Benlysta Application Scope

Adjunct treatment for systemic lupus erythematosus (SLE) and active lupus nephritis (LN) in adults and pediatric patients (≥5 years), in combination with standard therapy.

Benlysta Characteristics

Ingredients:
Belimumab (recombinant human IgG1λ monoclonal antibody targeting soluble BLyS/BAFF).
Properties:
Selective BLyS (BAFF) inhibitor that reduces B-cell survival and autoantibody production; available as IV lyophilized powder and SC 200 mg/mL presentations.
Packaging Specification: IV: Single-dose vials 120 mg and 400 mg (lyophilized powder for infusion). SC: 200 mg/mL prefilled autoinjector or prefilled syringe (1 mL).

Storage:
Refrigerate 2–8 °C; do not freeze; protect from light. Follow label for reconstituted/diluted IV solution handling.
Expiry Date: As printed on the carton/vial; use-by and in-use stability per U.S. Prescribing Information.
Executive Standard: Meets USPI/FDA and EMA SmPC requirements for licensed biologics.
Approval Number: U.S. FDA BLA 125370 (initial approval 2011).
Date of Revision: Refer to the current USPI/SmPC revision date on the official label.
Manufacturer: GlaxoSmithKline (GSK).

Guidelines for the Use of Benlysta

Dosage and Administration:
- Recommended Dose:
  - SLE (Adults & Pediatrics ≥5 y):
    - IV: 10 mg/kg at Weeks 0, 2, 4, then every 4 weeks.
    - SC: 200 mg once weekly (prefilled syringe or autoinjector).
  - Lupus Nephritis (Adults):
    - IV: 10 mg/kg at Weeks 0, 2, 4, then every 4 weeks, with standard therapy.
    - SC option: 400 mg once weekly for 4 doses, then 200 mg once weekly, with standard therapy.
- Administration: IV infusion after reconstitution/dilution per label; SC self-injection (abdomen, thigh, or upper arm) with 200 mg/mL device.
- Missed Dose: Take as soon as remembered and resume the regular schedule (see label for exact SC instructions).
Adverse Reactions:
- Common Adverse Reactions: Nausea, diarrhea, fever, nasopharyngitis/URTI, insomnia, depression, infusion reactions (IV), injection-site reactions (SC).
- Serious Adverse Reactions: Serious infections, hypersensitivity/anaphylaxis, depression/suicidality, PML (rare), malignancy risk signal consistent with immunomodulators.
Contraindications: History of serious hypersensitivity to belimumab or excipients.
Precautions:
- Monitor for infections; consider holding during active serious infection.
- Monitor mood/suicidality.
- Live vaccines are not recommended during treatment.
- Use in pregnancy only if benefit outweighs risk; consider infant exposure with SC/IV biologics.

Benlysta Interactions

No major CYP-mediated interactions; avoid live vaccines and consider additive immunosuppression with other biologics.

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.