ZARZIO filgrastim (rbe) 480 microgram/0.5 mL solution for injection pre-filled syringe

Main information

  • Trade name:
  • ZARZIO filgrastim (rbe) 480 microgram/0.5 mL solution for injection pre-filled syringe
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ZARZIO filgrastim (rbe) 480 microgram/0.5 mL solution for injection pre-filled syringe
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 195065
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

195065

ZARZIO filgrastim (rbe) 480 microgram/0.5 mL solution for injection pre-filled syringe

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

7/05/2013

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. ZARZIO filgrastim (rbe) 480 microgram/0.5 mL solution for injection pre-filled syringe

Product Type

Single Medicine Product

Effective date

10/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving

myelosuppressive anti-cancer drugs in doses not usually requiring bone marrow transplantation. ,indicated for reducing the duration of neutropenia and

clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia. ,indicated for the mobilisation of

autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy, in order to accelerate neutrophil and platelet recovery

by infusion of such cells after myeloablative or myelosuppressive therapy in patients with non-myeloid malignancies. ,indicated for the mobilisation of

peripheral blood progenitor cells, in normal volunteers, for use in allogeneic peripheral blood progenitor cell transplantation.,In patients receiving

myeloablative chemotherapy, is indicated for reducing the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow

transplantation.,indicated for chronic administration to increase neutrophil counts and to reduce the incidence and duration of infections in patients with

severe chronic neutropenia.,indicated in patients with HIV infection, for reversal of clinically significant neutropenia and subsequent maintenance of

adequate neutrophil counts during treatment with antiviral and/or other myelosuppressive medications.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Glass Type I Clear

36 Months

Store at 2 to 8

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 x 1 syringe

(S4) Prescription Only Medicine

1 x 5 syringe

(S4) Prescription Only Medicine

1 x 10 syringe

(S4) Prescription Only Medicine

Components

1. ZARZIO

Dosage Form

Injection, solution

Route of Administration

Intravenous

Subcutaneous

Visual Identification

Colorless to slightly yellowish solution

Active Ingredients

Filgrastim

960 microgram/mL

© 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 05:21:20 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: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

ZARZIO

Zarzio

®

filgrastim 300 µg/0.5 mL and 480 µg /0.5 mL solution for injection (pre-filled syringes)

Consumer Medicine Information

WHAT IS IN THIS

LEAFLET

This leaflet answers some common

questions about Zarzio

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking this medicine

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

WHAT ZARZIO

®

IS

USED FOR

Your doctor has prescribed Zarzio

because:

1.

You are receiving

chemotherapy for cancer.

Some chemotherapy will reduce

the number of neutrophils (white

blood cells) in your body.

Although Zarzio

is not a

treatment for cancer, it does help

the body to make new neutrophils

and this will reduce the chance of

developing infections that might

require antibiotics and/or hospital

stays. It may even increase your

chance of receiving your

chemotherapy on time and at the

right dose.

2.

You are receiving a bone

marrow or stem cell transplant

Blood cells are produced in the

bone marrow and arise from

special 'parent cells', called stem

cells. Some chemotherapy has

toxic effects on bone marrow, so

your doctor may choose to collect

stem cells from your bone

marrow or blood, or from a

donor's bone marrow or blood,

before you receive your

chemotherapy. These collected

stem cells are then stored and

may be given back to you later, to

replace those lost during

chemotherapy. This procedure is

called a bone marrow or stem cell

transplant.

There are normally only a small

number of stem cells in your

blood; Zarzio

is typically used to

increase this number before stem

cell collection. You may also

receive Zarzio

after a bone

marrow or stem cell transplant, to

help speed up your recovery.

3.

You are donating stem cells for

another person

If you are aged between 16 and

60 years and have volunteered to

donate your stem cells for another

person, Zarzio

may be used to

increase the number of stem cells

in your blood before they are

collected. Your stem cells can

then be given to a patient after

he/she has received their

chemotherapy.

4.

You are suffering from severe

chronic neutropenia

Severe chronic neutropenia is a

disease in which the body does

not make enough neutrophils,

increasing your risk of fever

and/or infection. Zarzio

helps

the body to make and maintain

the right number of infection-

fighting neutrophils, decreasing

the risk of infection and the need

for antibiotics and/or hospital

stays.

5.

