1. Indications and Usage
\nSystemic Lupus Erythematosus (SLE):
\nIndicated for adult and pediatric patients (5 years of age and older) with active, autoantibody-positive SLE who are receiving standard therapy .
\nLupus Nephritis (LN):
\nIndicated for adult and pediatric patients (5 years of age and older) with active lupus nephritis who are receiving standard therapy .
\nLimitation of Use: Safety and efficacy have not been established in patients with severe active CNS lupus or severe active lupus nephritis (as monotherapy) .
\n2. Dosage and Administration
\nRoute of Administration:
\nFor Intravenous (IV) Infusion ONLY. Do not administer by IV push or bolus .
\nRecommended Dosage (IV):
\nDose: 10 mg\/kg.
\nSchedule: Administer at weeks 0, 2, and 4, and then every 4 weeks thereafter .
\nAdministration Instructions:
\nInfusion Time: Administer over a period of at least 1 hour .
\nPre-medication: Consider using antihistamines and\/or antipyretics prior to infusion to reduce the risk of infusion reactions .
\nReconstitution: Must be reconstituted with Sterile Water for Injection and diluted with 0.9% Sodium Chloride Injection (Normal Saline). Do not use Dextrose solutions .
\nDose Adjustments:
\nInfusion Reactions: If a reaction occurs, slow the rate or discontinue immediately depending on severity .
\n3. Mechanism of Action
\nBLyS Inhibition:
\nBelimumab is a recombinant human IgG1\u03bb monoclonal antibody that binds to and inhibits the biological activity of B-lymphocyte stimulator (BLyS), also known as B-cell activating factor (BAFF) .
\nB-Cell Modulation:
\nBy 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 .
\n4. Safety and Warnings
\nInfusion Reactions \/ Hypersensitivity:
\nSevere, life-threatening hypersensitivity reactions (including anaphylaxis) have been reported. Patients should be monitored for several hours after the first two infusions .
\nInfections:
\nSerious infections (e.g., bacterial sepsis, opportunistic infections) may occur. Do not initiate in patients with active serious infections .
\nPsychiatric Events:
\nDepression, suicidal ideation, and anxiety have been reported. Monitor patients for signs of worsening depression .
\nMalignancy:
\nThe risk of malignancies may be increased due to immunosuppression .
\n5. Adverse Reactions
\nMost Common (Incidence \u22655%):
\nNausea, diarrhea, fever (pyrexia), nasopharyngitis, bronchitis, insomnia, limb pain, depression, and migraine .
\n6. Drug Interactions
\nLive Vaccines:
\nDo not administer live vaccines concurrently (e.g., MMR, Varicella) due to the potential for decreased immune response and infection risk .
\nOther Immunosuppressants:
\nNo formal drug interaction studies have been completed, but it is often used with standard therapies like corticosteroids, antimalarials, and immunosuppressants (e.g., mycophenolate mofetil) .
\n7. Pharmaceutical Information
\nChemical Composition:
\nActive Ingredient: Belimumab.
\nAvailable Strength: 120 mg and 400 mg single-dose vials (Lyophilized powder) .
\nAppearance: White to off-white lyophilized cake .
\nStorage: Store refrigerated at 2\u00b0C\u20138\u00b0C (36\u00b0F\u201346\u00b0F) in the original carton to protect from light. Do not freeze .<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name:\u500d\u529b\u817e \u00ae\uff08Benlysta\u00ae\uff09
\nGeneric Name: Belimumab
\nStrength: 120 mg per vial (1 vial\/box)
\nManufacturer: GlaxoSmithKline Manufacturing S.P.A.
\nMarketing Authorization Holder: GlaxoSmithKline (Ireland) Limited; domestic filing entity: GlaxoSmithKline (China) Investment Co., Ltd.
\nApproval Date in China: July 12, 2019
\nRegistration Number: \u56fd\u836f\u51c6\u5b57 SJ20190032
\nStorage: Store at 2\u20138\u00b0C (36\u201346\u00b0F) in the original package, protected from light. Do not freeze.<\/p>\n
Price&Cost:Contact Us now for the best price of Belimumab\uff08Benlysta\uff09<\/p>\n","protected":false},"featured_media":0,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[],"product_cat":[25],"product_tag":[],"class_list":["post-3942","product","type-product","status-publish","product_cat-injection","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n