The first biologic treatment
of its kind for active PsA
TREMFYA® is a biologic treatment, and the first medication of its kind to be approved by the Food and Drug Administration (FDA) for adults with active psoriatic arthritis.
TREMFYA® Legacy
TREMFYA® has 15+ years of combined clinical research* and 7+ years on the market across indications.
*Based on a clinical trial of TREMFYA® initiated in 2009.
Results with TREMFYA®:
less joint pain, stiffness, and swelling
Results with TREMFYA®:
less joint pain, stiffness,
and swelling
At 24 weeks
At 24 weeks
In two medical studies, more than 5 out of 10 people who took TREMFYA® had at least a 20% improvement in active PsA symptoms (joint pain, stiffness, swelling) at 24 weeks compared to placebo. Individual results may vary.
At 2 years
At 2 years
One medical study showed that less joint pain, stiffness, and swelling is possible even at 2 years.†
†For patients who continued on TREMFYA® for 2 years, a similar percentage (7 out of 10 patients) saw a 20% improvement in PsA symptoms at 2 years. At 24 weeks and thereafter, patients and healthcare providers knew that TREMFYA® was being used. This may have increased results. Individual results may vary.
†For patients who continued on TREMFYA® for 2 years, a similar percentage (7 out of 10 patients) saw a 20% improvement in PsA symptoms at 2 years. At 24 weeks and thereafter, patients and healthcare providers knew that TREMFYA® was being used. This may have increased results. Individual results may vary.
TREMFYA® Safety Information
Ask your doctor about the benefits and risks of TREMFYA®. Prescription medications, including TREMFYA®,
have possible risks involved with treatment, so it’s important to discuss them with your doctor.
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
- 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
- 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
- vomiting
- tiredness (fatigue)
- yellowing of the skin or the whites of your eyes
- nausea
- stomach pain (abdominal)
- loss of appetite
- dark urine
- unexplained rash
- vomiting
- tiredness (fatigue)
- yellowing of the skin or the whites of your eyes
- nausea
- stomach pain (abdominal)
- loss of appetite
- dark urine
These are not all the possible side effects of TREMFYA®.
Please read the Important Safety Information located at the bottom of the screen and the Medication Guide for TREMFYA® to learn more about these and other risks for TREMFYA®. Discuss any questions you have with your doctor.
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:
- respiratory tract infections
- joint pain (arthralgia)
- fungal skin infections
- bronchitis
- headache
- diarrhea
- herpes simplex infections
- injection site reactions
- stomach flu (gastroenteritis)
- stomach pain
- respiratory tract infections
- joint pain (arthralgia)
- fungal skin infections
- bronchitis
- headache
- diarrhea
- herpes simplex infections
- injection site reactions
- stomach flu (gastroenteritis)
- stomach pain
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.
How often will you need
to take TREMFYA®?
Day 1
1 injection on day 1
Week 4
1 injection 4 weeks later
Week 12 & beyond
1 injection every 8 weeks
Not Actual Size
You can take TREMFYA® by using either the One-Press patient-controlled self-injector or a prefilled syringe.
TREMFYA® is a single-dose 100 mg injection taken under the skin at weeks 0 and 4, and then every 8 weeks. That’s only 6 doses per year after 2 starter doses.
TREMFYA® is intended for use under the guidance and supervision of a healthcare professional. Patients/caregivers may inject after proper training and healthcare professional approval.
Want to know more about dosing with TREMFYA®? Click here.
Want to learn more about TREMFYA®?
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WHAT IS TREMFYA® (guselkumab)?
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).
TREMFYA® is a prescription medicine used to treat adults with active psoriatic arthritis.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TREMFYA®?
TREMFYA® is a prescription medicine that 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:
|
|
- Infections. TREMFYA® 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:
|
|
- Liver problems. 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:
|
|
Do not use TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the 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®.
- 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 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.
What are the possible side effects of TREMFYA®?
TREMFYA® may cause serious side effects. See “What is the most important information I should know about TREMFYA®?”
The most common side effects of TREMFYA® include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, and bronchitis.
These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects.
Use TREMFYA® exactly as your healthcare provider tells you to use it.
Please read the full Prescribing Information, including Medication Guide, for TREMFYA® and discuss any questions that you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
TREMFYA® is available as a 100 mg/mL subcutaneous injection.
cp-510976v1
WHAT IS TREMFYA® (guselkumab)?
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).
TREMFYA® is a prescription medicine used to treat adults with active psoriatic arthritis.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TREMFYA®?
TREMFYA® is a prescription medicine that 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:
|
|
- Infections. TREMFYA® 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:
|
|
- Liver problems. 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:
|
|
Do not use TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the 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®.
- 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 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.
What are the possible side effects of TREMFYA®?
TREMFYA® may cause serious side effects. See “What is the most important information I should know about TREMFYA®?”
The most common side effects of TREMFYA® include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, and bronchitis.
These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects.
Use TREMFYA® exactly as your healthcare provider tells you to use it.
Please read the full Prescribing Information, including Medication Guide, for TREMFYA® and discuss any questions that you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
TREMFYA® is available as a 100 mg/mL subcutaneous injection.
cp-510976v1