You are receiving medicines for

HIV infection

Some medicines used to treat

HIV (Human Immunodeficiency

Virus) infection, or its

complications, can reduce the

number of infection-fighting

neutrophils in your blood. Your

doctor may prescribe Zarzio

the number of neutrophils falls

too low.

By boosting your neutrophil

count, Zarzio

will improve your

body's ability to fight infection

and may increase your chance of

receiving the full dose of some of

your HIV medicines. Zarzio

not a treatment for HIV infection.

How it works

Zarzio

is also known as Filgrastim

(rbe), and is a copy of a substance

normally present in your body called

Granulocyte Colony Stimulating

Factor or G-CSF. Through the use of

gene technology, Zarzio

is produced

in a specific type of bacteria, called

E.coli.

G-CSF is produced in the bone

marrow and assists in the production

of neutrophils, which are a type of

white blood cell. Neutrophils help the

body fight infections by surrounding

and destroying the bacteria that cause

infection. G-CSF also helps

neutrophils to do this work better.

ZARZIO

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it

for another reason.

This medicine is available only with

a doctor's prescription.

BEFORE YOU START

TO USE ZARZIO

®

When you must not take it

Do not take this medicine if you

have an allergy to:

Filgrastim, the active ingredient,

or to any of the other

ingredient(s) listed at the end of

this leaflet under Product

Description

any other similar medicines or

products that are produced by

DNA technology using the

bacteria E.Coli.

Some of the symptoms of an allergic

reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin

Do not use Zarzio

®

at the same

time as your chemotherapy or

radiotherapy.

Do not use Zarzio

®

in the 24 hours

before or the 24 hours after you

receive your chemotherapy,

radiotherapy, bone marrow

transplant or stem cell transplant.

This is because these types of

treatments may stop Zarzio

from

increasing the number of infection-

fighting neutrophils.

Do not use this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If it has expired or is damaged, return

it to your pharmacist for disposal.

Do not use Zarzio

®

if it has been

left out of the refrigerator for more

than 72 hours.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you are

pregnant or intend to become

pregnant or are breastfeeding.

Tell your doctor if you have or

have had any of the following:

a medical condition affecting the

bone marrow or blood

a family history of genetic

disorder

sickle cell disease

problems with your kidneys,

liver, heart or other organs

previous treatment for cancer

any infections, cancers or

tumours.

If you have not told your doctor

about any of these things, tell

him/her before you use Zarzio

®

.

Your doctor will decide whether it

is safe for you to use Zarzio

®

.

There is a limited experience with

the use of Zarzio

®

in children.

Your doctor will discuss the risks and

benefits of using this medicine in

children.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

HOW TO USE

ZARZIO

®

Follow all directions given to you

by your doctor, nurse or

pharmacist carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions, ask your doctor or

pharmacist for help.

Zarzio

is given by injection, usually

into the tissue just below the skin.

This is called a subcutaneous

injection and it is a simple procedure.

Your doctor, nurse or pharmacist

may suggest that you or your carer be

taught how to give a subcutaneous

injection. This will allow you to

have your Zarzio

injection at home.

Zarzio

is sometimes given by

injection into a vein. This is called

intravenous injection and is generally

given by a doctor or a nurse.

How much to inject

Your doctor will tell, you the

strength of Zarzio

you need and

how much you require. How much

you need will depend on the reason

for your treatment, your body weight

and the number of neutrophils in

your blood.

For Zarzio

to work properly, you

have to use exactly as your doctor

has instructed.

Where to inject

The best injection sites are:

your abdomen, except for the area

around the navel (belly button) or

the front side of your thighs.

ZARZIO

The sites are shown in the pictures

below

Change the injection site each time

you inject to avoid soreness at any

one site.

When to inject

For best results, you should inject

Zarzio

at about the same time each

day. Your doctor will tell you when

to begin your treatment and when to

stop it.

How long to use it

Patients receiving chemotherapy

or who have received a bone

marrow or a stem cell transplant

are only required to use Zarzio

short periods of time until the

number of infection-fighting

neutrophils are restored (usually 1 to

3 weeks).

Stem cell donors

should receive Zarzio

treatment for

4 to 5 days.

Patients with severe chronic

neutropenia

are required to use Zarzio

regularly

and for a long period of time, to keep

the number of infection-fighting

neutrophils at a normal level.

Patients with HIV infection

need to use Zarzio

daily until their

neutrophils numbers are normal.

Usually, the dose is then reduced to

three injections per week to maintain

the neutrophil numbers. Your doctor

will tell you how many injections

you need each week and on which

days they should be given.

