What is Hizentra - Human normal immunoglobulin (SCIg)?
Hizentra is a solution to be injected under the skin. It contains the active substance human normal immunoglobulin (200 mg / ml).
What is Hizentra used for - Human normal immunoglobulin (SCIg)?
Hizentra is indicated in patients whose blood does not contain a sufficient amount of antibodies (proteins that help the body fight infections and other diseases), also known as immunoglobulins. It is used for the treatment of the following conditions:
- primary immunodeficiency diseases (PID, observed in patients with an inability from birth to produce a sufficient number of antibodies);
- low levels of antibodies in the blood in patients with chronic lymphatic leukemia (a form of cancer that affects a type of white blood cell) or with myeloma (a tumor that affects another type of white blood cell) and that contract 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 expert in the care of patients with a weakened immune system; however, even the patients themselves (or caregivers) can administer the medicine after being instructed to do so and after initial monitoring. Hizentra should be administered by subcutaneous infusion (ie by an injection performed very slowly under the skin), at sites such as the abdomen, thigh, upper arm and hip. Usually the injection is given once a week, in order to administer a monthly dosage of about 2-4 ml per kilogram of body weight, but the dose and frequency of injection depend on the patient's body weight and can be adjusted to based on the answer. At the start of treatment the doctor may decide to administer an initial dose of 1-2.5 ml / kg.
How does Hizentra work - Normal human immunoglobulin (SCIg)?
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 has been used as a medicine since the 1980s and carries out a wide-ranging activity against organisms that cause infections. Hizentra helps to restore abnormally low IgG levels in the patient's blood, returning them to normal levels.
What studies have been performed on Hizentra - Human normal immunoglobulin (SCIg)?
Since normal human immunoglobulin has been used for some time in the treatment of these diseases, and in accordance with current guidelines, Hizentra was studied in a main study involving 51 patients with PID, previously already treated with immunoglobulin human for at least six months. Hizentra has been given to these patients every week for 28 weeks. The main measure of effectiveness was the comparison between the lowest IgG levels (referred to as "basal levels") observed during treatment with Hizentra and the lowest levels recorded during the previous immunoglobulin treatment.
What benefit has Hizentra - Human normal immunoglobulin (SCIg) shown during the studies?
The lowest IgG levels observed in treatment with Hizentra (mean baseline level of 8.1 g per liter) were comparable to those identified during the previous immunoglobulin treatment.
What are the risks associated with Hizentra - Human normal immunoglobulin (SCIg)?
Adverse reactions may occur occasionally such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia (joint pain), low blood pressure and mild to moderate low back pain. 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 substances. It must not be used in patients with hyperprolinemia (a genetic disorder that causes elevated 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 with injections that can also be performed at home, can prevent serious bacterial infections in patients with PID and that side effects are not frequent or severe. He therefore decided that Hizentra's benefits are greater than its risks and recommended that it be given marketing authorization.
Other information on Hizentra - Human normal immunoglobulin (SCIg)
On 14 April 2011, the European Commission issued a marketing authorization valid for Hizentra to CSL Behring GmbH, valid throughout the European Union. The marketing authorization is valid for five years, after which it can be renewed. For more information about treatment with Hizentra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 04-2011.
