COSENTYX

Main information

  • Trade name:
  • COSENTYX secukinumab (rch) 150 mg/1 mL solution for injection in prefilled pen
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COSENTYX secukinumab (rch) 150 mg/1 mL solution for injection in prefilled pen
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218800
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218800

COSENTYX secukinumab (rch) 150 mg/1 mL solution for injection in prefilled pen

ARTG entry for

Medicine Registered

Sponsor

Novartis Pharmaceuticals Australia Pty Ltd

Postal Address

PO Box 101,NORTH RYDE, NSW, 1670

Australia

ARTG Start Date

12/01/2015

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. COSENTYX secukinumab (rch) 150 mg/1 mL solution for injection in prefilled pen

Product Type

Single Medicine Product

Effective date

29/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Plaque psoriasis

COSENTYX is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or

phototherapy.

Psoriatic arthritis

Cosentyx is indicated for the treatment of adult patients with active psoriatic arthritis when the response to previous disease-modifying anti-rheumatic

drug (DMARD) therapy has been inadequate

Ankylosing spondylitis

COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Glass Type I Clear

24 Months

Store at 2 to 8

degrees Celsius

Child resistant closure

Store in Original

Container

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 pen

(S4) Prescription Only Medicine

2 pens

(S4) Prescription Only Medicine

Components

1. COSENTYX secukinumab (rch) 150 mg/1 mL solution for injection in prefilled pen

Dosage Form

Injection, solution

Route of Administration

Subcutaneous

Visual Identification

Pen containing a clear, colourless-slightly yellow liquid in 1 mL glass

syringe, with seal bridges, cap, and label.

Active Ingredients

Secukinumab

150 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 04:27:34 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

COSENTYX

COSENTYX

®

solution for injection

Secukinumab (rch)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about COSENTYX.

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 COSENTYX

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 COSENTYX is

used for

COSENTYX is used for the

treatment of the following

inflammatory diseases:

Plaque psoriasis

Psoriatic arthritis

Ankylosing spondylitis

Plaque psoriasis

COSENTYX is used to treat a skin

condition called 'plaque psoriasis' in

adults.

Plaque psoriasis causes inflammation

of the skin.

COSENTYX is used in adults with

moderate to severe plaque psoriasis.

Psoriatic arthritis

COSENTYX is used to treat a

condition called 'psoriatic arthritis'.

The condition is an inflammatory

disease of the joints, often

accompanied by psoriasis.

Ankylosing spondylitis

COSENTYX is used to treat a

condition called 'ankylosing

spondylitis' in adults. The condition

is an inflammatory disease primarily

affecting the spine which causes

inflammation of the spinal joints.

In patients with plaque psoriasis,

psoriatic arthritis, and ankylosing

spondylitis the body produces

increased amounts of a protein called

IL-17A. This may lead to symptoms

such as itching, pain, scaling in

psoriasis, swollen and tender joints in

psoriatic arthritis, and pain in the

spine in ankylosing spondylitis.

COSENTYX contains the active

substance secukinumab. This

ingredient is a fully-human

monoclonal antibody and belongs to

a group of medicines called

interleukin (IL) inhibitors.

Monoclonal antibodies are proteins

that recognise and bind specifically

to certain proteins in the body.

COSENTYX works by neutralising

the activity of the IL-17A protein,

which is present at increased levels in

conditions such as psoriasis, psoriatic

arthritis, and ankylosing spondylitis.

It will reduce the inflammation and

other symptoms of the condition.

If you have any questions about

how COSENTYX works or why

this medicine has been prescribed

for you, ask your doctor,

pharmacist or healthcare provider.

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.

COSENTYX is not recommended for

children and adolescents (under 18

years of age) because it has not been

studied in this age group.

COSENTYX may be used by people

aged 65 years and over.

COSENTYX is available only with a

doctor's prescription and is not

addictive.

Before you have

COSENTYX

When you must not take it

Do not take COSENTYX if you

have had a severe allergic reaction

to secukinumab or any of the other

ingredients listed at the end of this

leaflet.

COSENTYX

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 take COSENTYX if you

have an active infection which your

doctor thinks is important.

Do not take COSENTYX if there

are visible signs of deterioration.

If you think you may be allergic,

ask your doctor for advice before

using COSENTYX.

