Guselkumab (gus-ELK-ue-mab)

Treats plaque psoriasis and psoriatic arthritis.

Brand Name(s):

Tremfya

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. This medicine is usually given in the stomach, thighs, or upper arms.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Allow the medicine to warm to room temperature for 30 minutes before you use it. Do not warm it in any other way.
• Check the liquid in the prefilled syringe or One-Press® injector. It should be clear and colorless or slightly yellow and may contain small particles. Do not use the medicine if it is cloudy, discolored, or has large particles in it. Do not shake.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis.
• Inject the medicine within 5 minutes of removing the cap off the One-Press® injector or needle cover off the prefilled syringe. Do not put the cap back on as this could damage the needle. Do not use it if it has been dropped after removing the cap.
• You might not use all of the medicine in each prefilled syringe or One-Press® injector. Use each prefilled syringe and One-Press® injector only one time. Do not save an open syringe or One-Press® injector.
• Use a new needle and syringe each time you inject your medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Keep the medicine in its original carton until you are ready to use it. Protect it from light. Do not shake.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how guselkumab works. Make sure your doctor knows about all other medicines that you are using.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, an infection, active tuberculosis (TB), or a history of TB or any infection.
• You will need to have a skin test for tuberculosis (TB) before you start this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or has been exposed to TB.
• This medicine may also cause you to get infections more easily. Tell your doctor if you have any type or history of infection before you start treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Diarrhea, nausea, loss of appetite, stomach pain
• Fever, chills, cough, sore throat, stuffy or runny nose, body aches
• Painful cold sores or blisters on lips, nose, eyes, or genitals

If you notice these less serious side effects, talk with your doctor:

• Headache
• Joint pain
• Redness, pain, swelling, or itching where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088