S2i: Understand the pharmacology of human immunoglobulin
This information is specific for intravenous immunoglobulin, but note there are many others which can be utilised.
Chemical
- Solution of human plasma protein (in particular IgG antibodies) with a broad spectrum of antibody activity
- Managed under the national blood arrangement and funded by National Blood Authority
- Current list of immunoglobulins available from lifeblood:
- Intravenous immunoglobulin (IVIg)
- Subcutaneous immunoglobulin (SCIg)
- Normal human immunoglobulin
- Specific immunoglobulin (eg: RhD, cytomegalovirus, hepatitis B, tetanus and zoster)
Use
- Criteria for clinical use of IVIg:
- Condition which Ig has established therapeutic role
- Eg: GBS, ITP, Kawasaki disease
- Condition which Ig has emerging therapeutic role
- Eg: ADEM, bullous pemphigoid, HLH, TSS
- Condition which Ig use is in exceptional circumstances only
- Eg: myocarditis related to COVID 19 vaccination, MS, autoimmune congenital heart block
- Typically for the use of replacement of antibodies and with autoimmune disorders
- Condition which Ig has established therapeutic role
Presentation
- Clear, colourless solution
- Supplied in glass bottles
- Prepared from large pools of human plasma collected from thousands of donors
- Privigen AU (only IVIg made from entirely Australian volunteer donors all others from USA + European volunteer donors)
- Process:
- cold ethanol fractionation -> octanoic acid fractionation -> depth filtration -> anion exchange chromatography
- Prepared solutions:
- 5g (50ml), 10g (100ml), 20g (200ml) at concentration 10%
- Tested for:
- Hepatitis B, C, HIV
- Occurs via three step process: incubation at pH 4, 20nm nanofiltration and depth filtration
- Storage:
- 25 degrees for up to 3 years
- Do not freeze
- Protect from light
Dose
- Given IV only
- Dose depends on clinical indication
- Typically based on body weight
Onset
- Immediate
Duration
- Variable
MoA
- Mainly consists of IgG that are present in normal human population
- Part of adaptive immune system and therefore activity against infectious agents
PD
- Immune related affects
PK
A
IV only. Must be used immediately after opening bottle
D
Rapidly between plasma and extravascular fluid. Equilibrium reached in 3-5 days
M
By cells in the reticuloendothelial system
E
Adverse Effects
- Typically occur due to infusion rate rather than product
- Most likely to occur in first hour of commencing infusion
- Specific: Haemolytic anaemia, aseptic meningitis syndrome, thromboembolism, acute renal failure, TRALI
- General: chills, headache, dizziness, fever, vomiting, arthralgia
Special notes
CI
Hypersensitivity to active substance or excipients, IgA deficiency
Comparison table of IVIg
Author: Suzanne Luong