Do not take 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.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to have it

If any of these apply to you, tell

your doctor or pharmacist before

using COSENTYX:

you currently have an infection or

if you have long-term or repeated

infections

you have tuberculosis

you have inflammatory bowel

disease (Crohn's disease or

ulcerative colitis)

you had a recent vaccination or if

you will receive a live vaccine

during treatment with

COSENTYX

Tell your doctor if you are

pregnant, think that you may be

pregnant or are planning to have a

baby.

COSENTYX is not recommended

during pregnancy unless the benefits

clearly outweigh the potential risks.

Tell your doctor if you are breast-

feeding or plan to breast-feed.

If you have not told your doctor

about any of the above, tell them

before you start taking

COSENTYX.

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.

Tell your doctor or pharmacist if you:

are taking a blood thinning

medicine called warfarin.

are taking, have recently taken or

might take any other medicines.

have recently had or are going to

have a vaccination. You should

not receive certain types of

vaccines (live vaccines) while

using COSENTYX.

Such medicines may be affected by

COSENTYX or may affect how well

it works. You may need different

amounts of your medicines, or you

may need to take different medicines.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

How COSENTYX is

given

Follow all directions given to you

by your doctor, nurse or

pharmacist carefully.

They may differ from the

information contained in this leaflet.

Always use COSENTYX as your

doctor has told you. You should

check with your doctor, nurse or

pharmacist if you are not sure.

COSENTYX is intended for

subcutaneous use. This means that it

is injected into the fatty tissue just

under the skin.

The injection may be given by your

doctor or nurse or you may be taught

how to inject yourself with the

medicine.

You and your doctor should decide

if you should inject COSENTYX

yourself.

It is important not to try to inject

yourself until you have been trained

by your doctor, nurse or pharmacist.

A caregiver may also give you your

COSENTYX injection after proper

training.

If you do not understand the

instructions on the label ask your

doctor or pharmacist for help.

How much is given

Your doctor will decide how much

COSENTYX you need.

Plaque psoriasis

The recommended dose is 300 mg by

subcutaneous injection with initial

loading dose at weeks 0, 1, 2 and 3,

followed by monthly maintenance

dosing starting at week 4. Each 300

mg dose is given as two sub-

cutaneous injections of 150 mg.

Psoriatic arthritis

The recommended dose is 150 mg by

subcutaneous injection with initial

dosing at Weeks 0, 1, 2, and 3,

followed by monthly maintenance

dosing starting at Week 4.

For patients who did not respond

well to medicines called tumour

necrosis factor (TNF) blockers or

patient who also have moderate to

severe plaque psoriasis, the

recommended dose is 300 mg by

subcutaneous injection with initial

dosing at Weeks 0, 1, 2 and 3,

followed by monthly maintenance

dosing starting at Week 4. Each

300 mg dose is given as two

subcutaneous injections of 150 mg.

COSENTYX may be administered

with or without methotrexate.

Ankylosing spondylitis

The recommended dose is 150 mg by

subcutaneous injection with initial

dosing at Weeks 0, 1, 2 and 3

followed by monthly maintenance

dosing starting at Week 4.

COSENTYX

Do not exceed the recommended

dose.

Choosing the injection sites

The injection sites are where the skin

will be pierced to administer the

subcutaneous injection.

The recommended site is the front of

your thighs. You may also use the

lower abdomen, but not the area five

centimetres around the navel (belly

button). If a caregiver is giving you

the injection, the outer upper arms

may also be used (Shown in grey in

the diagram for illustrative purposes).

Choose a different site each time

you give yourself an injection.

Do not inject into areas where the

skin is tender, bruised, red, scaly

or hard.

Avoid areas with scars or stretch

marks

Injecting COSENTYX

yourself

Discuss with your doctor whether

or not you will inject COSENTYX

yourself.

Do not try to inject yourself if you

have not been properly trained or

if you are not sure how to do it.

After proper training in injection

technique, your doctor will tell you

that you may inject it yourself.

Read the following instructions on

how to use the prefilled pen all the

way through before removing

COSENTYX from the refrigerator.

These instructions are to help you

to inject correctly.

How to use the prefilled

pens

Read ALL the way through these

instructions before injecting.

These instructions will help you to

inject correctly using the pen.

For a more comfortable injection,

take the carton containing two pens

out of the refrigerator 15 to 30

minutes before injecting.

This will enable them to reach room

temperature. COSENTYX should be

administered within one hour after

removal from 2°C to 8°C storage.

