Hizentra

Main information

  • Trade name:
  • Hizentra Human Normal Immunoglobulin 20% Solution for Subcutaneous Injection 10 mL vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Hizentra Human Normal Immunoglobulin 20% Solution for Subcutaneous Injection 10 mL vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207385
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207385

Hizentra Human Normal Immunoglobulin 20% Solution for Subcutaneous Injection 10 mL vial

ARTG entry for

Medicine Registered

Sponsor

CSL Behring Australia Pty Ltd

Postal Address

189-209 Camp Road,BROADMEADOWS, VIC, 3047

Australia

ARTG Start Date

8/05/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. Hizentra Human Normal Immunoglobulin 20% Solution for Subcutaneous Injection 10 mL vial

Product Type

Single Medicine Product

Effective date

11/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Hizentra is indicated in adults and children for replacement therapy in: Primary Immunodeficiency Disease (PID) and Symptomatic

hypogammaglobulinaemia secondary to underlying disease or treatment.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

30 Months

Store below 25

degrees Celsius

Not recorded

Protect from Light

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

10 mL

(S4) Prescription Only Medicine

Components

1. Hizentra Human Normal Immunoglobulin 20% Solution for Subcutaneous Injection 10 mL vial

Dosage Form

Injection, solution

Route of Administration

Subcutaneous

Visual Identification

Clear and pale-yellow or light-brown solution; during storage it may show

formation of slight turbidity or a small amount of particulate matter

Active Ingredients

normal immunoglobulin

2 g

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 28.11.2017 at 12:30:57 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

Hizentra AU CMI 5.00

Page 1 of 7

Hizentra

®

Human Normal Immunoglobulin 20% (20 g per 100 mL), solution for subcutaneous

administration.

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about

Hizentra

It does not contain all the available information. If you

require further information about this medicine or your

treatment, have any questions, or are not sure about

something in this leaflet, consult your doctor or

pharmacist.

All medicines have benefits and risks. Your doctor has

weighed the benefits that Hizentra

will have for you

against the possible risks.

If you have any concerns about using this medicine,

ask your doctor. Follow your doctor’s advice even if it

is different from what this leaflet says.

Keep this leaflet with the medicine.

You may need to read it again.

The information in this leaflet is subject to change.

Please check with your doctor whether there is any new

information about this medicine that you should know

since you were last treated.

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 breast-feeding

have had any vaccinations within the last two weeks

are allergic to any medicine or food

have IgA deficiency

Hizentra AU CMI 5.00

Page 2 of 7

have a history of heart, or blood vessel disease, or

blood clots, have thick blood, have been immobile for

some time. Also tell the doctor what medicine you are

using as some medicines such as those that contain

the hormone estrogen (for example, birth control

pills), may increase your risk of developing a blood

clot.

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 non-enveloped

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. Doses may be given at repeated

intervals, from daily to once every two weeks. Your

doctor may adjust the dose based on your response to the

treatment.

Do not change the dose or dosing interval without

consulting with 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.

How to prepare it

If your doctor considers that you should receive

Hizentra

®

at home, the instructions below should be

followed carefully.

Hizentra AU CMI 5.00

Page 3 of 7

Step 1: Clean surface

Clean a table or other flat surface.

Step 2: Assemble supplies

Gather the Hizentra

pre-filled syringe(s) or vial(s) and

the following supplies (not provided with Hizentra

), as

directed by your doctor: The Hizentra

vials/pre-filled

syringes must be at room temperature before

administration.

Administration tubing

Subcutaneous needle and required tubing

Syringes

Transfer device or drawing up needle(s)

Gauze and tape, or transparent dressing (if required)

Infusion pump (if required)

Sharps container

Alcohol (antiseptic) wipes

Treatment diary.

Step 3: Wash hands

Thoroughly wash and dry your

hands (Figure 1).

Figure 1

Step 4: Check vials or pre-filled syringes

If using pre-filled syringes,

carefully peel back the

transparent covering from the

tray and inspect the protective

cap. Peel back the outer layer of

the wrap-around label to allow

for viewing of Hizentra

through

the fully transparent inner layer,

but don’t remove the label

completely (Figure 2).

If using vials, inspect the

protective cap of the vials

(Figure 3).

Figure 2

Figure 3

Hizentra

is a pale-yellow to light-brown clear solution.

Check for particles or colour changes. Do not use the pre-

filled syringe or vial if:

the liquid looks cloudy, contains particles, or has

changed colour.

the protective cap of the pre-filled syringe or the vial

is missing or defective.

the expiry date on the label has passed.

Step 5: Preparation of Hizentra

®

for infusion

If using Hizentra

®

pre-filled syringes, go to Step 5.1

If using Hizentra

®

vials, go to Step 5.2

Step 5.1: Hizentra

®

pre-filled syringe(s)

The pre-filled syringes are

supplied fully assembled

(Figure 4) and ready to use.

Figure 4

If you are using a syringe pump, Hizentra

pre-filled

syringes can be placed directly in the syringe pump if the

syringe size matches the pump requirements. Please

follow the manufacturer’s instructions.

If the pre-filled syringe does not match the infusion pump

requirements, transfer the contents of the pre-filled syringe

to another syringe of a size specific for the infusion pump

by following the directions below:

Use a syringe-to-syringe transfer

device (tip-to-tip connector).

(Figure 5)

Remove the protective cap from

the pre-filled syringe. Attach the

transfer device by twisting it onto

the pre-filled syringe. Attach the

empty syringe by screwing it onto

the other side of the transfer

device (Figure 6).

