GAZYVA

Main information

  • Trade name:
  • GAZYVA obinutuzumab (rch) 1000 mg/40 mL concentrate solution for infusion vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GAZYVA obinutuzumab (rch) 1000 mg/40 mL concentrate solution for infusion vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210562
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210562

GAZYVA obinutuzumab (rch) 1000 mg/40 mL concentrate solution for infusion vial

ARTG entry for

Medicine Registered

Sponsor

Roche Products Pty Ltd

Postal Address

PO Box 255,DEE WHY, NSW, 2099

Australia

ARTG Start Date

15/05/2014

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. GAZYVA obinutuzumab (rch) 1000 mg/40 mL concentrate solution for infusion vial

Product Type

Single Medicine Product

Effective date

6/01/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

GAZYVA in combination with chlorambucil is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL).

GAZYVA in combination with bendamustine, followed by GAZYVA maintenance, is indicated for the treatment of patients with follicular lymphoma (FL)

who did not respond to, or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

36 Months

Store at 2 to 8

degrees Celsius

Not recorded

Refrigerate

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial per pack

(S4) Prescription Only Medicine

Components

1. GAZYVA obinutuzumab (rch) 1000 mg/40 mL concentrate solution for infusion vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous Infusion

Visual Identification

Clear, colourless to slightly brownish liquid

Active Ingredients

obinutuzumab

1000 mg

© 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 27.11.2017 at 09:32:04 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

GAZYVA

®

Contains the active ingredient obinutuzumab (rch)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about GAZYVA. 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 being given

GAZYVA 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.

You may need to read it again.

What GAZYVA is used

for

GAZYVA contains an active

ingredient called obinutuzumab.

GAZYVA belongs to a group of (or

anti-cancer) agents. There are many

different classes of anti-neoplastic

agents. GAZYVA belongs to a class

called monoclonal antibodies.

Monoclonal antibodies are proteins

which specifically recognise and bind

to other unique proteins in the body.

GAZYVA is used to treat chronic

lymphocytic leukaemia (CLL). It is

also used to treat follicular

lymphoma (FL) which is no longer

responsive to treatment with another

medicine called rituximab.

GAZYVA recognises and attaches to

a protein called CD20 which is found

on the surface of white blood cells

known as B lymphocytes. During the

process of binding to the protein, the

abnormal growth of the B

lymphocytes is stopped.

It is the abnormally growing B

lymphocytes that are responsible for

CLL and FL.

For CLL GAZYVA is used with the

chemotherapy medicine

chlorambucil. For FL GAZYVA is

used with the chemotherapy

medicine bendamustine. For further

information about chlorambucil or

bendamustine please ask your doctor,

nurse or pharmacist for the

Consumer Medicine Information

(CMI) for these medicines.

Ask your doctor if you have any

questions about why GAZYVA has

been prescribed for you.

This medicine is available only with

a doctor's prescription.

This medicine is not addictive.

Before you are given

GAZYVA

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

When you must not be given

GAZYVA

Do not use GAZYVA:

if you have had an allergic

reaction to GAZYVA or any of

the ingredients listed at the end of

this leaflet

if you have had an allergic

reaction to any other proteins that

are of mouse origin

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

Before you are given

GAZYVA

Tell your doctor if:

you have an infection, or a

history of a recurring or long-

term infection such as Hepatitis

B

you are taking or have

previously taken medicines

which may affect your immune

system, such as chemotherapy

or immunosuppressive

medicines

If you are taking or have taken

medicines which affect your immune

system, you may have an increased

risk of infections. There have been

reports of a rare, serious brain

infection called PML (progressive

multifocal leucoencephalopathy)

usually affecting people with a

weakened immune system. Your

chance of getting PML may be

higher if you are treated with

medicines that weaken the immune

system, including GAZYVA. PML

can cause severe disability or even

death.

you have a history of heart

disease with:

cardiac arrhythmias (abnormal

beating of the heart)

angina (chest pain)

heart failure or a recent heart

attack

GAZYVA

160826

Your doctor will supervise you

closely during treatment with

GAZYVA.

you are taking medicine to

control blood pressure

As GAZYVA may cause a temporary

drop in your blood pressure, your

doctor may advise you to temporarily

stop taking your blood pressure

medicine before you are given

GAZYVA.

you are taking medicine to

prevent blood clots

GAZYVA can reduce the number of

platelets in your blood, which may

cause life-threatening bleeding.

you have pre-existing lung

disease

You may have a greater chance of

breathing difficulties during

treatment with GAZYVA.

Your doctor will supervise you

closely during treatment with

GAZYVA.

you have kidney disease

You may have a greater chance of

suffering a side effect during

treatment with GAZYVA if your

kidneys are not functioning normally.

