Brand Name

Tremfya

Generic Name
Guselkumab
View Brand Information
FDA approval date: July 13, 2017
Classification: Interleukin-23 Antagonist
Form: Injection

What is Tremfya (Guselkumab)?

Living with moderate to severe plaque psoriasis or psoriatic arthritis can feel like a constant battle with your own body. The visible plaques, persistent itching, and painful joints can impact everything from your daily comfort to your self-confidence. For those who have tried other treatments without success, advanced therapies offer new hope. One such option is Tremfya (guselkumab), a prescription medication designed to target a specific source of inflammation driving these conditions.

Tremfya is part of a newer class of drugs known as biologics. Unlike traditional medications that are made from chemicals, biologics are complex proteins derived from living cells. They are designed to interact with specific parts of the immune system. Tremfya is not typically a first-line treatment; it is often prescribed when other therapies, such as topical treatments or oral medications, have not provided enough relief. Understanding how it works can empower you to have more informed conversations with your doctor and take an active role in your care.

What does Tremfya do?

Tremfya is approved by the U.S. Food and Drug Administration (FDA) to treat two related autoimmune conditions:

  • Adults with moderate to severe plaque psoriasis who may benefit from systemic therapy (medications taken by injection or orally) or phototherapy (ultraviolet light treatment).
  • Adults with active psoriatic arthritis, a condition that combines the skin symptoms of psoriasis with joint inflammation.

Patients taking Tremfya for plaque psoriasis can often expect a significant reduction in skin plaques, scaling, and itchiness. For those with psoriatic arthritis, the goal is to reduce joint pain, stiffness, and swelling, which can help improve physical function and prevent long-term joint damage.

Clinical studies have shown Tremfya to be highly effective. For example, in trials for plaque psoriasis, a large percentage of patients achieved 90% to 100% clearer skin after several months of treatment, a result that was often maintained with continued use (Janssen Biotech, Inc., 2020). This level of improvement can have a profound impact on a person’s quality of life.

How does Tremfya work?

To understand how Tremfya works, it helps to think of your immune system as a complex communication network. In autoimmune diseases like psoriasis, certain signals in this network become overactive, mistakenly telling the body to attack its own tissues. This leads to the rapid skin cell growth and inflammation that cause plaques and joint pain.

Tremfya works by targeting a very specific messenger protein in this network called interleukin-23 (IL-23). Think of IL-23 as a key conductor of an orchestra that is playing too loudly and out of tune. By precisely blocking IL-23, Tremfya quiets these specific inflammatory signals without suppressing the entire immune system.

This targeted approach is what sets it apart from some older, broader-acting medications. By interrupting this specific pathway, Tremfya helps calm the overactive immune response, leading to clearer skin and calmer joints. Its focused mechanism helps restore balance and control the underlying driver of the disease.

Tremfya side effects

Like all medications, Tremfya has potential side effects. Your healthcare provider will discuss these with you and monitor your health closely throughout treatment.

The most common side effects are generally mild to moderate and may include:

  • Upper respiratory infections (like the common cold or sinus infections)
  • Headache
  • Injection site reactions (such as redness, pain, or swelling)
  • Joint pain
  • Diarrhea
  • Stomach flu (gastroenteritis)

Because Tremfya affects the immune system, it may lower your ability to fight infections. Your doctor will screen you for tuberculosis (TB) before you start treatment and will monitor you for any signs of infection. It is important to tell your doctor if you develop a fever, cough, or other symptoms of an infection.

Serious side effects are rare but possible. Seek immediate medical attention if you experience signs of a serious allergic reaction, such as trouble breathing, hives, or swelling of your face, lips, tongue, or throat. People with an active, serious infection should not start Tremfya until the infection is treated (Mayo Clinic, 2024).

Tremfya dosage

Tremfya is administered as an injection under the skin (subcutaneous injection). It is not a daily medication. After an initial “starter” dose, you will receive another dose four weeks later, followed by a maintenance dose every eight weeks.

Many patients learn to administer their injections at home after being trained by a healthcare professional. This can offer convenience and flexibility in managing your treatment schedule.

