<p>Hizentra is used in patients whose blood does not contain enough antibodies (proteins that help the body to fight infections and other diseases), also known as immunoglobulins. It is used to treat the following conditions:</p><ul><li>primary immunodeficiency syndromes (PID, when people are born with an inability to produce enough antibodies);</li><li>secondary immunodeficiencies (SID) in people who have severe or recurrent infections that do not respond to treatments and who are unable to produce certain antibodies;</li><li>chronic inflammatory demyelinating polyneuropathy (CIDP). In this condition, the immune system (the body’s defence system) works abnormally and destroys the protective covering over the nerves.</li></ul><p>Hizentra contains the active substance human normal immunoglobulin.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><div class="table-responsive"><table class="table"><tbody><tr><td> <p>Replacement therapy in adults, children and adolescents (0-18 years) in:</p> <p>- Primary immunodeficiency syndromes with impaired antibody production (see section 4.4).</p> <p>- 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.</p> <p>*PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines.</p> <p>Immunomodulatory therapy in adults, children and adolescents (0-18 years):</p> <p>- Hizentra is indicated for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg.</p> <p> </p> </td> </tr></tbody></table></div></div>
Therapeutic Area (MeSH)
ATC Code
J06BA01
ATC Item
N/A
Pharmacotherapeutic Group
Immune sera and immunoglobulins
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| human normal immunoglobulin (SCIg) | N/A | human normal immunoglobulin (SCIg) |
EMA Name
Hizentra
Medicine Name
Hizentra
Aliases
N/ANo risk management plan link.
