TREMFYA Guselkumab 100 mg/mL Injection, 1 syringe — NDC 57894-640-11 (Billing 57894-0640-11)
This is a package of 1 syringe of TREMFYA Guselkumab 100 mg/mL Injection from Janssen Biotech, Inc., marketed since Jul 2017 and currently FDA-listed; retail pharmacies pay about $14,743.70 per mL (NADAC). It is the main listing for this product, which comes in 5 package sizes.
NDC database record
One package, one record: these facts belong to NDC 57894-640-11 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 57894 labeler · 640 product · 11 package
- Package marketed since
- Jan 28, 2019
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 5789464011 0
- Medicaid fills, this package
- 22,462 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 079520
- GCN: 46024
- GPI-14 (Medi-Span): 9025054200E520
- HICL (First Databank): 044418
- AHFS class code: 84:06.28.00
- RxCUI (RxNorm): 1928686
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Interleukin-23 Antagonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Guselkumab injection is used to treat: plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) Guselkumab injection is in a class of medications called interleukin antagonists. It works by stopping the act...
Read the full MedlinePlus article ↗- Tremfya is approved for four conditions: moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis, and moderately to severe...
- What exactly does Tremfya treat, and is it right for me?
- Tremfya comes in a prefilled pen, a One-Press injector, and a prefilled syringe — all designed for subcutaneous (under-the-skin) injections. Adults can self-inject after proper tra...
- How do I give myself the injection at home?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Guselkumab — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $14,743.700 | $14,743.70 / 1 ml |
| Medicaid paysCMS SDUD · 12 mo | $13,964.23 | $13,964.23 / 1 ml |
| Medicare drug plans payPart D · Q2 2026 | $14,671.94 | $14,671.94 / 1 ml |
| Medicare Part B allowsASP · J1628 | $66.920 / J1628 unit | — |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Sep 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 57894-0640-01 57894-640-01 | 1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE | $14,728.90 / mL | $14,728.90 | 2017-07-13 | — | Active |
| 57894-0640-04 57894-640-04 | 1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE | — | — | 2017-07-13 | — | Active |
| 57894-0640-11 You're viewing this Main listing | 1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE | $14,743.70 / mL | $14,743.70 | 2019-01-28 | — | Active |
| 57894-0640-99 57894-640-99 | 1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE | — | — | 2019-01-28 | — | Active |
| 57894-0640-06 57894-640-06 | 1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE | $14,620.10 / mL | $14,620.10 | 2025-03-25 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 76% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 57894-0640-01?
What NDC number is used to bill for this package of TREMFYA Guselkumab 100 mg/mL Injection?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tremfya 100 mg/mLthis 57894-0640-11 | Janssen | 1 syringe | $14,743.700 | — | Availability likely | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Jul 13, 2029 |
Is there a biosimilar for TREMFYA 100 MG/ML ONE-PRESS?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
- FDA Purple Book · refreshed Oct 5, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Guselkumab Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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0.6 mg / 1 mL
UNII 4QD397987E
An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
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1.5 mg / 1 mL
UNII X573657P6P
Histidine monohydrochloride monohydrate is an amino acid salt used as a buffer in medicines. It helps maintain the proper acidity level of liquid formulations to keep the drug stable and effective.
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0.5 mg / 1 mL
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
-
79 mg / 1 mL
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Janssen Biotech, Inc. labeler code 57894
- Darzalex Faspro daratumumab and hyaluronidase-fihj (human recombinant) 1800 mg/15mL; 30000 U/15mL Injection NDC 57894-503-01
- Darzalex IV Daratumumab 100 mg/5mL Injection, Solution, Concentrate NDC 57894-505-05
- Rybrevant Faspro AMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT) 1600 mg/10mL; 20000 mg/10mL Injection NDC 57894-510-01
- Rybrevant Faspro AMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT) 2240 mg/14mL; 28000 mg/14mL Injection NDC 57894-514-01
- Rybrevant Faspro AMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT) 2400 mg/15mL; 30000 mg/15mL Injection NDC 57894-515-01
- Rybrevant Faspro AMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT) 3520 mg/22mL; 44000 mg/22mL Injection NDC 57894-522-01
- TREMFYA Guselkumab 200 mg/20mL Injection NDC 57894-650-02
- TREMFYA guselkumab 200 mg/2mL Injection NDC 57894-651-02
- IMAAVY nipocalimab-aahu 185 mg/mL Injection, Solution, Concentrate NDC 57894-800-01
- IMAAVY nipocalimab-aahu 185 mg/mL Injection, Solution, Concentrate NDC 57894-801-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE TREMFYA is an interleukin-23 antagonist indicated for the treatment of: adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. ( 1.1 ) adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis. ( 1.2 ) adults with moderately to severely active ulcerative colitis.
( 1.3 ) adults with moderately to severely active Crohn's disease. ( 1.4 )
1.1Plaque Psoriasis TREMFYA is indicated for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy.
1.2Psoriatic Arthritis TREMFYA is indicated for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis.
1.3Ulcerative Colitis TREMFYA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
1.4Crohn's Disease TREMFYA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For the treatment of ulcerative colitis or Crohn's disease: Obtain liver enzymes and bilirubin levels prior to initiating treatment with TREMFYA. ( 2.1 , 5.4 ). For the treatment of plaque psoriasis or psoriatic arthritis, if clinically indicated, evaluate liver enzymes and bilirubin at baseline prior to initiating treatment with TREMFYA ( 2.1 , 5.4 ).
Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment initiation. ( 2.1 ) Recommended Dosage Plaque Psoriasis Adults 100 mg administered by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter. ( 2.2 ) Pediatric Patients 6 Years of Age and Older Who Also Weigh at Least 40 kg 100 mg administered by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.
( 2.2 ) Psoriatic Arthritis Adults 100 mg administered by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter. TREMFYA can be used alone or in combination with a conventional DMARD (e.g., methotrexate). ( 2.3 ) Pediatric Patients 6 Years of Age and Older Who Also Weigh at Least 40 kg 100 mg administered by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.
TREMFYA may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (e.g., methotrexate). ( 2.3 ) Ulcerative Colitis and Crohn's Disease Induction : 200 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8 or 400 mg administered by subcutaneous injection at Week 0, Week 4, and Week 8. ( 2.4 ) Maintenance : 100 mg administered by subcutaneous injection at Week 16, and every 8 weeks thereafter, or 200 mg administered by subcutaneous injection at Week 12, and every 4 weeks thereafter.
Use the lowest effective recommended dosage to maintain therapeutic response. ( 2.4 )
2.1Recommended Evaluations and Immunizations Prior to Treatment Initiation Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with TREMFYA [see Warnings and Precautions (5.3) ] . For the treatment of ulcerative colitis or Crohn's disease, obtain liver enzymes and bilirubin levels prior to initiating treatment with TREMFYA [see Warnings and Precautions (5.4) ] . For the treatment of plaque psoriasis or psoriatic arthritis, if clinically indicated, evaluate liver enzymes and bilirubin prior to initiating treatment with TREMFYA [see Warnings and Precautions (5.4) ].
Complete all age-appropriate vaccinations according to current immunization guidelines [see Warnings and Precautions (5.5) ] .
2.2Recommended Dosage for Moderate-to-Severe Plaque Psoriasis Administer TREMFYA by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter. Adults The recommended dosage is 100 mg. Pediatric Patients 6 Years of Age and Older Who Also Weigh at Least 40 kg The recommended dosage is 100 mg.
2.3Recommended Dosage for Active Psoriatic Arthritis Administer TREMFYA by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter. TREMFYA may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (e.g., methotrexate). Adults The recommended dosage is 100 mg. Pediatric Patients 6 Years of Age and Older Who Also Weigh at Least 40 kg The recommended dosage is 100 mg.
2.4Recommended Dosage for Moderately to Severely Active Ulcerative Colitis and Crohn's Disease Adults Induction: The recommended induction dosage of TREMFYA is: 200 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8 [see Dosage and Administration (2.6) ] or 400 mg administered by subcutaneous injection (given as two consecutive injections of 200 mg each) at Week 0, Week 4, and Week 8. Maintenance: The recommended maintenance dosage of TREMFYA is: 100 mg administered by subcutaneous injection at Week 16, and every 8 weeks thereafter, or 200 mg administered by subcutaneous injection at Week 12, and every 4 we… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE 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. Subcutaneous Injection ( 3 ) 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 ( 3 ) Injection: 200 mg/20 mL (10 mg/mL) solution in a single-dose vial.
⛔ Contraindications ▾
4 CONTRAINDICATIONS TREMFYA is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients [see Warnings and Precautions (5.1) ] . History of serious hypersensitivity reactions to guselkumab or to any of the excipients. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions : Serious hypersensitivity reactions, including anaphylaxis, may occur. ( 5.1 ) Infections : TREMFYA may increase the risk of infections. Do not initiate treatment with TREMFYA in patients with clinically important active infection until the infection resolves or is adequately treated.
If such an infection develops, discontinue TREMFYA until the infection resolves. ( 5.2 ) Tuberculosis (TB) : Evaluate for TB prior to initiating treatment with TREMFYA. Monitor patients for signs and symptoms of active TB during and after treatment with TREMFYA.
( 5.3 ) Hepatotoxicity : Drug-induced liver injury has been reported. For the treatment of ulcerative colitis or Crohn's disease, evaluate liver enzymes and bilirubin levels at baseline, for at least 16 weeks of treatment, and periodically thereafter according to routine patient management. For the treatment of plaque psoriasis or psoriatic arthritis, if clinically indicated, evaluate liver enzymes and bilirubin at baseline, and periodically thereafter according to routine patient management.
Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. ( 5.4 ) Immunizations : Avoid use of live vaccines. ( 5.5 )
5.1Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, have been reported with post market use of TREMFYA. Some cases required hospitalization. If a serious hypersensitivity reaction occurs, discontinue TREMFYA and initiate appropriate therapy.
5.2Infections TREMFYA may increase the risk of infection [see Adverse Reactions (6.1) ] . In placebo-controlled clinical trials of up to 48 weeks in subjects with ulcerative colitis and Crohn's disease, serious infections occurred in ≤ 2% of subjects who received TREMFYA. In the 16-week placebo-controlled trials in subjects with plaque psoriasis, the rate of serious infections for the TREMFYA group and the placebo group was ≤ 0.2%.
A similar rate of serious infections was seen in placebo-controlled trials in subjects with psoriatic arthritis. The overall rates of infections were similar between subjects in the TREMFYA groups and subjects in the placebo groups in clinical trials for all indicated populations [see Adverse Reactions (6.1) ] . Treatment with TREMFYA should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing TREMFYA. Instruct patients to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection or is not responding to standard therapy, monitor the patient closely and discontinue TREMFYA until the infection resolves.
5.3Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating TREMFYA treatment. Do not administer TREMFYA to patients with active TB infection. Initiate treatment of latent TB prior to administering TREMFYA.