Before you begin, your doctor will perform a blood test to screen for tuberculosis. Throughout your treatment, they will continue to monitor you for any signs of infection or other side effects. Regular check-ins are a crucial part of the treatment plan to ensure Tremfya remains a safe and effective option for you.

Does Tremfya have a generic version?

Currently, there is no generic version of Tremfya. As a biologic medication, its complexity makes it difficult to replicate exactly.

The equivalent of a generic for a biologic drug is called a “biosimilar.” A biosimilar is a biologic product that is highly similar to, and has no clinically meaningful differences from, an existing FDA-approved biologic (FDA, 2023). At present, the FDA has not approved any biosimilars for Tremfya (guselkumab). Therefore, it is only available under its brand name.

Conclusion

Tremfya (guselkumab) represents a significant advancement in the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis. By precisely targeting interleukin-23, it offers a way to control the underlying inflammation that drives these conditions, often leading to dramatic improvements in skin clarity and joint health.

While it comes with potential side effects, its safety profile is well-understood, and risks can be effectively managed through careful monitoring by your healthcare team. Every patient’s experience is unique, but for many, Tremfya provides a path toward lasting relief and a better quality of life. Partnering closely with your doctor will help you determine if this advanced therapy is the right choice for your health journey.

References

  1. Janssen Biotech, Inc. (2020). TEMPYA® (guselkumab) Prescribing Information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761061s007lbl.pdf
  2. Mayo Clinic. (2024). Guselkumab (Subcutaneous Route). https://www.mayoclinic.org/drugs-supplements/guselkumab-subcutaneous-route/side-effects/drg-20406253
  3. U.S. Food and Drug Administration (FDA). (2023). Biosimilar and Interchangeable Biologics: https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices

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Brand Information

TREMFYA (Guselkumab)
1DOSAGE FORMS AND STRENGTHS
TREMFYA is a clear and colorless to light yellow solution.
2CONTRAINDICATIONS
TREMFYA is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients
3ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of labeling:
  • Hypersensitivity Reactions
  • Infections
  • Tuberculosis
  • Hepatotoxicity
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
3.2Postmarketing Experience
The following adverse reactions have been reported during post-approval of TREMFYA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to TREMFYA exposure.
Immune system disorders: Hypersensitivity, including anaphylaxis [see
Skin and subcutaneous tissue disorders: Rash [see
4DESCRIPTION
Guselkumab, an interleukin-23 antagonist, is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody. Guselkumab is produced in a mammalian cell line using recombinant DNA technology and has an approximate molecular weight of approximately 147 kDa.
TREMFYA
5PATIENT COUNSELING INFORMATION
Advise the patients and/or caregivers to read the FDA-approved patient labeling
6INSTRUCTIONS FOR USE
TREMFYA
200 mg/2mL (100 mg/mL) Prefilled Syringe
This Instructions for Use contains information on how to inject TREMFYA.
Important Information You Need to Know Before Injecting TREMFYA
TREMFYA comes in a single-dose prefilled syringe containing one 200 mg dose.
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 correct way to prepare and inject TREMFYA before using the prefilled syringe.
Read this Instructions for Use before using your TREMFYA prefilled syringe and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.
Each TREMFYA prefilled syringe can only be used one time. Throw the used prefilled syringe away (see
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 device and lock into place.
FigureStorage information
Store in refrigerator between
Do not freeze TREMFYA prefilled syringe.
Do not shake your TREMFYA prefilled syringe.
Keep TREMFYA prefilled syringe and all medicines out of reach of children.
Keep TREMFYA prefilled syringe in the original carton to protect from light and physical damage.
Prefilled syringe parts
Figure
1. Get ready
Figure
Check your dose to see if you will need to use 1 or 2 prefilled syringes and inspect carton(s)
Remove the carton(s) from the refrigerator.
Check the expiration ('EXP') date. Do not use your prefilled syringe if the expiration date has passed or if the seal on the carton is broken. Contact your healthcare provider or pharmacist for a new prefilled syringe.
Figure
Allow TREMFYA to come to room temperature
Let the cartons sit on a flat surface at room temperature for approximately
Do not warm the prefilled syringe(s) any other way.
2. Prepare to inject TREMFYA
Figure
Take the prefilled syringe out of the carton.
Inspect liquid to see that it is clear and colorless to slightly yellow
Check the liquid in the viewing window. It should be clear and colorless to slightly yellow and may contain tiny white or clear particles. You may also see air bubbles. This is normal.
Do not inject if the liquid is:
  • cloudy or
  • discolored or
  • has large particles
Do not use the prefilled syringe if it is dropped. Call your healthcare provider or pharmacist for a new prefilled syringe.
Figure
Choose injection site
Select a site from the following areas for your injection:
  • Front of thighs
  • 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)
If you need to give 2 injections to complete your dose, choose different areas or leave at least 2 inches between injection sites.
Do not inject into skin that is tender, bruised, red, scaly, thick or hard. Avoid areas with scars or stretch marks.
Figure
Wash hands and 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.
3. Inject TREMFYA
Figure
Remove needle cover when you are ready to inject
Hold the prefilled syringe by the body and pull needle cover straight off. It is normal to see a few drops 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 the prefilled syringe if it is dropped. Call your healthcare provider or pharmacist for a new prefilled syringe.
Do not hold or pull the plunger at any time.
Figure
Pinch injection site and insert needle at about a 45-degree angle
It is important to pinch enough skin to inject under the skin and not into muscle.
Insert needle with a quick dart-like motion.
Figure
Slowly press plunger all the way down until it stops to inject all of the liquid
You will feel some resistance as you press the plunger, this is normal.
Figure
Release pressure from plunger to remove the needle from the skin
The needle will retract into the device and lock into place.
If your prescribed dose requires two injections, repeat Steps 2 to 4 with the second prefilled syringe.
4. After your injection
Figure
Check injection site
There may be a small amount of blood or liquid at the injection site. Gently hold pressure over the injection site with a cotton ball or gauze pad until any bleeding stops.
Do not rub the injection site.
If needed, cover the injection site with a bandage.
Figure
Dispose of your prefilled syringe
Put the used prefilled syringe in an FDA-cleared sharps disposal container right away after use.
Do not throw away (dispose of) your prefilled syringe in your household trash.
Do not recycle your used sharps disposal container.
For more information, see
Disposing of TREMFYA prefilled syringe
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  • made of 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. You may also consult your pharmacist.
FigureNeed help?
Call your healthcare provider to talk about any questions you may have. For additional assistance or to share your feedback, call 800-526-7736.
