These highlights do not include all the information needed to use USTEKINUMAB-TTWE safely and effectively. See full prescribing information for USTEKINUMAB-TTWE. USTEKINUMAB-TTWE injection, for subcutaneous or intravenous useInitial U.S. Approval: 2024 Ustekinumab-ttwe is biosimilarBiosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of USTEKINUMAB-TTWE has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information to STELARA (ustekinumab)

MEDICATION GUIDE USTEKINUMAB-TTWE (us-te-KIN-ne-mab ttwe) injection, for subcutaneous or intravenous use
This Medication Guide has been approved by the U.S. Food and Drug Administration.		Revised: 01/2026
What is the most important information I should know about USTEKINUMAB-TTWE? USTEKINUMAB-TTWE is a medicine that affects your immune system. USTEKINUMAB-TTWE can increase your risk of having serious side effects, including: Serious infections: USTEKINUMAB-TTWE 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 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 healthcare provider should check you for TB before starting USTEKINUMAB-TTWE. 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 USTEKINUMAB-TTWE and during treatment with USTEKINUMAB-TTWE. Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with USTEKINUMAB-TTWE. You should not start USTEKINUMAB-TTWE if you have any kind of infection unless your healthcare provider says it is okay. Before starting USTEKINUMAB-TTWE, tell your healthcare provider if you: think you have an infection or have symptoms of an infection such as:
	fever, sweat, 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 urinate more often than normal 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 USTEKINUMAB-TTWE, call your healthcare provider right away if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. USTEKINUMAB-TTWE 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 USTEKINUMAB-TTWE may also be more likely to get these infections. Cancers. USTEKINUMAB-TTWE 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 ustekinumab products and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with USTEKINUMAB-TTWE, tell your healthcare provider if you develop any new skin growths.
What is USTEKINUMAB-TTWE? USTEKINUMAB-TTWE is a prescription medicine used to treat: adults and children 6 years of age and older with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). adults and children 6 years of age and older with active psoriatic arthritis. adults with moderately to severely active Crohn's disease. adults with moderately to severely active ulcerative colitis. It is not known if USTEKINUMAB-TTWE is safe and effective in children with Crohn's disease or ulcerative colitis or in children less than 6 years of age with plaque psoriasis or psoriatic arthritis.
Who should not use USTEKINUMAB-TTWE? Do not use USTEKINUMAB-TTWE if you are allergic to ustekinumab products or any of the ingredients in USTEKINUMAB-TTWE. See the end of this Medication Guide for a complete list of ingredients in USTEKINUMAB-TTWE.
Before you use or receive USTEKINUMAB-TTWE, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about USTEKINUMAB-TTWE?" ever had an allergic reaction to ustekinumab products. Ask your healthcare provider if you are not sure. have recently received or are scheduled to receive an immunization (vaccine). People who are being treated with USTEKINUMAB-TTWE should avoid receiving live vaccines. Tell your healthcare provider 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 USTEKINUMAB-TTWE or one year after you stop receiving USTEKINUMAB-TTWE. have any new or changing lesions within psoriasis areas or on normal skin. are receiving or have received allergy shots, especially for serious allergic reactions. Allergy shots may not work as well for you during treatment with USTEKINUMAB-TTWE. USTEKINUMAB-TTWE may also increase your risk of having an allergic reaction to an allergy shot. receive or have received phototherapy for your psoriasis. are pregnant or plan to become pregnant. It is not known if USTEKINUMAB-TTWE can harm your unborn baby. You and your healthcare provider should decide if you will receive USTEKINUMAB-TTWE. are breastfeeding or plan to breastfeed. USTEKINUMAB-TTWE can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive USTEKINUMAB-TTWE. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I use USTEKINUMAB-TTWE? Use USTEKINUMAB-TTWE exactly as your healthcare provider tells you to. The healthcare provider will determine the right dose of USTEKINUMAB-TTWE, the amount for each injection, and how often it should be given. Be sure to keep all scheduled follow-up appointments. Adults with Crohn's disease and ulcerative colitis will receive the first dose of USTEKINUMAB-TTWE through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider. It takes at least 1 hour to receive the full dose of medicine. USTEKINUMAB-TTWE will then be received as an injection under the skin (subcutaneous injection) 8 weeks after the first dose of USTEKINUMAB-TTWE, as described below. Adults and children 6 years of age and older with plaque psoriasis or psoriatic arthritis will receive USTEKINUMAB-TTWE as an injection under the skin as described below. Injecting USTEKINUMAB-TTWE under