Hizentra – Human normal immunoglobulin uses, dose and side effects

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Contents hide
1 1. What Hizentra is and what it is used for
2 2. What you need to know before using Hizentra
3 Do NOT infuse Hizentra:
4 Warnings and cautions
5 Other medicines and Hizentra
6 Pregnancy, breastfeeding and fertility
7 Driving and using machines
8 Hizentra contains proline
9 3. How to use Hizentra
10 If you use more Hizentra than you should
11 If you forget to use Hizentra
12 4. Possible side effects
13 5. How to store Hizentra
14 6. Contents of the packaging and other information
15 Content declaration
16 What the medicine looks like and contents of the pack
17 Marketing Authorization Holder and Manufacturer

200 mg/ml injection for subcutaneous injection, solution
Human normal immunoglobulin (SCIg = subcutaneous immunoglobulin)

1. What Hizentra is and what it is used for

What Hizentra is

Hizentra belongs to a class of medicines called human normal immunoglobulins. Immunoglobulins are also called antibodies and are blood proteins that help your body fight infections.

How Hizentra works

Hizentra contains immunoglobulins that have been produced from the blood of healthy people. Immunoglobulins are produced by the body’s immune system. They help your body fight infections caused by bacteria and viruses or maintain the balance of your immune system (called immunomodulation). The medicine works in the same way as the immunoglobulins that are naturally present in your blood.

What is Hizentra used for

Substitution treatment (replacement treatment )

Hizentra is used to raise abnormally low levels of immunoglobulin 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 born with impaired ability or inability to produce immunoglobulins (primary immunodeficiency). It includes the following permits:
    • low levels of immunoglobulins ( hypogammaglobulinemia ) or lack of immunoglobulins (agammaglobulinemia) in the blood
    • combination of low levels of immunoglobulins, recurrent infections and inability to produce sufficient amounts of antibodies after vaccination (common variable immunodeficiency)
    • combination of low levels of or lack of immunoglobulins and absence of or non-functioning immune cells (severe combined immunodeficiency)
    • deficiency of certain immunoglobulin G subclasses that cause recurrent infection er.
  2. Treatment of low immunoglobulin levels and recurrent bacterial infection in patients with chronic lymphocytic leukemia ( CLL ), a specific type of blood cancer, when prophylactic antibiotic treatments have failed or are contraindicated .
  3. Treatment of low levels of immunoglobulins and recurrent bacterial infection in patients with multiple myeloma (MM), another type of blood cancer.
  4. Treatment of low levels of immunoglobulins in patients before and after allogeneic haematopoietic stem cell transplantation ( HSCT ).

Immunomodulatory therapy in CIDP patients

Hizentra is also used in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a type of autoimmune disease. CIDP is characterized by chronic inflammation in the peripheral nerves, which causes muscle weakness and/or numbness mainly in the arms and legs. It is believed that the body’s defense attack amplifies such inflammation and that the immunoglobulins found in Hizentra help protect the nerves from the attack (immunomodulatory therapy ).

2. What you need to know before using Hizentra

Do NOT infuse Hizentra:

  • if you are allergic to human immunoglobulins, polysorbate 80 or L- proline .
    • Before treatment, tell your doctor or healthcare professional if you have previously reacted to any of these substances.
  • if you have hyperprolinaemia (a genetic disorder with high levels of the amino acid proline in your blood).
  • in a blood vessel.

Warnings and cautions

  • Talk to your doctor or healthcare professional before using Hizentra.

You may be allergic (hypersensitive) to immunoglobulin without knowing it. However, severe allergic reactions are uncommon. It can occur even if you have received human immunoglobulin before and tolerated it well. This may happen if you do not have enough immunoglobulin type A ( IgA ) in your blood ( IgA deficiency).

  • If you have an immunoglobulin type IgA deficiency, tell your doctor or healthcare professional before treatment . Hizentra contains residual amounts of IgA , which may cause an allergic reaction .

In such rare cases, allergic reactions such as a sudden drop in blood pressure or shock may occur (see also section 4 “Possible side effects”).