Things to do before you

inject

Make sure you have all materials you

need for your injection:

a new Zarzio

syringe

an alcohol swab

a puncture-resistant sharps

container.

Follow these instructions exactly to

help avoid contamination and

possible infection.

If you are unsure, check with your

doctor, nurse or pharmacist.

Find a clean, flat working surface,

such as a table, where you can

inject undisturbed.

Remove the syringe from the

refrigerator. For a more

comfortable injection, leave at

room temperature for

approximately 30 minutes. Do not

warm Zarzio

in any other way

(e.g. do not warm in a microwave

or hot water).

Check that the syringe has not

been used before.

Do not shake the syringe. If the

Zarzio

solution appears frothy or

bubbly, allow the syringe to sit

undisturbed for a few minutes to

reduce the froth or bubbles before

measuring your dose.

Do not remove the needle cover

until you are ready to inject.

Check the expiry date on the

label. Do not use if the date has

passed the last day of the month

shown.

Check the appearance of the

solution. The solution should be

clear and colourless or slightly

yellow in colour. If it is cloudy,

coloured or there are clumps or

flakes, you must not use it.

Wash and dry your hands

thoroughly.

How to prepare for your

injection

Hold the syringe vertically with

the needle pointing up, this helps

reduce the amount of medicine

that may leak out of the needle.

Carefully remove the needle

cover, taking care not to touch the

exposed needle.

Check the dose (in mL) that your

doctor has prescribed and locate

the correct volume mark on the

syringe barrel. Carefully push the

plunger until the grey upper edge

of the plunger reaches the correct

volume mark. This will push the

air and any excess liquid out of

the syringe.

Double-check that you have the

correct dose.

How to inject

Clean the site where the injection

is to be made with an alcohol

swab, moving the alcohol swab in

an expanding circle and allow the

site to dry.

ZARZIO

Pinch a large area of skin

between your thumb and

forefinger, to create a firm

injection site.

Pick up the syringe and hold it as

you would a pencil.

Insert the needle directly into the

skin (at an angle between 45° and

90° or as advised by your doctor,

nurse or pharmacist).

After the needle is in, pull back

the plunger very slightly. If blood

comes into the syringe, the needle

has entered the blood vessel.

Remove the needle. Select

another site, clean the new site

with an alcohol swab and reinsert

the needle. Again, pull back the

plunger very slightly to check for

blood. If blood does not appear in

the syringe, inject the Zarzio

gently pushing the plunger all the

way in.

Withdraw the needle and using

the alcohol swab apply pressure

for several minutes to the

injection site.

Do not put the needle cover back

on the used syringe. You cannot

reuse the syringe.

Discard the used syringe into an

approved, puncture-resistant

sharps container.

Do not change the dose or the way

you inject Zarzio

®

without

consulting your doctor. Always

follow your doctor's instructions.

If you forget your injection

If you miss your scheduled dose,

inject it as soon as you can, provided

it is still on the same day.

If you miss a whole day before you

remember to inject yourself, do not

take a 'catch-up' dose or increase

your next dose.

Advise your doctor, nurse or

pharmacist as soon as possible about

the missed dose.

If you have trouble remembering to

inject your dose, ask your pharmacist

for some hints.

If you inject too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone Australia 13 11 26 or

New Zealand 0800 POISON or

0800 764766) for advice, or go to

Accident and Emergency at the

nearest hospital, if you think that

you or anyone else may have taken

too much Zarzio

®

. Do this even if

there are no signs of discomfort or

poisoning.

You may need urgent medical

attention.

Too much Zarzio

may lead to

neutrophil levels that are too high.

Research has shown that doses

almost 15 times greater than the most

common dose do not immediately

result in any harmful effects.

WHILE YOU ARE

TAKING ZARZIO

®

Things you must do

Be alert for any signs or symptoms

of infection.

There are many ways an infection

can show itself.

You should watch for:

fever (a temperature of 38.2°C or

greater, or as your doctor

suggests)

chills

rash

sore throat

diarrhoea

earache

difficult or painful breathing,

coughing or wheezing.

If you develop any of these

symptoms, go straight to the

hospital.

If you are about to start on any

new medication, tell your doctor,

nurse or pharmacist that you are

using Zarzio

®

.

Tell any other doctors who treat you

that you are using this medicine.

If you become pregnant during

treatment with Zarzio

®

, tell your

doctor immediately.