Consider anti-TB therapy prior to initiating TREMFYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor all patients for signs and symptoms of active TB during and after TREMFYA treatment. In clinical trials, 105 subjects with plaque psoriasis, 143 subjects with psoriatic arthritis, 43 subjects with ulcerative colitis, and 36 subjects with Crohn's disease with latent TB who were concurrently treated with TREMFYA and appropriate TB prophylaxis did not develop active TB.
In clinical trials of TREMFYA in subjects with Crohn's disease, active TB was reported in 2 subjects during treatment with TREMFYA [see Adverse Reactions (6.1) ] .
5.4Hepatotoxicity A serious adverse reaction of drug-induced liver injury was reported in a clinical trial subject with Crohn's disease following three doses o… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of labeling: Hypersensitivity Reactions [see Contraindications (4) and Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Tuberculosis [see Warnings and Precautions (5.3) ] Hepatotoxicity [see Warnings and Precautions (5.4) ] Most common adverse reactions associated with TREMFYA are: Plaque Psoriasis and Psoriatic Arthritis (≥1%): upper respiratory infections, headache, injection site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.
( 6.1 ) Ulcerative Colitis (≥3%) : injection site reactions, arthralgia, upper respiratory tract infections, headache, gastroenteritis, fatigue, pyrexia, and rash. ( 6.1 ) Crohn's Disease (≥3%) : respiratory tract infections, abdominal pain, injection site reactions, headache, fatigue, arthralgia, diarrhea, and gastroenteritis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical 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. Table 1: Adverse Reactions Occurring in ≥1% of Adult Subjects with Moderate-to-Severe Plaque Psoriasis through Week 16 in Trials PsO1 and PsO2 TREMFYA Subjects receiving 100 mg of TREMFYA at Week 0, Week 4, and every 8 weeks thereafter 100 mg N=823 n (%) Adalimumab U.S. licensed adalimumab N=196 n (%) Placebo N=422 n (%) Upper respiratory infections Upper respiratory infections include nasopharyngitis, upper respiratory tract infection (URTI), pharyngitis, and viral URTI.
118 (14.3) 21 (10.7) 54 (12.8) Headache Headache includes headache and tension headache. 38 (4.6) 2 (1.0) 14 (3.3) Injection site reactions Injection site reactions include injection site erythema, bruising, hematoma, hemorrhage, swelling, edema, pruritus, pain, discoloration, induration, inflammation, and urticaria. 37 (4.5) 15 (7.7) 12 (2.8) Arthralgia 22 (2.7) 4 (2.0) 9 (2.1) Diarrhea 13 (1.6) 3 (1.5) 4 (0.9) Gastroenteritis Gastroenteritis includes gastroenteritis and viral gastroenteritis.
11 (1.3) 4 (2.0) 4 (0.9) Tinea infections Tinea infections include tinea pedis, tinea cruris, tinea infection, and tinea manuum infections. 9 (1.1) 0 0 Herpes simplex infections Herpes simplex infections include oral herpes, herpes simplex, genital herpes, genital herpes simplex, and nas… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1CYP450 Substrates The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, interferon) during chronic inflammation. Results from an exploratory drug-drug interaction trial in subjects with moderate-to-severe plaque psoriasis suggested a low potential for clinically relevant drug interactions for drugs metabolized by CYP3A4, CYP2C9, CYP2C19 and CYP1A2 but the interaction potential cannot be ruled out for drugs metabolized by CYP2D6. However, the results were highly variable because of the limited number of subjects in the trial.
Upon initiation of TREMFYA in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect or drug concentration and consider dosage adjustment as needed [see Clinical Pharmacology (12.3) ] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to TREMFYA during pregnancy. Patients should be encouraged to enroll in the registry by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing [email protected]. Risk Summary Available data from literature, post-marketing reports, and ongoing pregnancy registry with TREMFYA use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
Monoclonal antibodies are actively transported across the placenta (see Clinical Considerations ). In a combined embryofetal development and pre- and post-natal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of guselkumab during organogenesis through parturition at doses up to 18 times the exposure (AUC) in humans administered 200 mg intravenously and 16 times the exposure (AUC) to the 400 mg dose given subcutaneously. Neonatal deaths in monkeys were observed at 4 to 18 times the exposure (AUC) in humans administered 200 mg intravenously and 4 to 16 times the exposure (AUC) to the 400 mg dose given subcutaneously (see Data ) .
The clinical significance of these nonclinical findings is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated Maternal and Embryo/Fetal Risk Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease (IBD) is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.
Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses and peaks during the third trimester. Therefore, TREMFYA may be present in infants exposed in utero . The potential clinical impact of guselkumab exposure in infants exposed in utero should be considered.
Data Animal Data In a combined embryofetal development and pre- and post-natal development study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of guselkumab from the beginning of organogenesis to parturition at a dose (50 mg/kg) resulting in exposures (AUC) 18 times the exposure in humans administered 200 mg intravenously and 16 times the human exposure at 400 mg given subcutaneously. Neonatal deaths occurred in the offspring of one control monkey, three monkeys administered guselkumab at 10 mg/kg/week (4 times the exposure (AUC) in humans administered 200 mg intravenously or 400 mg given subcutaneously) and three monkeys administered guselkumab at 50 mg/kg/week (18 times the exposure (AUC) in humans administered 200 mg intravenously and 16 times the exposure (AUC) following a 400 mg subcutaneous dose).
The clinical significance of these findings is unknown. No guselkumab-related effects on functional or immunological development were observed in the infants from birth through 6 months of age.
