MABTHERA

Main information

  • Trade name:
  • MABTHERA SC rituximab (rch) 1400mg/11.7mL solution for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MABTHERA SC rituximab (rch) 1400mg/11.7mL solution for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207334
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207334

MABTHERA SC rituximab (rch) 1400mg/11.7mL solution for injection vial

ARTG entry for

Medicine Registered

Sponsor

Roche Products Pty Ltd

Postal Address

PO Box 255,DEE WHY, NSW, 2099

Australia

ARTG Start Date

28/05/2014

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. MABTHERA SC rituximab (rch) 1400mg/11.7mL solution for injection vial

Product Type

Single Medicine Product

Effective date

3/10/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

MABTHERA SC is indicated for treatment of patients with: - CD20 positive, previously untreated, Stage III/IV follicular, B-Cell non-Hodgkin's lymphoma, -

CD20 positive, relapsed or refractory low grade or follicular, B-cell non-Hodgkin's lymphoma, - CD 20 positive, diffuse large B-cell non-Hodgkin's

lymphoma, in combination with chemotherapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

30 Months

Store at 2 to 8

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial

(S4) Prescription Only Medicine

Components

1. MABTHERA SC rituximab (rch) 1400mg/11.7mL solution for injection vial

Dosage Form

Injection

Route of Administration

Subcutaneous

Visual Identification

Clear to opalescent, colourless to yellowish solution

Active Ingredients

Rituximab

1400 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 28.11.2017 at 12:32:32 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

MabThera

®

SC

subcutaneous injection

For the treatment of Non-Hodgkin's Lymphoma (1400 mg strength) and Chronic Lymphocytic

Leukaemia (1600 mg strength)

pronounced (mab-thir-ra)

contains the active ingredient rituximab (rch)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about MabThera SC for

subcutaneous (under the skin)

injection. 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

MabThera SC against the benefits

they expect it will have for you.

If you have any concerns about

being given this medicine, ask your

doctor or pharmacist.

Keep this leaflet.

You may need to read it again.

What MabThera SC is

used for

MabThera SC contains the active

ingredient rituximab.

MabThera SC belongs to a group of

medicines known as anti-cancer

agents. There are many different

classes of anti-cancer agents.

MabThera SC belongs to a class

called monoclonal antibodies.

Monoclonal antibodies are proteins

which specifically recognise and bind

to other unique proteins in the body.

MabThera SC is used to treat non-

Hodgkin's lymphoma and chronic

lymphocytic leukaemia. MabThera

SC in chronic lymphocytic leukaemia

was approved building on data from

both the intravenous form of

MabThera and MabThera SC in non-

Hodgkin's lymphoma.

MabThera SC works by binding to a

protein on the surface of certain

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

certain types of non-Hodgkin's

lymphoma and chronic lymphocytic

leukaemia..

MabThera SC may be used on its

own or together with chemotherapy.

If your doctor thinks it is appropriate

for your circumstances you may

continue to receive MabThera SC

after the initial course of treatment.

Your doctor may have prescribed

MabThera SC for another reason.

Ask your doctor if you have any

questions why MabThera SC has

been prescribed for you.

This medicine is available only with

a doctor's prescription.

Before you are given

MabThera SC

When you must not be given

MabThera SC

Do not use MabThera SC:

if you have had an allergic

reaction to rituximab 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

severe skin rash, itching, hives,

swelling of the face, lips, mouth

or throat which may cause

difficulty in swallowing or

breathing, swelling of the hands,

feet or ankles.

If you are not sure if you should

start receiving MabThera SC, talk

to your doctor.

Before you are given

MabThera SC

Your doctor must know about all

the following before you are given

MabThera SC.

Tell your doctor if:

1.

you have an infection, or a

history of a recurring or long-

term infection such as hepatitis

B

MABTHERA SC FOR NHL AND CLL 160923

2.

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 leuko-encephalopathy)

usually affecting people with a

weakened immune system. Your

chance of getting PML may be

higher if you are treated with

MabThera SC and/or other medicines

that weaken the immune system.

PML can cause severe disability or

even death.

3.

you have a history of heart

disease with:

angina

cardiac arrhythmias (abnormal

beating of the heart)

congestive heart failure

Your doctor will supervise you

closely during treatment with

MabThera SC.

4.

you are taking medicine to

control blood pressure

MabThera SC may cause a reduction

in blood pressure at the beginning of

treatment. Because MabThera SC

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 MabThera SC.

5.

you have pre-existing lung

disease

You may have a greater chance of

breathing difficulties during

treatment with MabThera SC.