Keep all your doctor's

appointments so that your health

can be monitored.

Treatment with Zarzio

leads to

changes in the number of certain

blood cells. Your doctor may order

blood tests to check the levels of

infection-fighting neutrophils and

blood cells.

Blood tests may also be undertaken

after you have completed your

Zarzio

treatment until your blood

cells have returned to normal levels.

Things you must not do

Do not use Zarzio

®

to treat any

other complaints unless your

doctor tells you to.

ZARZIO

Do not give Zarzio

®

to anyone else,

even if they have the same

condition as you.

SIDE EFFECTS

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are using Zarzio

®

.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following and they worry

you.

Some of these are known side

effects of chemotherapy and may

not be related to Zarzio

®

:

temporary bone pain, such as in

the lower back or in the long

bones of the arms and legs.

This pain is usually relieved with

non-prescription painkillers, like

paracetamol. If you continue to

have bone pain even after having

taken this form of pain relief,

you should speak to your doctor,

as you may need a prescription

medication

abdominal discomfort

bleeding or bruising more than

usual, severe nose bleeds

reddish or purple blotches under

the skin

cough, breathlessness

diarrhoea

hair loss

headache

painful and swollen joints

worsening of existing arthritis

muscle pain

redness, swelling or itching at

the site of injection

skin disorders - worsening of

existing symptoms

skin rash or red, itchy spots

sore mouth, mouth ulcers

tiredness, looking pale.

Tell your doctor immediately if

you notice any of the following:

pain in the upper left side of the

stomach (abdomen)

left shoulder pain

dizziness

fever and painful skin lesions,

often painful, most commonly

on your arms, legs and

sometimes on your face and

neck

blood in the urine.

The above list includes serious side

effects that may require medical

attention.

Tell your doctor immediately, or

go to Accident and Emergency at

your nearest hospital if you notice

any of the following:

breathing problems such as

shortness of breath, rapid

breathing

fever

swelling or puffiness

less frequent urination

swelling of your stomach-area

(abdomen) and feeling of fullness

general feeling of tiredness.

These may be serious side effects of

Zarzio

. You may need urgent

medical attention.

Serious side effects are rare or

uncommon.

If any of the following happen, stop

taking Zarzio

®

and go straight to

the hospital, as you may need

medical attention:

rash over a large area of the body,

itching or hives

shortness of breath, wheezing or

difficulty breathing

swelling of the face, lips, tongue

or others parts of the body

faintness

rapid pulse or sweating.

These are very serious side effects. If

you have them you may have had a

serious allergic reaction to Zarzio

You may need urgent medical

attention or hospitalisation.

Tell your doctor or pharmacist if

you notice anything else that is

making you feel unwell.

Other side effects not listed above

may also occur in some people.

AFTER USING

ZARZIO

®

Storage

Keep Zarzio

®

in a refrigerator at a

temperature of 2°C to 8°C.

Exposure to room temperature for up

to 72 hours will not harm Zarzio

Keep Zarzio

®

in its carton

protected from light.

Keep it where children cannot

reach it.

Disposal

Once you have injected Zarzio

, do

not put the cover back on the used

syringe. Place the used syringe into

an approved, puncture-resistant,

sharps container.

Dispose of the full puncture

resistant sharps container as

instructed by your doctor, nurse or

pharmacist.

Never put used syringes into your

normal household rubbish bin.

ZARZIO

PRODUCT

DESCRIPTION

What it looks like

Zarzio

is a colorless, to slightly

yellowish solution and supplied as a

ready to use syringe.

Available in the following strengths:

300 micrograms of filgrastim in a

volume of 0.5 mL;

480 micrograms of filgrastim in a

volume of 0.5 mL

The syringes are packed in pack sizes

of 1, 5 and 10.

Not all strengths or presentations

may be marketed.

Ingredients

The active ingredients in Zarzio

Filgrastim.

Inactive ingredients:

glutamic acid

sorbitol,

polysorbate 80

sodium hydroxide (for pH

adjustment)

water for injections.

Supplier

Sandoz Pty Ltd

ABN 60 075 449 553

54 Waterloo Road

Macquarie Park NSW

2113

Australia

Tel: 1800 726 369

This leaflet was prepared July 2018.

Australian Register

Number(s)

Zarzio

300 µg/0.5 mL AUST R

195066(syringe)

Zarzio

480 µg/0.5 mL AUST R

195065 (syringe)