  • If you notice such reactions during the infusion of Hizentra, stop the infusion and contact your doctor or go to the nearest hospital immediately.
  • Tell your doctor if you have a history of cardiovascular disease or blood clots, have thick blood or have been immobilized for a long time. These things may increase the risk of you getting a blood clot after using Hizentra. Also tell your doctor which medicines you use, because some drugs, such as those that contain hormone- et estrogen (such as birth control pills ), may increase the risk that you will have a blood clot. Contact your doctor immediately if you get signs and symptoms such as shortness of breath, chest pain, pain and swelling in one extremity , weakness or numbness in one side of the body after receiving Hizentra.
  • Contact your doctor if you get the following signs and symptoms: severe headache, stiff neck, drowsiness, fever, photosensitivity, nausea and vomiting after receiving Hizentra. Your doctor will decide if more tests are needed and if treatment with Hizentra should be continued.

Your doctor/nurse will avoid any complications by ensuring that:

  • you are not hypersensitive to human normal immunoglobulin.
    This medicine should be infused slowly at first. The recommended infusion rate given in section 3 “How to use Hizentra” should be followed carefully.
  • you are closely monitored for any symptoms throughout the infusion period, especially if:
    • you are receiving human normal immunoglobulin for the first time
    • you have switched from another medicine
    • it has been a long break (more than eight weeks) since the previous infusion .
    In these cases, it is recommended that you be closely monitored during the first infusion one and then for one hour. If the above points do not apply to you, it is recommended that you be observed for at least 20 minutes after receiving the medicine.

Other medicines and Hizentra

  • Tell your doctor or healthcare professional if you are taking, have recently taken or might take any other medicines.
  • You must not mix other medicines with the contents of the Hizentra vial.
  • Tell your vaccinating doctor before vaccination that you are being treated with Hizentra. Hizentra may impair the effect of some live virus vaccines, such as measles, mumps, rubella and chickenpox vaccines. Therefore, after receiving the medicine, you should wait up to 3 months before receiving these vaccines. For measles vaccinations, this deterioration can persist for up to 1 year.

Pregnancy, breastfeeding and fertility

  • Tell your doctor or healthcare professional if you are pregnant, planning to become pregnant or breast-feeding. Your doctor will decide if you can receive Hizentra during pregnancy or while you are breast-feeding.

No clinical studies have been performed with Hizentra in pregnant women. However, drugs containing immunoglobulins have been used by pregnant or lactating women for many years and no adverse effects on the course of pregnancy, the fetus, or the newborn have been observed.

If you are breastfeeding and receiving Hizentra, the medicine’s immunoglobulins may also be present in breast milk. Therefore, your child may be protected against certain infections.

Driving and using machines

Patients may experience effects such as dizziness or nausea during treatment with Hizentra, which may affect their ability to drive or use machines. If this happens, do not drive or use machines until these effects have disappeared.

Hizentra contains proline

You should not take it if you suffer from hyperprolinaemia (see also section 2 “What you need to know before using Hizentra”). Tell your doctor before treatment.

Other important information about Hizentra

Blood tests

After receiving Hizentra, the results of certain blood tests (serological tests) may be affected for some time.

  • Tell your doctor that you are being treated with Hizentra before any blood test.

Information about what Hizentra is made of

Hizentra is made from human blood plasma (the liquid part of the blood). When medicines are made from human blood or plasma, special measures are taken to prevent the transmission of infection to patients. These include:

  • careful selection of blood and plasma donors to ensure that those who may have an infection are excluded and
  • test of each donor and plasma pool for signs of viruses / infections.

The manufacturers of these drugs also have stepped in the preparation of one of blood or plasma that can inactivate or remove viruses. Despite these measures, the risk of transmitting infectious agents can not be completely ruled out when medicinal products derived from human blood or plasma are given. This also applies to any unknown or new viruses and other types of infection.

