guselkumab
Tremfya
Pharmaceutical company: Janssen Biotech, Inc
Pharmacologic classification: Immunomodulators
Therapeutic classification: Interleukin 23 receptor antagonists
AVAILABLE FORMS
Injection (IV): 200 mg/20 ml single-dose vial
Injection (subcut): 100 mg/1 mL single-dose patient-controlled injector, or prefilled pen or syringe; 200 mg/2 mL single dose prefilled pen or syringe
INDICATIONS AND DOSAGES
Moderate to severely active Crohn disease
Adults Induction dose of 200-mg IV infusion or 400 mg subcut (given as two consecutive injections of 200 mg each) at week 0, week 4, and week 8. Then, maintenance doses of either 100 mg subcut at week 16, then every 8 weeks thereafter; or 200 mg subcut at week 12, then every 4 weeks thereafter. Use the lowest effective recommended dosage to maintain therapeutic response.
Moderate to severe plaque psoriasis
Adults 100 mg subcut at week 0, week 4, and every 8 weeks thereafter.
Active psoriatic arthritis
Adults 100 mg subcut at week 0, week 4, and every 8 weeks thereafter. May be administered alone or in combination with a conventional disease-modifying antirheumatic drug such as methotrexate.
Moderate to severe ulcerative colitis
Adults Induction dose of 200 mg IV infusion at week 0, week 4, and week 8. Then, maintenance doses of either 100 mg subcut at week 16, then every 8 weeks thereafter, or 200 mg subcut at week 12, then every 4 weeks thereafter. Use the lowest effective recommended dosage to maintain therapeutic response.
ADVERSE REACTIONS
CNS: fatigue, headache.
GI: abdominal pain, diarrhea, gastroenteritis.
Hematologic: neutropenia.
Hepatic: increased LFTs.
Musculoskeletal: arthralgia.
Respiratory: bronchitis, URI.
Skin: rash, tinea infections.
Other: herpes simplex infections, injection site reactions.
INTERACTIONS
Drug-drug.. CYP450 substrates with a narrow therapeutic index (phenytoin, repaglinide warfarin): May alter substrate levels. Monitor for therapeutic effect or drug concentration and consider dosage adjustment as needed.
Live vaccines: May increase risk of infections. Avoid use together.
CONTRAINDICATIONS AND CAUTIONS
- Contraindicated in patients with serious hypersensitivity to the drug or any of its components.
- Treatment shouldn't be started in patients with active infections until the infection resolves or is adequately treated.
- Use cautiously in patients with a chronic infection or history of recurrent infection due to increased risk of infection.
- Drug induced liver toxicity has been reported. Consider other treatment options in patients with acute liver disease or cirrhosis.
- Safety and effectiveness of this drug haven't been established in children.
- Dialyzable drug: Unlikely.
PREGNANCY-LACTATION-REPRODUCTION
- Studies during pregnancy are inadequate. Humanized monoclonal antibodies, like guselkumab, cross the placenta.
- Patient enrollment in pregnancy exposure registry is encouraged. (www.mothertobaby.org/ongoing-study/tremfya-guselkumab, 1-866-626-6847).
- It's unknown if this drug appears in human milk or how drug affects milk production or infants who are breastfed. Weigh benefit to patient against risk to infant before use.
Reactions in bold italics are
life-threatening.
Released: July 2025
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