Tremfya

What is Tremfya?

Tremfya is a prescription medicine used to treat adults:

• with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light)
• with active psoriatic arthritis (PsA).

It is not known if Tremfya is safe and effective in children under 18 years of age.

What is the most important information I should know about Tremfya?

Tremfya may cause serious side effects, including:

• Serious allergic reactions. Stop using Tremfya and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:
  • fainting, dizziness, feeling lightheaded (low blood pressure)
  • swelling of your face, eyelids, lips, mouth, tongue or throat
  • trouble breathing or throat tightness
  • chest tightness
  • skin rash, hives
  • itching
• Infections. Tremfya is a medicine that may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with Tremfya and may treat you for TB before you begin treatment with Tremfya if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with Tremfya.
  Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
  • fever, sweats, or chills
  • cough
  • shortness of breath
  • blood in your phlegm (mucus)
  • muscle aches
  • warm, red, or painful skin or sores on your body different from your psoriasis
  • weight loss
  • diarrhea or stomach pain
  • burning when you urinate or urinating more often than normal

See "What are the possible side effects of Tremfya?" for more information about side effects.

Who should not use Tremfya?

Do not use Tremfya if you have had a serious allergic reaction to guselkumab or any of the other ingredients in Tremfya. See the end of this Medication Guide for a complete list of ingredients in Tremfya.

What should I tell my healthcare provider before using Tremfya?

Before using Tremfya, tell your healthcare provider about all of your medical conditions, including if you:

• have any of the conditions or symptoms listed in the section "What is the most important information I should know about Tremfya?"
• have an infection that does not go away or that keeps coming back.
• have TB or have been in close contact with someone with TB.
• have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with Tremfya.
• are pregnant or plan to become pregnant. It is not known if Tremfya can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Tremfya passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use Tremfya?

See the detailed Instructions for Use that comes with Tremfya for information on how to prepare and inject a dose of Tremfya, and how to properly throw away (dispose of) used Tremfya prefilled syringes or One-Press injectors.

• Use Tremfya exactly as your healthcare provider tells you to use it.
• If you miss your Tremfya dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. Call your healthcare provider if you are not sure what to do.

If you inject more Tremfya than prescribed, call your healthcare provider right away.

What are the possible side effects of Tremfya?

Tremfya may cause serious side effects including:

• See "What is the most important information I should know about Tremfya?"

The most common side effects of Tremfya include:

• upper respiratory infections
• joint pain (arthralgia)
• fungal skin infections
• headache
• diarrhea
• herpes simplex infections
• injection site reactions
• stomach flu (gastroenteritis)
• bronchitis

These are not all the possible side effects of Tremfya. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Tremfya

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Tremfya for a condition for which it was not prescribed. Do not give Tremfya to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Tremfya that is written for health professionals.

How should I store Tremfya?

• Store in refrigerator at 36° to 46°F (2° to 8°C). Do not freeze Tremfya prefilled syringe.
• Keep Tremfya prefilled syringe and all medicines out of reach of children.
• Do not shake your Tremfya prefilled syringe.
• Keep Tremfya prefilled syringe in the original carton to protect from light and physical damage.

What are the ingredients in Tremfya?

Active ingredient: guselkumab

Inactive ingredients: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose and water for injection

Not made with natural rubber latex.

For more information, call 1-800-526-7736 or go to www.tremfya.com.

Instructions for use for Tremfya

Tremfya (trem fye' ah)
(guselkumab)

• Instructions for Prefilled Syringe
• Instructions for One-Press Injector

Prefilled Syringe

Single-dose

Important

Tremfya comes as a single-dose prefilled syringe containing one 100 mg dose. Each Tremfya prefilled syringe can only be used one time. Throw the used prefilled syringe away (See step 3) after one dose, even if there is medicine left in it. Do not reuse your Tremfya prefilled syringe.

If your healthcare provider decides that you or a caregiver may be able to give your injections of Tremfya at home, you should receive training on the right way to prepare and inject Tremfya using the prefilled syringe before attempting to inject. Do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider.

Read this Instructions for Use before using your Tremfya prefilled syringe and each time you get a refill. There may be new information. This guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.

The Tremfya prefilled syringe is intended for injection under the skin, not into the muscle or vein. After injection, the needle will retract into the body of the device and lock into place.