Measures taken are considered effective against viruses with an envelope that human immunodeficiency virus ( HIV, AIDS – viruses et), hepatitis B virus and hepatitis C virus (liver inflammation), and against viruses without an envelope as hepatitis A virus and parvovirus B19.

  • It is strongly recommended that the name and manufacturing kit number of the medicinal product be registered each time you receive a dose of Hizentra, in order to have a list of manufacturing kits used (see section 3 “How to use Hizentra”).

Hizentra contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per vial, it is essential ‘sodium-free.

3. How to use Hizentra

Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.

Dosage

Your doctor will calculate the correct dose for you depending on your body weight and how you respond to treatment.

Do not change the dose or the time interval between doses without consulting your doctor.

If you have the impression that you are taking Hizentra more often or less often, talk to your doctor.

If you think you have missed a dose, talk to your doctor as soon as possible.

Substitution treatment

Your doctor will decide if you need a starting dose (for adults and children) of at least 1-2.5 ml/kg bodyweight spread over several days. Thereafter, maintenance doses can be given at repeated intervals, from daily to once every two weeks, to achieve a total dose per month of approximately 2-4 ml/kg body weight. Your doctor may adjust the dose based on how you respond to treatment.

Immunomodulatory therapy

Your doctor will start treatment with Hizentra 1 week after your last intravenous infusion of immunoglobulin by giving it under the skin ( subcutaneously ) with a weekly dose of 1.0 to 2.0 ml/kg body weight. Your doctor will determine your weekly dose of Hizentra. The weekly maintenance doses can be divided into smaller doses and given as often as needed during the week. For dosing every two weeks, your doctor will double the weekly dose of Hizentra. Healthcare professionals can adjust the dose depending on how you respond to treatment.

Method of administration and route of administration

If you receive treatment at home, it will be started by healthcare professionals experienced in the treatment of immunodeficiency / CIDP with subcutaneous immunoglobulin (SCIg) and in advising patients on treatment at home.

You will receive instructions and be trained in:

  • aseptic infusion technique
  • how to keep a treatment diary, and
  • measures to be taken in case of serious side effects .

Infusion site (s)

  • Hizentra should only be injected under the skin.
  • You can infuse Hizentra in places such as the abdomen, thighs, upper arm and the outside of the hip. If large doses are given (more than 50 ml), it is recommended to inject in several places.
  • You can use an unlimited number of injection sites at the same time. The injection sites should be at least 5 cm apart.
  • In cases where you are using an aid-assisted infusion technique (eg infusion using a pump), more than one infusion set can be used at the same time.
  • In cases where you use manual infusion technique with syringe , you can only use one infusion site per syringe . If you need to give another Hizentra syringe , you must use a new sterile injection needle and change the infusion site.
  • The volume of drugs infused in different places can vary.

Infusion rate (s)

Your doctor will determine the appropriate infusion technique and infusion rate for you based on your dose, dosing frequency, and your tolerance to the medicine.

Infusion with infusion equipment

The recommended initial infusion rate is up to 20 ml/hour/place. If well tolerated, you can gradually increase the infusion rate to 35 ml/hour/place for the following two infusions. Thereafter, the infusion rate may be further increased depending on how well you tolerate the treatment.

Manual infusion

The recommended initial infusion rate is up to 0.5 ml / min / place (30 ml / hour / place). If well tolerated, you can increase the infusion rate to up to 2.0 ml / min / place (120 ml / hour / place) for subsequent infusions . Thereafter, the infusion rate may be further increased depending on how well you tolerate it.