the skin USTEKINUMAB-TTWE is intended for use under the guidance and supervision of a healthcare provider. In children, it is recommended that USTEKINUMAB-TTWE be administered by a healthcare provider. If a healthcare provider decides that you or a caregiver may give the injections of USTEKINUMAB-TTWE at home, you or a caregiver should receive training on the right way to prepare and give the injections. Do not try to inject USTEKINUMAB-TTWE until you have been shown how to give the injections by a healthcare provider. USTEKINUMAB-TTWE can be injected under the skin in the 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-TTWE. If you inject too much USTEKINUMAB-TTWE, call the healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest emergency room right away. Read the detailed Instructions for Use at the end of this Medication Guide for instructions about how to prepare and inject a dose of USTEKINUMAB-TTWE, and how to properly throw away (dispose of) used needles, syringes, and vials. The syringe, needle, and vial must never be re-used. After the rubber stopper is punctured, USTEKINUMAB-TTWE can become contaminated by harmful bacteria which could cause an infection if re-used. Therefore, throw away any unused portion of USTEKINUMAB-TTWE.
What should I avoid while using USTEKINUMAB-TTWE? You should avoid receiving a live vaccine during treatment with USTEKINUMAB-TTWE. See "Before you use or receive USTEKINUMAB-TTWE, tell your healthcare provider about all of your medical conditions, including if you:"
What are the possible side effects of USTEKINUMAB-TTWE? USTEKINUMAB-TTWE may cause serious side effects, including: See "What is the most important information I should know about USTEKINUMAB-TTWE?" Serious allergic reactions. Serious allergic reactions including death can occur with USTEKINUMAB-TTWE. Stop using USTEKINUMAB-TTWE and get medical help right away if you get any of the following symptoms of a serious allergic reaction:
	feeling faint swelling of your face, eyelids, tongue, or throat chest discomfort	trouble breathing skin rash
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 USTEKINUMAB-TTWE, including:
	headache seizures	confusion vision problems
Lung inflammation. Cases of lung inflammation have happened in some people who receive ustekinumab products, 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 USTEKINUMAB-TTWE. The most common side effects of USTEKINUMAB-TTWE include:
	nasal congestion, sore throat, and runny nose upper respiratory infections fever headache tiredness itching nausea and vomiting influenza	redness at the injection site vaginal yeast infections urinary tract infections sinus infection bronchitis diarrhea stomach pain joint pain
These are not all of the possible side effects of USTEKINUMAB-TTWE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Quallent Pharmaceuticals Health LLC at 1-877-605-7243.
How should I store USTEKINUMAB-TTWE? Store USTEKINUMAB-TTWE vials, and prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C). Store USTEKINUMAB-TTWE vials standing up straight (upright). Store USTEKINUMAB-TTWE in the original carton to protect it from light until time to use it. Do not freeze USTEKINUMAB-TTWE. Do not shake USTEKINUMAB-TTWE. If needed, individual USTEKINUMAB-TTWE prefilled syringes may be stored at room temperature up to 86°F (30°C) for a maximum single period of up to 35 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. You may return the prefilled syringe to the refrigerator 1 time only for a maximum of 60 days, either during the 35-day period or at the end of the 35-day period. Record the date when the prefilled syringe is returned to the refrigerator on the carton. Throw away (discard) the prefilled syringe if not used within 35 days of room temperature storage and you did not return it to the refrigerator, or if it has been returned to the refrigerator and is not used within 60 days. Do not use USTEKINUMAB-TTWE after the expiration date on the carton or on the prefilled syringe. Keep USTEKINUMAB-TTWE and all medicines out of the reach of children.
General information about the safe and effective use of USTEKINUMAB-TTWE. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use USTEKINUMAB-TTWE for a condition for which it was not prescribed. Do not give USTEKINUMAB-TTWE to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about USTEKINUMAB-TTWE that was written for health professionals.
What are the ingredients in USTEKINUMAB-TTWE? Active ingredient: ustekinumab-ttwe Inactive ingredients: Single-dose prefilled syringe, and single-dose vial for subcutaneous use contain histidine, histidine hydrochloride monohydrate, polysorbate 80, and sucrose. Single-dose vial for intravenous infusion contains edetate disodium, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 80, and sucrose. Manufactured by: Samsung Bioepis Co., Ltd., 76, Songdogyoyuk-ro, Yeonsu-gu, Incheon, 21987, Republic of Korea U.S. License No. 2046 Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands For more information, call 1-877-605-7243.

Revised: 1/2026

Document Id: cb6d8d30-9458-42ed-8aee-2aae13f4760b

Set id: 2b34392a-ecf6-41bd-8706-d4e9f0b25da8

Version: 6

Effective Time: 20260112

Quallent Pharmaceuticals Health LLC