Siltartoxatug Application Scope

Siltartoxatug is a passive immunization agent indicated for emergency prevention of tetanus in adults.

Siltartoxatug Characteristics

Ingredients: Siltartoxatug (recombinant anti-tetanus toxin fully human monoclonal antibody, IgG1 subtype).
Properties: Colorless or pale yellow clear liquid, may have slight opalescence. Do not use if appearance changes.
Packaging Specification: 10 mg (0.5 mL)/vial.
Storage: Store refrigerated at 2-8°C; avoid freezing.
Expiry Date: Refer to the product packaging.
Executive Standard: Refer to the most recent product labeling.
Approval Number: S20250012.
Date of Revision: February 20, 2025.
Manufacturer: Zhuhai Trinomab Pharmaceutical Co., Ltd.

Guidelines for the Use of Siltartoxatug

Dosage and Administration: Administer via intramuscular injection in the gluteal region only; do not administer intravenously. No skin test is required prior to use. No observation period is needed for outpatient use.
- Recommended Dose: Single dose of 10 mg (0.5 mL).
- Administration: Intramuscular injection in the gluteal region. If used concomitantly with adult adsorbed tetanus vaccine, use separate syringes and administer at different body sites; do not mix in the same syringe or inject at the same site. Open and use the entire vial immediately; do not divide doses or use for a second person.
- Missed Dose: Not applicable, as this is a single-dose product for emergency use.
Adverse Reactions:
- Common Adverse Reactions: Increased transaminases (including AST and ALT elevations), hematuria (each 0.7%). Injection site reactions (pain, erythema, hypoesthesia, swelling; mild and resolved spontaneously). Allergic reactions (0.2%, e.g., mild allergic dermatitis).
- Serious Adverse Reactions: No serious adverse reactions related to siltartoxatug were reported in clinical trials. Serious AEs (1.4% incidence) were unrelated to the study drug.
Contraindications: Hypersensitivity to the active ingredient or any excipients, or a history of other severe allergies.
Precautions:
- No skin test required. Do not administer intravenously. Do not use if the liquid’s appearance has changed or if the vial is cracked. If used with tetanus vaccine, use separate syringes and different injection sites. Use the entire contents immediately after opening. Safety and efficacy not established in pregnant/lactating women or patients <18 years old.

Siltartoxatug Interactions

Clinical trials showed that concomitant use with adsorbed tetanus vaccine affects siltartoxatug exposure to some extent, but does not have a clinically significant impact on passive immunization effects or vaccine-induced active immunity.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.