During the injection you will hear

2 loud clicks.

The first click indicates that the

injection has started. Several seconds

later a second click will indicate that

the injection is almost finished.

You must keep holding the pen

firmly against your skin until you

see a green indicator fill the

window and stop moving.

Before your injection, gather

together the necessary items not

included in the COSENTYX pack:

alcohol swabs

clean, dry cotton swab or gauze

sharps disposal container

1.

When you are ready to use the

pens, wash your hands

thoroughly with soap and

water.

2.

Inspect the pen.

The liquid should be clear. Its

colour may vary from colourless

to slightly yellow. You may see a

small air bubble, which is normal.

Needle

Needle guard

Inspection window

Internal needle cover

Do NOT use the pen if the

liquid contains easily visible

particles, is cloudy or is

distinctly brown.

3.

Find a clean, comfortable area.

Using a circular motion, clean

the injection site with the

alcohol swab.

Leave it to dry before injecting.

Do not touch the cleaned area

again before injecting.

4.

Only remove the cap when you

are ready to use the pen.

COSENTYX

Twist off the cap in the

direction of the arrows. Once

removed, throw away the cap.

Use the pen within 5 minutes of

removing the cap. Do not try to

re-attach the cap.

5.

Hold the pen at 90 degrees to

the cleaned injection site.

Ensure the inspection window

on the pen is visible before

injecting.

6.

Press the pen firmly against the

skin to start the injection.

The first click indicates the

injection has started.

Keep holding the pen firmly

against your skin.

The green indicator shows the

progress of the injection.

7.

Listen for the second click.

This indicates the injection is

almost complete.

After the injection, check the

green indicator fills the window

and has stopped moving. The

pen can now be removed.

8.

Check the green indicator fills

the window.

This means the medicine has been

delivered.

Contact your doctor if the

green indicator is not visible.

There may be a small amount of

blood at the injection site.

You can press a cotton ball or

gauze over the injection site and

hold it for 10 seconds.

Do not rub the injection site.

You may cover the injection site

with a small adhesive bandage, if

needed.

9.

Dispose of the used pen in a

sharps disposal container (i.e. a

puncture-resistant closable

container, or similar). Never try

to reuse the spent pen.

10.

If you have been prescribed a

300 mg dose and therefore a

second injection is required,

choose a different site and

repeat steps 2 to 9 with the

second pen.

How long to take

COSENTYX

This is a long-term treatment.

Keep taking this medicine for as

long as your doctor tells you.

Your doctor will regularly monitor

your condition to check that the

treatment is having the desired

effect.

If you use more COSENTYX

than you should (overdose)

If you or anyone else accidentally

received more COSENTYX than

you should or sooner than

according to the doctor's

prescription, immediately

telephone your doctor or the

Poisons Information Centre

(telephone 13 11 26) for advice, or

go to Accident and Emergency at

the nearest hospital.

Do this even if there are no obvious

signs of discomfort or poisoning.

If you forget to have it

If you have forgotten to inject a dose

of COSENTYX, inject the next dose

as soon as you remember. Then talk

to your doctor to discuss when you

should inject the next dose.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering to

have your medicine, ask your

pharmacist for some hints.

While you are taking

COSENTYX

Things you must do

Discontinue treatment and tell

your doctor or pharmacist

COSENTYX

immediately if you get any of these

symptoms during treatment with

COSENTYX.

Signs or symptoms of a potentially

serious infection. These may include:

fever, flu-like symptoms, night

sweats

feeling tired or short of breath;

cough which will not go away

warm, red and painful skin, or a

painful skin rash with blisters

burning when passing urine

Signs or symptoms of an allergic

reaction. These may include:

difficulty breathing or swallowing

low blood pressure, which can

cause dizziness or light-

headedness

swelling of the face, lips, mouth

or throat

severe itching of the skin, with a

red rash or raised bumps

Keep all of your doctor's

appointments so that your progress

can be checked.

Your doctor will do tests from time

to time to make sure the medicine is

working and to prevent unwanted

side effects.

Your doctor will decide if and when

you may restart the treatment.

If you need to be vaccinated, tell

your doctor you are taking

COSENTYX before you have the

vaccination.

Live vaccines will not be suitable for

you.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking COSENTYX.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are taking this medicine.

Things you must not do

Never leave the prefilled pen lying

around where others might tamper

with it.

Do not open the sealed box until

you are ready to use COSENTYX.