Storage information

• Store in refrigerator at 36° to 46°F (2° to 8°C). Do not freeze Tremfya prefilled syringe.
• Keep Tremfya prefilled syringe and all medicines out of reach of children.
• Do not shake your Tremfya prefilled syringe.
• Keep Tremfya prefilled syringe in the original carton to protect from light and physical damage.

Prefilled syringe parts

Before use

After use

You will need these supplies:

• 1 Tremfya prefilled syringe

Not provided in the Tremfya prefilled syringe carton:

• 1 Alcohol swab
• 1 Cotton ball or gauze pad
• 1 Adhesive bandage
• 1 Sharps container (See Step 3)

1. Prepare for your injection

Inspect carton

• Remove your Tremfya prefilled syringe carton from the refrigerator.
• Keep the prefilled syringe in the carton and let it sit on a flat surface at room temperature for at least 30 minutes before use.
• Do not warm the prefilled syringe any other way.
• Check the expiration date ('EXP') on the back panel of the carton.
• Do not use your prefilled syringe if the expiration date has passed.
• Do not inject Tremfya if the perforations on the carton are broken. Call your healthcare provider or pharmacist for a refill.

Choose injection site

Select from the following areas for your injection:

• Front of thighs (recommended)
• Lower stomach area (lower abdomen), except for a 2-inch area right around your navel (belly-button)
• Back of upper arms (only if someone else is giving you the injection)

Do not inject into skin that is tender, bruised, red, hard, thick, scaly or affected by psoriasis.

Clean injection site

• Wash your hands well with soap and warm water.
• Wipe your chosen injection site with an alcohol swab and allow it to dry.
• Do not touch, fan, or blow on the injection site after you have cleaned it.

Inspect liquid

• Take your Tremfya prefilled syringe out of the carton.
• Check the Tremfya prefilled syringe liquid in the viewing window. It should be clear to slightly yellow and may contain tiny white or clear particles. You may also see one or more air bubbles. This is normal.
• Do not inject if the liquid is cloudy or discolored, or has large particles. Call your healthcare provider or pharmacist for a refill.

2. Inject Tremfya using prefilled syringe

Remove needle cover

• Hold your prefilled syringe by the body and pull needle cover straight off. It is normal to see a drop of liquid.
• Inject Tremfya within 5 minutes of removing the needle cover.
• Do not put needle cover back on, as this may damage the needle or cause a needle stick injury.
• Do not touch needle or let it touch any surface.
• Do not use a Tremfya prefilled syringe if it is dropped. Call your healthcare provider or pharmacist for a refill.

Position fingers and insert needle

• Place your thumb, index and middle fingers directly under the finger flange, as shown.
• Do not touch plunger or area above finger flange as this may cause the needle safety device to activate.
• Use your other hand to pinch skin at the injection site. Position syringe at about a 45 degree angle to the skin.
• It is important to pinch enough skin to inject under the skin and not into the muscle.
• Insert needle with a quick, dart-like motion.

Release pinch and reposition hand

• Use your free hand to grasp the body of the prefilled syringe.

Press plunger

• Place thumb from the opposite hand on the plunger and press the plunger all the way down until it stops.

Release pressure from plunger

• The safety guard will cover the needle and lock into place, removing the needle from your skin.

3. After your injection

Dispose of your prefilled syringe

• Put your used Tremfya prefilled syringe in an FDA-cleared sharps disposal container right away after use.
• Do not throw away (dispose of) your Tremfya prefilled syringe in your household trash.
• Do not recycle your used sharps disposal container.
• For more information, see "How should I dispose of the used prefilled syringe?"

Check injection site

• There may be a small amount of blood or liquid at the injection site. Hold pressure over your skin with a cotton ball or gauze pad until any bleeding stops.
• Do not rub the injection site.
• If needed, cover injection site with a bandage.

Need help?

Call your healthcare provider to talk about any questions you may have. For additional assistance or to share your feedback call 800-JANSSEN (800-526-7736).

How should I dispose of the used prefilled syringe?

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

• made of a heavy-duty plastic
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
• upright and stable during use
• leak-resistant
• properly labeled to warn of hazardous waste inside the container

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes.

