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
- 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
- Mayo Clinic. (2024). Guselkumab (Subcutaneous Route). https://www.mayoclinic.org/drugs-supplements/guselkumab-subcutaneous-route/side-effects/drg-20406253
- 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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Related Latest Advances
Brand Information
TREMFYA (Guselkumab)
1DOSAGE FORMS AND STRENGTHS
TREMFYA is a clear and colorless to light yellow solution.
Subcutaneous Injection
- Injection: 100 mg/mL in a single-dose One-Press patient-controlled injector.
- Injection: 100 mg/mL in a single-dose prefilled pen (TREMFYA PEN).
- Injection: 200 mg/2 mL in a single-dose prefilled pen (TREMFYA PEN).
- Injection: 100 mg/mL in a single-dose prefilled syringe.
- Injection: 200 mg/2 mL (100 mg/mL) in a single-dose prefilled syringe.
Intravenous Infusion
- Injection: 200 mg/20 mL (10 mg/mL) solution in a single-dose vial.
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.
Adverse Reactions in Adults with Plaque Psoriasis
In clinical trials, a total of 1823 adult subjects with moderate-to-severe plaque psoriasis received TREMFYA. Of these, 1393 subjects were exposed to TREMFYA for at least 6 months and 728 subjects were exposed for at least 1 year.
Data from two placebo- and active-controlled trials (PsO1 and PsO2) in 1441 subjects (mean age 44 years; 70% males; 82% white) were pooled to evaluate the safety of TREMFYA (100 mg administered subcutaneously at Weeks 0 and 4, followed by every 8 weeks).
Weeks 0 to 16:
In the 16-week placebo-controlled period of the pooled clinical trials (PsO1 and PsO2), adverse events occurred in 49% of subjects in the TREMFYA group compared to 47% of subjects in the placebo group and 49% of subjects in the U.S. licensed adalimumab group. Serious adverse events occurred in 1.9% of subjects in the TREMFYA group (6.3 events per 100 patient-years of follow-up) compared to 1.4% of subjects in the placebo group (4.7 events per 100 patient-years of follow-up), and in 2.6% of subjects in U.S. licensed adalimumab group (9.9 events per 100 patient-years of follow-up).
Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the TREMFYA group than in the placebo group during the 16-week placebo-controlled period.
Adverse reactions that occurred in < 1% but > 0.1% of subjects in the TREMFYA group and at a higher rate than in the placebo group through Week 16 in trials PsO1 and PsO2 were migraine, candida infections, and urticaria.
Specific Adverse Reactions
- Infections
- Elevated Liver Enzymes
Elevated liver enzymes were reported more frequently in the TREMFYA group (2.6%) than in the placebo group (1.9%). Of the 21 subjects who were reported to have elevated liver enzymes in the TREMFYA group, all events except one were mild to moderate in severity and none of the events led to discontinuation of TREMFYA. - Safety through Week 48
Through Week 48, no new adverse reactions were identified with TREMFYA use and the frequency of the adverse reactions was similar to the safety profile observed during the first 16 weeks of treatment.
Adverse Reactions in Pediatric Subjects with Plaque Psoriasis
The safety of TREMFYA was studied in one placebo- and active-controlled clinical trial (PsO5) that included 120 pediatric subjects 6 years of age and older with moderate-to-severe plaque psoriasis
Adverse Reactions in Adults with Psoriatic Arthritis
TREMFYA was studied in two placebo-controlled trials (PsA1 and PsA2) in adult subjects with psoriatic arthritis (748 subjects on TREMFYA and 372 subjects on placebo). Of the 748 subjects who received TREMFYA, 375 subjects received TREMFYA 100 mg at Week 0, Week 4, and every 8 weeks (q8w) thereafter and 373 subjects received TREMFYA 100 mg every 4 weeks (q4w). The overall safety profile observed in adult subjects with psoriatic arthritis treated with TREMFYA is generally consistent with the safety profile in adult subjects with plaque psoriasis with the addition of bronchitis and neutrophil count decreased. In the 24-week placebo-controlled period, combined across the two studies, bronchitis occurred in 1.6% of subjects in the TREMFYA q8w group and 2.9% of subjects in the TREMFYA q4w group compared with 1.1% of subjects in the placebo group. Neutrophil count decreased occurred in 0.3% of subjects in the TREMFYA q8w and 1.6% of subjects in the TREMFYA q4w group compared with 0% of subjects in the placebo group. The majority of events of neutrophil count decreased were mild, transient, not associated with infection and did not lead to discontinuation. A similar risk of infection and serious infections was seen in placebo-controlled trials in subjects with psoriatic arthritis as in subjects with plaque psoriasis.
