Guselkumab

What it is used for

TREMFYA is an interleukin-23 antagonist indicated for the treatment of: adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis.

adults with moderately to severely active ulcerative colitis. adults with moderately to severely active Crohn's disease. 1.1 Plaque Psoriasis TREMFYA is indicated for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy.

1.2 Psoriatic Arthritis TREMFYA is indicated for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis. 1.3 Ulcerative Colitis TREMFYA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis. 1.4 Crohn's Disease TREMFYA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease.

The most important thing to know

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 Liver problems.

With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA. With the treatment of plaque psoriasis or psoriatic arthritis, your healthcare provider may do blood tests to check your liver before and as necessary during treatment with TREMFYA.

Your healthcare provider may stop treatment with TREMFYA if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: unexplained rash vomiting tiredness (fatigue) yellowing of the skin or the whites of your eyes nausea stomach pain (abdominal) loss of appetite dark urine See "

Side effects, and when to stop

" for more information about side effects. What is TREMFYA? TREMFYA is a prescription medicine used to treat: adults and children 6 years of age and older who also weigh at least 88 pounds (40 kg) with moderate-to-severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light) adults and children 6 years of age and older who also weigh at least 88 pounds (40 kg) with active psoriatic arthritis (PsA) adults with moderately to severely active ulcerative colitis adults with moderately to severely active Crohn's disease It is not known if TREMFYA is safe and effective in children under 18 years of age with ulcerative colitis or Crohn's disease or in children under 6 years of age with plaque psoriasis or psoriatic arthritis.

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. 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. Children should be brought up to date with all vaccines before starting TREMFYA. are pregnant or plan to become pregnant.

It is not known if TREMFYA can harm your unborn baby. Pregnancy Registry: If you become pregnant during treatment with TREMFYA, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA. You can enroll in this registry by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing [email protected].

The purpose of this registry is to collect information about the safety of TREMFYA during pregnancy. 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) the used TREMFYA prefilled syringe, One-Press injector or prefilled pen (TREMFYA PEN). 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. Adults or children 6 years of age or older who also weigh at least 88 pounds (40 kg) with plaque psoriasis or psoriatic arthritis will receive TREMFYA as an injection under the skin (subcutaneous injection).

Adults may self-inject with the TREMFYA prefilled pen, prefilled syringe, or One-Press injector. Adults with ulcerative colitis or Crohn's disease will receive their beginning (induction) doses with TREMFYA through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider or as injections under the skin (subcutaneous injection).

After completing the beginning (induction) doses, patients will receive TREMFYA as an injection under the skin (subcutaneous injection). How will my child receive TREMFYA? See the detailed "Instructions for Use" that comes with TREMFYA. Children with plaque psoriasis or psoriatic arthritis will receive TREMFYA as an injection under the skin (subcutaneous injection).

Children should not self

Storing it

Store TREMFYA in the refrigerator between 36 °F to 46 °F (2 °C to 8 °C). Keep TREMFYA in the original carton to protect it from light until time of use. TREMFYA is not made with natural rubber latex. Do not freeze TREMFYA. Do not shake TREMFYA. Keep TREMFYA and all medicines out of the reach of children.