Tremfya Generic Name & Formulations
Legal Class
Rx
General Description
Guselkumab 100mg/mL; soln for SC inj; preservative-free.
Pharmacological Class
Interleukin-23 antagonist.
How Supplied
Single-dose prefilled syringe—1; Single-dose One-Press injector—1
Manufacturer
Generic Availability
NO
Tremfya Indications
Indications
Active psoriatic arthritis.
Tremfya Dosage and Administration
Adult
≥18yrs: 100mg by SC inj at Weeks 0 and 4, then every 8 weeks thereafter. May be given alone or in combination with a conventional DMARD (eg, methotrexate).
Children
<18yrs: not established.
Tremfya Contraindications
Not Applicable
Tremfya Boxed Warnings
Not Applicable
Tremfya Warnings/Precautions
Warnings/Precautions
Use under physician supervision. May increase risk of infections. Active infection: do not initiate until resolved. Chronic or history of recurrent infection: consider the risks and benefits. If a serious infection develops or is not responding to standard therapy, monitor closely and discontinue until resolved. Evaluate for tuberculosis (TB) infection and treat latent TB prior to initiating. Monitor for active TB during and after therapy. History of latent or active TB (without confirmed adequate treatment); consider anti-TB therapy prior to initiation. Discontinue and treat if serious hypersensitivity reactions occur. Consider completion of all age appropriate immunizations based on current guidelines prior to initiating. Pregnancy. Nursing mothers.
Tremfya Pharmacokinetics
See Literature
Tremfya Interactions
Interactions
Concomitant live vaccines: not recommended. Concomitant CYP450 substrates with narrow therapeutic index: monitor and adjust dose as needed.
Tremfya Adverse Reactions
Adverse Reactions
Upper respiratory infections, headache, inj site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, herpes simplex infections; hypersensitivty reactions.
Tremfya Clinical Trials
See Literature
Tremfya Note
Not Applicable
Tremfya Patient Counseling
See Literature
Tremfya Generic Name & Formulations
Legal Class
Rx
General Description
Guselkumab 100mg/mL; soln for SC inj; preservative-free.
Pharmacological Class
Interleukin-23 antagonist.
How Supplied
Single-dose prefilled syringe—1; Single-dose One-Press injector—1
Manufacturer
Generic Availability
NO
Tremfya Indications
Indications
Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Tremfya Dosage and Administration
Adult
≥18yrs: 100mg by SC inj at Weeks 0 and 4, then every 8 weeks thereafter.
Children
<18yrs: not established.
Tremfya Contraindications
Not Applicable
Tremfya Boxed Warnings
Not Applicable
Tremfya Warnings/Precautions
Warnings/Precautions
Use under physician supervision. May increase risk of infections. Active infection: do not initiate until resolved. Chronic or history of recurrent infection: consider the risks and benefits. If a serious infection develops or is not responding to standard therapy, monitor closely and discontinue until resolved. Evaluate for tuberculosis (TB) infection and treat latent TB prior to initiating. Monitor for active TB during and after therapy. History of latent or active TB (without confirmed adequate treatment); consider anti-TB therapy prior to initiation. Discontinue and treat if serious hypersensitivity reactions occur. Consider completion of all age appropriate immunizations based on current guidelines prior to initiating. Pregnancy. Nursing mothers.
Tremfya Pharmacokinetics
See Literature
Tremfya Interactions
Interactions
Concomitant live vaccines: not recommended. Concomitant CYP450 substrates with narrow therapeutic index: monitor and adjust dose as needed.
Tremfya Adverse Reactions
Adverse Reactions
Upper respiratory infections, headache, inj site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, herpes simplex infections; hypersensitivty reactions.
Tremfya Clinical Trials
See Literature
Tremfya Note
Not Applicable
Tremfya Patient Counseling
See Literature
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