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Drug information

Gamunex

POM
Read time: 21 mins
Last updated: 24 Sep 2020
Published: 24 Sep 2020

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 4.2)

• Chronic inflammatory demyelinating polyneuropathy (CIDP)

• Multifocal motor neuropathy (MMN)

Immunomodulation in adults aged ≥18 years in:

• Severe acute exacerbations of myasthenia gravis

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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).