Your doctor will supervise you

closely during treatment with

GAZYVA.

you have liver disease

The safety and efficacy of GAZYVA

have not been established in people

with liver problems.

you intend to have or have had

immunisation with any vaccine

Some vaccines should not be given at

the same time as GAZYVA or in the

months after you receive GAZYVA.

Your doctor will check if you should

have any vaccines before you receive

GAZYVA.

It is not known if GAZYVA will

affect your normal response to a

vaccine.

you are allergic to any other

medicines or any other substances

such as foods, preservatives or

dyes

you are pregnant or intend to

become pregnant

It is not known whether GAZYVA is

harmful to an unborn baby. It is not

recommended that you are given

GAZYVA while you are pregnant.

If you are of child bearing potential,

it is recommended that you do not

become pregnant for 18 months

following the end of treatment with

GAZYVA.

If you are of child bearing potential,

it is recommended that you use

effective contraceptive methods

during treatment and for up to 18

months following the end of

treatment with GAZYVA.

you are breast feeding or plan to

breast feed

It is not known if GAZYVA passes

into breast milk. It is recommended

that you discontinue breast feeding

while you are treated with GAZYVA

and for 18 months after your final

infusion of GAZYVA.

If you have not told your doctor

about any of the above, tell them

before you start taking GAZYVA.

Use in children

The safety and efficacy of GAZYVA

in children and adolescents under 18

years of age have not been

established.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you have bought without a

prescription from a pharmacy,

supermarket or health food shop.

As GAZYVA may cause a temporary

drop in your blood pressure, your

doctor may advise you to temporarily

stop taking your blood pressure

medicine before you are given

GAZYVA.

GAZYVA can reduce the number of

platelets in your blood. Taking

medicine to prevent blood clots while

you are receiving GAZYVA may

further reduce the number of

platelets. This may cause life-

threatening bleeding. Your doctor

will supervise you closely during

treatment with GAZYVA.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

GAZYVA.

How GAZYVA is given

Follow all directions given to you

by your doctor or nurse carefully.

They may differ from the

information contained in this leaflet.

GAZYVA must be prepared by a

healthcare professional and will be

given in a hospital or clinic by a

doctor or nurse.

GAZYVA is given by slow infusion

into a vein (intravenous (IV)

infusion). The number of infusions

you will be given depends on how

you respond to the treatment.

Before you receive GAZYVA you

will be given other medicines to help

reduce the severity of possible

infusion reactions.

For CLL

The first infusion: you will be given

100 mg of GAZYVA by IV infusion

over 4 hours.

The second infusion: if the first

infusion was well tolerated, you

will be given 900 mg of GAZYVA

by IV infusion, either on the same

day as the first infusion or a day

later.

The duration of the infusion and

when you receive the second infusion

will be determined by your doctor.

Subsequent infusions: if the

previous infusion was well

tolerated, you will be given 1000

mg of GAZYVA by IV infusion.

The duration of the infusion and

when you receive the infusion will be

determined by your doctor.

You will be closely monitored

during each infusion.

GAZYVA

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Your doctor may adjust your infusion

depending on how well each one is

tolerated.

For FL

The first infusion: you will be given

1000 mg of GAZYVA by IV

infusion.

Subsequent infusions: if the first

infusion was well tolerated, you

will be given 1000 mg of GAZYVA

by IV infusion.

The duration of each infusion and

when you receive the infusion will be

determined by your doctor.

Maintenance treatment: if you

respond to initial treatment your

doctor may decide to continue your

treatment with GAZYVA.

You may receive GAZYVA once

every 2 months for up to 2 years.

You will be closely monitored

during each infusion.

Your doctor may adjust your infusion

depending on how well each one is

tolerated.

If you miss a dose

As GAZYVA is given under the

supervision of your doctor, you are

unlikely to miss a dose. However, if

you forget or miss your appointment

to receive GAZYVA, you should not

wait until the next planned dose but

make another appointment as soon as

possible.

If you take too much

(overdose)

As GAZYVA is given under the

supervision of your doctor, it is

very unlikely that you will be given

too much. However, if you

experience any side effects after

being given GAZYVA, tell your

doctor immediately.

While you are

receiving GAZYVA

Things you must do

Tell your doctor or nurse

immediately if you have any signs

or symptoms of an infusion

reaction or allergic reaction, or

heart problems.

Some signs and symptoms can

include:

swelling of your face, lips, tongue

or throat with difficulty breathing

swelling of other parts of your

body

shortness of breath, wheezing or

trouble breathing

rash, itching or hives on the skin

feeling sick (nausea)

fever, chills

feeling tired

headache

chest pain

abnormal or irregular heartbeat

Tell your partner or caregiver you

are receiving GAZYVA and ask

them to tell you if they notice any

changes in your movement or

behaviour. If they notice any

changes you should tell your

doctor about them immediately.

Your doctor may need to perform

some tests and alter your treatment.

