SIMPONI

Main information

  • Trade name:
  • SIMPONI golimumab (rmc) 100 mg solution for injection pre-filled syringe
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SIMPONI golimumab (rmc) 100 mg solution for injection pre-filled syringe
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 208278
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

208278

SIMPONI golimumab (rmc) 100 mg solution for injection pre-filled syringe

ARTG entry for

Medicine Registered

Sponsor

Janssen-Cilag Pty Ltd

Postal Address

Locked Bag 2070,NORTH RYDE, NSW, 1670

Australia

ARTG Start Date

2/04/2014

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. SIMPONI golimumab (rmc) 100 mg solution for injection pre-filled syringe

Product Type

Single Medicine Product

Effective date

20/03/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Rheumatoid arthritis (RA)

SIMPONI, in combination with methotrexate, is indicated for:

The treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy,

including methotrexate, has been inadequate. SIMPONI has also been shown to inhibit the progression of joint damage as measured by X-ray.,Psoriatic

arthritis (PsA)

SIMPONI, alone or in combination with methotrexate, is indicated for: The treatment of active and progressive psoriatic arthritis in adult patients when the

response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. SIMPONI has also been shown to inhibit the progression of

peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,Axial

Spondyloarthritis,Ankylosing spondylitis (AS)

SIMPONI is indicated for: The treatment of active ankylosing spondylitis in adult patients.,Non-radiographic axial spondyloarthritis (nr-Axial SpA)

SIMPONI is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by

elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to,

nonsteroidal anti-inflammatory drugs (NSAIDs).,Ulcerative colitis (UC)

SIMPONI is indicated for:

The treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy. Patients

should show a clinical response within 6 weeks of treatment to continue treatment beyond that time (see CLINICAL TRIALS)

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Glass Type I Clear

2 Years

Store at 2 to 8

degrees Celsius

Not recorded

Protect from Light

Do not Freeze

Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

Packs of 1 or 3 syringes (1.0 mL)

(S4) Prescription Only Medicine

Components

1. SIMPONI golimumab (rmc) 100 mg solution for injection pre-filled syringe

Dosage Form

Injection, solution

Route of Administration

Subcutaneous

Visual Identification

Clear to slightly opalescent, colourless to light yellow solution

Active Ingredients

Golimumab

100 mg/mL

Public Summary

Page 1 of

Produced at 27.11.2017 at 11:14:52 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

© 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 2 of

Produced at 27.11.2017 at 11:14:52 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

SIMPONI

(170913) ACMI

SIMPONI

®

Golimumab (rmc)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about SIMPONI. It does

not contain all the available

information. It does not take the

place of talking to your doctor, nurse

or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using SIMPONI

against the benefits it is expected to

have for you.

If you have any concerns about

using this medicine, ask your

doctor, nurse or pharmacist.

Keep this leaflet.

You may need to read it again.

What SIMPONI is used

for

SIMPONI contains the active

ingredient golimumab. Golimumab is

a human monoclonal antibody that is

produced by recombinant

technology. Monoclonal antibodies

are proteins that recognise and bind

to other specific proteins in the body.

Golimumab acts by binding to a

specific protein in the body called

tumour necrosis factor (TNF) alpha.

In people with diseases such as

rheumatoid arthritis, psoriatic

arthritis and ankylosing spondylitis,

the body produces too much TNF,

which can cause the body's immune

system to attack normal healthy parts

of the body. SIMPONI can block the

damage caused by too much TNF.

SIMPONI is used to treat:

rheumatoid arthritis

psoriatic arthritis

ankylosing spondylitis and non-

radiographic axial

spondyloarthritis

ulcerative colitis.

Rheumatoid arthritis

Rheumatoid arthritis is an

inflammatory disease of the joints.

SIMPONI is used in patients who

have not responded well enough to

previous treatments with other

disease-modifying medicines.

SIMPONI is used with a disease-

modifying medicine called

methotrexate.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory

disease of the joints in which

psoriasis usually occurs in

association with arthritis. Often the

fingers and toes are affected,

although it may occur in other parts

of the body.

SIMPONI is used in patients who

have not responded well enough to

previous treatments with other

disease-modifying medicines.

SIMPONI can be used with or

without a disease-modifying

medicine called methotrexate.