6.

you intend to have or have had

immunisation with any vaccine

(e.g. measles, rubella, flu,

vaccines for travel purposes)

Some vaccines should not be given at

the same time as MabThera SC or in

the months after you receive

MabThera SC. Your doctor will

check if you should have any

vaccines before you receive

MabThera SC.

7.

you are allergic to any other

medicines or any other

substances such as foods,

preservatives or dyes

8.

you are pregnant or intend to

become pregnant

It is not known whether MabThera

SC is harmful to an unborn baby. It is

not recommended that you are given

MabThera SC while you are

pregnant.

If you are a woman of child bearing

potential, you must use effective

contraceptive methods to prevent

pregnancy during treatment and for

12 months after completing treatment

with MabThera SC.

9.

you are breast feeding or plan

to breast feed.

It is not known if MabThera SC

passes into breast milk. It is

recommended that you discontinue

breast feeding while you are treated

with MabThera SC.

If you have not told your doctor

about any of the above, tell them

before you are given MabThera

SC.

Use in children

The safety and effectiveness of

MabThera SC have not been

established in children.

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 healthfood shop.

As MabThera SC may cause a

temporary drop in your blood

pressure at the beginning of

treatment, your doctor may advise

you to temporarily stop taking your

blood pressure medicine before you

are given MabThera SC.

It is not known if MabThera SC will

affect your normal response to a

vaccine.

It is possible that after treatment with

MabThera SC you may experience

allergic reactions if you are treated

with other medications containing

monoclonal antibodies.

Your doctor and pharmacist will

have more information on medicines

to be careful with or to avoid while

undergoing treatment with MabThera

How MabThera SC is

given

Your treatment with MabThera SC

will always begin with an infusion of

MabThera intravenous formulation

into a vein. If the infusion is

tolerated, then further treatment with

MabThera SC can be given by

subcutaneous injection. This means it

is injected with a short needle into

the fatty tissue just under the skin.

MabThera SC is given as a fixed

dose of 1400 mg per injection over

approximately 5 minutes for

treatment of non-Hodgkin’s

lymphoma.

MabThera SC is given as a fixed

dose of 1600 mg per injection over

approximately 7 minutes for

treatment of chronic lymphocytic

leukaemia..

Your doctor will decide on the

frequency of injections.

MabThera SC may be given with or

without chemotherapy. When given

in combination with chemotherapy,

the standard treatment with

MabThera SC consists of 1

subcutaneous injection on day 1 of

each chemotherapy cycle.

MabThera SC must always be

administered by a healthcare

professional.

Depending on the circumstances of

your disease or response to the drug

your doctor may decide to change

your treatment.

MABTHERA SC FOR NHL AND CLL 160923

Maintenance treatment

If you respond to initial treatment

your doctor may decide to continue

your treatment with MabThera SC.

for up to 2 years.

Overdose

As MabThera SC is given to you

under the supervision of your

doctor, it is very unlikely that you

will receive too much. However, if

you experience any side effects

after being given MabThera SC,

tell your doctor immediately.

While you are

receiving MabThera

Things you must do

If you are a woman of child

bearing potential, you must use

effective contraceptive methods to

prevent pregnancy during

treatment with MabThera SC and

for 12 months after completing

treatment.

Tell your doctor if you become

pregnant while receiving

MabThera SC.

Tell all doctors, dentists and

pharmacists who are treating you

that you are receiving MabThera

SC.

Tell your partner or caregiver you

are receiving MabThera SC 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.

Be sure to keep all 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 breast feed your infant

during treatment with MabThera

SC.

It is not known whether MabThera

SC crosses into human milk.

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

MabThera SC affects you.

MabThera SC generally does not

cause any problems with your ability

to drive or operate machinery.

However, as with many other

medicines, MabThera SC may cause

dizziness in some people.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are receiving

MabThera SC.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

MabThera SC helps many people

who have non-Hodgkin's lymphoma

or chronic lymphocytic leukaemia

but it may have unwanted 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 get some of

the side effects.

Your doctor may recommend that

you take medication to prevent pain

or allergy before you receive your

MabThera SC injection.

Ask your doctor or pharmacist to

answer any questions you may

have.

The following is a list of the more

common side effects.

