ARZERRA

Main information

  • Trade name:
  • ARZERRA ofatumumab (rmc)1000mg/50mL injection concentrate vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ARZERRA ofatumumab (rmc)1000mg/50mL injection concentrate vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218896
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218896

ARZERRA ofatumumab (rmc) 1000mg/50mL injection concentrate vial

ARTG entry for

Medicine Registered

Sponsor

Novartis Pharmaceuticals Australia Pty Ltd

Postal Address

PO Box 101,NORTH RYDE, NSW, 1670

Australia

ARTG Start Date

2/10/2014

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. ARZERRA ofatumumab (rmc)1000mg/50mL injection concentrate vial

Product Type

Single Medicine Product

Effective date

11/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

1. Previously Untreated CLL :

ARZERRA is indicated, in combination with chlorambucil or bendamustine, for the treatment of patients with chronic lymphocytic leukaemia (CLL) who

have not received prior therapy and are inappropriate for fludarabine-based therapy.,2. Refractory CLL:

ARZERRA, as a single agent, is indicated for the treatment of patients chronic lymphocytic leukaemia (CLL) refractory to fludarabine and alemtuzumab.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

3 Years

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 vial

(S4) Prescription Only Medicine

Components

1. ARZERRA ofatumumab (rmc) 1000mg/50mL injection concentrate vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous Infusion

Visual Identification

A clear to hazy, colourless to pale yellow liquid, practically free of visible

particles

Active Ingredients

Ofatumumab

20 mg/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 26.11.2017 at 04:13:39 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

ARZERRA

®

20 mg/mL injection concentrate vial

Ofatumumab (rmc)

Consumer Medicine Information

What is in this leaflet

Please read this leaflet carefully

before you start using Arzerra.

This leaflet answers some common

questions about Arzerra

(ofatumumab). It does not contain all

the available information. It does not

take the place of talking to your

doctor or pharmacist.

The information in this leaflet was

last updated on the date listed on the

final page. More recent information

on the medicine may be available.

You should ensure that you speak

to your pharmacist or doctor to

obtain the most up to date

information on the medicine. You

can also download the most up to

date leaflet from

www.novartis.com.au.

Those updates may contain important

information about the medicine and

its use of which you should be aware.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking Arzerra

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 Arzerra is used

for

Arzerra contains ofatumumab, which

belongs to a group of medicines

called monoclonal antibodies.

Arzerra is used to treat chronic

lymphocytic leukaemia (CLL). CLL

is a cancer of the blood which affects

the lymphocytes (a type of white

blood cell). The lymphocytes

multiply too quickly and live too

long, so there are too many of them

circulating in your blood. The disease

can also affect other organs in your

body. The antibody in Arzerra

recognises a substance on the surface

of lymphocytes and causes the

lymphocyte to die.

Your doctor may have prescribed

Arzerra for another reason.

This medicine is available only with

a doctor's prescription.

Arzerra is not addictive.

Before you are given

Arzerra

When you must not receive

Arzerra

You must not receive Arzerra if:

you have ever had a severe

allergic (hypersensitive) reaction

to Arzerra (ofatumumab). Check

with your doctor if you think this

may apply to you.

you have ever had an allergic

reaction to any of the ingredients

listed toward the end of this

leaflet. (See "Ingredients").

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

Arzerra must not be used 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.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Tell your doctor if

Before you are given Arzerra your

doctor needs to know:

if you have had heart problems

if you have lung disease

if you have had hepatitis B (a

liver disease). Arzerra could

cause your hepatitis B to become

active again. Your doctor may

treat you with a suitable anti-viral

medicine to help prevent this.

Check with your doctor if you

think any of these may apply to

you.

You may need extra check-ups while

you are being treated with Arzerra.

Vaccination and Arzerra

If you are having any vaccinations

tell your doctor, or the person

giving you the vaccine, that you are

being treated with Arzerra.

ARZERRA

Your response to the vaccine may be

weakened.