Manufactured by:
Janssen Biotech, Inc.
Horsham, PA 19044, USA
US License No. 1864
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Approved: August / 2025
7INSTRUCTIONS FOR USE
TREMFYA
[trem fye' ah Pen]
200 mg/2 mL Prefilled Pen
This Instructions for Use contains information on how to inject with TREMFYA PEN.
Important Information You Need to Know Before Injecting with TREMFYA PEN
TREMFYA PEN comes in a single-dose Prefilled Pen containing one 200 mg dose.
If your healthcare provider decides that you or a caregiver may be able to give your injections with TREMFYA PEN at home, you should receive training on the correct way to prepare and inject with TREMFYA PEN before using the Prefilled Pen.
Read this Instructions for Use before using your Prefilled Pen and each time you get a new Prefilled Pen. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.
Each TREMFYA PEN can only be used one time. Throw the used Prefilled Pen away (see
FigureStorage information
Store in refrigerator between
Do not freeze your TREMFYA PEN.
Do not shake your TREMFYA PEN.
Keep your TREMFYA PEN and all medicines out of reach of children.
Keep your TREMFYA PEN in the original carton to protect from light and physical damage.
TREMFYA PEN parts
Figure
1. Get ready
Figure
Check your prescribed dose to see if you will need to use 1 or 2 Prefilled Pens and inspect carton(s)
Remove the carton(s) from the refrigerator.
Check the expiration ('EXP') date.
Do not use the Prefilled Pen if the expiration date has passed or if the seal on the carton is broken. Contact your healthcare provider or pharmacist for a new Prefilled Pen.
Figure
Allow TREMFYA PEN to come to room temperature
Let the carton(s) sit on a flat surface at room temperature for approximately
Do not warm the Prefilled Pen(s) any other way.
2. Prepare to inject with TREMFYA PEN
Figure
Take your Prefilled Pen out of the carton.
Inspect liquid in window to see that it is clear and colorless to slightly yellow
Check the liquid in the viewing window. It should be clear and colorless to slightly yellow and may contain tiny white or clear particles. You may also see 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 Prefilled Pen.
Figure
Choose injection site
Select from the following areas for your injection:
  • Front of thighs
  • 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)
If you need to give 2 injections to complete your dose, choose different areas or leave at least 2 inches between injection sites.
Do not inject into skin that is tender, bruised, red, scaly, thick or hard. Avoid areas with scars or stretch marks.
Figure
Wash hands and 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.
3. Inject with TREMFYA PEN
Figure
Remove cap when you are ready to inject
Pull the cap straight off. It is normal to see a few drops of liquid.
Inject with TREMFYA PEN within 5 minutes of removing cap.
Do not put the cap back on as this may damage the needle.
Do not use your Prefilled Pen if it is dropped after removing the cap. Call your healthcare provider or pharmacist for a new Prefilled Pen.
Figure
Position the Prefilled Pen straight onto the injection site then push and hold the Prefilled Pen
Position your Prefilled Pen straight onto the injection site with the yellow needle guard against the skin and the viewing window facing you.
Press down on the Prefilled Pen and keep holding it down against the skin.
You will hear the first click.
Figure
Keep holding your Prefilled Pen firmly against the skin for about 10 seconds to hear a second click
You are almost done.
Figure
Keep holding firmly against the skin and confirm your injection is complete
Your injection is complete when the plunger rod stops moving and fills the viewing window.
Figure
Lift straight up
If your prescribed dose requires two injections, repeat Steps 2 to 4 with the second Prefilled Pen.
4. After your injection
Figure
Check injection site
There may be a small amount of blood or liquid at the injection site. Gently hold pressure over the injection site with a cotton ball or gauze pad until any bleeding stops.
Do not rub the injection site. If needed, cover the injection site with a bandage.
Figure
Dispose of your Prefilled Pen and cap
Put your used Prefilled Pen and cap in an FDA-cleared sharps disposal container right away after use.
Do not throw away (dispose of) your Prefilled Pen in your household trash.
Do not recycle your used sharps disposal container.
For more information, see
Disposing of TREMFYA PEN
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  • made of 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. You may also consult your pharmacist.
FigureNeed help?
Call your healthcare provider to talk about any questions you may have. For additional assistance or to share your feedback, call 800-526-7736.
Manufactured by:
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Approved: March / 2025
8Instructions for Use
TREMFYA
(trem fye' ah)
(guselkumab)
Prefilled Syringe
Figure
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
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.
For children, TREMFYA should be administered by a healthcare provider or an adult caregiver who has 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 leaflet 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.
FigureStorage information
Store in refrigerator at
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
Figure
After use
Figure
1. Prepare for your injection
Figure
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
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.
Figure
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.