TREMFYA was additionally studied in a placebo-controlled trial (PsA3) in 1054 subjects with psoriatic arthritis (668 subjects on TREMFYA and 386 subjects on placebo). Of the 668 subjects who received TREMFYA, 388 subjects received TREMFYA 100 mg at Week 0, Week 4, and q8w thereafter and 280 subjects received TREMFYA 100 mg q4w. The overall safety profile observed in subjects with psoriatic arthritis treated with TREMFYA in trial PsA3 is consistent with the safety profile observed in trials PsA1 and PsA2.
Specific Adverse Reactions
- Elevated Liver Enzymes
In the 24-week placebo-controlled period in trials PsA1, PsA2, and PsA3, elevated liver enzymes were reported more frequently in the TREMFYA q4w (6.1%) group compared with the q8w group (4.8%) and to the placebo group (2.8%). Through Week 24, all events were mild to moderate in severity and none led to discontinuation of TREMFYA.
Adverse Reactions in Adults with Ulcerative Colitis
TREMFYA was studied up to 12 weeks in adult subjects with moderately to severely active ulcerative colitis in a randomized, double-blind, placebo-controlled induction trial (UC1) and a randomized, double-blind, placebo-controlled, induction dose-finding trial (UC3; NCT04033445). Long-term safety up to 44 weeks was evaluated in subjects who responded to induction therapy in trials UC1 or UC3 in a randomized, double-blind, placebo-controlled maintenance trial (UC2). In a randomized, double-blind, placebo-controlled trial (UC4), subjects received subcutaneous TREMFYA at Weeks 0, 4, and 8 followed by one of two recommended subcutaneous TREMFYA dosing regimens for a total duration of up to 24 weeks
Trials UC1, UC2 and UC3
In the induction trials (UC1 and UC3), 522 subjects received at least one dose of the TREMFYA intravenous induction regimen (i.e., 200 mg at Week 0, Week 4, and Week 8). Clinical response was defined as a decrease in modified Mayo score (mMS) of ≥30% and ≥2 points from baseline with either a ≥1 decrease from baseline in rectal bleeding subscore (RBS) or RBS of 0 or 1. In the maintenance trial (UC2), subjects who achieved clinical response after 12 weeks of TREMFYA intravenous induction treatment were randomized and received either TREMFYA 100 mg every 8 weeks (with the first dose given at Week 4 of trial UC2) or TREMFYA 200 mg every 4 weeks (with the first dose given at Week 0 of trial UC2), by subcutaneous (SC) injection for up to an additional 44 weeks.
Respiratory tract infections occurred in ≥2% of subjects treated with TREMFYA and at a higher rate than placebo (8.8% TREMFYA-treated subjects vs. 7.3% placebo-treated subjects) through Week 12 in the induction trials (UC1 and UC3). Respiratory tract infections included COVID-19, influenza, nasopharyngitis, respiratory tract infection, upper respiratory tract infection, and viral respiratory tract infection.
Adverse reactions that occurred in ≥3% of subjects treated with TREMFYA and at a higher rate than placebo through Week 44 in the maintenance trial (UC2) are shown in Table 2.
