Ustekinumab Injection

IMPORTANT NOTICE:

Ustekinumab injection is available as different products that are biologic medications (medications made from living organisms).These biologic products are considered to be "biosimilar" to ustekinumab injection which means they work just as well and are just as safe to use as ustekinumab injection. Ustekinumab injection mentioned in the monograph below refersto any of these products.

WHY is this medicine prescribed?

Ustekinumab injection is used to treat:

• plaque psoriasis (skin disease in which red, scaly patches form on some areas of the body)
• psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin)
• Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever)
• ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum)

Ustekinumab injection is in a class of medications called interleukin antagonists. It works 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 comes as a solution (liquid) in prefilled syringes and vials to inject subcutaneously (under the skin).It also comes as a solution to inject intravenously (into a vein) over at least 60 minutes by a doctor or nurse in a medical office.Your doctor will tell you how often to use ustekinumab injection based on your condition.

Use ustekinumab injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.

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

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, do not use it again. Dispose of used needles and syringes 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.

Always look at ustekinumab 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 a prefilled syringe if it is damaged, expired, frozen, or if the liquid is cloudy or contains large particles.

You can inject ustekinumab injection anywhere on the front of your thighs (upper leg), buttocks, or lower stomach area except your navel (belly button) and the area 2 inches (5 centimeters) around it.If another person is injecting your medication, the outer area of the upper arm 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. 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 receiving an ustekinumab injection product,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving an ustekinumab injection product. 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 ustekinumab injection, call your doctor.

• check with your doctor to see if you need to receive any vaccinations before beginning your treatment with ustekinumab injection. Do not have any vaccinations during your treatment without talking to your doctor. Also tell your doctor if anyone in your household needs to receive a vaccine during your treatment with ustekinumab injection.

• tell your doctor if you have received BCG vaccine in the past year. You should not receive BCG vaccine during your treatment, and for one year after your treatment.

• you should know that ustekinumab injection may decrease your ability to fight infections and increase the risk that you will get an 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 new or changing skin lesions, 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, 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 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. 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
• diarrhea
• joint pain

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:

• sudden severe headache, confusion, vision changes, or seizures
• rash; itching; hives; swelling of the face, eyelids, tongue, or throat; feeling faint; tightness in the chest or throat; or difficulty breathing
• shortness of breath or cough that doesn't go away
• new or worsening skin lesions

Ustekinumab injection products may increase the risk that you will develop cancer, including skin cancer. Your doctor will check your skin during your 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?

Store ustekinumab injection upright in the original container in the refrigerator and protect it from light. Do not freeze ustekinumab injection. Dispose of any medication that has been frozen.

If needed, ustekinumab injection may be stored at room temperature in the original carton to protect it from light. Once stored at room temperature, do not return the medication to the refrigerator.How long it can be stored at room temperature depends on the product you are receiving. Talk to you pharmacist about how long ustekinumab injection can be stored at room temperature.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

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.

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

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.