In INSTRUCTIONS for use

Follow the steps below and use aseptic technique to administer Hizentra.
1Clean the surfaceThoroughly clean a table or other flat surface with an antiseptic wet wipe.
2Collect the materialPlace Hizentra and other materials and equipment needed for infusion on a clean, level surface.
3Wash and dry your hands thoroughly
4Check the vialsVisually inspect Hizentra for particles in the solution or discoloration and also check the expiration date before administering Hizentra. Do not use solutions that are cloudy or contain particles. Do not use solutions that have been frozen. Administer a solution that is at room or body temperature. Once a vial has been opened, the solution should be used immediately.
5Prepare Hizentra for infusionClean 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 swab or antiseptic and allow it to dry. Transfer Hizentra to a syringe for infusion  – Attach a transfer device or needle to a sterile syringe using aseptic technique. If a vented spike is used, follow the manufacturer’s instructions. If a needle is used, retract the plunger to draw as much air into the syringe as the amount of Hizentra to be drawn. Then insert the needle into the central part of the stopper and, to avoid foaming, inject air into the empty vial (not into the liquid). Finally, pull up the desired volume of Hizentra. Repeat this step when several vials are used to achieve the desired dose .








6For heater hoseAttach the administration tubing or needle set to the syringe. Inject solution into the hose to remove any remaining air (priming).
7Prepare the infusion site (s)Select the infusion site (s) – The number of infusion sites and their location depend on the volume of the total dose . Each infusion site should be at least 5 cm apart. You can use an unlimited number of infusion sites at the same time.
Clean the infusion site (s) with a skin disinfectant. Allow each infusion site to dry before proceeding.
8Insert the needleGrasp the skin between 2 fingers and insert the needle into the subcutaneous tissue .
Attach the needle to the skin – Use gauze and tape or transparent bandage if necessary to hold the needle in place.
9Infuse HizentraStart an infusion . If an infusion pump is used, follow the manufacturer’s instructions.
10Minutes for infusion oneRecord the following data in your treatment diary:• the date of administration one,The batch number (Lot) of the medicine, andThe infused volume, infusion rate, number of infusion sites and their location.
11CleaningDiscard any unused product and use administration aids after administration in accordance with local requirements.

If you have any further questions on the use of this product, ask your doctor or healthcare professional.

If you use more Hizentra than you should

If you think you have taken too much Hizentra or missed a dose , talk to your doctor as soon as possible.

If you forget to use Hizentra

If you think you have missed a dose , talk 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.

  • In rare cases, you may become allergic (hypersensitive) to immunoglobulins and allergic reactions that cause a sudden drop in blood pressure or shock may occur (for example, you may feel dizzy, faint when you stand up, have cold hands and feet, feel abnormal heartbeats or chest pain or look blurred).
  • In rare cases, you may experience pain and / or swelling in an arm or leg with a feeling of warmth in the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens with deep breathing, unexplained rapid pulse , numbness or weakness in one side of the body, sudden confusion, difficulty speaking or understanding which may be a sign of a blood clot.
  • In rare cases, you may have a severe headache with nausea, vomiting, stiff neck, fever and photosensitivity which may be a sign of AMS (aseptic meningitis syndrome) which is a temporary transient non- infectious inflammation of the membrane surrounding the brain and spinal cord.
    • If you notice such signs during the infusion of Hizentra, stop the infusion and go to the nearest hospital immediately.

See also section 2 of this leaflet for the risks of allergic reactions, blood clots and AMS.

Side effects that have been seen in clinical trials are described in descending order with the most common first. Side effects that have been seen after marketing have an unknown frequency:

The following side effects are very common (affects more than 1 patient in 10):

  • Headache
  • Rash
  • Reactions at the infusion site

The following side effects are common (affects 1 to 10 patients in 100):

  • Dizziness
  • Migraine
  • High blood pressure ( hypertension )
  • Diarrhea
  • Stomach pain
  • Nausea
  • Vomiting
  • Itching ( pruritus )
  • Hives ( urticaria )
  • Muscle and skeletal pain (musculoskeletal pain)
  • Joint pain ( arthralgia )
  • Fever
  • Fatigue (fatigue) including general malaise
  • Chest pain
  • Flu-like symptoms
  • Pain

The following side effects are uncommon (affects 1 to 10 patients in 1,000):

  • Hypersensitivity
  • Involuntary tremors in one or more parts of the body ( tremor , including psychomotor hyperactivity)
  • Rapid pulse ( tachycardia )
  • Hot flashes
  • Muscle spasms
  • Muscle weakness
  • Chills, including low body temperature
  • Abnormal results on blood tests that may indicate impaired liver and kidney function

In rare cases, wounds at the infusion site or burning sensation may occur.

