WEZLANA ustekinumab-auub 45 mg/.5mL Injection, Solution, 1 syringe — NDC 84612-076-01 (Billing 84612-0076-01)

1 INDICATIONS AND USAGE WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. ( 1.1 ) Active psoriatic arthritis in adult and pediatric patients 6 years of age and older. ( 1.2 ) Moderately to severely active Crohn's disease in adult patients.

( 1.3 ) Moderately to severely active ulcerative colitis in adult patients . ( 1.4 )

1.1Plaque Psoriasis (PsO) WEZLANA is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

1.2Psoriatic Arthritis (PsA) WEZLANA is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis.

1.3Crohn's Disease (CD) WEZLANA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease.

1.4Ulcerative Colitis (UC) WEZLANA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

2 DOSAGE AND ADMINISTRATION Adult Patients with Plaque Psoriasis Subcutaneous Recommended Dosage ( 2.1 ): Weight Range (kilograms) Recommended Dosage less than or equal to 100 kg 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks greater than 100 kg 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks Pediatric Patients 6 Years of Age and Older with Plaque Psoriasis Subcutaneous Recommended Dosage ( 2.1 ) : Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter.

Weight Range (kilograms) Recommended Dose less than 60 kg 0.75 mg/kg 60 kg to 100 kg 45 mg greater than 100 kg 90 mg Psoriatic Arthritis Adult Subcutaneous Recommended Dosage ( 2.2 ): The recommended dosage is 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks. For patients with co-existent moderate-to-severe plaque psoriasis weighing greater than 100 kg, the recommended dosage is 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks.

Psoriatic Arthritis Pediatric Patients 6 Years of Age and Older Subcutaneous Recommended Dosage ( 2.2 ): Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter. Weight Range (kilograms) Recommended Dose less than 60 kg 0.75 mg/kg 60 kg or more 45 mg greater than 100 kg with co- existent moderate-to-severe plaque psoriasis 90 mg Crohn's Disease Initial Adult Intravenous Recommended Dose ( 2.3 ): A single intravenous infusion using weight-based dosing: Weight Range (kilograms) Recommended Dose 55 kg or less 260 mg greater than 55 kg to 85 kg 390 mg greater than 85 kg 520 mg Crohn's Disease Maintenance Adult Subcutaneous Recommended Dosage ( 2.3 ) : A subcutaneous 90 mg dose 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

Ulcerative Colitis Initial Adult Intravenous Recommended Dose ( 2.4 ): A single intravenous infusion using weight-based dosing: Weight Range (kilograms) Recommended Dose 55 kg or less 260 mg greater than 55 kg to 85 kg 390 mg greater than 85 kg 520 mg Ulcerative Colitis Maintenance Adult Subcutaneous Recommended Dosage ( 2.4 ): A subcutaneous 90 mg dose 8 weeks after the initial intravenous dose, then every 8 weeks thereafter

2.1Recommended Dosage in Plaque Psoriasis Subcutaneous Adult Dosage Regimen For patients weighing 100 kg or less, the recommended dosage is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks. For patients weighing more than 100 kg, the recommended dosage is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks. In subjects weighing more than 100 kg, 45 mg was also shown to be efficacious.

However, 90 mg resulted in greater efficacy in these subjects [see Clinical Studies (14) ] . Subcutaneous Pediatric Dosage Regimen Administer WEZLANA subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter. The recommended dose of WEZLANA for pediatric patients 6 years of age and older with plaque psoriasis based on body weight is shown below (Table 1).

Table 1. Recommended Dose of WEZLANA for Subcutaneous Injection in Pediatric Patients 6 Years of Age and Older with Plaque Psoriasis Body Weight of Patient at the Time of Dosing Recommended Dose less than 60 kg 0.75 mg/kg 60 kg to 100 kg 45 mg more than 100 kg 90 mg For pediatric patients weighing less than 60 kg, the administration volume for the recommended dose (0.75 mg/kg) is shown in Table 2; withdraw the appropriate volume from the vial. Table 2.

Injection Volumes of WEZLANA 45 mg/0.5 mL Vials for Pediatric Patients 6 Years of Age and Older with Plaque Psoriasis and Pediatric Patients 6 Years of Age and Older with Psoriatic Arthritis Refer to

2.2Psoriatic Arthritis; Subcutaneous Pediatric Dosage Regimen. Weighing Less Than… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS WEZLANA (ustekinumab-auub) is a clear to opalescent and colorless to light yellow solution. Subcutaneous Injection Injection: 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe Injection: 45 mg/0.5 mL solution in a single-dose vial Intravenous Infusion Injection: 130 mg/26 mL (5 mg/mL) solution in a single-dose vial Subcutaneous Injection ( 3 ) Injection: 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe Injection: 45 mg/0.5 mL solution in a single-dose vial Intravenous Infusion ( 3 ) Injection: 130 mg/26 mL (5 mg/mL) solution in a single-dose vial

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Infections Inform patients that WEZLANA may lower the ability of their immune system to fight infections and to contact their healthcare provider immediately if they develop any signs or symptoms of infection [see Warnings and Precautions (5.1) ] . Malignancies Inform patients of the risk of developing malignancies while receiving WEZLANA [see Warnings and Precautions (5.4) ] .

