Guselkumab Injection

Before using guselkumab injection,

• tell your doctor and pharmacist if you are allergic to guselkumab injection, any other medications, or any of the ingredients in guselkumab injection. 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 are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using guselkumab injection, 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 guselkumab injection. Do not have any vaccinations during your treatment without talking to your doctor. Also talk to your doctor if anyone in your household needs to receive a vaccine during your treatment with guselkumab injection.
• you should know that guselkumab 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 guselkumab injection, call your doctor immediately: sweating; chills; muscle aches; cough; shortness of breath; fever; weight loss; extreme tiredness; flu-like symptoms; vomiting; sore throat; runny, stuffed nose, or sneezing; warm, red, or painful skin; painful or frequent urination; diarrhea; stomach pain; or other signs of infection.
• you should know that using guselkumab 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 guselkumab 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. Call your doctor, if you are unclear about your dosing schedule.

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

• headache
• redness, itching, swelling, pain, discoloration, hives, or irritation at the injection site
• joint pain
• diarrhea

Guselkumab 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).

Keep all appointments with your doctor.

Guselkumab injection syringe has glass parts and should be handled carefully.

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.

• Tremfya^®