Hizentra - Human normal immunoglobulin (SCIg)
What is Hizentra - Human Normal Immunoglobulin (SCIg)?
Hizentra is a solution to be injected under the skin. Contains the active substance human normal immunoglobulin (200 mg / ml).
What is Hizentra - Human normal immunoglobulin (SCIg) used for?
Hizentra is used in patients whose blood does not contain enough antibodies (proteins that help the body fight infections and other diseases), also known as immunoglobulins. It is used to treat the following conditions:
- primary immunodeficiency diseases (PID, seen in patients with an "inability from birth to produce enough antibodies);
- low levels of antibodies in the blood in patients with chronic lymphocytic leukemia (a form of cancer affecting one type of white blood cell) or with myeloma (a cancer affecting 'another type of white blood cell) and who get frequent infections.
The medicine can only be obtained with a prescription.
How is Hizentra used - Human normal immunoglobulin (SCIg)?
Treatment with Hizentra should be started by a doctor or nurse who has experience in the care of patients with weakened immune systems; however, patients themselves (or their caregivers) can also administer the medicine after being instructed to do so and after initial monitoring. Hizentra should be given by subcutaneous infusion (ie as an injection done very slowly under the skin), into sites such as the abdomen, thigh, upper arm and hip. Usually the injection is given once a week. , so that a monthly dosage of approximately 2-4 ml per kilogram of body weight is administered, but the dose and frequency of injection depend on the patient's body weight and can be adjusted according to the response. Your doctor may decide to administer an initial loading dose of 1-2.5 ml / kg.
How does Hizentra - Human normal immunoglobulin (SCIg) work?
The active substance in Hizentra, human normal immunoglobulin, is a highly purified protein extracted from human plasma (a component of blood). It contains immunoglobulin G (IgG), which is a type of antibody. IgG is used as a medicine. since the 1980s and has a wide-ranging activity against organisms that cause infections. Hizentra helps to restore abnormally low IgG levels in the patient's blood, bringing them back to normal values.
How has Hizentra - Human normal immunoglobulin (SCIg) been studied?
Since human normal immunoglobulin has long been used in the treatment of these diseases, and in accordance with current guidelines, Hizentra was studied in one main study involving 51 patients with PID who were previously treated with immunoglobulin. human for at least six months. Hizentra was given to these patients every week for 28 weeks. The main measure of effectiveness was the comparison between the lowest IgG levels (called 'baseline levels') seen during treatment with Hizentra and the lowest levels seen during previous immunoglobulin treatment.
What benefit has Hizentra - Human normal immunoglobulin (SCIg) shown during the studies?
The lowest IgG levels observed with Hizentra treatment (mean baseline level of 8.1 g per liter) were comparable to those seen during previous immunoglobulin treatment.
What are the risks associated with Hizentra - Human normal immunoglobulin (SCIg)?
Adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia (joint pain), low blood pressure and mild to moderate back pain may occasionally occur. For the full list of side effects reported with Hizentra, see the package leaflet. Hizentra must not be used in patients who may be allergic to human normal immunoglobulin or any of the other substances. It must not be used in patients with hyperprolinemia (a genetic disorder causing high levels of the amino acid proline in the blood). It must not be injected into a blood vessel (a vein or an artery).
Why has Hizentra - Human Normal Immunoglobulin (SCIg) been approved?
The CHMP noted that Hizentra, given weekly via injections that can also be done at home, can prevent serious bacterial infections in patients with PID and that side effects are infrequent or severe.He therefore decided that Hizentra's benefits are greater than its risks and recommended that it be given marketing authorization.
Other information about Hizentra - Human normal immunoglobulin (SCIg)
On April 14, 2011, the European Commission granted CSL Behring GmbH a "Marketing Authorization" for Hizentra, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can For more information about Hizentra therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 04-2011.
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