Tremfya One-Press

Guselkumab is used in adults to treat psoriatic arthritis or moderate to severe plaque psoriasis.

Guselkumab may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to guselkumab or Polysorbate 80.

Before you start treatment with guselkumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Tell your doctor if you have ever had:

• an active or chronic infection;
• active tuberculosis infection that is not being treated; or
• if you have recently received or are scheduled to receive any vaccine.

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

Make sure you are current on all vaccines before you start treatment with guselkumab.

Tell your doctor if you are pregnant or plan to become pregnant, or if you are breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of guselkumab on the baby.

Guselkumab is not approved for use by anyone younger than 18 years old.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Guselkumab is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

The first two injections are usually given 4 weeks apart, followed by one injection every 8 weeks. Your doctor will determine how long to treat you with guselkumab.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Store in the refrigerator. Protect from light and do not freeze.

Take the medicine out of the refrigerator and allow it to reach room temperature for 30 minutes before injecting your dose. Do not remove the needle cap until you are ready to give the injection.

Do not shake the prefilled syringe. Prepare your dose only when you are ready to give an injection.

Guselkumab should appear clear to light yellow in color. Do not use the medicine if it looks cloudy or has particles in it. Call your pharmacist for new medicine.

Do not inject guselkumab into an active psoriasis lesion. Avoid injecting into skin that is thick, scaly, bruised, red, or tender.

Each One-Press injector or prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while using guselkumab. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Get emergency medical help if you have signs of an allergic reaction: hives, rash, itching; chest tightness, difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Guselkumab can weaken (suppress) your immune system, and you may get an infection more easily.

Call your doctor at once if you have signs of infection, such as:

• fever, chills, body aches, night sweats;
• weight loss, feeling very tired;
• cough (may contain blood or mucus), shortness of breath;
• pain or burning when you urinate;
• severe diarrhea or stomach cramps; or
• skin redness, tingling, blisters, oozing, or sores that look different from psoriasis.

Common side effects may include:

• headache, joint pain;
• diarrhea, stomach pain;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• cough, feeling short of breath;
• skin infections; or
• pain, itching, swelling, redness, or bruising where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect guselkumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Your pharmacist can provide more information about guselkumab.