Trial UC4
In trial UC4, 418 subjects were enrolled, of whom 279 subjects were randomized to receive TREMFYA. Randomization was 1:1:1 to subcutaneous TREMFYA 400 mg at Weeks 0, 4, and 8 followed by subcutaneous TREMFYA 100 mg every 8 weeks (with the first dose given at Week 16) for up to an additional 8 weeks (from Week 16 through Week 24); subcutaneous TREMFYA 400 mg at Weeks 0, 4, and 8 followed by subcutaneous TREMFYA 200 mg every 4 weeks (with the first dose given at Week 12 for up to an additional 12 weeks (from Week 12 through Week 24); or placebo.
Adverse reactions reported in trial UC4 through Week 24 in ≥3% of subjects treated with either subcutaneous TREMFYA dosing regimen and at a higher rate than placebo are shown in Table 3.
Specific Adverse Reactions
Infections
In the 44-week trial (UC2), serious infections occurred in 0.8% of subjects treated with TREMFYA versus 0% of subjects in the placebo group. In the 24-week trial (UC4), serious infections occurred in 1.8% of subjects treated with TREMFYA versus 0.7% of subjects in the placebo group.
Adverse Reactions in Adults with Crohn's Disease
TREMFYA was studied in four clinical trials in adult subjects with moderately to severely active Crohn's disease
Trials CD1, CD2, and CD4
In trials CD1, CD2, and CD4; 1349 subjects were enrolled, of whom 649 were randomized to intravenous TREMFYA 200 mg at Weeks 0, 4, and 8 followed by either subcutaneous TREMFYA 100 mg every 8 weeks (with the first dose given at Week 16) for up to an additional 32 weeks (from Week 16 through Week 48) or subcutaneous TREMFYA 200 mg every 4 weeks (with the first dose given at Week 12) for up to an additional 36 weeks (from Week 12 through Week 48); and 211 subjects were randomized to receive placebo.
Through Week 12 in trials CD1, CD2, and CD4; headache (including headache, migraine, and sinus headache) was reported in ≥3% of subjects treated with intravenous TREMFYA and at a greater rate than placebo (3.4% TREMFYA-treated subjects vs. 1.9% placebo-treated subjects). In TREMFYA-treated subjects in trial CD2, one case of active extrapulmonary TB was reported between Weeks 12–48 and one case of active pulmonary TB was reported after Week 48. Both subjects had negative baseline screenings and resided in TB-endemic regions
Trial CD3
In trial CD3, 347 subjects were enrolled, of whom 230 subjects were randomized to receive TREMFYA. Randomization was 1:1:1 to subcutaneous TREMFYA 400 mg at Weeks 0, 4, and 8 followed by subcutaneous TREMFYA 100 mg every 8 weeks (with the first dose given at Week 16) for up to an additional 32 weeks (from Week 16 through Week 48); subcutaneous TREMFYA 400 mg at Weeks 0, 4, and 8 followed by subcutaneous TREMFYA 200 mg every 4 weeks (with the first dose given at Week 12) for up to an additional 36 weeks (from Week 12 through Week 48); or placebo.
Adverse reactions reported in trial CD3 through Week 48 in ≥3% of subjects treated with either subcutaneous TREMFYA dosing regimen and at a higher rate than placebo are shown in Table 4.
Specific Adverse Reactions
Infections
In the 48-week clinical trial in subjects with Crohn's disease (CD3), serious infections occurred in 1.5% of subjects treated with TREMFYA versus 0% of subjects in the placebo group.
Elevated Liver Enzymes
Through Week 12 in CD1, CD2, and CD4; ALT ≥5× ULN was reported in 2/645 (0.3%) subjects treated with intravenous TREMFYA 200 mg at Weeks 0, 4, and 8 and 0/211 subjects treated with placebo. These elevations occurred without concomitant elevations in total bilirubin.
