Iqymune
4.1 Therapeutic indications
Replacement therapy in adults, and children and adolescents (0 – 18 years) in:
• Primary immunodeficiency syndromes (PID) with impaired antibody production.
• Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l
*PSAF= failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines.
Immunomodulation in adults, and children and adolescents (0 – 18 years) in:
• Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count
• Guillain Barré syndrome
• Kawasaki disease (in conjunction with acetylsalicylic acid; see section 4.2)
• Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
• Multifocal motor neuropathy (MMN),
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Drug Licencing
Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).