Benlysta Belimumab for Injection

1. Indications and Usage
Systemic Lupus Erythematosus (SLE):
Indicated for adult and pediatric patients (5 years of age and older) with active, autoantibody-positive SLE who are receiving standard therapy .
Lupus Nephritis (LN):
Indicated for adult and pediatric patients (5 years of age and older) with active lupus nephritis who are receiving standard therapy .
Limitation of Use: Safety and efficacy have not been established in patients with severe active CNS lupus or severe active lupus nephritis (as monotherapy) .
2. Dosage and Administration
Route of Administration:
For Intravenous (IV) Infusion ONLY. Do not administer by IV push or bolus .
Recommended Dosage (IV):
Dose: 10 mg/kg.
Schedule: Administer at weeks 0, 2, and 4, and then every 4 weeks thereafter .
Administration Instructions:
Infusion Time: Administer over a period of at least 1 hour .
Pre-medication: Consider using antihistamines and/or antipyretics prior to infusion to reduce the risk of infusion reactions .
Reconstitution: Must be reconstituted with Sterile Water for Injection and diluted with 0.9% Sodium Chloride Injection (Normal Saline). Do not use Dextrose solutions .
Dose Adjustments:
Infusion Reactions: If a reaction occurs, slow the rate or discontinue immediately depending on severity .
3. Mechanism of Action
BLyS Inhibition:
Belimumab is a recombinant human IgG1λ monoclonal antibody that binds to and inhibits the biological activity of B-lymphocyte stimulator (BLyS), also known as B-cell activating factor (BAFF) .
B-Cell Modulation:
By blocking the binding of BLyS to the B-cell receptor, belimumab reduces the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells .
4. Safety and Warnings
Infusion Reactions / Hypersensitivity:
Severe, life-threatening hypersensitivity reactions (including anaphylaxis) have been reported. Patients should be monitored for several hours after the first two infusions .
Infections:
Serious infections (e.g., bacterial sepsis, opportunistic infections) may occur. Do not initiate in patients with active serious infections .
Psychiatric Events:
Depression, suicidal ideation, and anxiety have been reported. Monitor patients for signs of worsening depression .
Malignancy:
The risk of malignancies may be increased due to immunosuppression .
5. Adverse Reactions
Most Common (Incidence ≥5%):
Nausea, diarrhea, fever (pyrexia), nasopharyngitis, bronchitis, insomnia, limb pain, depression, and migraine .
6. Drug Interactions
Live Vaccines:
Do not administer live vaccines concurrently (e.g., MMR, Varicella) due to the potential for decreased immune response and infection risk .
Other Immunosuppressants:
No formal drug interaction studies have been completed, but it is often used with standard therapies like corticosteroids, antimalarials, and immunosuppressants (e.g., mycophenolate mofetil) .
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Belimumab.
Available Strength: 120 mg and 400 mg single-dose vials (Lyophilized powder) .
Appearance: White to off-white lyophilized cake .
Storage: Store refrigerated at 2°C–8°C (36°F–46°F) in the original carton to protect from light. Do not freeze .