Hizentra is a solution for injection under the skin. It contains the active substance human normal immunoglobulin (200 mg/ml).
|Table of Contents|
|What is it used for?|
|How is it used?|
|How does it work?|
|How has it been studied?|
|What benefits has it shown during the studies?|
|What is the risk associated?|
|Why has it been approved?|
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
low levels of antibodies in the blood in patients with chronic lymphocytic leukaemia a cancer of a type of white blood cell or myeloma a cancer of another type of white blood cell and who have frequent infections.
The medicine can only be obtained with a prescription.
Treatment with Hizentra should be started by a doctor or nurse who is experienced in the treatment of patients with weakened immune systems, but patients (or their carers) may administer it themselves once they have been trained and initially monitored. Hizentra is given as a subcutaneous infusion (very slow injection under the skin) in an area such as the abdomen, thigh, upper arm or hip. The injection is normally given on a weekly basis, to provide a total monthly dose of around 2 to 4 ml per kg body weight, but the dose and frequency of injection depend on the patient?s body weight and may be adjusted according to their response. At the start of treatment the doctor may decide to give an initial loading dose of 1 to 2.5 ml/kg.
The active substance in Hizentra, human normal immunoglobulin, is a highly purified protein extracted from human plasma (part of the blood). It contains immunoglobulin G (IgG), which is a type of antibody. IgG has been used as a medicine since the 1980s and has a wide range of activity against organisms that can cause infection. Hizentra works by restoring abnormally low IgG levels to their normal range in the patient?s blood.
As human normal immunoglobulin has been used to treat these diseases for some time, and in accordance with current guidelines, Hizentra was investigated in one main study involving 51 PID patients who had already received human immunoglobulin treatment for at least six months. The patients received Hizentra every week for 28 weeks. The main measure of effectiveness was how the lowest IgG levels (called ?trough levels?) seen during Hizentra treatment compared with the lowest levels seen during previous immunoglobulin treatment.
The lowest IgG levels seen during treatment with Hizentra (average trough level of 8.1 g per litre) were comparable to those seen during previous immunoglobulin treatment.
Adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia (joint pain), low blood pressure and moderate to low back pain may occur occasionally. For the full list of all side effects reported with Hizentra, see the package leaflet.
Hizentra should not be used in patients who may be allergic to normal human immunoglobulin or any of the other ingredients. It 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 such as a vein or an artery.
The CHMP noted that Hizentra can prevent serious bacterial infections in PID patients through weekly injections which may be given at home, while the side effects are not frequent or severe. It decided that Hizentra?s benefits are greater than its risks and recommended that it be given marketing authorisation.
Hizentra EMA1665552011 Page 2