Guselkumab Application Scope

Moderate to severe plaque psoriasis, active psoriatic arthritis, and moderate to severe ulcerative colitis in adults.

Characteristics

Ingredients:
- Active Ingredient: Guselkumab
- Excipients:
  - Subcutaneous Injection (Prefilled Syringe/Pen): L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, water for injection.
  - Intravenous Infusion (Vial): EDTA disodium dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80, sucrose, water for injection.
Properties:
- Type: Monoclonal antibody
- Mechanism of Action: Selective inhibitor of interleukin-23 (IL-23), specifically targeting the p19 subunit, thereby inhibiting the activation of T-helper cells involved in inflammatory processes.
Packaging Specification:
- Subcutaneous Injection:
  - 200 mg/2 mL (100 mg/mL) in a single-dose prefilled syringe.
  - 200 mg/2 mL (100 mg/mL) in a single-dose prefilled pen.
- Intravenous Infusion:
  - 200 mg/20 mL (10 mg/mL) solution in a single-dose vial.
Storage:
- Subcutaneous Injection:
  - Refrigerate at 2°C to 8°C (36°F to 46°F).
  - May be stored at room temperature (up to 25°C or 77°F) for a maximum of 30 days.
- Intravenous Infusion:
  - Refrigerate at 2°C to 8°C (36°F to 46°F).
  - Do not freeze.
  - Protect from light.
Expiry Date: Refer to the expiration date printed on the packaging.
Executive Standard: Approved by regulatory authorities such as the U.S. FDA and EMA.
Approval Number: U.S. FDA Biologics License Application (BLA) 761061.
Date of Revision: March 2025.
Manufacturer: Janssen Biotech, Inc., a subsidiary of Johnson & Johnson.

Guidelines for the Use of Guselkumab

Dosage and Administration:
- Plaque Psoriasis:
  - Induction: 100 mg subcutaneously at weeks 0, 4.
  - Maintenance: 100 mg subcutaneously every 8 weeks.
- Psoriatic Arthritis:
  - Induction: 100 mg subcutaneously at weeks 0, 4.
  - Maintenance: 100 mg subcutaneously every 8 weeks.
  - May be used alone or in combination with conventional disease-modifying antirheumatic drugs (cDMARDs) such as methotrexate.
- Ulcerative Colitis:
  - Induction: 200 mg subcutaneously at weeks 0, 4.
  - Maintenance: 200 mg subcutaneously every 8 weeks.
- Administration:
  - Subcutaneous injections should be administered by a healthcare professional or a trained patient/caregiver.
  - Allow the prefilled syringe or pen to reach room temperature before injection.
  - Inspect the solution for particulate matter or discoloration before use; do not use if discolored or contains particles.
  - Rotate injection sites to minimize tissue irritation.
Adverse Reactions:
- Common (≥10%):
  - Upper respiratory tract infections.
- Less Common (1–10%):
  - Headache.
  - Injection site reactions.
  - Arthralgia.
  - Elevated liver enzymes.
  - Diarrhea.
  - Gastroenteritis.
  - Tinea infections.
  - Herpes simplex infections.
- Serious:
  - Hypersensitivity reactions, including anaphylaxis.
  - Serious infections.
Contraindications: History of serious hypersensitivity reactions to guselkumab or any of its excipients.
Precautions:
- Monitor for signs of infection; discontinue if a serious infection develops.
- Evaluate for tuberculosis before initiating therapy.
- Use with caution in patients with a history of recurrent infections.
- Not recommended for use during pregnancy unless clearly needed.
- Lactation: Unknown if distributed in human milk; maternal IgG is known to be present in human milk.

Interactions

Drug Interactions:
No known significant drug interactions.
Caution when used concomitantly with other immunosuppressive agents due to increased risk of infections.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.