Infusion reactions

Medicines of this type (monoclonal

antibodies) are given into a vein

(intravenously) as an infusion (a

drip) over several hours. They can

cause infusion reactions (side effects)

when they are injected into the body.

You will be given medicines such as

anti-histamines, steroids or pain

relievers to help reduce any reaction

(see also 'Side effects').

If you think you have had an

infusion reaction before, tell your

doctor before you are given

Arzerra.

Progressive multifocal

leukoencephalopathy (PML)

Medicines like Arzerra may cause a

serious and life threatening brain

condition called progressive

multifocal leukoencephalopathy

(PML).

Tell your doctor immediately if

you have memory loss, trouble

thinking, difficulty with walking or

loss of vision. If you had these

symptoms prior to treatment with

Arzerra, tell your doctor

immediately about any changes in

these symptoms.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, have taken any recently,

or if you start new ones.

This includes herbal medicines and

other medicines you've bought

without a prescription.

Pregnancy and breast-

feeding

Tell your doctor if you are

pregnant or think you could be,

before you are given Arzerra.

There is no information about the

safety of Arzerra in pregnant women.

Use a reliable method of

contraception to prevent

pregnancy while you're being

treated with Arzerra, and for

twelve months after your last

treatment.

Breast-feeding is not recommended

during treatment with Arzerra,

because it is not known whether it

passes into human milk.

Driving and using machines

Arzerra is unlikely to affect your

ability to drive or use machines.

Arzerra contains sodium

Arzerra contains 34.8 mg sodium in

each 300 mg dose and 232 mg

sodium in each 2000 mg dose.

You need to take this into account

if you are on a controlled sodium

diet.

How do I use Arzerra?

If you have any questions on the

use of this product, ask the doctor

who is giving Arzerra to you.

How much to take

The usual dose for the first infusion

is 300 mg. This dose will usually be

increased to 1000 mg or 2000 mg for

the remaining infusions.

How it is given

Arzerra is given into a vein

(intravenously) as an infusion (a

drip) over several hours.

If you have not been previously

treated for CLL you will usually have

a maximum of 13 infusions. You will

be given an infusion followed by a

second infusion 8 days later. The

remaining infusions will then be

given once a month for up to 11

months.

If you have been previously treated

for CLL, you will usually have a

course of 12 infusions. You will be

given an infusion once a week for

eight weeks. This is followed by a

four- to five-week gap. The

remaining infusions will be given

once a month for four months.

Before each infusion of Arzerra, you

will be given medicines which help

to reduce any infusion reactions.

These may include anti-histamines,

steroids and pain relievers. You will

be checked closely and if you do

have any reactions these will be

treated.

Side effects

Check with your doctor as soon as

possible if you think you are

experiencing any side effects or

allergic reactions due to receiving

Arzerra, even if the problem is not

listed below.

Like all medicines, Arzerra can cause

side effects, although not everybody

gets them. If they occur, they are

most likely to be minor and

temporary. However, some may be

serious and need medical attention.

Infusion reactions

Medicines of this type (monoclonal

antibodies) can cause infusion

reactions, which are occasionally

severe, and can cause death. These

reactions normally occur 1 to 2 hours

after starting the infusion. They are

more likely during the first treatment.

Very common symptoms of an

infusion reaction include (these may

affect more than 1 in 10 people):

skin rash

feeling sick (nausea)

high temperature

Common symptoms of an infusion

reaction include (these may affect up

to 1 in 10 people):

Severe allergic reaction. Signs

include:

raised and itchy rash (hives)

swelling, sometimes of the

face or mouth (angioedema),

causing difficulty in breathing

collapse

chills, flushing,

ARZERRA

cough, difficulty in breathing,

shortness of breath, chest

tightness

pain in joints, muscles or back

drop in blood pressure which may

make you feel dizzy or

lightheaded

throat pain or irritation

high blood pressure

rapid heart beat

feeling tired

diarrhoea

shaking or excessive shivering

blocked nose

excessive sweating

Uncommon symptoms of an infusion

reaction (this may affect up to 1 in

100 people):

fluid in the lungs (pulmonary

oedema) causing breathlessness

slow heart beat.

