Ilumetri Tildrakizumab 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.
2. Dosage and Administration
Route of Administration:
For Subcutaneous Injection ONLY.
Recommended Dosage:
Standard Dose: 100 mg or 200 mg (for patients >90 kg if clinically indicated) administered subcutaneously.
Dosing Schedule:
Induction: Administer at Week 0 and Week 4.
Maintenance: Administer every 12 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:
Tildrakizumab is a humanized IgG1/κ monoclonal antibody that binds selectively to the p19 subunit of interleukin-23 (IL-23).
Note: It does not bind to IL-12.
Blocking Signaling:
By inhibiting IL-23, tildrakizumab blocks its interaction with the IL-23 receptor on the cell surface.
Downstream Effect:
This inhibition reduces the release of proinflammatory cytokines (including IL-17 and IL-22) and chemokines, thereby modulating the inflammatory cascade responsible for psoriasis.
4. Safety and Warnings
Infections:
Tildrakizumab may increase the risk of infections. Evaluate patients for tuberculosis (TB) infection prior to initiating therapy.
Hypersensitivity:
Hypersensitivity reactions (e.g., angioedema, urticaria) have been reported. If a serious hypersensitivity reaction occurs, discontinue tildrakizumab.
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, and injection site reactions.
6.Drug Interactions
CYP450 Substrates:
Chronic inflammation can alter CYP450 enzyme formation. Blocking IL-23 signaling may normalize CYP450 activity. Caution is advised with CYP1A2, CYP2C9, and CYP3A4 substrates.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Tildrakizumab.
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.