Ankylosing Spondylitis and non-

radiographic axial

spondyloarthritis

Ankylosing spondylitis and non-

radiographic axial spondyloarthritis

are inflammatory diseases of the

spine.

SIMPONI should be used in patient

who have not responded well, or

cannot use, non-steroidal anti-

inflammatory drugs

Ulcerative Colitis

Ulcerative colitis is an inflammatory

disease of the bowel.

SIMPONI is used in patients who

have not responded well enough to

other treatments.

Ask your doctor if you have any

questions about why SIMPONI has

been prescribed for you.

Your doctor may have prescribed

SIMPONI for another reason.

Before you use

SIMPONI

When you must not use it

Do not use SIMPONI if:

1.

You have an allergy to

SIMPONI or to any of the

ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction

may include wheezing, shortness

of breath, difficulty breathing, or

a tight feeling in your chest,

swelling of the face, lips, tongue

or other parts of the body, rash,

itching, hives or flushed red skin,

dizziness or light-headedness.

2.

You have a severe infection

including tuberculosis, infection

of the bloodstream, and other

infections that can occur when

the body's natural defences are

lowered.

SIMPONI can affect your body's

ability to fight a serious infection.

SIMPONI

(160902) ACMI

If you are not sure whether you

have a serious infection, check

with your doctor.

3.

You are already taking another

medicine for arthritis, which

contains either of the

substances called anakinra

(Kineret) or abatacept

(Orencia).

4.

You have moderate to severe

heart failure.

5.

The packaging is torn or show

signs of tampering.

6.

The expiry date on the pack has

passed.

Do not use SIMPONI in children.

There is not enough information at

present to recommend use of

SIMPONI in children.

Before you start to use it

Tell your doctor if:

1.

You have an allergy to:

latex, as the needle cover on the

pre-filled syringe and the injector

pen contains dry natural rubber

any other medicines or substances

2.

You are pregnant or plan to

become pregnant

The effects of SIMPONI in

pregnant women are not known.

Therefore, the use of this

medicine in pregnant women is

not recommended.

Use appropriate contraception

to avoid becoming pregnant

while using SIMPONI and for

at least 6 months after the last

dose.

3.

You are breastfeeding or plan

to breastfeed.

It is not known whether

SIMPONI passes into breast milk.

If you are breastfeeding, your

doctor may advise you to stop

breastfeeding while you are using

this medicine, and for at least six

months after the last dose.

4.

You currently have or

previously had any other

medical conditions, especially

the following:

congestive heart failure

conditions affecting the nervous

system, such as multiple sclerosis

or Guillain-Barre syndrome, or if

you experience any numbness,

weakness, tingling, or sight

disturbances

tuberculosis, or have been in

contact with someone who has

had this condition.

You should tell your doctor, even

if you have been treated for it.

infections, or if you are prone to

infections, or if you have a

history of infections.

SIMPONI may affect your body's

immunity. You might get

infections more easily. Some

cases of serious infections,

including tuberculosis, invasive

fungal infections and sepsis have

been reported in patients treated

with SIMPONI.

hepatitis B, or have been in

contact with someone who has

this condition.

Reactivation of hepatitis B has

been reported in people treated

with TNF blockers. However,

these reports are very rare.

cancer

A type of blood cancer called

lymphoma has been reported in

patients receiving TNF blockers.

The reports are rare but are more

frequent than expected for people

in general. Cancers, other than

lymphoma, have also been

reported.

blood disorders, or a history of

blood disorders.

5.

You have lived in or travelled

to an area where fungal

infections called histoplasmosis,

coccidioidomycosis, or

blastomycosis are common.

These infections are caused by a

fungus that can affect the lungs or

other parts of your body.

Ask your doctor if you don't

know whether these infections

are common in the area in

which you have lived in or

travelled to.

6.

You are scheduled to receive

any vaccines

Patients receiving SIMPONI

should not receive some type of

vaccines.

7.

You have ever received other

TNF alpha antagonist

treatments such as infliximab

(REMICADE) or adalimumab

(HUMIRA).

If you have not told your doctor

about any of the above, tell them

before you start using SIMPONI.

Your doctor will discuss with you the

benefits of using it against the

potential risks.

Taking or being given other

medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a

prescription from your pharmacy,

supermarket or health food shop.

Tell your doctor or pharmacist if

you are taking a medicine

containing the substance anakinra

(Kineret), abatacept (Orencia) or

rituximab (Mabthera).

