- human normal immunoglobulin
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/11/687/002, EU/1/11/687/003, EU/1/11/687/008, EU/1/11/687/009, EU/1/11/687/005, EU/1/11/687/007, EU/1/11/687/001, EU/1/11/687/012, EU/1/11/687/006, EU/1/11/687/004, EU/1/11/687/014, EU/1/11/687/010, EU/1/11/687/011, EU/1/11/687/013.
Hizentra 200 mg/ml solution for subcutaneous injection in vial
PACKAGE LEAFLET: INFORMATION FOR THE USER
Hizentra 200 mg/ml solution for subcutaneous injection
Human normal immunoglobulin (SCIg = Subcutaneous Immunoglobulin)
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
What is in this leaflet
1. What Hizentra is and what it is used for
2. What you need to know before you use Hizentra
3. How to use Hizentra
4. Possible side effects
5. How to store Hizentra
6. Contents of the pack and other information
1. WHAT HIZENTRA IS AND WHAT IT IS USED FOR
What Hizentra is
Hizentra belongs to the class of medicines called human normal immunoglobulins.
Immunoglobulins are also known as antibodies and are blood proteins that help your body to fight infections.
How Hizentra works
Hizentra contains immunoglobulins that have been prepared from the blood of healthy people. Immunoglobulins are produced by human body’s immune system. They help your body to fight infections caused by bacteria and viruses and maintain the balance in your immune system (referred to as immunomodulation).
The medicine works in exactly the same way as the immunoglobulins naturally present in your blood.
What Hizentra is used for
Hizentra is used to raise abnormally low immunoglobulin levels in your blood to normal levels (replacement therapy). The medicine is used in adults and children (0 – 18 years) in the following situations:
1. Treatment of patients who are born with a reduced ability or inability to produce immunoglobulins (primary immunodeficiencies). This includes conditions such as:
2. Treatment of low immunoglobulin levels and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), a certain type of blood cancer, where prophylactic antibiotics have failed or are contra-indicated.
3. Treatment of low immunoglobulin levels and recurrent bacterial infections in patients with multiple myeloma (MM), another kind of blood cancer.
4. Treatment of low immunoglobulin levels in patients pre- and post- allogeneic haematopoietic stem cell transplantation (HSCT).
Immunomodulatory therapy in CIDP patients
Hizentra is also used in patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a form of autoimmune disease. CIDP is characterised by chronic inflammation of the peripheral nerves that causes muscle weakness and/or numbness mainly in the legs and arms. It is believed that the body’s defence attack underlines such inflammation, and the immunoglobulins present in Hizentra help to protect the nerves from being attacked (immunomodulatory therapy).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HIZENTRA
Do NOT infuse Hizentra:
Warnings and precautions
You may be allergic (hypersensitive) to immunoglobulins without knowing it.
However, true allergic reactions are rare. They may occur even if you received human immunoglobulins previously and tolerated them well. It may happen particularly if you do not have enough of the immunoglobulin type A (IgA) in your blood (IgA deficiency).
In these rare cases allergic reactions such as a sudden fall in blood pressure or shock may occur (see also section 4 “Possible side effects”).
Your healthcare professional will avoid potential complications by ensuring:
In these cases, it is recommended that you are monitored during the first infusion and for an hour afterwards. If the points above do not apply for you it is recommended that you are observed for at least 20 minutes after administration.
Other medicines and Hizentra
Pregnancy, breast-feeding and fertility
No clinical studies have been performed with Hizentra in pregnant women. However, medicines that contain immunoglobulins have been used in pregnant or breast-feeding women for years, and no harmful effects on the course of pregnancy or on the baby have been observed.
If you are breast-feeding and receive Hizentra, the immunoglobulins of the medicine can also be found in the breast milk. Therefore, your baby may be protected from certain infections.
Driving and using machines
Patients may experience effects, such as dizziness or nausea, during treatment with Hizentra that might affect the ability to drive and use machines.
If this happens, you should not drive or use machines until these effects have disappeared.
Hizentra contains proline
You must not take it if you suffer from hyperprolinaemia (see also section 2 “What you need to know before you use Hizentra”). Please tell your doctor prior to treatment.
Other important information about Hizentra
After receiving Hizentra, the results of certain blood tests (serological tests) may be impaired for a certain time.
Information on what Hizentra is made of
Hizentra is made from human blood plasma (this is the liquid part of the blood). When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include:
Manufacturers of these medicines also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV, the AIDS virus), hepatitis B virus and hepatitis C virus (liver inflammation), and for the non-enveloped hepatitis A virus and parvovirus B19.
3. HOW TO USE HIZENTRA
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Your doctor will calculate the correct dose for you taking into account your weight and response to treatment.
The dose or dosing interval should not be changed without consulting your doctor.
If you think you should receive Hizentra more or less frequently, please speak to your doctor.
If you think you have missed a dose, speak to your doctor as soon as possible.
Your doctor will determine whether you need a loading dose (for adults and children) of at least 1 to 2.5 ml/kg of body weight divided over several days. Following this, maintenance doses may be given at repeated intervals, from daily to once every two weeks, to reach a cumulative monthly dose of about 2 to 4 ml/kg of body weight. Your healthcare professional may adjust the dose based on your response to the treatment.