Through Week 48 in CD3, ALT ≥5× ULN was reported in 0/115 subjects treated with subcutaneous TREMFYA 400 mg at Weeks 0, 4, and 8 followed by subcutaneous TREMFYA 100 mg every 8 weeks; 2/115 (1.7%) subjects treated with subcutaneous TREMFYA 400 mg at Weeks 0, 4, and 8 followed by subcutaneous TREMFYA 200 mg every 4 weeks; and 0/117 subjects treated with placebo. These elevations occurred without concomitant elevations in total bilirubin.
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
TREMFYA for Subcutaneous Injection
Available as a 100 mg/mL solution in a 1 mL or 2 mL glass prefilled syringe, in a 1 mL or 2 mL prefilled pen (TREMFYA PEN), or in a 1 mL One-Press patient-controlled injector for subcutaneous use.
- Each TREMFYA 1 mL prefilled syringe, prefilled pen (TREMFYA PEN), or One-Press patient-controlled injector delivers 100 mg guselkumab, L-histidine (0.6 mg), L-histidine monohydrochloride monohydrate (1.5 mg), polysorbate 80 (0.5 mg), sucrose (79 mg) and water for injection at pH 5.8.
- Each TREMFYA 2 mL prefilled syringe or prefilled pen (TREMFYA PEN) delivers 200 mg guselkumab, L-histidine (1.2 mg), L-histidine monohydrochloride monohydrate (3 mg), polysorbate 80 (1 mg), sucrose (158 mg) and water for injection at pH 5.8.
TREMFYA for Intravenous Infusion
Available as 10 mg/mL solution in a 20 mL single-dose vial for intravenous use.
Each TREMFYA 20 mL vial delivers 200 mg guselkumab, EDTA disodium dihydrate (0.4 mg), L-histidine (11.3 mg), L-histidine monohydrochloride monohydrate (26.6 mg), L-methionine (8 mg), polysorbate 80 (10 mg), sucrose (1700 mg) and water for injection at pH 5.8.
5HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
TREMFYA
Subcutaneous Injection
- Carton of one 100 mg/mL single-dose One-Press patient‑controlled injector (NDC: 57894-640-11)
- Carton of one 100 mg/mL single-dose prefilled pen (TREMFYA PEN) (NDC: 57894-640-06)
- Carton of one 200 mg/2 mL single-dose prefilled pen (TREMFYA PEN) (NDC: 57894-651-02)
- Induction Pack for Ulcerative Colitis or Crohn's Disease: Carton containing two 200 mg/2 mL single-dose prefilled pens (400 mg/4 mL total) (TREMFYA PEN) (NDC: 57894-651-04)
- Carton of one 100 mg/mL single-dose prefilled syringe with a 27G, half inch fixed needle assembled in a passive needle guard delivery system (NDC: 57894-640-01)
- Carton of one 200 mg/2 mL (100 mg/mL) single-dose prefilled syringe with a 27G, half inch fixed needle assembled in a passive needle guard delivery system (NDC: 57894-651-22)
Intravenous Infusion
- Carton of one 200 mg/20 mL (10 mg/mL) single-dose vial (NDC: 57894-650-02)
6PATIENT COUNSELING INFORMATION
Advise patients and/or caregivers to read the FDA-approved patient labeling
Hypersensitivity Reactions
Advise patients to discontinue TREMFYA and seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions
Infections
Instruct patients of the importance of communicating any history of infections to the healthcare provider and contacting their healthcare provider if they develop any symptoms of an infection
Tuberculosis
Advise patients to contact their healthcare provider if they experience symptoms suggestive of TB (e.g., unexplained fever, cough, or difficulty breathing)
Hepatotoxicity
Inform patients that TREMFYA may cause liver injury. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of liver dysfunction (e.g., unexplained rash, nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine)
Immunizations
Advise patients treated with TREMFYA to avoid use of live vaccines
Ulcerative Colitis and Crohn's Disease Subcutaneous Induction Dosing Instructions (400 mg Subcutaneous dose)
If patients are to receive the 400 mg subcutaneous induction dosage for ulcerative colitis or Crohn's disease, instruct patients or caregivers to administer two 200 mg prefilled pens or prefilled syringes to achieve the full 400 mg dose
Instruction on Injection Technique
Instruct patients or caregivers to perform the first self-injection under the supervision and guidance of a qualified healthcare professional for proper training in subcutaneous injection technique, including injection of the full dose
Proper Sharps Disposal Instructions
Counsel patients and caregivers on the proper technique of needle and syringe disposal. Instruct patients to dispose needles and syringes in a puncture-resistant container. Advise patients and caregivers not to reuse needles or syringes.