Tell all doctors, dentists and

pharmacists who are treating you

that you are receiving GAZYVA.

Tell your doctor if you become

pregnant or intend to start a family

while receiving GAZYVA, if you

intend to breast feed whilst

receiving GAZYVA, or if you

intend to vaccinate your baby and

were pregnant with your baby

whilst receiving GAZYVA.

Be sure to keep all of your

appointments with your doctor so

that your progress can be checked.

Your doctor will perform regular

blood tests.

Things you must not do

Do not stop your GAZYVA

treatment without talking to your

doctor first.

Tell your doctor if you feel that

GAZYVA is not helping your

condition.

Do not take any other medicines,

whether they require a

prescription or not without first

telling your doctor or consulting

with a pharmacist.

Things to be careful of

Be careful driving or operating

machinery until you know how

GAZYVA affects you.

GAZYVA generally does not cause

any problems with your ability to

drive or operate machinery. However

if you experience any of the reactions

listed under the section Things you

must do you should refrain from

driving or operating machinery until

the reaction stops.

Side effects

Tell your doctor or nurse as soon

as possible if you do not feel well

while you are receiving GAZYVA.

GAZYVA helps most people with

CLL, or FL which is no longer

responsive to treatment with

rituximab, but it may have unwanted

side effects in some people.

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.

If you are over 75 years of age or

older or suffer problems with your

kidneys you may have an increased

chance of getting side effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Do not be alarmed by the following

lists of side effects.

You may not experience any of them.

GAZYVA

160826

During an infusion

Tell your doctor or nurse

immediately if you notice any of

the following while receiving an

infusion:

swelling of your face, lips, tongue

or throat with difficulty breathing

swelling of other parts of your

body

shortness of breath, wheezing or

trouble breathing

rash, itching or hives on the skin

vomiting or feeling sick (nausea)

fever, flushing or chills

diarrhoea

cough or throat irritation

feeling tired

headache

chest pain

dizziness or light headedness

abnormal or irregular heartbeat

These may be serious side effects.

You may need medical attention.

After an infusion

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital if you notice

any of the following:

swelling of your face, lips, tongue

or throat with difficulty breathing

swelling of other parts of your

body

shortness of breath, wheezing or

trouble breathing

skin problems including rash,

itchiness or hives, hardened or

discoloured skin lesions which

may increase in size

stomach cramps or pains

severe or bloody diarrhoea

nausea and vomiting including

vomiting blood or material that

looks like coffee grounds

fever, chills

severe coughing

abnormal or irregular heartbeat

chest pain

bleeding or bruising more than

normal

one or a combination of the

following: confusion,

disorientation or memory loss,

changes in the way you move,

walk or talk, decreased strength

or progressive weakness in your

body, blurred or loss of vision.

These may be serious side effects.

You may need medical attention.

Tell your doctor or pharmacist if

you notice any of the following:

frequent infections such as fever,

severe chills, sore throat, mouth

ulcers or urinary infections

stuffy nose or chest

joint, bone or muscle pain

arm, leg or back pain

diarrhoea, constipation or

haemorrhoids

urinary incontinence

increased weight

persistent cough

hair loss

night sweats

feeling depressed

This is not a complete list of all

possible side effects. Your doctor or

pharmacist has a more complete list.

Others may occur in some people and

there may be some side effects not

yet know.

Tell your doctor or pharmacist if

you notice anything else that is

making you feel unwell, even if it is

not on this list.

Ask your doctor, nurse or

pharmacist if you don't understand

anything in this list.

Product description

Storage

GAZYVA will be stored in the

pharmacy or on the hospital ward in

a refrigerator at a temperature

between 2°C and 8°C.

Availability

GAZYVA is supplied as a single-

dose glass vial containing 40 mL of

solution for intravenous infusion (25

mg/mL). It is diluted before infusion

into a vein.

What GAZYVA looks like

GAZYVA is a clear, colourless to

slightly brownish liquid.

Ingredients

Each vial of GAZYVA contains

1000 mg of the active ingredient

obinutuzumab.

It also contains:

histidine

histidine hydrochloride

monohydrate

trehalose dehydrate

poloxamer 188

Distributor

Manufacturer/Distributor/

Supplier

GAZYVA is distributed by:

Roche Products Pty Limited

ABN 70 000 132 865

4-10 Inman Road

Dee Why, NSW 2099

AUSTRALIA

Medical enquiries: 1800 233 950

Please check with your pharmacist

for the latest Consumer Medicine

Information (CMI).

Australian Registration Number:

AUST R 210562

This leaflet was prepared on 26

August 2016.

GAZYVA

160826

9-5-2018

Australian Public Assessment Reports for prescription medicines (AusPARs)

Australian Public Assessment Reports for prescription medicines (AusPARs)

Added Obinutuzumab (Gazyva)

Therapeutic Goods Administration - Australia