Ilumetri Tildrakizumab injection

1. Indications and Usage
ILUMYA is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
2. Dosage and Administration
Route: Subcutaneous injection.
Recommended Dose: 100 mg administered at Week 0 and Week 4, followed by every 12 weeks thereafter.
Administration: Injection sites include the thigh, abdomen, or upper arm. Rotate sites and avoid areas where the skin is tender, bruised, erythematous, or indurated.
Missed Dose: Administer as soon as possible, then resume the every 12-week schedule.
3. Mechanism of Action
Tildrakizumab is a humanized IgG1κ monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23). This binding inhibits the interaction of IL-23 with its receptor on Th17 cells, thereby reducing the production of pro-inflammatory cytokines (such as IL-17 and IL-22) and ameliorating the inflammatory response and clinical signs of psoriasis.
4. Safety and Warnings
Infections: ILUMYA may increase the risk of infections. Evaluate patients for active infections before initiation.
Hypersensitivity: Serious hypersensitivity reactions (e.g., angioedema, urticaria) have been reported.
Vaccinations: Avoid the use of live or live-attenuated vaccines during treatment.
Pregnancy and Lactation: No adequate studies in pregnant women; use only if the benefit justifies the risk. It is unknown if present in human milk.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most common adverse reactions (incidence ≥2% and greater than placebo) include upper respiratory tract infection, injection site reactions, diarrhea, headache, and candidiasis. These were based on the reSURFACE 1 and reSURFACE 2 Phase 3 trials.
Clinical Research: In the pivotal trials, tildrakizumab demonstrated significant improvement in PASI 75 response rates and skin clearance compared to placebo and etanercept at Week 12 and Week 28.
6. Drug Interactions
No formal drug interaction studies have been conducted. Concomitant use of live vaccines is contraindicated. No clinically significant pharmacokinetic interactions with small-molecule drugs are expected.
7. Pharmaceutical Information
Active Ingredient: Tildrakizumab-asmn.
Strength: 100 mg/1 mL (single-dose prefilled syringe).
Inactive Ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and water for injection.
Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze or shake.