8.2Lactation Risk Summary There are no data on the presence of guselkumab in human milk, the effects on the breastfed infant, or the effects on milk production. Guselkumab was not detected in the milk of lactating cynomolgus monkeys. Endogenous maternal IgG and monoclonal antibodies are transferred into human milk.
The effects of local gastrointestinal exposure and the extent of systemic exposure in the breastfed infant to g… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to TREMFYA during pregnancy. Patients should be encouraged to enroll in the registry by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing [email protected]. Risk Summary Available data from literature, post-marketing reports, and ongoing pregnancy registry with TREMFYA use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
Monoclonal antibodies are actively transported across the placenta (see Clinical Considerations ). In a combined embryofetal development and pre- and post-natal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of guselkumab during organogenesis through parturition at doses up to 18 times the exposure (AUC) in humans administered 200 mg intravenously and 16 times the exposure (AUC) to the 400 mg dose given subcutaneously. Neonatal deaths in monkeys were observed at 4 to 18 times the exposure (AUC) in humans administered 200 mg intravenously and 4 to 16 times the exposure (AUC) to the 400 mg dose given subcutaneously (see Data ) .
The clinical significance of these nonclinical findings is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated Maternal and Embryo/Fetal Risk Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease (IBD) is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.
Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses and peaks during the third trimester. Therefore, TREMFYA may be present in infants exposed in utero . The potential clinical impact of guselkumab exposure in infants exposed in utero should be considered.
Data Animal Data In a combined embryofetal development and pre- and post-natal development study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of guselkumab from the beginning of organogenesis to parturition at a dose (50 mg/kg) resulting in exposures (AUC) 18 times the exposure in humans administered 200 mg intravenously and 16 times the human exposure at 400 mg given subcutaneously. Neonatal deaths occurred in the offspring of one control monkey, three monkeys administered guselkumab at 10 mg/kg/week (4 times the exposure (AUC) in humans administered 200 mg intravenously or 400 mg given subcutaneously) and three monkeys administered guselkumab at 50 mg/kg/week (18 times the exposure (AUC) in humans administered 200 mg intravenously and 16 times the exposure (AUC) following a 400 mg subcutaneous dose).
The clinical significance of these findings is unknown. No guselkumab-related effects on functional or immunological development were observed in the infants from birth through 6 months of age.
🧒 Pediatric Use ▾
8.4Pediatric Use Plaque Psoriasis The safety and effectiveness of TREMFYA for the treatment of moderate-to-severe plaque psoriasis have been established in pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy [see Adverse Reactions (6.1) and Clinical Studies (14.1) ] . The safety and effectiveness of TREMFYA have not been established in pediatric patients with plaque psoriasis who are younger than 6 years of age. Psoriatic Arthritis The safety and effectiveness of TREMFYA have been established for treatment of active psoriatic arthritis in pediatric patients 6 years of age and older.
Use of TREMFYA in this age group is supported by evidence from adequate and well controlled trials of TREMFYA in adults with plaque psoriasis and psoriatic arthritis, pharmacokinetic data from adult subjects with plaque psoriasis and psoriatic arthritis and pediatric subjects with plaque psoriasis, and safety data from a clinical trial in 120 subjects 6 to 17 years of age with plaque psoriasis. The observed pre-dose (trough) concentrations are generally comparable between adult subjects with plaque psoriasis, adult subjects with psoriatic arthritis and pediatric subjects with plaque psoriasis, and the systemic exposure is expected to be comparable between adult and pediatric patients with psoriatic arthritis [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.1 , 14.2) ] .
The safety and effectiveness of TREMFYA have not been established in pediatric patients with psoriatic arthritis who are younger than 6 years of age. Ulcerative Colitis The safety and effectiveness of TREMFYA have not been established in pediatric patients with ulcerative colitis. Crohn's Disease The safety and effectiveness of TREMFYA have not been established in pediatric patients with Crohn's disease.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 6418 subjects with plaque psoriasis, psoriatic arthritis, ulcerative colitis, or Crohn's disease exposed to TREMFYA, a total of 489 subjects were 65 years or older, and 55 subjects were 75 years or older. Clinical studies of TREMFYA, within each indication, did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects. No clinically meaningful differences in the pharmacokinetics of guselkumab were observed based on age [see Clinical Pharmacology (12.3) ] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Guselkumab is a human monoclonal IgG1λ antibody that selectively binds to the p19 subunit of interleukin 23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Guselkumab inhibits the release of proinflammatory cytokines and chemokines.
12.2Pharmacodynamics In evaluated adult subjects with moderate-to-severe plaque psoriasis, guselkumab reduced serum levels of IL-17A, IL-17F and IL-22 relative to pre-treatment levels based on exploratory analyses of the pharmacodynamic markers. In evaluated adult subjects with active psoriatic arthritis, serum levels of acute phase proteins C-reactive protein, serum amyloid A and IL-6, and Th17 effector cytokines IL-17A, IL-17F and IL-22 were elevated at baseline. Serum levels of these proteins measured at Week 4 and Week 24 were decreased compared to baseline following guselkumab treatment at Week 0, Week 4, and every 8 weeks thereafter.
The relationship between these pharmacodynamic markers and the mechanism(s) by which guselkumab exerts its clinical effects is unknown.
