Ustekinumab Injection

IMPORTANT NOTICE:

Ustekinumab injection, ustekinumab-aekn injection, and ustekinumab-auub injection are biologic medications (medications made from living organisms). Biosimilar ustekinumab-aekn injection,and ustekinumab-auub injection are highly similar to ustekinumab injection and work the same way as ustekinumab injection in the body. Therefore, the term ustekinumab injection products will be used to represent these medications in this discussion.

WHY is this medicine prescribed?

Ustekinumab injection products are used to treat moderate to severe plaque psoriasis (skin disease in which red, scaly patches form on some areas of the body) in adults and children 6 years of age and older who may benefit from medications or phototherapy (a treatment that involves exposing the skin to ultraviolet light). Ustekinumab injection products are also used to treat psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) in adults and children 6 years of age and older. Ustekinumab injection products (Stelara, Wezlana) are also used to treat Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) and ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults. Ustekinumab injection products are in a class of medications called interleukin antagonists. They work by stopping the action of interleukin, a substance in the body that causes inflammation.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ustekinumab injection products come as a solution (liquid) in single-dose, prefilled syringes and single-dose vials, to inject subcutaneously (under the skin) or intravenously (into a vein). For the treatment of plaque psoriasis and psoriatic arthritis, ustekinumab injection products are usually injected subcutaneously every 4 weeks for the first two doses and then every 12 weeks for as long as treatment continues. For the treatment of Crohn's disease and ulcerative colitis, ustekinumab injection products (Stelara, Wezlana) are usually injected intravenously for the first dose and then given subcutaneously every 8 weeks for as long as treatment continues.

You will receive your first subcutaneous dose of ustekinumab injection products in your doctor's office. After that, your doctor may continue to give you injections or allow you to inject ustekinumab injection products yourself or have a caregiver perform the injections. Ask your doctor or pharmacist to show you or the person who will be performing the injections how to inject ustekinumab products. Before you use ustekinumab injection products yourself the first time, read the written instructions that come with the product.

If your medication comes in a prefilled syringe or vial, use each syringe or vial only once and inject all the solution in the syringe. Even if there is still some solution left in the syringe or device, do not use it again. Dispose of used needles, syringes, and devices in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Do not shake a prefilled syringe or vial that contains ustekinumab injection products.

Always look at ustekinumab injection solution before injecting it. Check that the expiration date has not passed and that the liquid is clear or slightly yellow. The liquid may contain a few visible white particles. Do not use the vial or prefilled syringe if it is damaged, expired, frozen, or if the liquid is cloudy or contains large particles.

You can inject ustekinumab injection products subcutaneously anywhere on the front of your thighs (upper leg), buttocks, or abdomen (stomach) except your navel and the area 2 inches (5 centimeters) around it. If another person is injecting your medication, the outer area of the upper arms also may be used. To reduce the chances of soreness or redness, use a different site for each injection. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars or stretch marks.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ustekinumab injection products. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before using ustekinumab injection products,

• tell your doctor and pharmacist if you are allergic to ustekinumab, any other medications, or any of the ingredients in ustekinumab injection products. If you will be using a prefilled syringe, tell your doctor if you or the person who will be injecting the medication that you are allergic to latex or rubber. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had any type of cancer. Also tell your doctor if you have received or are receiving allergy shots (a series of injections given regularly to prevent the body from developing allergic reactions to specific substances). If you have psoriasis, tell your doctor if you have been treated with light therapy.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using an ustekinumab injection product, call your doctor.

• check with your doctor to see if you need to receive any vaccinations. It is important to have all vaccines appropriate for your age before beginning your treatment with ustekinumab injection products. Do not have any vaccinations during your treatment without talking to your doctor. It is especially important not to receive the Bacillus Calmette-Guerin (BCG) vaccine for one year before your treatment, during your treatment, and for one year after your treatment. Also talk to your doctor if anyone in your household needs to receive a vaccine during your treatment with ustekinumab injection products.

• you should know that ustekinumab injection products may decrease your ability to fight infection from bacteria, viruses, and fungi and increase the risk that you will get a serious or life-threatening infection. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores), and chronic infections that do not go away. If you experience any of the following symptoms during or shortly after your treatment with ustekinumab injection products, call your doctor immediately: weakness; sweating; chills; muscle aches; sore throat; cough; shortness of breath; fever; weight loss; extreme tiredness; flu-like symptoms; warm, red, or painful skin; painful, difficult, or frequent urination; diarrhea; stomach pain; or other signs of infection.

• you should know that using ustekinumab injection products increases the risk that you will develop tuberculosis (TB; a serious lung infection), especially if you are already infected with tuberculosis but do not have any symptoms of the disease. Tell your doctor if you have or have ever had TB, if you have lived in a country where TB is common, or if you have been around someone who has TB. Your doctor will perform a skin test to see if you have an inactive TB infection. If necessary, your doctor will give you medication to treat this infection before you start using ustekinumab injection products. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, chest pain, coughing up blood or mucus, weakness or tiredness, weight loss, loss of appetite, chills, fever, or night sweats.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Use the missed dose as soon as you remember it and then continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Ustekinumab injection products may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• runny, stuffed nose, or sneezing
• tiredness
• redness or irritation at the injection site
• nausea
• vomiting

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• new or changing skin lesions
• sudden severe headache
• seizures
• confusion
• vision changes
• feeling faint
• rash
• itching
• hives
• swelling of the face, eyelids, tongue, or throat
• difficulty breathing
• tightness in the chest or throat

Ustekinumab injection products may increase the risk that you will develop cancer, including skin cancer. Your doctor will check your skin during treatment for signs of skin cancer. Talk to your doctor about the risks of using this medication.

Ustekinumab injection products may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store ustekinumab injection product vials and prefilled syringes in the refrigerator, but do not freeze them. If needed, vials (Wezlana) and prefilled syringes (Selarsdi, Stelara, Wezlana) may be stored at room temperature for up to 30 days. Keep the vials and prefilled syringes upright in their original cartons to protect them from light. Dispose of any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to ustekinumab injection products.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.