mg/mL single-dose prefilled syringe
• Starjemza 45 mg/0.5 mL solution in a single-dose vial.

Intravenous infusion:

• Starjemza 130 mg/26 mL (5 mg/mL) solution in a single-dose vial.

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.

You should not receive the BCG vaccine during the one year before receiving Starjemza or for at least one year after your last dose.

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.

Other drugs may interact with Starjemza, 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:

• medicines with a narrow safety margin that are broken down by CYP450 liver enzymes, such as warfarin (Coumadin, Jantoven) and cyclosporine (Gengraf, Neoral, Sandimmune). Blocking IL-12 and IL-23 can change how quickly the liver clears these medicines, so your doctor may check your levels or response and adjust your dose when Starjemza is started or stopped
• allergen immunotherapy (allergy shots). Starjemza may reduce how well allergy shots work and may increase the risk of an allergic reaction to them.

In psoriasis studies, ustekinumab has not been evaluated in combination with medicines that suppress the immune system or with phototherapy. In studies in psoriatic arthritis, Crohn's disease, and ulcerative colitis, taking methotrexate, azathioprine, 6-mercaptopurine, or oral corticosteroids alongside ustekinumab did not appear to change how safe or effective it was.

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.

Store Starjemza vials and prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C). Store vials standing up straight. Keep the medicine in the original carton to protect it from light until time to use it. Do not freeze. Do not shake.

Prefilled syringes and vials have different room-temperature rules. Check which one you have been given.

Prefilled syringes

• If needed, an individual prefilled syringe may 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.
• Once a prefilled syringe has been stored at room temperature, do not return it to the refrigerator.
• Throw away the prefilled syringe if it is not used within 30 days at room temperature.

45 mg vials

• An individual 45 mg vial may be stored at room temperature up to 77°F (25°C), out of the original carton, for up to 8 hours.
• After the medicine has been drawn into a syringe with the needle attached, the filled syringe may be kept at up to 77°F (25°C) for up to 4 hours before injection.
• Once a 45 mg vial has been stored at room temperature, do not return it to the refrigerator.

Do not use Starjemza after the expiration date on the carton, the prefilled syringe, or the vial.

Active ingredient: ustekinumab-hmny

Inactive ingredients

Single-dose prefilled syringe and single-dose vial for subcutaneous use: histidine, L-histidine hydrochloride monohydrate, polysorbate 80, and sucrose.

Single-dose vial for intravenous infusion: edetate disodium, histidine, L-histidine hydrochloride monohydrate, methionine, polysorbate 80, and sucrose.

The needle cover on the prefilled syringe contains dry natural rubber, a derivative of latex.

Starjemza is manufactured by Bio-Thera Solutions, Ltd., Guangzhou, China, and distributed in the US by Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ.

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 Starjemza.

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.

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.