Hizentra

Human Normal Immunoglobulin

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What Hizentra® is used for

Your medicine is Hizentra®, a solution for subcutaneous infusion. Hizentra® contains human immunoglobulins. Immunoglobulins are also called antibodies and are a type of protein found in the blood. Immunoglobulins are produced by your body’s immune system to fight infections caused by bacteria and viruses. If you do not have enough antibodies you may not be able to fight off diseases. Hizentra® can be used as antibody replacement therapy, to correct this lack of antibodies.

Your doctor may have prescribed Hizentra® for another reason.

Ask your doctor if you have any questions about why it has been prescribed for you.

Before you are given Hizentra®

When you must not have it

Do not have Hizentra® if you have:

  • a history of allergy to human immunoglobulin products (allergic reactions may include skin rash, face swelling, wheezing or breathing difficulties)
  • previously been told you react to any of the ingredients in Hizentra® (the ingredients are presented in the last page on this leaflet under the heading Ingredients)
  • been told you have antibodies to immunoglobulin A (IgA)
  • too much proline in your blood (hyperprolinaemia).

If you are not sure whether you should be given this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you:

  • are pregnant or breastfeeding
  • have had any vaccinations within the last two weeks
  • are allergic to any medicine or food
  • have IgA deficiency
  • have a history of heart or blood vessel disease, blood clots or thick blood
  • have been immobile for some time
  • have any other medical conditions.

If you have not told your doctor about any of the above, tell them before you are given Hizentra®.

About blood products

When medicines are made from human blood or plasma, processes are used to prevent infections being passed from the blood/plasma donor to the person receiving the medicine. These processes include careful selection of the people who donate blood and plasma to make sure that those who might be carrying infections are excluded. In addition, each donation and pools of donations are tested for indicators of virus or virus infection(s).

Manufacturers of these medicines also include steps in the processing of blood or plasma that inactivate or remove viruses. Despite these processes, when medicines are prepared from human blood or plasma, the possibility of passing on an infection cannot be totally ruled out. Unknown or new viruses or other types of infection could also be passed on.

However, the measures taken in the manufacture of this medicine are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the nonenveloped viruses hepatitis A (HAV) and B19 virus (B19V).

There is reassuring clinical experience regarding the lack of HAV or B19V infections following treatment with immunoglobulin products. The antibodies which are in Hizentra® may also make an important contribution to limiting the possibility an infection could be passed on.

Please discuss the risks and benefits of this product with your doctor.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may affect the way other medicines work.

Vaccinations:
This product may affect how some vaccines work. Tell your doctor or healthcare professional that you are taking Hizentra® before you get a vaccine.

How to use Hizentra®

Treatment should be started and supervised by a doctor. Hizentra® is administered as an injection or infusion subcutaneously (under the skin). If your doctor decides that you should receive Hizentra® at home, they will ensure you receive detailed instructions and training on how to use it.

If you do not understand the instructions ask your doctor or health professional.

How much is given

Your doctor will determine the dose(s) of Hizentra® that you will receive, and when you need to have it.

How to prepare it

If your doctor considers that you should receive Hizentra® at home, the instructions below should be followed carefully.

Step 1
Collect Hizentra® and ensure the vial is at room or body temperature before use.

Gather the equipment needed.

This may include infusion pump, administration tubing, subcutaneous needle or catheter set, Ysite connector, alcohol wipes, syringes, transfer needle, gauze or transparent dressing, tape, sharps disposal container, and treatment diary or log book.

Step 2
Thoroughly clean a table or other flat surface using an alcohol wipe.

Step 3
Wash hands with soap and water and dry hands thoroughly with a clean towel.

Step 4
Check Hizentra® vials

Carefully look at the liquid in each vial of Hizentra®.

Do not shake.

Hizentra® is clear and paleyellow to lightbrown. If Hizentra® appears to be cloudy or to contain particulates, it must not be used. If it is missing the protective cap, or is past its expiry date, it must not be used.

Step 5
Transfer Hizentra® from vial(s) to syringe

  1. Remove the protective cap from the vial.
  1. Clean the vial stopper with an alcohol wipe. Let the stopper dry.
  1. Attach a sterile transfer needle to a sterile syringe.
  1. Pull out the plunger of the syringe to fill the syringe with air. The amount of air should be the same as the amount of Hizentra® you will transfer from the vial.
  2. Put the Hizentra® vial on a flat surface. Keeping the vial upright, insert the transfer needle into the centre of the rubber stopper.
  3. Check that the tip of the needle is not in the liquid. Then, push the plunger of the syringe down. This will inject the air from the syringe into the airspace of the vial.
  4. Leaving the needle in the stopper, carefully turn the vial upside down.
  1. Slowly pull back on the plunger of the syringe to fill the syringe with Hizentra®.
  2. Take the filled syringe and needle out of the stopper. Take off the needle and throw it away into the sharps container.

Repeat steps 4 and 5 if multiple vials are required to achieve the prescribed dose of Hizentra®.