12.3Pharmacokinetics Guselkumab exhibited linear pharmacokinetics in healthy adult subjects and adult subjects with plaque psoriasis following subcutaneous injections. In subjects with plaque psoriasis, following subcutaneous administration of 100 mg of TREMFYA at Weeks 0 and 4, and every 8 weeks thereafter, mean steady-state trough serum guselkumab concentration was approximately 1.2 mcg/mL. The pharmacokinetics of guselkumab in adult subjects with psoriatic arthritis was similar to that in adult subjects with plaque psoriasis.
Following subcutaneous administration of 100 mg of TREMFYA at Weeks 0, 4, and every 8 weeks thereafter, mean steady-state trough serum guselkumab concentration was approximately 1.2 mcg/mL. Following subcutaneous maintenance dosing of 100 mg TREMFYA every 8 weeks or 200 mg TREMFYA every 4 weeks in adult subjects with ulcerative colitis, mean steady-state trough serum guselkumab concentrations were approximately 1.4 mcg/mL and 10.7 mcg/mL, respectively. Following subcutaneous maintenance dosing of 100 mg TREMFYA every 8 weeks, or 200 mg TREMFYA every 4 weeks, in adult subjects with Crohn's disease mean steady-state trough serum guselkumab concentrations were approximately 1.2 mcg/mL and 10.1 mcg/mL, respectively.
Absorption Following a single 100 mg subcutaneous injection in healthy adult subjects, guselkumab reached a mean (± SD) maximum serum concentration of 8.09 ± 3.68 mcg/mL by approximately 5.5 days post dose. The absolute bioavailability of guselkumab following a single 100 mg subcutaneous injection was estimated to be approximately 49% in healthy adult subjects. Following the recommended intravenous induction dose regimen of TREMFYA 200 mg at Weeks 0, 4, and 8, mean (± SD) peak serum guselkumab concentration at Week 8 was 68.3 ± 17.3 mcg/mL in adult subjects with ulcerative colitis.
Following the recommended subcutaneous induction dose regimen of TREMFYA 400 mg at Weeks 0, 4, and 8, mean (± SD) peak serum guselkumab concentration was estimated to be 28.8 ± 8.8 mcg/mL in adult subjects with ulcerative colitis. The total systemic exposure (AUC) after the recommended induction dose regimen was similar following subcutaneous and intravenous induction. Following the recommended intravenous induction dose regimen of TREMFYA 200 mg at Weeks 0, 4, and 8, mean (± SD) peak serum guselkumab concentration at Week 8 was 70.5 ± 24.5 mcg/mL in adult subjects with Crohn's disease.
Following the recommended subcutaneous induction dose regimen of TREMFYA 400 mg at Weeks 0, 4, and 8, mean (± SD) peak serum guselkumab concentration was estimated to be 27.7 ± 9.1 mcg/mL in adult subjects with Crohn's disease. The total systemic exposure (AUC) after the recommended induction dose regimen was similar following subcutaneous and intravenous induction. Distri… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Guselkumab is a human monoclonal IgG1λ antibody that selectively binds to the p19 subunit of interleukin 23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Guselkumab inhibits the release of proinflammatory cytokines and chemokines.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied TREMFYA ® (guselkumab) injection is a clear and colorless to light yellow solution supplied as follows: 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) Storage and Handling TREMFYA is sterile and preservative-free.
Discard any unused portion. Store in a refrigerator between 2 ºC to 8 ºC (36 ºF to 46 ºF). Store in original carton until time of use.
Protect from light until use. Do not freeze. Do not shake.
Not made with natural rubber latex.
📦 Storage and Handling ▾
Storage and Handling TREMFYA is sterile and preservative-free. Discard any unused portion. Store in a refrigerator between 2 ºC to 8 ºC (36 ºF to 46 ºF). Store in original carton until time of use. Protect from light until use. Do not freeze. Do not shake. Not made with natural rubber latex.
📋 Description ▾
11 DESCRIPTION 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 ® (guselkumab) injection is a sterile, preservative free, clear, and colorless to light yellow solution.
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.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients and/or caregivers to read the FDA-approved patient labeling (Medication Guide and Instructions for Use) before starting TREMFYA therapy, and each time the prescription is renewed, as there may be new information they need to know. Hypersensitivity Reactions Advise patients to discontinue TREMFYA and seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions (5.1) ]. 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 [see Warnings and Precautions (5.2) ] .
Tuberculosis Advise patients to contact their healthcare provider if they experience symptoms suggestive of TB (e.g., unexplained fever, cough, or difficulty breathing) [see Warnings and Precautions (5.3) ] . 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) [see Warnings and Precautions (5.4) ] .
Immunizations Advise patients treated with TREMFYA to avoid use of live vaccines [see Warnings and Precautions (5.5) ] . 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 [see Medication Guide and Instructions for Use] . 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 [see Medication Guide and Instructions for Use] .
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 [see Use in Specific Populations (8.1) ] .
💬 Medication Guide ▾
Medication Guide TREMFYA ® (trem fye´ ah) (guselkumab) injection, for subcutaneous or intravenous use This Medication Guide had been approved by the U.S. Food and Drug Administration. Revised: 05/2026 What is the most important information I should know about TREMFYA?
TREMFYA may cause serious side effects, including: Serious allergic reactions. Stop using TREMFYA and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: fainting, dizziness, feeling lightheaded (low blood pressure) swelling of your face, eyelids, lips, mouth, tongue or throat trouble breathing or throat tightness chest tightness skin rash, hives itching Infections. TREMFYA is a medicine that may lower the ability of your immune system to fight infections and may increase your risk of infections.
Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA and may treat you for TB before you begin treatment with TREMFYA if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: fever, sweats, or chills cough shortness of breath blood in your phlegm (mucus) muscle aches warm, red, or painful skin or sores on your body different from your psoriasis weight loss diarrhea or stomach pain burning when you urinate or urinating more often than normal Liver problems.
With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA. With the treatment of plaque psoriasis or psoriatic arthritis, your healthcare provider may do blood tests to check your liver before and as necessary during treatment with TREMFYA. Your healthcare provider may stop treatment with TREMFYA if you develop liver problems.
Tell your healthcare provider right away if you notice any of the following symptoms: unexplained rash vomiting tiredness (fatigue) yellowing of the skin or the whites of your eyes nausea stomach pain (abdominal) loss of appetite dark urine See " What are the possible side effects of TREMFYA? " for more information about side effects. What is TREMFYA? TREMFYA is a prescription medicine used to treat: adults and children 6 years of age and older who also weigh at least 88 pounds (40 kg) with moderate-to-severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light) adults and children 6 years of age and older who also weigh at least 88 pounds (40 kg) with active psoriatic arthritis (PsA) adults with moderately to severely active ulcerative colitis adults with moderately to severely active Crohn's disease It is not known if TREMFYA is safe and effective in children under 18 years of age with ulcerative colitis or Crohn's disease or in children under 6 years of age with plaque psoriasis or psoriatic arthritis.
Do not use TREMFYA if you have had a serious allergic reaction to guselkumab or any of the other ingredients in TREMFYA. See the end of this Medication Guide for a complete list of ingredients in TREMFYA. Before using TREMFYA , tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about TREMFYA?" have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine).
You should avoid receiving live vaccines during treatment with TREMFYA. Children should be brought up to date with all vaccines before starting TREMFYA. are pregnant or plan to become pregnant. It is not known if TREMFYA c… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Guselkumab exhibited linear pharmacokinetics in healthy adult subjects and adult subjects with plaque psoriasis following subcutaneous injections. In subjects with plaque psoriasis, following subcutaneous administration of 100 mg of TREMFYA at Weeks 0 and 4, and every 8 weeks thereafter, mean steady-state trough serum guselkumab concentration was approximately 1.2 mcg/mL. The pharmacokinetics of guselkumab in adult subjects with psoriatic arthritis was similar to that in adult subjects with plaque psoriasis.
Following subcutaneous administration of 100 mg of TREMFYA at Weeks 0, 4, and every 8 weeks thereafter, mean steady-state trough serum guselkumab concentration was approximately 1.2 mcg/mL. Following subcutaneous maintenance dosing of 100 mg TREMFYA every 8 weeks or 200 mg TREMFYA every 4 weeks in adult subjects with ulcerative colitis, mean steady-state trough serum guselkumab concentrations were approximately 1.4 mcg/mL and 10.7 mcg/mL, respectively. Following subcutaneous maintenance dosing of 100 mg TREMFYA every 8 weeks, or 200 mg TREMFYA every 4 weeks, in adult subjects with Crohn's disease mean steady-state trough serum guselkumab concentrations were approximately 1.2 mcg/mL and 10.1 mcg/mL, respectively.
Absorption Following a single 100 mg subcutaneous injection in healthy adult subjects, guselkumab reached a mean (± SD) maximum serum concentration of 8.09 ± 3.68 mcg/mL by approximately 5.5 days post dose. The absolute bioavailability of guselkumab following a single 100 mg subcutaneous injection was estimated to be approximately 49% in healthy adult subjects. Following the recommended intravenous induction dose regimen of TREMFYA 200 mg at Weeks 0, 4, and 8, mean (± SD) peak serum guselkumab concentration at Week 8 was 68.3 ± 17.3 mcg/mL in adult subjects with ulcerative colitis.
Following the recommended subcutaneous induction dose regimen of TREMFYA 400 mg at Weeks 0, 4, and 8, mean (± SD) peak serum guselkumab concentration was estimated to be 28.8 ± 8.8 mcg/mL in adult subjects with ulcerative colitis. The total systemic exposure (AUC) after the recommended induction dose regimen was similar following subcutaneous and intravenous induction. Following the recommended intravenous induction dose regimen of TREMFYA 200 mg at Weeks 0, 4, and 8, mean (± SD) peak serum guselkumab concentration at Week 8 was 70.5 ± 24.5 mcg/mL in adult subjects with Crohn's disease.
Following the recommended subcutaneous induction dose regimen of TREMFYA 400 mg at Weeks 0, 4, and 8, mean (± SD) peak serum guselkumab concentration was estimated to be 27.7 ± 9.1 mcg/mL in adult subjects with Crohn's disease. The total systemic exposure (AUC) after the recommended induction dose regimen was similar following subcutaneous and intravenous induction. Distribution In adult subjects with plaque psoriasis, apparent volume of distribution was
13.5L. In adult subjects with ulcerative colitis, apparent volume of distribution at steady-state was
10.1L. In adult subjects with Crohn's disease, apparent volume of distribution at steady-state was
11.4L. Elimination Apparent clearance in adult subjects with plaque psoriasis was 0.516 L/day. Mean half-life of guselkumab was approximately 15 to 18 days in subjects with plaque psoriasis across trials.
The apparent clearance in adult subjects with ulcerative colitis was 0.531 L/day. Mean half-life of guselkumab was approximately 17 days in subjects with ulcerative colitis. The apparent clearance in adult subjects with Crohn's disease was 0.568 L/day.