Do not use this medicine if the

liquid contains easily visible

particles, is cloudy or is distinctly

brown.

Do not use the prefilled pen if

either the seal on the outer box or

the seal of the blister are broken.

It may not be safe for you to use.

Do not shake the prefilled pen.

Do not use the pen if it has been

dropped with the cap removed.

Do not take it to treat any other

complaints unless your doctor tells

you to.

Do not give this medicine to anyone

else, even if they have the same

condition as you.

Things to be careful of

Dispose of the used COSENTYX

prefilled pens immediately after

use in a sharps container.

The COSENTYX prefilled pen

should never be re-used.

If you stop using

COSENTYX

Do not stop taking your medicine or

change dosage without checking with

your doctor first.

Side effects

As with all medicines, patients

treated with COSENTYX may

experience side effects, although not

everybody gets them.

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

COSENTYX.

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.

Some side effects are very common

(These side effects may affect more

than 1 in every 10 people)

Upper respiratory tract infections

with symptoms such as sore

throat and stuffy nose

(nasopharyngitis, rhinitis)

Some side effects are common

(These side effects may affect up to 1

in every 10 people)

Cold sores (oral herpes)

Diarrhoea

Runny nose (rhinorrhoea)

Hives

Headache

Nausea

Itchy rash (urticaria)

Some side effects are uncommon

(These side effects may affect up to 1

in every 100 people)

Oral thrush (oral candidiasis)

Signs of low levels of white

blood cells such as fever, sore

throat or mouth ulcers due to

infections (neutropenia)

Athlete's foot (tinea pedis)

Infection of the external ear (otitis

externa)

Discharge from the eye with

itching, redness and swelling

(conjunctivitis)

Painful period

Some side effects are rare (may

affect in to 1 in 1,000 people)

Severe allergic reaction with

shock (anaphylactic shock)

The frequency of some side effects

cannot be estimated from available

data

Fungal infections of the skin and

mucous membranes (thrush)

New cases of inflammatory bowel

disease or "flare-ups" can happen

with COSENTYX, and can

COSENTYX

sometimes be serious. If you have

inflammatory bowel disease

(ulcerative colitis or Crohn's disease),

tell your doctor if you have

worsening symptoms during

treatment with COSENTYX or

develop new symptoms of stomach

pain or diarrhoea.

COSENTYX may affect the results

of some blood tests, including:

slight increase in blood

cholesterol and blood fat

(triglycerides)

elevated liver enzymes

In clinical trials, major adverse

cardiovascular events were rarely

observed with COSENTYX.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice

anything else that is making you

feel unwell.

Other side effects not listed here or

not yet known may happen in some

people.

After taking

COSENTYX

Storage

If you have to store COSENTYX:

Keep it in a refrigerator at 2°C to

8°C out of the sight and reach of

children

Do not freeze it

Store it in the carton in order to

protect it from light.

Do not store COSENTYX or any

other medicine in the bathroom,

near a sink, or leave it in the car or

on a window sill.

A locked section of the refrigerator,

at least one-and-a-half metres above

the ground, is a good place to store

COSENTYX.

Disposal

If your doctor tells you to stop

taking this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product description

What it looks like

COSENTYX solution for injection is

a clear liquid. Its colour may vary

from colourless to slightly yellow.

COSENTYX is available in packs

containing 1 or 2 single-use pre-filled

pens.

Ingredients

Each COSENTYX pre-filled pen

contains 150 mg secukinumab as the

active substance.

The other ingredients are:

trehalose dihydrate

histidine

histidine hydrochloride

monohydrate

methionine

polysorbate 80

water for injection.

This medicine does not contain

sucrose, lactose, gluten, tartrazine or

any other azo dyes.

Sponsor

COSENTYX is supplied in Australia

Novartis Pharmaceuticals

Australia Pty Limited

ABN 18 004 244 160

54 Waterloo Road

Macquarie Park NSW 2113

Telephone 1 800 671 203

® = Registered Trademark

This leaflet was prepared in

May 2017

Australian Registration Numbers:

Pre-filled pen AUST R 218800

(cos230517c based on PI

cos230517i)

24-9-2018

Cosentyx (Novartis Europharm Limited)

Cosentyx (Novartis Europharm Limited)

Cosentyx (Active substance: secukinumab) - PSUSA - Modification - Commission Decision (2018)6213 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00010341/201712

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