  • You can reduce any side effects if you infuse Hizentra slowly.

Side effects can occur even if you have previously received human immunoglobulins and tolerated them well.

See also section 2 “What you need to know before using Hizentra” for more information on circumstances that increase the risk of side effects .

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Hizentra

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the outer carton and vial label after EXP.
  • As the solution does not contain preservatives , you must use / infuse it as soon as possible after opening the bottle.
  • Do not store above 25 ° C.
  • Do not freeze.
  • Keep the vial in the outer carton. Sensitive to light.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is human normal immunoglobulin. One ml contains 200 mg of human normal immunoglobulin, of which at least 98% is immunoglobulin type G (IgG).The approximate percentage of IgG subclasses is as follows:IgG1 …………… 69%
    IgG2 …………… 26%
    IgG3 …………. ..3%
    IgG4 …………… 2%
    This medicine contains trace amounts of IgA (not more than 50 micrograms / ml).
  • The other ingredients (excipients) are L- proline , polysorbate 80 and water for injections.

What the medicine looks like and contents of the pack

Hizentra is a solution for injection for subcutaneous injection (200 mg / ml). The color can vary from pale yellow to light brown.

Hizentra is available in 5 ml, 10 ml, 20 ml and 50 ml vials.

Hizentra is also available as pre-filled syringes of 5, 10 and 20 ml.

Pack sizes

Packs of 1, 10 or 20 vials

Hizentra is also available in packs of 1 or 10 pre-filled syringes.

Please note that alcohol wipes, needles and other materials or equipment are not included in the package.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

CSL Behring GmbH

Emil-von-Behring-Strasse 76

D-35041 Marburg

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Belgium / Belgique / BelgienCSL Behring NVTel: +32 15 28 89 20Luxembourg / LuxemburgCSL Behring NVTel: +32 15 28 89 20
BulgariaMagnormar BulgariaTel: +359 2 810 3949HungaryCSL Behring Kft.Tel: +36 1 213 4290
Czech RepublicCSL Behring sroTel: + 420 702 137 233MaltaAM Mangion Ltd.Tel: +356 2397 6333
DenmarkCSL Behring ABTel: +46 8 544 966 70The NetherlandsCSL Behring BVTel: +31 85 111 96 00
GermanyCSL Behring GmbHTel: +49 69 30584437NorwayCSL Behring ABTel: +46 8 544 966 70
EestiCentralPharma Communications OÜTel: +3726015540AustriaCSL Behring GmbHTel: +43 1 80101 2463
GreeceCSL Behring ΕΠΕ:Ηλ: +30 210 7255 660PolandCSL Behring Sp. z ooTel: +48 22 213 22 65
SpainCSL Behring SATel: +34 933 67 1870PortugalCSL Behring LdaTel: +351 21 782 62 30
FranceCSL Behring SATel: + 33 1 53 58 54 00RomaniaPrisum International Trading srlTel: +40 21 322 01 71
CroatiaMarti Farm dooTel: +385 1 5588297SloveniaMediSanus dooTel: +386 1 25 71 496
IrelandCSL Behring GmbHTel: +49 69 305 17254Slovak RepublicCSL Behring sroTel: +421 911 653 862
IcelandCSL Behring ABPhone: +46 8 544 966 70Finland / FinlandCSL Behring ABPuh / Tel: +46 8 544 966 70
ItalyCSL Behring SpATel: +39 02 34964 200SwedenCSL Behring ABTel: +46 8 544 966 70
ΚύπροςCSL Behring ΕΠΕ:Ηλ: +30 210 7255 660United KingdomCSL Behring UK Ltd.Tel: +44 1444 447405
LatviaCentralPharma Communications SIATel: +371 6 7450497
LithuaniaCentralPharma Communications UABTel: +370 5 243 0444
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