Mean half-life of guselkumab was approximately 17 days in subjects with Crohn's disease. Metabolism The exact pathway through which guselkumab is metabolized has not been characterized. As a human IgG monoclonal antibody, guselkumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Specific Populations Geriatric Subjects No apparent differences in clearance were… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics In evaluated adult subjects with moderate-to-severe plaque psoriasis, guselkumab reduced serum levels of IL-17A, IL-17F and IL-22 relative to pre-treatment levels based on exploratory analyses of the pharmacodynamic markers. In evaluated adult subjects with active psoriatic arthritis, serum levels of acute phase proteins C-reactive protein, serum amyloid A and IL-6, and Th17 effector cytokines IL-17A, IL-17F and IL-22 were elevated at baseline. Serum levels of these proteins measured at Week 4 and Week 24 were decreased compared to baseline following guselkumab treatment at Week 0, Week 4, and every 8 weeks thereafter.
The relationship between these pharmacodynamic markers and the mechanism(s) by which guselkumab exerts its clinical effects is unknown.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Clinical Studies in Plaque Psoriasis Adults with Moderate-to-Severe Plaque Psoriasis Four multicenter, randomized, double-blind trials (PsO1 [NCT02207231], PsO2 [NCT02207244], PsO3 [NCT02203032], and PsO4 [NCT02905331]) enrolled subjects 18 years of age and older with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy. Subjects had an Investigator's Global Assessment (IGA) score of ≥3 ("moderate") on a 5-point scale of overall disease severity, a Psoriasis Area and Severity Index (PASI) score ≥12, and a minimum affected body surface area (BSA) of 10%.
Subjects with guttate, erythrodermic, or pustular psoriasis were excluded. Trials PsO1 and PsO2 In trials PsO1 and PsO2, 1443 subjects were randomized to either TREMFYA (100 mg at Weeks 0 and 4 and every 8 weeks thereafter) administered with a prefilled syringe, placebo or U.S. licensed adalimumab (80 mg at Week 0 and 40 mg at Week 1, followed by 40 mg every other week thereafter). Both trials assessed the responses at Week 16 compared to placebo for the two co-primary endpoints: the proportion of subjects who achieved an IGA score of 0 ("cleared") or 1 ("minimal"); the proportion of subjects who achieved at least a 90% reduction from baseline in the PASI composite score (PASI 90).
Comparisons between TREMFYA and U.S. licensed adalimumab were secondary endpoints at the following time points: at Week 16 (trials PsO1 and PsO2), the proportions of subjects who achieved an IGA score of 0 or 1, a PASI 90, and a PASI 75 response; at Week 24 (trials PsO1 and PsO2), and at Week 48 (trial PsO1), the proportions of subjects achieving an IGA score of 0, an IGA score of 0 or 1, and a PASI 90 response. Other evaluated outcomes included improvement in psoriasis symptoms assessed on the Psoriasis Symptoms and Signs Diary (PSSD) and improvements in psoriasis of the scalp at Week 16.
In both trials, subjects were predominantly men and White, with a mean age of 44 years and a mean weight of 90 kg. At baseline, subjects had a median affected BSA of approximately 21%, a median PASI score of 19, and 18% had a history of psoriatic arthritis. Approximately 24% of subjects had an IGA score of 4 ("severe").
In both trials, 23% had received prior biologic systemic therapy. Clinical Response Table 5 presents the efficacy results at Week 16 in trials PsO1 and PsO2. Table 5: Efficacy Results at Week 16 in Adults with Moderate-to-Severe Plaque Psoriasis in Trials PsO1 and PsO2 (NRI NRI = Non-Responder Imputation ) Trial PsO1 Trial PsO2 Endpoint Placebo (N=174) n (%) TREMFYA (N=329) n (%) Placebo (N=248) n (%) TREMFYA (N=496) n (%) IGA response of 0/1 Co-Primary Endpoints , IGA response of 0 ("cleared") or 1 ("minimal") 12 (7) 280 (85) 21 (8) 417 (84) PASI 90 response 5 (3) 241 (73) 6 (2) 347 (70) Table 6 presents the results of an analysis of all the North America sites (i.e., U.S. and Canada), demonstrating superiority of TREMFYA to U.S. licensed adalimumab.
Table 6: Efficacy Results in Adults with Moderate-to-Severe Plaque Psoriasis in Trials PsO1 and PsO2 (NRI NRI = Non-Responder Imputation ) Trial PsO1 Trial PsO2 Endpoint TREMFYA (N=115) Subjects from sites in the United States and Canada n (%) Adalimumab U.S. licensed adalimumab (N=115) n (%) TREMFYA (N=160) n (%) Adalimumab (N=81) n (%) IGA response of 0/1 ("cleared" or "minimal") Week 16 97 (84) 70 (61) 119 (74) 50 (62) Week 24 97 (84) 62 (54) 119 (74) 46 (57) Week 48 91 (79) 62 (54) NA NA IGA response of 0 ("cleared") Week 24 61 (53) 27 (23) 76 (48) 23 (28) Week 48 54 (47) 28 (24) NA NA PASI 75 response Week 16 105 (91) 80 (70) 132 (83) 51 (63) PASI 90 response Week 16 84 (73) 47 (41) 102 (64) 34 (42) Week 24 92 (80) 51 (44) 113 (71) 41 (51) Week 48 84 (73) 53 (46) NA NA An improvement was seen in psoriasis involving the scalp in subjects randomized to TREMFYA compared to placebo at Week 16.
