Tremfya
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Dosage & Administration
Recommended Dosage
Plaque Psoriasis
Adults
Pediatric Patients 6 Years of Age and Older Who Also Weigh at Least 40 kg
Psoriatic Arthritis
Adults
Pediatric Patients 6 Years of Age and Older Who Also Weigh at Least 40 kg
Ulcerative Colitis and Crohn’s Disease
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Tremfya Prescribing Information
Indications and Usage (TREMFYA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease. | 03/2025 |
Indications and Usage (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. 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. | 09/2025 |
Dosage and Administration (
TREMFYA is available for subcutaneous use in the following presentations: prefilled pen (TREMFYA PEN), One-Press injector, and prefilled syringes [see Dosage Forms and Strengths (3)and How Supplied/Storage and Handling (16)] .
Preparation Instructions :
Administration Instructions :
Storage of Diluted Solution:
| 03/2025 |
Dosage and Administration (Administer TREMFYA by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter. Adults The recommended dose is 100 mg. Pediatric Patients 6 Years of Age and Older Who Also Weigh at Least 40 kg The recommended dose is 100 mg. 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 dose is 100 mg. Pediatric Patients 6 Years of Age and Older Who Also Weigh at Least 40 kg The recommended dose is 100 mg. TREMFYA is available for subcutaneous use in the following presentations: prefilled pen (TREMFYA PEN), One-Press injector, and prefilled syringes [see Dosage Forms and Strengths (3)and How Supplied/Storage and Handling (16)] .
| 09/2025 |
Dosage and Administration (Adults Induction: The recommended induction dosage of TREMFYA is:
Maintenance: The recommended maintenance dosage of TREMFYA is:
Use the lowest effective recommended dosage to maintain therapeutic response. | 09/2025 |
Warnings and Precautions (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, 71 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)] .A serious adverse reaction of drug-induced liver injury was reported in a clinical trial subject with Crohn's disease following three doses of a higher than the recommended induction regimen. This subject had peak alanine aminotransferase (ALT) of 18x the upper limit of normal (ULN), aspartate aminotransferase (AST) of 11x ULN, and total bilirubin of 2.4x ULN. TREMFYA was subsequently discontinued, and the liver test abnormalities resolved following administration of corticosteroids [see Adverse Reactions (6.1)] .In patients with ulcerative colitis or Crohn's disease, evaluate liver enzymes and bilirubin at baseline, for at least 16 weeks of treatment, and periodically thereafter according to routine patient management. In patients with plaque psoriasis or psoriatic arthritis, if clinically indicated, evaluate liver enzymes and bilirubin at baseline, and periodically thereafter according to routine patient management. Consider other treatment options in patients with evidence of acute liver disease or cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction. | 03/2025 |
Warnings and Precautions (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. A serious adverse reaction of drug-induced liver injury was reported in a clinical trial subject with Crohn's disease following three doses of a higher than the recommended induction regimen. This subject had peak alanine aminotransferase (ALT) of 18x the upper limit of normal (ULN), aspartate aminotransferase (AST) of 11x ULN, and total bilirubin of 2.4x ULN. TREMFYA was subsequently discontinued, and the liver test abnormalities resolved following administration of corticosteroids [see Adverse Reactions (6.1)] .In patients with ulcerative colitis or Crohn's disease, evaluate liver enzymes and bilirubin at baseline, for at least 16 weeks of treatment, and periodically thereafter according to routine patient management. In patients with plaque psoriasis or psoriatic arthritis, if clinically indicated, evaluate liver enzymes and bilirubin at baseline, and periodically thereafter according to routine patient management. Consider other treatment options in patients with evidence of acute liver disease or cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction. | 09/2025 |
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 Plaque PsoriasisTREMFYA 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. - adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis. ()
1.2 Psoriatic ArthritisTREMFYA 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. - adults with moderately to severely active ulcerative colitis. ()
1.3 Ulcerative ColitisTREMFYA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
- adults with moderately to severely active Crohn's disease. ()
