Tremfya Guselkumab Injection

1. Indications and Usage
Plaque Psoriasis:
Treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Psoriatic Arthritis (PsA):
Treatment of adult patients with active psoriatic arthritis, as monotherapy or in combination with methotrexate (MTX) or other non-biologic DMARDs.
2. Dosage and Administration
Route of Administration:
For Subcutaneous Injection ONLY.
Recommended Dosage:
Standard Dose: 100 mg administered every 8 weeks.
Dosing Schedule:
Plaque Psoriasis: Administer at Weeks 0, 4, and then every 8 weeks thereafter.
Psoriatic Arthritis: Administer at Weeks 0, 4, and then every 8 weeks thereafter.
Administration:
Patients may self-inject if their physician determines it is appropriate and they receive proper training.
Do not inject into skin that is tender, bruised, red, hard, or into psoriatic lesions.
3. Mechanism of Action
IL-23 Inhibition:
Guselkumab is a human IgG1 monoclonal antibody that binds specifically to the p19 subunit of interleukin-23 (IL-23).
Blocking the Pathway:
IL-23 is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. By inhibiting IL-23, guselkumab blocks its interaction with the IL-23 receptor on the cell surface.
Downstream Effect:
This inhibition reduces the release of proinflammatory cytokines and chemokines, thereby reducing the inflammatory cascade responsible for psoriasis and psoriatic arthritis.
4. Safety and Warnings
Infections:
Guselkumab may increase the risk of infections. Patients should be evaluated for tuberculosis (TB) infection prior to initiating therapy.
Hypersensitivity:
Hypersensitivity reactions (e.g., urticaria, angioedema) have been reported. If a serious hypersensitivity reaction occurs, discontinue guselkumab and initiate appropriate treatment.
Vaccinations:
Avoid administration of live vaccines during treatment.
5.Adverse Reactions
Most Common (Incidence ≥2% and greater than placebo):
Nasopharyngitis, headache, diarrhea, upper respiratory tract infection, injection site reactions, candidiasis, and neutropenia.
6.Drug Interactions
CYP450 Substrates:
Chronic inflammation may alter CYP450 enzyme formation. While no clinically relevant interactions were observed with CYP3A4, CYP2C9, CYP2C19, or CYP1A2 substrates, caution is advised with CYP2D6 substrates.
Immunosuppressants:
Safety and efficacy of guselkumab in combination with other immunosuppressants have not been established.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Guselkumab.
Available Strength: 100 mg/1 mL in a single-dose prefilled syringe or pen.
Appearance: Clear to slightly opalescent, colorless to pale yellow liquid.
Storage: Store at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.