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Benlysta

Benlysta

belimumab

Manufacturer:

GlaxoSmithKline
Concise Prescribing Info
Contents
Belimumab
Indications/Uses
Add-on therapy in adult patients w/ active, auto-antibody +ve SLE w/ a high degree of disease activity (eg +ve anti-dsDNA & low complement).
Dosage/Direction for Use
 Adult Recommended dose: 10 mg/kg IV infusion over 1 hr on days 0, 14 & 28, & at 4-wk intervals thereafter. Patient w/ allergies Premed w/ an oral antihistamine w/ or w/o an antipyretic before infusion.
Contraindications
Hypersensitivity.
Special Precautions
Patients w/ severe CNS lupus & lupus nephritis; HIV; existing or history of hepatitis B or C; history of major organ transplant or hematopoietic stem cell/marrow transplant or renal transplant; hypogammaglobulinaemia (IgG <400 mg/dL) or IgA deficiency (IgA <10 mg/dL). Concomitant use w/ other B-cell targeted therapy or cyclophosphamide. Infusion reactions & hypersensitivity. Increased risk of infections & malignancies. Progressive multifocal leukoencephalopathy resulting in neurological deficits may occur. Do not administer live vaccines 30 days prior or concurrent w/ therapy. Do not administer as an IV push or bolus. Severe renal impairment. Pregnancy & lactation. Childn <18 yr. Elderly >65 yr.
Adverse Reactions
Non-opportunistic infections eg nasopharyngitis, bronchitis, pharyngitis, cystitis & viral gastroenteritis. Hypersensitivity reaction including anaphylaxis w/ symptoms eg hypotension, angioedema, urticaria or other rash, pruritus & dyspnea. Infusion-related reaction w/ symptoms eg bradycardia, myalgia, headache, pyrexia, HTN, dizziness & arthralgia. Leucopenia; psychiatric disorders eg insomnia, depression; GI disorders eg nausea, vomiting, diarrhoea.
MIMS Class
Immunosuppressants
ATC Classification
L04AG04 - belimumab ; Belongs to the class of monoclonal antibodies. Used as immunosuppressants.
Presentation/Packing
Form
Benlysta powd for soln for infusion 120 mg
Packing/Price
1's
Form
Benlysta powd for soln for infusion 400 mg
Packing/Price
1's
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