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 the reconstituted solution in 0.9% NaCl to an exact volume of 250 mL.
-
A reconstituted solution should be opalescent and colorless to pale yellow.
- All products are preservative-free and therefore are single-use vials.
- Once diluted in 0.9% NaCl, the 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 the 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: D5W. 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)
- Potential increased risk for development of Progressive Multifocal Leukoencephalopathy (PML). Patients are to be monitored for new or worsening neurological signs and symptoms
- 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:
-
Premedication with an oral antihistamine, with or without an antipyretic, may be administered before infusion 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