Parenteral Manual

Belimumab (NON-FORMULARY)

Disclaimer: Official controlled document is the CHEO online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
Benlysta
Classification: 
Biologic
Original Date: 
January 2024
Indications: 
  • Systemic lupus erythematous (SLE)
  • Lupus nephritis
Reconstitution and Stability: 
Vial Size SWFI Final Concentration
120 mg 1.5 mL 80 mg/mL
400 mg 4.8 mL 80 mg/mL
  • Available as vials of 120 mg and 400 mg lyophilized powder.
  • Store vials in original cartons at 2 – 8°C.
  • Do not shake. Protect from light.
  • Dilute dose in 0.9% NaCl to an exact volume of 250 mL.
  • All products are preservative-free and therefore are single-use vials.
  • Once diluted in 0.9% NaCl, dose should be administered immediately. However, if necessary, prepared solutions can be at 2 – 8°C or room temperature for a total of 8 hours including infusion time.
  • Do not use if solution has discoloration, opaque particles or any foreign material observed.
Compatibility: 
  • Solutions compatible: 0.9% NaCl
  • Additives/Above Cassette Compatible: Unknown
  • Y-Site compatibility: Unknown
  • Incompatible: DO NOT infuse with any other medication or solution
Administration: 

(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)

SC YES - Autoinjector only
IM

NO
IV direct NO
IV Intermittent Infusion

Yes

Infusion time: 60 minutes
IV Continuous Infusion NO

 

Dosage: 

(For neonatal dosages, refer to Neonatal IV Drug Manual.)

  • 10 mg/kg/dose IV (max 400mg/dose) at 0, 2 and 4 weeks then every 4 weeks afterwards
Potential hazards of parenteral administration: 
  • Monitor for hypersensitivity reactions, including infusion-related and anaphylactic reactions (hypotension, tachycardia, bradycardia, dyspnea, wheezing, angioedema, rash, nausea, vomiting, diaphoresis).
  • Infusion-related Syndrome: consists of allergic reactions (eg. rash, urticaria, fever, chills, bronchospasm, angioedema) and other symptoms (eg. flushing, hypotension, rhinitis, nausea, asthenia, headache)
  • Progressive Multifocal Leukoencephalopathy (PML)
  • Severe pulmonary events, such as bronchospasm, dyspnea, hypoxia, lung infiltrates and acute respiratory failure may occur within 1-2 hours after starting the first infusion. Patients with pre-existing pulmonary insufficiency or tumor infiltration of the lungs are at higher risk.
Notes: 
  • Consider premedication with glucocorticoids in order to attenuate infusion-related events.
  • Live vaccines should NOT be given 30 days before or concurrently with belimumab
References: 

Benlysta Product Monograph, GlaxoSmithKline Inc, May 2023

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