TREMFYA Guselkumab 100 mg/mL Injection, 1 syringe
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Interleukin-23 Antagonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Tremfya is approved to treat moderate-to-severe plaque psoriasis and active psoriatic arthritis in adults and in children as young as 6 years old (who weigh at least about 88 lbs)....
- What conditions does Tremfya actually treat?
- Not necessarily. For plaque psoriasis and psoriatic arthritis, Tremfya is given as a subcutaneous injection — meaning under the skin — and adults can self-inject at home using the...
- How do I take this medication — do I have to go to a clinic every time?
Patient education
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💊 What it looks like
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🧪 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.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $14,742.76 | $14,742.76 / 1 syringe |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tremfya 100 mg/mLthis 57894-0640-99 | Janssen | 1 syringe | — | — | FDA listed | — |
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⏳ 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?
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💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 57894-0640-01 | 1 SYRINGE in 1 CARTON (57894-640-01) / 1 mL in 1 SYRINGE | $14,728.90 / mL | $14,728.90 | 2017-07-13 | Active |
| 57894-0640-04 | 1 SYRINGE in 1 CARTON (57894-640-04) / 1 mL in 1 SYRINGE | — | — | 2017-07-13 | Active |
| 57894-0640-11 | 1 SYRINGE in 1 CARTON (57894-640-11) / 1 mL in 1 SYRINGE | $14,745.80 / mL | $14,745.80 | 2019-01-28 | Active |
| 57894-0640-99 You're viewing this | 1 SYRINGE in 1 CARTON (57894-640-99) / 1 mL in 1 SYRINGE | — | — | 2019-01-28 | Active |
| 57894-0640-06 | 1 SYRINGE in 1 CARTON (57894-640-06) / 1 mL in 1 SYRINGE (57894-640-03) | $14,610.20 / mL | $14,610.20 | 2025-03-25 | Active |
This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 57894-0640-99?
What is the difference between NDC 57894-0640-99 and 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.
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 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…
💊 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…
🤒 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…
🔄 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…
🤰 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…
🧬 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…