Figure 5

Figure 6

Push the plunger of the pre-filled syringe to transfer

Hizentra

from the pre-filled syringe to the empty syringe.

Repeat this step if multiple pre-filled syringes are

necessary to achieve the prescribed dose. Remove the

empty pre-filled syringe and attach another pre-filled

syringe to the transfer device.

Hizentra AU CMI 5.00

Page 4 of 7

After the transfer is complete, remove the empty pre-filled

syringe and the transfer device by unscrewing them from

the syringe specific for your pump. Connect the filled

syringe to the infusion tubing.

Go to Step 6.

Step 5.2: Transfer Hizentra

®

from vial(s) to syringe

Take the protective cap off the

vial (Figure 7).

Clean the vial stopper with an

alcohol wipe (Figure 8). Allow

to dry.

Attach a needle or transfer device

to the syringe tip, using a clean

(non-touch) technique. If using a

transfer device, follow the

instructions provided by the

device manufacturer. If using a

needle and a syringe to transfer

Hizentra

, follow the instructions

below.

Attach a sterile transfer

needle to a sterile syringe

(Figure 9).

Pull out the plunger of the

syringe to fill the syringe

with air. Make sure the

amount of air is the same as

the amount of Hizentra

will transfer from the vial.

Put the Hizentra

vial on a

flat surface. Keeping the vial

upright, insert the transfer

needle into the centre of the

rubber stopper.

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.

Figure 7

Figure 8

Figure 9

Leaving the needle in the

stopper while keeping

pressure on the syringe

plunger, carefully turn the

vial upside down

(Figure 10).

Figure 10

Gently withdraw the needle so the tip sits in the

Hizentra

fluid and release the pressure on the

plunger. The fluid will automatically fill the syringe.

Once the automatic filling is complete slowly pull

back on the plunger to fill the syringe with any

remaining Hizentra

Take the filled syringe and needle out of the stopper.

Take off the needle and throw it away in the sharps

container.

When using multiple vials to achieve the desired dose,

repeat this step.

Step 6: Prepare the Subcutaneous needles and related

tubing

Attach the subcutaneous needle

to infusion tubing (if required).

Prime (fill) the infusion tubing.

To prime the tubing, connect the

syringe filled with Hizentra

the infusion tubing and gently

push on the syringe plunger to fill

the tubing with Hizentra

(Figure 11).

Figure 11

Stop priming before Hizentra

fluid reaches the needle.

Step 7: Prepare injection site(s)

Select an area on your abdomen, thigh, upper arm, or side

of upper leg/hip area for the infusion (Figure 12).

Never infuse into areas where the skin is tender, bruised,

red, or hard. Avoid infusing into scars or stretch marks.

The number of injection sites depends on the volume of

the total dose. Your healthcare professional can advise you

about this.

Hizentra AU CMI 5.00

Page 5 of 7

If you are using more than one injection site, be sure each

site is at least 5 cm apart.

Figure 12

Figure 13

Clean the skin at each site with an alcohol wipe

(Figure 13). Let the skin dry.

Step 8: Insert needle(s)

Using two fingers, pinch the skin

around the injection site. Insert

the needle into the skin

(Figure 14). Your healthcare

professional will advise you on

the positioning of the needle as it

is dependent on the type of

needle used.

Secure the needle in place as

directed by your healthcare

professional (Figure 15). This

will keep the needle from coming

out.

Figure 14

Figure 15

Step 9: Start infusion

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, remove the needle. Discard

the tubing and needle and restart from Step 6.

If using an infusion pump, prepare the pump following the

manufacturer’s instructions.

Follow the instructions that you

have been given by your

healthcare professional to start

the infusion. Infuse at the rate

you have been instructed

(Figure 16).

Figure 16

Step 10: Record treatment

Complete your treatment diary as instructed by your

healthcare professional.

Step 11: Clean up

Remove the needle set and cover

the injection site with a protective

dressing as directed by your

healthcare professional.

Discard the empty Hizentra

pre-

filled syringe(s) or vial(s),

needles, infusion tubing, and

syringes as directed by your

healthcare professional

(Figure 17).

General rubbish such as

packaging can be discarded in the

general waste.

If using an infusion pump, clean

and store it, following the

manufacturer’s instructions.

Figure 17

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

Hizentra AU CMI 5.00

Page 6 of 7

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

pain/tenderness, swelling/discolouration of an arm or

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)

infusion site ulcer.

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.

Keep the vial or pre-filled syringe in the outer carton

in order to protect from light.

Do not use after the expiry date.

Keep it out of the sight and reach of children.

Hizentra AU CMI 5.00

Page 7 of 7

Product description

What it looks like

Hizentra

is a clear and colourless or pale-yellow to

light-brown solution. It is packaged in single-use clear

glass vials or single-use pre-filled syringes.

Ingredients

Each vial or pre-filled syringe 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.

Distributor

CSL (Behring) Australia Pty Ltd

ABN 48 160 734 761

189–209 Camp Road

Broadmeadows VIC 3047

Australia

Date of most recent amendment

May 2017

Australian Register Numbers

Vials:

1 g in a 5 mL solution: AUST R 207386

2 g in a 10 mL solution: AUST R 207385

4 g in a 20 mL solution: AUST R 207383

10 g in a 50 mL solution: AUST R 207384

Pre-filled syringes:

1 g in a 5 mL solution: AUST R 285344

2 g in a 10 mL solution: AUST R 285345

Registered trademark of CSL Limited Group of

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