FDA approved Benlysta (belimumab) for Active Lupus Nephritis and SLEFDA approved Benlysta for lupus in children and adults

Belimumab is a B-lymphocyte stimulator (BLyS)-specific inhibitor that blocks the binding of soluble BLyS to its receptors on B cells. This inhibits the survival of B cells, reduces the differentiation of B cells into immunoglobulin-producing plasma cells, and decreases the production of autoantibodies.

Benlysta is indicated for the treatment of patients 5 years of age and older with: - Active systemic lupus erythematosus (SLE) who are receiving standard therapy. - Active lupus nephritis who are receiving standard therapy.

Limitations of Use: The efficacy of Benlysta has not been evaluated in patients with severe active central nervous system (CNS) lupus. Use of Benlysta is not recommended in this situation.

Benlysta may be administered intravenously or subcutaneously. Vials are for intravenous use only; autoinjectors and prefilled syringes are for subcutaneous use only.

**Intravenous Dosage (for active SLE or lupus nephritis):** - 10 mg/kg at 2-week intervals for the first 3 doses, then at 4-week intervals thereafter. - Reconstitute, dilute, and administer as an intravenous infusion over 1 hour. - Consider prophylactic premedication for infusion reactions and hypersensitivity reactions.

**Subcutaneous Dosage:** - **Adults:** - Active SLE: 200 mg once weekly. - Active Lupus Nephritis: 400 mg once weekly for 4 doses, then 200 mg once weekly. - **Pediatric Patients 5 Years and Older (weight-based, autoinjector only):** - Active SLE: ≥40 kg: 200 mg once weekly; 15 kg to <40 kg: 200 mg once every 2 weeks. - Active Lupus Nephritis: ≥40 kg: 400 mg once weekly for 4 doses, then 200 mg once weekly; 15 kg to <40 kg: 200 mg once weekly for 4 doses, then 200 mg once every 2 weeks.

Note: The prefilled syringe has not been studied in children less than 18 years of age. The 400-mg dose requires administration of two 200-mg injections.

Trial data not available in label.

- Benlysta should be administered by healthcare providers prepared to manage anaphylaxis. - Prior to intravenous dosing, consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions. - The infusion must be discontinued immediately if the patient experiences a serious hypersensitivity reaction. - Dextrose intravenous solutions are incompatible with Benlysta; only dilute in 0.9% Sodium Chloride Injection, 0.45% Sodium Chloride Injection, or Lactated Ringer’s Injection. - Contraindications are not explicitly listed in the provided label text, but the label references Contraindications (4) and Warnings and Precautions (5.2).

Benlysta is a targeted biologic therapy for active SLE and lupus nephritis in patients 5 years and older, used in combination with standard therapy. It offers both intravenous and subcutaneous administration options. However, it is not recommended for patients with severe active CNS lupus due to lack of efficacy data.