WARNINGS
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 TREMFY 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. 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
nausea
vomiting stomach pain (abdominal)
tiredness (fatigue)
loss of appetite
yellowing of the skin or the whites of your eyes
dark urine
See the section SIDE EFFECTS below for more information about side effects.
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.
USES
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)
with moderately to severely active ulcerative colitis
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.
HOW TO USE
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 with plaque psoriasis or psoriatic arthritis will receive TREMFYA as an injection under the skin (subcutaneous injection).
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).
What are the possible side effects of TREMFYA?
TREMFYA may cause serious side effects including:
respiratory tract infections
headache
injection site reactions
joint pain (arthralgia)
diarrhea • stomach flu (gastroenteritis)
fungal skin infections
herpes simplex infections
stomach pain
bronchitis
feeling very tired (fatigue)
fever (pyrexia)
skin rash (rash)
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.
What are the ingredients in TREMFYA?
Active ingredient: guselkumab
Inactive ingredients: Single-dose prefilled syringe, single-dose One-Press patient-controlled injector, single-dose prefilled pen (TREMFYA PEN) for subcutaneous use: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose and water for injection. Single-dose vial for intravenous infusion: EDTA disodium dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80, sucrose and water for injection.
OVERDOSE
If you inject more TREMFYA than prescribed, call your healthcare provider right away.
MISSED DOSE
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.
STORAGE
How should I store TREMFYA?
Store TREMFYA in the refrigerator between 36-degrees F to 46-degrees F (2-degrees C to 8-degrees 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.
NOTES
Medication Guide: revision date 09/2025
Prescribing Information: revision date 09/2025
1.) CYP450 Substrates
The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, interferon) during chronic inflammation.
Results from an exploratory drug-drug interaction trial in subjects with moderate-to-severe plaque psoriasis suggested a low potential for clinically relevant drug interactions for drugs metabolized by CYP3A4, CYP2C9, CYP2C19 and CYP1A2 but the interaction potential cannot be ruled out for drugs metabolized by CYP2D6. However, the results were highly variable because of the limited number of subjects in the trial.
Upon initiation of TREMFYA in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect or drug concentration and consider dosage adjustment as needed.
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. 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 MotherToBaby@health.ucsd.edu. 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.