Examination of age, gender, race, body weight, and previous treatment with systemic or biologic a… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of TREMFYA. No effects on fertility parameters were observed after male guinea pigs were subcutaneously administered guselkumab at a dose of 25 mg/kg twice weekly (6 times the exposure (AUC) in humans administered 200 mg intravenously and 5 times the exposure (AUC) at the 400 mg subcutaneous dose). No effects on fertility parameters were observed after female guinea pigs were subcutaneously administered guselkumab at doses up to 100 mg/kg twice weekly (12 times the exposure (AUC) in humans administered 200 mg intravenously and 10 times the exposure (AUC) at the 400 mg subcutaneous dose).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of TREMFYA. No effects on fertility parameters were observed after male guinea pigs were subcutaneously administered guselkumab at a dose of 25 mg/kg twice weekly (6 times the exposure (AUC) in humans administered 200 mg intravenously and 5 times the exposure (AUC) at the 400 mg subcutaneous dose). No effects on fertility parameters were observed after female guinea pigs were subcutaneously administered guselkumab at doses up to 100 mg/kg twice weekly (12 times the exposure (AUC) in humans administered 200 mg intravenously and 10 times the exposure (AUC) at the 400 mg subcutaneous dose).
📖 Instructions for Use ▾
INSTRUCTIONS FOR USE TREMFYA ® [trem fye' ah] (guselkumab) injection, for subcutaneous use 200 mg/2mL (100 mg/mL) Prefilled Syringe This Instructions for Use contains information on how to inject TREMFYA. SINGLE-DOSE Important Information You Need to Know Before Injecting TREMFYA TREMFYA comes in a single-dose prefilled syringe containing one 200 mg dose. Your healthcare provider will tell you if you will need to use 1 or 2 prefilled syringes.
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 Step 4 ) after one dose, even if there is still medicine left in it.
Do not reuse your TREMFYA prefilled syringe. 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 information Store in refrigerator between 36°F to 46°F (2°C to 8°C). 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 30 minutes before use. 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… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Indications and Usage ( 1.1 , 1.2 ) 09/2025 Dosage and Administration ( 2.1 , 2.2 , 2.3 , 2.5 ) 09/2025 Dosage and Administration ( 2.4 ) 09/2025 Warnings and Precautions ( 5.2 , 5.4 ) 09/2025
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 100 mg/mL Syringe Carton - NDC 57894-640-01 Tremfya ® (guselkumab) Injection 100 mg/mL FOR SUBCUTANEOUS USE ONLY Rx only NDC 57894-640-01 One single-dose prefilled syringe Discard unused portion Contains no preservative ATTENTION: Dispense the enclosed Medication Guide to each patient PRINCIPAL DISPLAY PANEL - 100 mg/mL Syringe Carton - NDC 57894-640-01
PRINCIPAL DISPLAY PANEL - 100 mg/mL Syringe Carton - NDC 57894-640-11 Tremfya ® (guselkumab) Injection 100 mg/mL FOR SUBCUTANEOUS USE ONLY Rx only NDC 57894-640-11 Single-dose One-Press patient-controlled injector Discard unused portion Contains no preservative ATTENTION: Dispense the enclosed Medication Guide to each patient PRINCIPAL DISPLAY PANEL - 100 mg/mL Syringe Carton - NDC 57894-640-11
PRINCIPAL DISPLAY PANEL - 100 mg/mL Pen Carton NDC 57894-640-06 Tremfya ® PEN (guselkumab) Injection 100 mg/mL FOR SUBCUTANEOUS USE ONLY Rx only One single-dose prefilled pen Discard unused portion Attention: Dispense the enclosed Medication Guide to each patient. PRINCIPAL DISPLAY PANEL - 100 mg/mL Pen Carton
PRINCIPAL DISPLAY PANEL - 200 mg/20 mL Vial Carton NDC 57894-650-02 Tremfya ® (guselkumab) Injection 200 mg/20 mL (10 mg/mL) FOR INTRAVENOUS INFUSION ONLY Attention: Dispense the enclosed Medication Guide to each patient. Rx only Single-dose vial Discard unused portion PRINCIPAL DISPLAY PANEL - 200 mg/20 mL Vial Carton
PRINCIPAL DISPLAY PANEL - 200 mg/2 mL Pen Carton NDC 57894-651-02 Tremfya ® PEN (guselkumab) Injection 200 mg/2 mL FOR SUBCUTANEOUS USE ONLY Rx only One single-dose prefilled pen Discard unused portion ATTENTION: Dispense the enclosed Medication Guide to each patient. PRINCIPAL DISPLAY PANEL - 200 mg/2 mL Pen Carton
PRINCIPAL DISPLAY PANEL - 200 mg/2 mL Syringe Carton NDC 57894-651-22 Tremfya ® (guselkumab) Injection 200 mg/2 mL FOR SUBCUTANEOUS USE ONLY Rx only One single-dose prefilled syringe Discard unused portion ATTENTION: Dispense the enclosed Medication Guide to each patient. PRINCIPAL DISPLAY PANEL - 200 mg/2 mL Syringe Carton
PRINCIPAL DISPLAY PANEL - 200 mg/2 mL Pen Carton - NDC 57894-651-04 NDC 57894-651-04 Rx only Tremfya ® PEN (guselkumab) Injection 200 mg/2 mL FOR SUBCUTANEOUS USE ONLY Induction Pack for Crohn's Disease and Ulcerative Colitis (includes 1 induction dose) The entire carton is to be dispensed as a unit. Contains: Two cartons each containing one single-dose prefilled pen. Discard unused portion.
ATTENTION: Dispense the enclosed Medication Guide to each patient. PRINCIPAL DISPLAY PANEL - 200 mg/2 mL Pen Carton - NDC 57894-651-04