Tell your doctor if you notice any

of the following and they worry

you:

side effects at the injection site

including pain, swelling, bruising,

bleeding, skin redness, itching

and rash

wheezing or coughing

dizziness or lightheadedness,

especially on standing up

nausea (feeling sick) or vomiting

headache

fatigue (feeling tired) and/or

feeling weak

rhinitis (a runny nose)

fast heart beat

chest pain which may spread to

the neck and shoulders

pain where the cancer is located

muscle and joint pain

stomach pain or discomfort

throat irritation

sore mouth or mouth ulcers

bleeding or bruising more easily

than normal

shingles (herpes zoster infection)

diarrhoea

increased blood pressure

indigestion

loss of appetite

muscle stiffness

nervousness, feeling anxious or

agitated

increased cough

inability to sleep

pins and needles, or decreased

feeling in the skin

stuffy nose or chest

sweating or night sweats

watery, itchy or crusty eyes

changes to sense of taste

weight loss

ear pain and/or buzzing, hissing,

whistling, ringing or other

persistent noise in the ears

constipation

a general feeling of being unwell

MABTHERA SC FOR NHL AND CLL 160923

unusual hair loss or thinning

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital if you notice

any of the following:

severe skin rash, itching, hives

swelling of the face, lips, mouth

or throat which may cause

difficulty in swallowing or

breathing, swelling of the hands,

feet or ankles

one or a combination of the

following: severe shortness of

breath, severe difficulty

breathing, severe wheezing,

severe coughing

vision loss associated with

headaches, confusion and

seizures

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.

yellowing of skin and eyes, light

coloured bowel motions, dark

coloured urine

These are serious side effects. You

may need urgent medical attention.

Serious side effects are rare.

In combination with

chemotherapy

If you have been given MabThera

SC in combination with

chemotherapy, as well as the side

effects listed above, the following

additional side effect may also

occur:

bronchitis (inflammation in the

lungs)

If you are 65 years of age or over

and have been given MabThera SC

in combination with

chemotherapy, the following side

effects may occur more commonly:

frequent infections with

symptoms such as fever, severe

chills, sore throat or mouth ulcers

These events may be related to

MabThera SC, but you may get

other side effects from your

chemotherapy.

Please consult your doctor for

possible side effects that may be

caused by your chemotherapy.

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 known.

Tell your doctor if you notice

anything else that is making you

feel unwell.

Ask your doctor or pharmacist if

you don't understand anything in

this list.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

After receiving

MabThera SC

Storage

MabThera SC should be stored in the

pharmacy or on the hospital ward.

MabThera SC should be kept in a

refrigerator at 2 to 8°C. It should not

be frozen.

MabThera SC should be stored away

from light.

Product Description

Availability

MabThera SC is available as a

solution for subcutaneous injection in

in 1400 mg/11.7mL and 1600 mg/

13.4mL as single dose vials. It is

supplied as one vial per carton.

MabThera is also available as a

concentrate for intravenous infusion

in 100 mg/10 mL and 500 mg/50 mL

single dose vials.

What MabThera SC looks

like

MabThera SC is available as a clear

to opalescent, colourless to yellowish

solution.

Ingredients

MabThera SC contains the active

ingredient rituximab (rch). Each vial

of MabThera SC also contains the

following inactive ingredients:

vorhyaluronidase alfa

histidine

histidine hydrochloride

trehalose dihydrate

methionine

polysorbate 80

water for injection

Distributor

MabThera SC is distributed by:

Roche Products Pty Limited

ABN 70 000 132 685

4-10 Inman Road

Dee Why NSW 2099

Medical enquiries: 1800 233 950

Please check with your pharmacist

for the latest Consumer Medicine

Information.

Australian Registration Number:

AUST R 207334 (1400mg)

AUST R 235147 (1600mg)

This leaflet was prepared on 23

September 2016

MABTHERA SC FOR NHL AND CLL 160923

15-10-2018

Riximyo (Sandoz GmbH)

Riximyo (Sandoz GmbH)

Riximyo (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6811 of Mon, 15 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Ritemvia (Celltrion Healthcare Hungary Kft.)

Ritemvia (Celltrion Healthcare Hungary Kft.)

Ritemvia (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6480 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

24-9-2018

Blitzima (Celltrion Healthcare Hungary Kft.)

Blitzima (Celltrion Healthcare Hungary Kft.)

Blitzima (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6228 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Rixathon (Sandoz GmbH)

Rixathon (Sandoz GmbH)

Rixathon (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6230 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

23-7-2018

Rituzena (Celltrion Healthcare Hungary Kft.)

Rituzena (Celltrion Healthcare Hungary Kft.)

Rituzena (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)4884 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

2-5-2018

Truxima (Celltrion Healthcare Hungary Kft.)

Truxima (Celltrion Healthcare Hungary Kft.)

Truxima (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)2707 of Wed, 02 May 2018

Europe -DG Health and Food Safety