Stelara

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Read the Medication Guide and the Instructions for Use provided by your pharmacist before you start using ustekinumab and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Before starting this drug, you should take a tuberculosis (TB) skin test to check for a type of tuberculosis that may not be causing any symptoms (latent TB). If you are diagnosed with TB, to prevent a serious TB infection you must first be treated for it before you start ustekinumab.

Inject this medication under the skin as directed by your doctor. For the treatment of psoriasis or psoriatic arthritis, the first 2 doses are usually given 4 weeks apart and then the medication is given every 12 weeks thereafter. For the treatment of Crohn's disease or ulcerative colitis, the first dose of this medication is usually given by injection into a vein by a health care professional and then the medication is given by injection under the skin every 8 weeks thereafter. When given under the skin, the injection is given in the upper arms, buttock, thighs, or abdomen. The dosage is based on your weight, medical condition, and response to treatment.

Do not shake medication. This product may contain a few small white particles. Before using, check this product for other particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is irritated, sore, or infected. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Tell your doctor if your condition does not get better or if it gets worse.

Bruising, itching, pain, redness, swelling, or hardening of the skin at the injection site may occur. Injection site reactions usually go away after 1 or 2 days. Headache, back pain, or sinus/throat pain may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: cough that doesn't go away, shortness of breath.

This medication can affect your immune system. It can lower your body's ability to fight an infection. You may be more likely to get serious infections, such as lung infections, bone/joint infections, skin infections, sinus infections, or bowel/gallbladder infections. It may also be harder to fight an infection you already have. Tell your doctor right away if you develop any signs of an infection, such as nausea/vomiting that doesn't stop, worsening redness/swelling/tenderness at the injection site after 2 days, fever/chills, cold/flu symptoms, painful/frequent urination, unusual vaginal discharge/burning/itching/odor, or severe stomach pain. (See also Precautions section.)

Ustekinumab may cause a rare (sometimes fatal) condition called PRES (posterior reversible encephalopathy syndrome). Get medical help right away if you develop headache that doesn't go away, seizures, sudden vision changes, mental/mood changes (such as confusion).

There is a rare risk of developing cancer (including skin cancer) due to this medication. Discuss the risks and benefits of treatment with your doctor. Tell your doctor right away if you develop symptoms such as unusual lumps/growths, unusual skin changes (including a sore that does not heal or a change in the size/shape/color of a mole), swollen glands, unexplained weight loss.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as skin exams) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.