Serious Hypersensitivity Reactions Inform patients that serious hypersensitivity reactions have been reported with intravenous and subcutaneous administration of ustekinumab products. Instruct patients to discontinue WEZLANA and seek immediate medical attention if they experience any signs or symptoms of hypersensitivity reactions [see Warnings and Precautions (5.5) ]. Posterior Reversible Encephalopathy Syndrome (PRES) Inform patients to immediately contact their healthcare provider if they experience signs and symptoms of PRES (which may include headache, seizures, confusion, or visual disturbances) [see Warnings and Precautions (5.6) ] .

Immunizations Inform patients that WEZLANA can interfere with the usual response to immunizations and that they should avoid live vaccines [see Warnings and Precautions (5.7) ] . Administration Instruct patients to follow sharps disposal recommendations, as described in the Instructions for Use.

MEDICATION GUIDE WEZLANA ® (wez-LAH-nah) (ustekinumab-auub) injection, for subcutaneous or intravenous use This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 05/2026 What is the most important information I should know about WEZLANA?

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

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 WEZLANA and during treatment with WEZLANA. Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with WEZLANA. You should not start WEZLANA if you have any kind of infection unless your healthcare provider says it is okay.

Before starting WEZLANA, 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 WEZLANA, 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. WEZLANA 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 WEZLANA may also be more likely to get these infections.

Cancers. WEZLANA 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 WEZLANA, tell your healthcare provider if you develop any new skin growths. What is WEZLANA?

WEZLANA 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 WEZLANA is safe and effective in children less than 18 years of age with ulcerative colitis or in children less than 6 years of age with plaque psoriasis or psoriatic arthritis.

Who should not use WEZLANA? Do not use WEZLANA if you are allergic to any ustekinumab product or any of the ingredients in WEZLANA. See the end of this Medication Guide for a complete list of ingredients in WEZLANA.

Before you use or receive WEZLANA, 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… [Excerpted — this section continues on DailyMed.]

INSTRUCTIONS FOR USE WEZLANA ® (wez-LAH-nah) (ustekinumab-auub) injection, for subcutaneous use single-dose prefilled syringe This Instructions for Use contains information on how to inject WEZLANA using a prefilled syringe. The WEZLANA prefilled syringe is for subcutaneous use only (inject directly under the skin). Getting to Know The Prefilled Syringe Step 1.

Important Information You Need to Know Before Injecting WEZLANA Dosing: WEZLANA comes in two different doses: 45 mg and 90 mg. Check the prescription to make sure you have the correct dose. If the dose is 45 mg, you will receive one 45 mg prefilled syringe.

If the dose is 90 mg, you will receive either one 90 mg prefilled syringe or two 45 mg prefilled syringes. If you receive two 45 mg prefilled syringes for a 90 mg dose, you will need to give two injections, one right after the other. The look of the prefilled syringe will be different for each dose.

The amount of medicine in the syringe will also be different for each dose. The 45 mg dose will have a smaller amount of medicine and the 90 mg dose will have a larger amount of medicine. Check the figures below to see what the dose looks like in the syringe.

45 mg/0.5 mL 90 mg/mL Using the WEZLANA prefilled syringe: It is important that you do not try to give the injection until you have fully read and understood this Instructions for Use. If a healthcare provider decides that you or a caregiver can give the WEZLANA injection at home, you should receive training on the right way to prepare and give the injections. Do not try to inject WEZLANA until you have been shown the right way to give the injections by a healthcare provider.

Do not use the syringe if the carton is damaged or seal is broken. Do not use the syringe after the expiration date on the label. Do not shake the syringe.

Do not remove the needle cap from the syringe until you are ready to inject. Do not use the syringe if it has been frozen. Do not use the syringe if it has been dropped on a hard surface.

Part of the syringe may be broken even if you cannot see the break. Use a new syringe and call 1-800-77-AMGEN (1-800-772-6436). The syringe is not made with natural rubber latex.

Important: Keep the syringe and sharps disposal container out of the sight and reach of children. Frequently asked questions: For additional information and answers to frequently asked questions, visit www.WEZLANA.com . Where to get help: If you want more information or help using WEZLANA: Contact your healthcare provider Visit www.WEZLANA.com, or Call 1-800-77-AMGEN (1-800-772-6436).

Step 2. Storing and Preparing to Inject WEZLANA 2a Refrigerate the syringe carton until you are ready to use it. Keep the syringe in the refrigerator between 36 °F to 46 °F (2 °C to 8 °C).

Keep the syringe in the original carton to protect it from light or physical damage until you are ready to use it. Do not freeze the syringe. Do not store the syringe in extreme heat or cold.

For example, avoid storing in your vehicle`s glove box or trunk. Important: Keep the syringe out of the sight and reach of children. 2b Grasp the syringe by the body and remove it from the carton.

To prevent early activation of the needle safety guard, do not touch the NEEDLE GUARD CLIPS at any time during use. Do not grab the plunger rod, finger grip or the needle cap. Do not grab the needle guard clips.

Remove the number of syringes you need for your injection. Put any unused syringes back into refrigerator. WAIT 2c Wait 30 minutes for the syringe to reach room temperature.

Let the syringe warm up naturally. Do not heat with hot water, a microwave, or direct sunlight. Do not shake the syringe at any time.

Using the syringe at room temperature allows for a more comfortable injection. 2d If needed, individual WEZLANA prefilled syringes may be stored at room temperature for up to 30 days. Keep WEZLANA at room temperature between 68 °F to 77 °F (20 °C to 25 °C) for a maximum single period of up to 30 days.

Do not use WEZLANA if th… [Excerpted — this section continues on DailyMed.]