Administration Instructions
Instruct patients that if they forget to administer a dose of TREMFYA, then they should administer TREMFYA as soon as they remember. Instruct patients to administer the next dose at the regular scheduled time.
Pregnancy
Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in patients exposed to TREMFYA during pregnancy
7INSTRUCTIONS FOR USE
TREMFYA
200 mg/2mL (100 mg/mL) Prefilled Syringe
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.
Storage informationStore 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
1. Get ready
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.
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
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.
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.
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
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.
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.
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.
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
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.
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.
Need 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
8INSTRUCTIONS FOR USE
TREMFYA
[trem fye' ah Pen]
200 mg/2 mL Prefilled Pen
[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
Storage informationStore 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
1. Get ready
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.
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
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.
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.
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
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.
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.
Keep holding your Prefilled Pen firmly against the skin for about 10 seconds to hear a second click
You are almost done.
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.
Lift straight up
If your prescribed dose requires two injections, repeat Steps 2 to 4 with the second Prefilled Pen.
4. After your injection
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.
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.
Need 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
9Instructions for Use
TREMFYA
(trem fye' ah)
(guselkumab)
(trem fye' ah)
(guselkumab)
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
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.
Storage informationStore 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
After use
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
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
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.
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
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 "
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 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
10INSTRUCTIONS FOR USE
TREMFYA
One-Press Patient-Controlled Injector
One-Press Patient-Controlled Injector
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 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.
Storage informationStore 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.
Need 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
1. Preparing to Inject TREMFYA
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.
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.
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.
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,
- discolored, or
- has large particles.
Call your healthcare provider or pharmacist for a new One-Press injector.
2. Injecting TREMFYA
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.
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.
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.
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 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 "
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
11INSTRUCTIONS FOR USE
TREMFYA
100 mg/mL Prefilled Pen
100 mg/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 100 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.
For children, TREMFYA PEN 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 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
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
1. Get ready
Allow TREMFYA PEN to come to room temperature and inspect carton
Remove the carton from the refrigerator and let the carton sit on a flat surface at room temperature for approximately
Do not warm the Prefilled Pen any other way.
Check to see that you have the correct medicine and dose.
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.
2. Prepare to inject with TREMFYA PEN
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.
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 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, scaly, thick or hard. Avoid areas with scars or stretch marks.
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
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.
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 teal 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.
Keep holding your Prefilled Pen firmly against the skin for about 10 seconds to hear a second click
You are almost done.
Keep holding firmly against the skin and confirm your injection is complete
Your injection is complete when the yellow plunger rod stops moving and fills the viewing window.
Lift straight up
4. After your injection
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.
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.
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.
Manufactured by:
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Approved: September / 2025
12PRINCIPAL 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
13PRINCIPAL DISPLAY PANEL - 100 mg/mL Syringe Carton - NDC 57894-640-11
Tremfya
100 mg/mL
FOR SUBCUTANEOUS USE ONLY
NDC 57894-640-11
Single-dose One-Press
Discard unused portion
ATTENTION: Dispense the enclosed
14PRINCIPAL 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
15PRINCIPAL 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
16PRINCIPAL 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
17PRINCIPAL 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
18PRINCIPAL 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