1.4 Crohn's DiseaseTREMFYA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease.
- For the treatment of ulcerative colitis or Crohn’s disease: Obtain liver enzymes and bilirubin levels prior to initiating treatment with TREMFYA. (,
2.1 Recommended 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)].
).5.4 HepatotoxicityA serious adverse reaction of drug-induced liver injury was reported in a clinical trial subject with Crohn's disease following three doses of a higher than the recommended induction regimen. This subject had peak alanine aminotransferase (ALT) of 18x the upper limit of normal (ULN), aspartate aminotransferase (AST) of 11x ULN, and total bilirubin of 2.4x ULN. TREMFYA was subsequently discontinued, and the liver test abnormalities resolved following administration of corticosteroids[see Adverse Reactions (6.1)].In patients with ulcerative colitis or Crohn's disease, evaluate liver enzymes and bilirubin at baseline, for at least 16 weeks of treatment, and periodically thereafter according to routine patient management.In patients with plaque psoriasis or psoriatic arthritis, if clinically indicated, evaluate liver enzymes and bilirubin at baseline, and periodically thereafter according to routine patient management.Consider other treatment options in patients with evidence of acute liver disease or cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction. - 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 Recommended 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)].
).5.4 HepatotoxicityA serious adverse reaction of drug-induced liver injury was reported in a clinical trial subject with Crohn's disease following three doses of a higher than the recommended induction regimen. This subject had peak alanine aminotransferase (ALT) of 18x the upper limit of normal (ULN), aspartate aminotransferase (AST) of 11x ULN, and total bilirubin of 2.4x ULN. TREMFYA was subsequently discontinued, and the liver test abnormalities resolved following administration of corticosteroids[see Adverse Reactions (6.1)].In patients with ulcerative colitis or Crohn's disease, evaluate liver enzymes and bilirubin at baseline, for at least 16 weeks of treatment, and periodically thereafter according to routine patient management.In patients with plaque psoriasis or psoriatic arthritis, if clinically indicated, evaluate liver enzymes and bilirubin at baseline, and periodically thereafter according to routine patient management.Consider other treatment options in patients with evidence of acute liver disease or cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction. - Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment initiation. ()
2.1 Recommended 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)].
Recommended Dosage
Plaque Psoriasis
Adults
- 100 mg administered by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter. ()
2.2 Recommended Dosage for Moderate-to-Severe Plaque PsoriasisAdminister TREMFYA by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.AdultsThe recommended dose is 100 mg.Pediatric Patients 6 Years of Age and Older Who Also Weigh at Least 40 kgThe recommended dose is 100 mg.
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 Recommended Dosage for Moderate-to-Severe Plaque PsoriasisAdminister TREMFYA by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.AdultsThe recommended dose is 100 mg.Pediatric Patients 6 Years of Age and Older Who Also Weigh at Least 40 kgThe recommended dose is 100 mg.
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 Recommended Dosage for Active Psoriatic ArthritisAdminister 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).AdultsThe recommended dose is 100 mg.Pediatric Patients 6 Years of Age and Older Who Also Weigh at Least 40 kgThe recommended dose is 100 mg.
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 Recommended Dosage for Active Psoriatic ArthritisAdminister 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).AdultsThe recommended dose is 100 mg.Pediatric Patients 6 Years of Age and Older Who Also Weigh at Least 40 kgThe recommended dose is 100 mg.
Ulcerative Colitis and Crohn’s Disease
- 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. (Induction:)
2.4 Recommended Dosage for Moderately to Severely Active Ulcerative Colitis and Crohn's DiseaseAdultsInduction: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 weeks thereafter.
Use the lowest effective recommended dosage to maintain therapeutic response. - 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. (Maintenance:)
2.4 Recommended Dosage for Moderately to Severely Active Ulcerative Colitis and Crohn's DiseaseAdultsInduction: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 weeks thereafter.
Use the lowest effective recommended dosage to maintain therapeutic response.
TREMFYA is a clear and colorless to light yellow solution.
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 MotherToBaby@health.ucsd.edu.
TREMFYA is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients
[see
]
.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.
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available