Belimumab Intravenous Infusion for Adults

Who can administer

May be administered by registered competent doctor or nurse/midwife

Belimumab is NOT recommended for administration in severe active central nervous system lupus, HIV, a history of/active Hepatitis B or C, hypogammaglobinaemia or IgA deficiency or a history of major organ transplant or hematopoietic stem cell/marrow transplant or renal transplant
Belimumab should not be initiated in patients with active severe infections (including serious chronic infections). Careful consideration should be given to interrupting belimumab in patients who develop an infection while on this treatment, until the infection is resolved
For other cautions etc- see SPC
Pneumococcal vaccination should be considered before initiating treatment
Infusion reactions may occur - see under Monitoring Requirements below ^{(ref 1)}
Premedication: an anti-pyretic and an antihistamine may be administered before each infusion
- Paracetamol 1g IV (if >50kg, 15mg/kg if <50kg)
- Chlorphenamine 10mg IV
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded
See monitoring requirements below

Benlysta 120mg vial (concentrate for infusion)
Benlysta 400mg vial (concentrate for infusion)

Gloves, protective eyewear and a mask should be worn by those handling this drug ^{(ref 1)}

Water for injection
1.5mL per 120mg vial
4.8ml per 400mg vial

Remove vial from the fridge and allow it to warm to room temperature for 10 to 15 minutes
A 21 to 25 gauge needle is recommended for use when piercing the vial stopper for reconstitution and dilution.
The stream of water for injection should be directed towards the side of the vial to minimise foaming
Gently swirl the vial for 60 seconds every 5 minutes until the powder is dissolved. Do not shake
Reconstitution typically is completed within 10 to 15 minutes, but may take up to 30 minutes
Once reconstitution is complete, the solution should be opalescent and colourless to pale yellow and without particles. Small air bubbles, however, are expected and acceptable
After reconstitution, the solution contains 80mg belimumub per mL
Protect the reconstituted solution from sunlight
The total time from reconstitution to completion of infusion should not exceed 8 hours

Dilute further prior to administration

Sodium chloride 0.9% ONLY

Intermittent intravenous infusion

Add required dose to 250mL infusion fluid ^{(ref 1)}
Gently invert the bag to mix
Administer over 60 minutes
If patient weighs 40kg or less, an infusion bag of 100ml may be used, providing the final concentration does not exceed 4mg/mL,
The infusion rate may be slowed or interrupted if the patient develops an infusion reaction (see under Monitoring- below)

Systemic lupus erythematosus/active lupus nephritis

Give 10mg/kg on Days 0, 14 and 28, and at 4-week intervals thereafter
Monitor for improvement after 6 months treatment and consider discontinuation if no improvement in disease control

Elderly patients

Renal Impairment

Hepatic impairment

Dose adjustment unlikely to be required (but no specific studies have been conducted)

Monitor for severe or life-threatening hypersensitivity reactions and infusion reactions - stop infusion immediately if the patient develops a potentially life-threatening adverse reaction
Monitor blood pressure, pulse, respiratory rate and temperature frequently
- e.g. every 15 minutes initially, then every 30 to 60 minutes if previous observations stable
- Monitor during and for several hours post-infusion
  - e.g. for 5 hours after at least the first two infusions (taking into account the possibility of a late onset reaction)
  - From the third infusion onwards, monitoring for two hours post infusion may be sufficient (providing no adverse reaction noted post first two doses) ^{(ref 2)}
  - Warn patient that hypersensitivity reactions may occur/reoccur on the day of, or the day after, infusion and to seek immediate medical help if symptoms develop
  - The package leaflet should be provided to the patient each time the drug is administered
The risk of hypersensitivity is greatest with the first two infusions; however the risk should be considered for every infusion administered.
Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk
Monitor for symptoms suggestive of PML (e.g., cognitive, neurological or psychiatric symptoms or signs) during the course of treatment therapy
Monitor for new or worsening psychiatric symptoms.

Management of infusion related reactions: depending on the severity of the reactions, the infusion rate may either be slowed or stopped
Live vaccines should not be given for 30 days before, or concurrently with belimumab as clinical safety has not been established
Transition to subcutaneous administration: See SPC for details

Store between 2 and 8⁰C

Do not freeze

SPC November 2022

1: Injectable Drugs guide, downloaded from Medusa 28th June 2023

2: Local expert opinion, email on file June 29th, 2023

Selective immunosuppressants
Humanised monoclonal antibody