Your doctor will initiate therapy with Hizentra 1 week after your last intravenous immunoglobulin infusion by administrating under the skin (subcutaneously) with a weekly dose of 1.0 to 2.0 ml/kg of body weight. Your doctor will determine your weekly Hizentra dose. The weekly maintenance doses may be divided into smaller doses and administered as often as required during the week. For dosing every two weeks, your doctor will double the weekly Hizentra dose.
Your healthcare professional may adjust the dose based on your response to the treatment.
Method and route of administration
In case of home treatment, this will be initiated by a healthcare professional experienced in the treatment of immunodeficiency/CIDP with SCIg and in the guidance of patients for home treatment.
You will be instructed in:
Your doctor will determine the appropriate infusion technique and the infusion rate for you taking into account your individual dose, dosing frequency and product tolerability.
The recommended initial infusion rate is up to 20 ml/hour/site. If well-tolerated, you may gradually increase the infusion rate to 35 ml/hour/site for the subsequent two infusions. Thereafter, the infusion rate can be increased further as per your tolerability.
Manual push infusion:
The recommended initial infusion rate is up to 0.5 ml/min/site (30 ml/hour/site). If well-tolerated, you may increase the infusion rate up to 2.0 ml/min/site (120 ml/hour/site) for subsequent infusions. Thereafter, the infusion rate can be increased further as per your tolerability.
Instructions for use
Follow the steps below and use aseptic technique to administer Hizentra.
1 Clean surface
Thoroughly clean a table or other flat surface using an antiseptic wipe.
2 Assemble supplies
Place Hizentra and other supplies and equipment needed for the infusion on a clean, flat surface.
3 Thoroughly wash and dry hands
4 Check Vials
Visually inspect Hizentra for particles in the solution or discoloration as well as the expiry date before administering Hizentra.
Do not use solutions that are cloudy or contain particles.
Do not use solutions that have been frozen. Administer solution which is at room or body temperature.
Once a vial has been opened, use the solution immediately.
5 Preparation of Hizentra for infusion
Clean the vial stopper – Remove the protective cap from the vial to expose the central portion of the rubber stopper. Clean the stopper with an alcohol wipe or antiseptic preparation and allow it to dry.
Transfer Hizentra to syringe for infusion – Attach a transfer device or needle to a sterile syringe, using aseptic technique. If using a transfer device (vented spike), follow the instructions provided by the device manufacturer. If using a needle, pull back on the plunger to draw air into the syringe that is comparable to the amount of Hizentra to be withdrawn. Then, insert the needle into the centre of the vial stopper and, to avoid foaming, inject air into headspace of the vial (not into the liquid). Finally, withdraw the desired volume of Hizentra. When using multiple vials to achieve the desired dose, repeat this step.
6 Prepare the tubing
Attach the administration tubing or needle set to the syringe. Prime the tubing to eliminate all remaining air.
7 Prepare infusion site(s)
Select the infusion site(s) – The number and location of infusion sites depends on the volume of the total dose. Each infusion site should be at least 5 cm apart.
You may use an unlimited number of sites simultaneously.
Clean the infusion site(s) using an antiseptic skin preparation, Allow each site to dry before proceeding.
8 Insert the needle
Grasp the skin between two fingers and insert the needle into the subcutaneous tissue.
Secure the needle to the skin – If necessary, use gauze and tape or transparent dressing to hold the needle in place.
9 Infuse Hizentra
If using an infusion pump, follow the manufacturer’s instructions.
10 Record the infusion
Record the following data in your treatment diary:
11 Clean up
Discard any unused product and all used administration supplies after administration in accordance with local requirements.
If you have any further questions on the use of this medicine, please ask your doctor or healthcare professional.
If you use more Hizentra than you should
If you think you have had too much Hizentra, speak to your doctor as soon as possible.
If you forget to use Hizentra
If you think you have missed a dose, speak to your doctor as soon as possible.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Please see also section 2 of this leaflet about the risk of allergic reactions, blood clots and AMS.
Side effects observed in controlled clinical studies are presented in order of decreasing frequency. Side effects observed in post-marketing are of unknown frequency:
The following side effects are very common (affects more than 1 patient in 10):
The following side effects are common (affects 1 to 10 patients in 100):
The following side effects are uncommon (affects 1 to 10 patients in 1,000):
In isolated cases, infusion site ulcer or burning sensation may occur.
You may reduce possible side effects if you infuse Hizentra slowly.
Side effects such as these may occur even when you have previously received human immunoglobulins and tolerated them well.
Please also refer to section 2 “What you need to know before you use Hizentra” for additional details on circumstances which increase the risk of side effect.
Reporting of side effects
If you get any side effects, talk to your doctor or healthcare professional. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below).
By reporting side effects, you can help provide more information on the safety of this medicine.
or search for MHRA Yellow Card in the Google Play or Apple App Store
5. HOW TO STORE HIZENTRA
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Hizentra contains
What Hizentra looks like and contents of the pack
Hizentra is a solution for subcutaneous injection (200 mg/ml). The colour can vary from pale-yellow to light-brown.
Hizentra is available in vials of 5, 10, 20 or 50 ml.
Hizentra is also available in pre-filled syringes of 5 and 10 ml.
Packs of 1, 10 or 20 vials
Hizentra is also available in packs of 1 or 10 pre-filled syringes.
Please note that alcohol swabs, needles and other supplies or equipment are not contained in the pack.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 02/2020
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
4 Milton Road, Haywards Heath, West Sussex, RH16 1AH, UK
+44 (0)1444 447 400
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