Intravenous Immunoglobulins (IVIG)

6 different IVIG products 

  • Flebogamma 5 and 10% DIF
  • Gamunex
  • Intragam 10
  • Kiovig
  • Octagam
  • Privigen 

Brand

Strength

Stabiliser

Brand

Flebogamma 5% & 10% DIF

Strength

5% and 10%

Stabiliser

5g sorbitol in each 100ml

Brand

Gamunex

Intragram 10

Kiovig

Strength

10%

Stabiliser

Glycine

Brand

Octagam

Strength

10%

Stabiliser

Maltose

Brand

Privigen

Strength

10%

Stabiliser

L-proline

Manufacturing Process

  • Prepared from large pools of human plasma collected from several thousand blood donors 
  • Cold alcohol fractionation is used to isolate immunoglobulin-containing fraction
  • Purification techniques including additional precipitation procedures & ion exchange chromatography to separate out desired IgG
  • Contains IgG & small amounts of IgA antibodies
  • Manufacturing process differs between different IVIG products
  • Dedicated steps for viral inactivation/removal 
  • Different storage requirements for different IVIG products – generally refrigerate, do not freeze, protect from light

Indications

  1. Immunoglobulin-replacement therapy
    1. Acquired hypogammaglobulinaemia secondary to haematological malignancies
    2. Primary immunodeficiency diseases with antibody deficiency
  2. Immunomodulation therapy
    1. CIPD/GBS
    2. Idiopathic thrombocytopenic purpura
    3. Inflammatory myopathies (polymyositis, dermatomyositis, inclusion body myositis)
    4. Kawasaki disease
    5. Lambert-Eaton myasthenic syndrome
    6. Myasthenia gravis
    7. Multifocal motor neuropathy

Contraindications

  • True anaphylaxis/severe systemic response to normal human immunoglobulin preparation/to any constituent of the product
  • IgA antibodies (eg. selective IgA deficiency) – IVIG products contain trace elements of IgA
  • Fructose intolerance 

A/E

  • Chills, fever
  • Headache, dizziness
  • Nausea/vomiting
  • Hypersensitivity reactions (pruritis, rash, urticaria, oedema and/or respiratory disorder) 
  • Arthralgia, low back pain
  • Changes in blood pressure
  • Chest pain 
  • Thrombotic events (including myocardial infarction/stroke) 
  • Aseptic meningitis
  • Renal dysfunction
  • Haemolytic anaemia

Drug Interactions

  • Impairment of efficacy of live attenuated virus vaccines
  • Avoid concomitant use of loop diuretics

Infection Risk

Very low (much lower than in other blood products)

Dosing

Weight based dosing – dependent on type of IVIG/indication

MoA

  • Immunomodulating agent
    • Modulation of complement activation
    • Suppression of various inflammatory mediators (cytokines, chemokines)
  • Contains natural antibodies key to immunoregulatory effects of immune globulin in immune-mediated disorders

PK

A

N / A

D

N / A

M

Protein metabolism

E

T½ 30-40 days (varies with preparation)

Author: Novia Tan