Tell your doctor or a nurse

immediately if you get any of these

symptoms.

Additional side effects that have been

observed with Arzerra:

Very common side effects

These may affect more than 1 in 10

people:

infections of the lungs or airways

(respiratory tract) such as

pneumonia

infections of the ear, nose or

throat

Very common side effects that may

show up in your blood tests:

low levels of white blood cells

low levels of red blood cells

(anaemia)

Common side effects

These may affect up to 1 in 10

people:

a fever due to an infection and

low levels of white blood cells

blood infections

urinary tract infections

shingles

cold sores

blockage in the gut (intestine),

which may feel like stomach pain

If you have persistent stomach

pain, see your doctor as soon as

possible.

Common side effects that may show

up in your blood tests:

low levels of platelets in the

blood (cells that help blood to

clot)

Uncommon side effects

These may affect up to 1 in 100

people:

increase in potassium, phosphate

and uric acid in the blood that can

cause kidney problems (tumour

lysis syndrome)

The symptoms of this condition

include:

producing less urine than normal

muscle spasms

If you notice these symptoms,

contact your doctor as soon as

possible.

Uncommon side effects that may

show up in your blood tests:

problems with blood clotting

the bone marrow failing to

produce enough red or white

blood cells

Rare side effects

This may affect up to 1 in 1000

people:

Infection or reactivation of

hepatitis B virus.

This is not a complete list of all

possible side effects. Others may

occur in some people and there may

be some side effects not yet known.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

If you get side effects

Tell your doctor or pharmacist if

any of the side effects listed become

severe or troublesome, or if you

notice any side effects not listed in

this leaflet.

How is Arzerra

stored?

Arzerra Concentrate

Store and transport refrigerated

(2°C - 8°C).

Store the vial in the outer carton in

order to protect from light.

Do not freeze.

Keep out of the reach and sight of

children.

Do not use Arzerra after the expiry

date which is stated on the carton

and vial label.

The expiry date refers to the last day

of that month.

Diluted preparation

Store the diluted infusion solution

between 2°C and 8°C and use

within 24 hours.

Discard any unused infusion

solution 24 hours after it was

prepared. Do not freeze.

Product description

What Arzerra looks like

Arzerra is a colourless to pale yellow

solution containing 20 mg/mL of

ofatumumab.

Arzerra 100 mg is available in a pack

containing 3 vials. Each glass vial is

closed with a latex-free rubber

stopper and aluminium over-seal, and

contains 5 mL of concentrate (100

mg of ofatumumab).

Arzerra 1,000 mg is available in a

pack containing 1 vial. Each glass

vial is closed with a latex-free rubber

stopper and aluminium over-seal, and

contains 50 mL of concentrate (1,000

mg of ofatumumab).

Ingredients

ARZERRA

Each mL of Arzerra contains

ofatumumab 20 mg as the active

ingredient. The other ingredients are:

arginine

disodium edetate

hydrochloric acid (E507)

polysorbate 80 (E433)

sodium acetate (E262)

sodium chloride

water for injections.

Sponsor

Arzerra is supplied in Australia by:

Novartis Pharmaceuticals Australia

Pty Limited

ABN 18 004 244 160

54 Waterloo Road, Macquarie Park

NSW 2113 Australia

Telephone 1 800 671 203

www.novartis.com.au

® Registered Trademark

Arzerra Australian Registration

Numbers:

AUST R 196945 Arzerra

ofatumumab (rmc) 100 mg/5 mL

injection concentrate vial

AUST R 218896 Arzerra

ofatumumab (rmc) 1000 mg/50 mL

injection concentrate vial

This leaflet was prepared in

September 2015.

For internal use only

(arz090915c based on PI arz090915i)

ARZERRA

There are no safety alerts related to this product.

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