(us'' te kin' ue mab)
WHY is this medicine prescribed?
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 12 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 that has not improved when treated with other medications. 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 psoriasis and psoriatic arthritis.
HOW should this medicine be used?
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, 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 have a caregiver to 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 (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before receiving ustekinumab injection,
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 may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
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:
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 ( http://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 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.http://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 (http://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 athttps://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.
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.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: August 15, 2018.
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