Guselkumab — Membership Pricing

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What Guselkumab is approved for (FDA label)

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 ) 1.1 Plaque 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. 1.2 Psoriatic 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. 1.3 Ulcerative Colitis TREMFYA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis. 1.4 Crohn's Disease TREMFYA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease.

Source: Read the full FDA label on DailyMed. Label effective date: June 4, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Guselkumab (FDA label)

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.

Source: FDA prescribing information (DailyMed). Set ID: 1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56. SPL document ID: 01b4ab20-c027-482f-b358-b9beae545cb3. Label effective date: June 4, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Guselkumab (FDA label)

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 . 6.1 Clinical 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.

Source: FDA prescribing information (DailyMed). Set ID: 1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56. SPL document ID: 01b4ab20-c027-482f-b358-b9beae545cb3. Label effective date: June 4, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Guselkumab (FDA label)

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 )

Source: FDA prescribing information (DailyMed). Set ID: 1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56. SPL document ID: 01b4ab20-c027-482f-b358-b9beae545cb3. Label effective date: June 4, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Guselkumab (FDA label)

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.

Source: FDA prescribing information (DailyMed). Set ID: 1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56. SPL document ID: 01b4ab20-c027-482f-b358-b9beae545cb3. Label effective date: June 4, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Guselkumab (FDA label)

7.1 CYP450 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) ] .

Source: FDA prescribing information (DailyMed). Set ID: 1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56. SPL document ID: 01b4ab20-c027-482f-b358-b9beae545cb3. Label effective date: June 4, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.