Hizentra
Authorised
This medicine is authorised for use in the European Union
human normal immunoglobulin (SCIg)
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
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:
- primary immunodeficiency syndromes (PID, when people are born with an inability to produce enough antibodies);
- 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;
- 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.
Hizentra contains the active substance human normal immunoglobulin.
Hizentra can only be obtained with a prescription and treatment should be started by a doctor or nurse who is experienced in the treatment of patients with weakened immune systems or CIDP.
Hizentra is available as a solution for injection. It is given by subcutaneous infusion (very slow injection under the skin) through a device that controls the speed of infusion. It is given in the abdomen (belly), thigh, upper arm or hip. Patients (or their carers) may inject Hizentra at home once they have been trained.
The dose and how often Hizentra is given depend on the disease being treated. The dose may need to be adjusted depending on how well the medicine is working.
For more information about using Hizentra, see the package leaflet or contact a doctor or pharmacist.
The active substance in Hizentra, human normal immunoglobulin, is a highly purified protein extracted from donated human blood. It contains mainly immunoglobulin G (IgG), which is composed of a range of antibodies involved in fighting organisms that can cause infection. Hizentra works by restoring abnormally low IgG levels to their normal range in the patient’s blood. It can also help to control the immune system when it is working abnormally such as in CIDP. Normal immunoglobulin has been used as a medicine since the 1980s.
As human normal immunoglobulin has been used to treat these diseases for many years, in accordance with current guidelines, two small studies and an analysis of scientific literature were needed to establish the effectiveness and safety of Hizentra in patients.
In the first study, Hizentra was investigated in 51 patients with PID who had already received human immunoglobulin by injection into a vein for at least six months. The patients received Hizentra for 28 weeks and the lowest IgG levels during treatment with Hizentra (average level of 8.1 g per litre) were comparable to those seen during previous immunoglobulin treatment. In addition, no infections occurred during the study period.
In the second study Hizentra was studied in 172 patients with CIDP who had previously received human immunoglobulin treatment by injection into a vein. Patients received Hizentra or placebo (a dummy treatment) for 13 weeks and the study measured the proportion of patients in whom the disease came back within 13 weeks. For patients on placebo, the disease came back in about 63% of patients; for patients on Hizentra, the disease came back in 33 and 39% of patients, depending on the dose used.
The scientific literature analysis involved seven studies comparing the use of Hizentra in patients with SID with other subcutaneous infusion or intravenous (injected directly into a vein) immunoglobulin treatments. All studies showed increases in antibody levels and/or a reduction in infection rates after receiving Hizentra or another subcutaneous immunoglobulin treatment; the effects were comparable to those seen with intravenous immunoglobulin treatment.
The most common side effects with Hizentra (which may affect more than 1 in 10 people) are headache, rash, muscle and joint pain (including muscle spasm and weakness), reactions around the injection area (swelling, soreness, redness, pitting, warmth, itching, bruising and rash) and flu-like illness. Rarely patients may have a sudden drop in blood pressure or an anaphylactic shock (sudden, severe allergic reaction).
Hizentra must not be used in patients with hyperprolinaemia (a genetic disorder causing high levels of the amino acid proline in the blood). It must not be injected into a blood vessel.
For the full list of side effects and restrictions with Hizentra, see the package leaflet.
The European Medicines Agency decided that Hizentra’s benefits are greater than its risks and it can be authorised for use in the EU. Hizentra was shown to prevent serious bacterial infections in patients with PID or SID and reduce the chance of CIDP coming back. It may be given at home, with manageable side effects.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hizentra have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Hizentra are continuously monitored. Side effects reported with Hizentra are carefully evaluated and any necessary action taken to protect patients.
Hizentra received a marketing authorisation valid throughout the EU on 14 April 2011.
Product information
Latest procedure affecting product information:
II/0150/G
18/07/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Hizentra
- Active substance
- human normal immunoglobulin (SCIg)
- International non-proprietary name (INN) or common name
- human normal immunoglobulin (SCIg)
- Therapeutic area (MeSH)
- Immunologic Deficiency Syndromes
- Anatomical therapeutic chemical (ATC) code
- J06BA01
Pharmacotherapeutic group
Immune sera and immunoglobulinsTherapeutic indication
Replacement therapy in adults, children and adolescents (0-18 years) in: - Primary immunodeficiency syndromes with impaired antibody production (see section 4.4). - 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. Immunomodulatory therapy in adults, children and adolescents (0-18 years): - Hizentra is indicated for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg.
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