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Benlysta斑麗達

Benlysta

belimumab

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Belimumab
Indications/Uses
Powd for concentrate for soln for infusion (IV) Add-on therapy in adults & childn ≥5 yr w/ active, autoantibody-positive SLE w/ a high-degree of disease activity despite standard therapy. Soln for inj (SC) Add-on therapy in adults w/ active, autoantibody-positive SLE w/ a high-degree of disease activity despite standard therapy.
Dosage/Direction for Use
Powd for concentrate for soln for infusion Recommended dose: 10 mg/kg IV infusion over 1 hr on days 0, 14 & 28, & at 4-wk intervals thereafter. Soln for inj Recommended dose: 200 mg SC once wkly. Transition from IV to SC: Administer 1st SC inj 1-4 wk after the last IV dose.
Contraindications
Special Precautions
Not recommended in severe active CNS lupus; severe active lupus nephritis; HIV; history of, or current, hepatitis B or C; hypogammaglobulinaemia or IgA deficiency; history of major organ transplant or hematopoietic stem cell/marrow transplant or renal transplant. Concomitant use w/ other B-cell targeted therapy or IV cyclophosphamide. Infusion &/or hypersensitivity reactions. Increased risk of infections, malignancies & lymphoproliferative disorders. Do not administer live vaccines 30 days prior to or concurrent w/ therapy. Reports of psychiatric disorders (depression, suicidal ideation & behaviour including suicides); progressive multifocal leukoencephalopathy. Patients w/ active or latent TB. Patients w/ severe renal impairment. Women of childbearing potential must use effective contraception during treatment & for at least 4 mth after the last treatment. Pregnancy & lactation. Elderly ≥65 yr. Powd for concentrate for soln for infusion: Do not administer as IV bolus. Childn <5 yr. Soln for inj: Childn <18 yr.
Adverse Reactions
Bacterial infections eg, bronchitis, UTI; diarrhoea, nausea. Gastroenteritis viral, pharyngitis, nasopharyngitis, viral upper resp tract infection; leucopenia; hypersensitivity reactions; depression; migraine; inj site reactions; pain in extremity; infusion- or inj-related systemic reactions, pyrexia.
Drug Interactions
On initiation or discontinuation of belimumab, therapeutic monitoring should be considered for patients being treated w/ CYP substrates w/ a narrow therapeutic index (eg, warfarin).
MIMS Class
ATC Classification
L04AA26 - belimumab ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Presentation/Packing
Form
Benlysta powd for concentrate for soln for infusion 120 mg
Packing/Price
1's
Form
Benlysta powd for concentrate for soln for infusion 400 mg
Packing/Price
1's
Form
Benlysta soln for inj 200 mg/mL
Packing/Price
1's
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