Figure
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.
Figure
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
Figure
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.
Figure
Position fingers and insert needle
Place your thumb, index and middle fingers
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
Insert needle with a quick, dart-like motion.
Figure
Release pinch and reposition hand
Use your free hand to grasp the body of the prefilled syringe.
Figure
Press plunger
Place thumb from the opposite hand on the plunger and press the plunger
Figure
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
Figure
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 "
Figure
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.
FigureNeed help?
Call your healthcare provider to talk about any questions you may have. For additional assistance or to share your feedback call 1-800-526-7736.
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
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Approved: September 2025
9INSTRUCTIONS FOR USE
TREMFYA
One-Press Patient-Controlled Injector
This "Instructions for Use" contains information on how to inject TREMFYA.
Figure
Important Information You Need to Know Before Injecting TREMFYA
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
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.
For children, TREMFYA should be administered by a healthcare provider or an adult caregiver who has been shown the right way to give the injections 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 leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.
FigureStorage information
Store in refrigerator at
Do not freeze your One-Press injector.
Do not shake your One-Press injector.
Keep your One-Press injector and all medicines out of reach of children.
Keep your One-Press injector in the original carton to protect from light and physical damage.
FigureNeed help?
Call your healthcare provider to talk about any questions you may have. For additional assistance or to share your feedback call 1-800-526-7736.
One-Press injector parts
Before use After use
Figure
1. Preparing to Inject TREMFYA
Figure
Inspect carton and allow TREMFYA to come to room temperature
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
Do not warm your One-Press injector any other way.
Figure
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 seal on the carton is broken. Call your healthcare provider or pharmacist for a new One-Press injector.
Figure
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 for adults and only if someone else is giving you the injection). This injection site is not for use in children.
Do not inject into skin that is tender, bruised, red, hard, thick, scaly, or affected by psoriasis.
Figure
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.
Figure
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,
  • discolored, or
  • has large particles.
Call your healthcare provider or pharmacist for a new One-Press injector.
2. Injecting TREMFYA
Figure
Pull off bottom cap
Keep hands away from the needle guard after the cap is removed. It is normal to see a few drops of liquid.
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.
Figure
Place straight on skin.
Push handle all the way down until teal body is not visible
You may hear a click when the injection begins. Keep pushing.
If you feel resistance, keep pushing. This is normal.
The medication injects as you push. Do this at a speed that is comfortable for you.
Figure
Confirm your injection is complete
Your injection is complete when:
  • The teal body is not visible.
  • You cannot press the handle down anymore.
  • You may hear a click.
Figure
Lift straight up
The yellow band indicates that the needle guard is locked.
3. After your injection
Figure
Dispose of your One-Press injector
Put your used One-Press injector in a 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 "
Figure
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.
Disposing of TREMFYA 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. You may also consult your pharmacist.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Revised: September 2025
11PRINCIPAL DISPLAY PANEL - 100 mg/mL Syringe Carton - NDC 57894-640-01
Tremfya
100 mg/mL
FOR SUBCUTANEOUS USE ONLY
Rx only
NDC 57894-640-01
One single-dose prefilled syringe
ATTENTION: Dispense the enclosed
PRINCIPAL DISPLAY PANEL - 100 mg/mL Syringe Carton - NDC 57894-640-01
13PRINCIPAL DISPLAY PANEL - 100 mg/mL Pen Carton
NDC 57894-640-06
Tremfya
100 mg/mL
FOR SUBCUTANEOUS USE ONLY
Rx only
One single-dose prefilled pen
Attention: Dispense the enclosed
PRINCIPAL DISPLAY PANEL - 100 mg/mL Pen Carton
14PRINCIPAL DISPLAY PANEL - 200 mg/20 mL Vial Carton
NDC 57894-650-02
Tremfya
200 mg/20 mL
FOR INTRAVENOUS
Attention: Dispense the
Single-dose vial
PRINCIPAL DISPLAY PANEL - 200 mg/20 mL Vial Carton
15PRINCIPAL DISPLAY PANEL - 200 mg/2 mL Pen Carton
NDC 57894-651-02
Tremfya
200 mg/2 mL
FOR SUBCUTANEOUS USE ONLY
Rx only
One single-dose prefilled pen
ATTENTION: Dispense the enclosed
PRINCIPAL DISPLAY PANEL - 200 mg/2 mL Pen Carton
16PRINCIPAL DISPLAY PANEL - 200 mg/2 mL Syringe Carton
NDC 57894-651-22
Tremfya
200 mg/2 mL
FOR SUBCUTANEOUS USE ONLY
Rx only
One single-dose prefilled syringe
ATTENTION: Dispense the enclosed
PRINCIPAL DISPLAY PANEL - 200 mg/2 mL Syringe Carton
17PRINCIPAL DISPLAY PANEL - 200 mg/2 mL Pen Carton - NDC 57894-651-04
NDC 57894-651-04
Tremfya
200 mg/2 mL
FOR SUBCUTANEOUS USE ONLY
Induction Pack for Crohn's Disease
The entire carton is to
Contains: Two cartons each containing
ATTENTION: Dispense the enclosed
PRINCIPAL DISPLAY PANEL - 200 mg/2 mL Pen Carton - NDC 57894-651-04