Ustekinumab Injection

Ustekinumab injection is 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 or older who may benefit from medications or phototherapy (a treatment that involves exposing the skin to ultraviolet light). It is also used alone or in combination with methotrexate (Otrexup, Rasuvo, Trexall) to treat psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) in adults. Ustekinumab injection is 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) in adults. Ustekinumab injection is also used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults. Ustekinumab injection is in a class of medications called monoclonal antibodies. It works by stopping the action of certain cells in the body that cause the symptoms of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Ustekinumab comes as a solution (liquid) to inject subcutaneously (under the skin) or intravenously (into a vein). For the treatment of plaque psoriasis and psoriatic arthritis, it is 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, it is 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 in your doctor's office. After that, your doctor may continue to give you injections or allow you to inject ustekinumab injection 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. Before you use ustekinumab injection yourself the first time, read the written instructions that come with it.

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.

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 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 subcutaneously anywhere on the front of your thighs (upper leg), upper outer arms, buttocks, or abdomen (stomach) except your navel and the area 2 inches (5 centimeters) around it. 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.

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

Before receiving ustekinumab injection,

• tell your doctor and pharmacist if you are allergic to ustekinumab, any other medications, or any of the ingredients in ustekinumab injection. If you will be using the 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 while receiving ustekinumab injection. 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 phototherapy or allergy shots (a series of injections given regularly to prevent the body from developing allergic reactions to specific substances).
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving ustekinumab injection, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using ustekinumab injection.
• 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. Do not have any vaccinations during your treatment without talking to your doctor. It is especially important not to receive the 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.
• you should know that ustekinumab injection 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 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.

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

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.

Ustekinumab injection 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
• 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:

• 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 may increase the risk that you will develop cancer. Talk to your doctor about the risks of using this medication.

Ustekinumab injection 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).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store ustekinumab vials and prefilled syringes in the refrigerator, but do not freeze them. 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.

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.

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.

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.

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