For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: www.fda.gov/safesharpsdisposal

Instructions for use last revised 12/2017

One-Press Patient-Controlled Injector

Single-dose

Important

Tremfya comes in a single-dose One-Press injector containing one 100 mg dose. Each One-Press injector can only be used one time. Throw away (See Step 3) after one dose, even if there is medicine left in it. Do not reuse your One-Press injector.

If your healthcare provider decides that you or a caregiver may be able to give your injections of Tremfya at home, you should receive training on the right way to prepare and inject Tremfya using the One-Press injector. Do not try to inject yourself until you have been trained by your healthcare provider.

Please read this Instructions for Use before using your One-Press injector and each time you get a new One-Press injector. There may be new information. This guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Storage information

• Store in refrigerator at 36° to 46°F (2° to 8°C).
• Do not freeze your One-Press injector.
• Keep your One-Press injector and all medicines out of reach of children.
• Do not shake your One-Press injector.
• Keep your One-Press injector in the original carton to protect from light and physical damage.

Need help?

Call your healthcare provider to talk about any questions you may have. For additional assistance or to share your feedback call 800-JANSSEN (800-526-7736).

One-Press injector parts

You will need:

• 1 One-Press injector

Not provided in the carton:

• 1 Alcohol swab
• 1 Cotton ball or gauze pad
• 1 Adhesive bandage
• 1 Sharps container (See Step 3)

1. Prepare for your injection

Inspect carton

• Remove your One-Press injector carton from the refrigerator.
• Keep your One-Press injector in the carton and let it sit on a flat surface at room temperature for at least 30 minutes before use.
• Do not warm your One-Press injector any other way.
• Check the expiration date ('EXP') on the carton.
• Do not use your One-Press injector if the expiration date has passed.
• Do not inject Tremfya if the perforations on the carton are broken. Call your healthcare provider or pharmacist for a new One-Press injector.

Choose injection site

Select from the following areas for your injection:

• Front of thighs (recommended)
• Lower stomach area (lower abdomen), except for a 2-inch area right around your navel (belly-button)
• Back of upper arms (only if someone else is giving you the injection)

Do not inject into skin that is tender, bruised, red, hard, thick, scaly, or affected by psoriasis.

Wash hands

• Wash your hands well with soap and warm water.
• Clean injection site
• Wipe your chosen injection site with an alcohol swab and allow it to dry.
• Do not touch, fan, or blow on the injection site after you have cleaned it.

Inspect liquid in window

• Take your One-Press injector out of the carton.
• Check the liquid in the window. It should be clear to slightly yellow and may contain tiny white or clear particles. You may also see one or more air bubbles. This is normal.
• Do not inject if the liquid is cloudy or discolored, or has large particles. Call your healthcare provider or pharmacist for a new One-Press injector.

2. Inject Tremfya using the One-Press injector

• Twist and pull off bottom cap
• Keep hands away from the needle guard after the cap is removed.
• Inject Tremfya within 5 minutes of removing the cap.
• Do not put the cap back on, this could damage the needle.
• Do not use a One-Press injector if it is dropped after removing the cap. Call your healthcare provider or pharmacist for a new One-Press injector.

Place on skin

• Position the One-Press injector straight onto the skin (about 90 degrees relative to injection site).

Push handle straight down

• Medication injects as you push. Do this at a speed that is comfortable for you.
• Do not lift the One-Press injector during the injection. The needle guard will lock and the full dose will not be delivered.

Complete injection

• Injection is complete when the handle is pushed all the way down, you hear a click, and the teal body is no longer visible.

Lift straight up

• The yellow band indicates that the needle guard is locked.

3. After your injection

Dispose of your One-Press injector

• Put your used One-Press injector in an FDA-cleared sharps disposal container right away after use.
• Do not throw away (dispose of) your One-Press injector in your household trash.
• Do not recycle your used sharps disposal container.
• For more information, see "How should I dispose of the used one-press injector?".

Check injection site

• There may be a small amount of blood or liquid at the injection site. Hold pressure over your skin with a cotton ball or gauze pad until any bleeding stops.
• Do not rub the injection site.
• If needed, cover injection site with a bandage.

How should I dispose of the used One-Press injector?

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

• made of a heavy-duty plastic
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
• upright and stable during use
• leak-resistant
• properly labeled to warn of hazardous waste inside the container

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes.

For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: www.fda.gov/safesharpsdisposal

Instructions for use last revised 02/2019