Ilumetri Tildrakizumab Injection

1. Indications and Usage
Moderate to Severe Plaque Psoriasis: Indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
2. Dosage and Administration
Route of Administration: Subcutaneous injection ONLY.
Recommended Dosage: 300 mg (two 150 mg injections) administered at weeks 0, 4, and 8, followed by 300 mg every 12 weeks.
Critical Administration Instructions:
Injection Site: Rotate injection sites (thighs, abdomen, or upper arms). Do not inject into areas with active psoriatic lesions.
Preparation: Allow the pre-filled syringe or auto-injector to reach room temperature (20 to 25°C) for at least 30 minutes before use.
Administration: Inject subcutaneously over approximately 10 seconds. Do not shake.
3. Mechanism of Action
IL-23 Inhibition: Tildrakizumab is a highly selective human monoclonal antibody that binds specifically to the p19 subunit of interleukin-23 (IL-23).
Pathway Blockade: By binding to IL-23, it inhibits the release of pro-inflammatory cytokines, thereby reducing the inflammatory cascade and the proliferation of keratinocytes that characterize psoriatic lesions.
4. Safety and Warnings
Hypersensitivity: Serious allergic reactions, including angioedema and anaphylaxis, have been reported.
Infections: As an immunosuppressant, it may increase the risk of infections. Evaluate and treat active infections before initiation.
Tuberculosis (TB): Screen all patients for latent or active TB before starting therapy.
Malignancy: The risk of malignancy has not been established; use with caution in patients with a history of cancer.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Upper respiratory tract infections, injection site reactions, and arthralgia.
Clinical Research Highlights: Phase III clinical trials (e.g., reSURFACE 1 and 2) demonstrated that a significant proportion of patients achieved PASI 75 responses at week 12 and maintained durable skin clearance through week 52.
6. Drug Interactions
Immunosuppressants: No formal drug-drug interaction studies have been conducted. Caution is advised when used with other immunosuppressive agents due to increased infection risk.
Vaccines: Live or live-attenuated vaccines should be avoided during treatment. Non-live vaccines may have a reduced immunogenicity.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Tildrakizumab. Excipients: L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, sucrose, and water for injection.
Appearance: Clear to opalescent, colorless to pale yellow liquid.
Packaging: Available in 150 mg/1.5 mL pre-filled syringes or auto-injectors.
Storage: Store in a refrigerator at 2°C to 8°C. Do not freeze or shake.