Step 6
Prepare the infusion tubing

Prime (fill) the infusion tubing. To prime the tubing, connect the syringe filled with Hizentra® to the infusion tubing and gently push on the syringe plunger to fill the tubing with Hizentra®, until you see a drop of Hizentra® come out of the needle.

If using an infusion pump, prepare the pump according to the manufacturer’s instructions.

Step 7
Prepare the injection site

Select an area on your abdomen, thigh, upper arm, or side of upper leg/hip for the infusion.

The number of injection sites depends on the volume of the total dose. Your healthcare professional can advise you about this. If you are using more than one injection site, be sure each site is at least 5 cm apart.

Clean the injection site(s) as directed by your healthcare professional.

Step 8
Insert needle

With two fingers, pinch together the skin around the injection site. Insert the needle under the skin.

Put sterile gauze and tape or a transparent dressing over the injection site. This will keep the needle from coming out.

MAKE SURE YOU ARE NOT INJECTING HIZENTRA® INTO A BLOOD VESSEL. To test for this, pull the plunger back gently. If you see any blood flowing back into the tubing, take the needle out of the injection site. Throw away the needle and tubing. Start the infusion at a different site with new infusion tubing and a new needle.

 

Step 9
Start infusion

Follow the instructions that you have been given by your doctor or nurse to start the infusion. Infuse at the rate you have been instructed.

Step 10
Record treatment

Peel off the removable part of the label of the Hizentra® vial. Put this label in your treatment diary or logbook with the date and time of the infusion. Also include the exact amount of Hizentra® that you infused, and the rate of infusion.

Step 11
After the infusion

When all the Hizentra® has been infused, take off the dressing and take the needle out of the injection site, applying firm pressure.

Throw away any Hizentra® that is leftover in the singleuse vial, along with the used needle and tubing, into the sharps container.

Throw away dressing and tapes in the household waste.

If using an infusion pump, clean and store it, following the manufacturer’s instructions.

If too much is given (overdose)

The effects of an overdose of Hizentra® are not known.

Please tell your doctor if you accidently use more than instructed.

While you are having Hizentra®

This medicine is not expected to affect your ability to drive a car or operate machinery.

Things you must do

Tell your doctor if you are planning to have a vaccination. Hizentra® may impair the effect of some virus vaccines such as measles, mumps, rubella and chicken pox for a period of at least six weeks, and up to three months. After receiving this medicine, a period of three months should be allowed before vaccination with some virus vaccines. In the case of measles vaccine, this effect may last for up to one year, so if you are going to receive a measles vaccine you should have your measles antibody status checked.

Tell your doctor if you are about to have any blood tests. Hizentra® may interfere with the results of some tests, resulting in misleading results for some things.

Inform other doctors, dentists, and pharmacists who treat you that you have been given this medicine.

It is important for them to know if they are starting you on any other new medicines.

Tell your doctor if you are planning to travel overseas. It is important to obtain a written statement from your doctor explaining the reasons why you need to have this medicine and injecting devices with you, otherwise you may not be allowed to bring it into the country of travel. Please ensure you have multiple copies of the letter if travelling to more than one country.

Side effects

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you experience some of the side effects.

Do not be alarmed by the following lists of possible side effects. You may not experience any of them. If you have any questions, ask your doctor.

Tell your doctor immediately or go to the Accident and Emergency Department at your nearest hospital if you notice any of the following symptoms:

  • reduced urination
  • severe headache
  • neck stiffness
  • inability to stand bright light
  • painful eye movements
  • swollen and painful areas in the legs or arms
  • tingling, numbness or weakness on one side of the body
  • shortness of breath
  • chest pain
  • fever
  • allergic or anaphylactic reaction, symptoms of which may include:
  • swelling of the lips, tongue or eyes
  • loss of consciousness
  • hives
  • difficulty in breathing.

Tell your doctor if you notice any of the following and they worry you.

This list includes the more common side effects of Hizentra®. They are usually mild and often reduce over time.

  • swelling, pain, redness or itching where the injection was given
  • headache/migraine
  • nausea or vomiting
  • pain (including pain in the chest, back, joints, arms, legs)
  • muscle pain
  • fatigue
  • diarrhoea
  • stomach ache or bloating
  • cough
  • fever or chills
  • feeling faint, dizzy or light headed (fall in blood pressure).

Other side effects not listed above may also occur in some patients.

Tell your doctor if you notice any other effects.

After having Hizentra®

Storing Hizentra®

Store Hizentra® in a cool dry place where the temperature stays below 25°C. Do not freeze.

Leave vial in box until ready to use.

Do not use after the expiry date.

Keep it out of the reach and sight of children.

Product description

What it looks like

Hizentra® is a clear and colourless or paleyellow to lightbrown solution. It is packaged in single use clear glass vials.

Ingredients

Each vial of Hizentra® contains a sterile solution comprising 20% plasma proteins of which at least 98% are immunoglobulins. This medicine contains proline, polysorbate 80 and water. Hizentra® does not contain any preservatives, so any unused portion should be discarded immediately. Hizentra® is packaged using latex free materials.

Note: This information may not be actual at the time of reading. Always look for actual instructions in the package with the medication.
It is forbidden to use these materials without the advice of healthcare professional.

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