Using SIMPONI together with any of

these medicines may increase the risk

of infection.

Tell your doctor if you are

scheduled to receive any vaccines.

Patient receiving SIMPONI should

not receive some type of vaccines.

Tell your doctor if you are

receiving other treatments

for rheumatoid arthritis

for psoriatic arthritis

for ankylosing spondylitis

for ulcerative colitis

Your doctor or pharmacist has more

information on medicines to be

careful with or to avoid while using

SIMPONI.

SIMPONI

(160902) ACMI

How to use SIMPONI

SIMPONI is only available on

prescription.

Follow all directions given to you

by your doctor and pharmacist

carefully.

They may differ from the

information contained in this leaflet.

How much to use

For Rheumatoid Arthritis,

Psoriatic Arthritis or Ankylosing

Spondylitis and non-radiographic

axial spondyloarthritis:

The recommended dose is 50 mg

given as a single injection under

the skin (subcutaneous use).

For non-radiographic axial

spondyloarthritis (nr-AxSpA):

If you are being treated for non-

radiographic axial

spondyloarthritis and SIMPONI

has no effect on your condition

within 12 - 14 weeks, your doctor

may tell you to stop using this

medicine.

For Ulcerative Colitis:

The recommended dose is given

by injection under the skin

(subcutaneous use).

The starting dose is 200 mg,

followed by a dose of 100 mg 2

weeks later.

People who respond to the initial

2 doses of SIMPONI may be

continued on maintenance

treatment if needed.

The maintenance dose is 100mg

every 4 weeks.

Inject all the solution in the syringe

or injector pen.

This ensures that the correct dose is

administered.

When to use it

SIMPONI should be injected once a

month, on the same date each month.

SIMPONI can be used with or

without food or drink.

How to use it

At the start of your therapy, your

doctor or nurse may inject SIMPONI

for you. However, you and your

doctor can decide that you may inject

SIMPONI yourself. If this is the case,

you will receive training on how to

inject SIMPONI yourself.

If you are injecting SIMPONI

yourself, follow closely the

instructions provided in the

instruction leaflet inside your pack.

Ask your doctor or nurse if you

have any questions about

SIMPONI or about giving yourself

an injection.

Nurse support is available by

calling the SIMPONI patient

helpline (Ph: 1800 666 845).

How long to use it

Continue injecting SIMPONI for

as long as your doctor has told you

to.

Do not stop using SIMPONI

because you are feeling better,

unless your doctor tells you to.

Your condition may flare up if you

stop using SIMPONI.

If you forget to use it

If you forget to use SIMPONI on

your scheduled date, inject a dose

as soon as you remember.

Inject your next dose at your next

regularly scheduled date.

This will put you back on your

schedule.

Do not use a double dose to make

up for the dose that you missed.

If you are not sure what to do, ask

your pharmacist, support nurse or

doctor.

If you use too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(Australia - Ph: 13 11 26; New

Zealand - Ph: 0800 POISON or

0800 764 766), or go to Accident

and Emergency at your nearest

hospital, if you think that you or

anyone else may have used too

much SIMPONI.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

Always have the outer carton of

the medicine with you, even if it is

empty.

While you are using

SIMPONI

Things you must do

Tell any other doctors, dentists and

pharmacists who are treating you

that you are using SIMPONI.

Tell your doctor, nurse or

pharmacist if the medicine starts to

upset you or your symptoms

become worse.

Tell your doctor immediately if:

symptoms of hepatitis B (upset

stomach, loss of appetite,

vomiting, tiredness, dark yellow

or brown urine, and yellow eyes

or skin) appear

symptoms of TB (persistent

cough, weight loss, listlessness,

fever), or any other infection

appear

you have symptoms such as

persistent fever, sore throat,

bruising, bleeding or paleness.

These symptoms may be due to

the development of a blood

disorder, which may need close

monitoring by your doctor.

if you develop a skin rash or

hives.

If you suffer from congestive heart

failure, tell your doctor

immediately if your condition

worsens.

If you are planning to have

surgery, tell your doctor or

surgeon you are using SIMPONI.

SIMPONI

(160902) ACMI

Use appropriate contraception to

avoid becoming pregnant while

using SIMPONI and for at least 6

months after the last dose.

Tell your doctor if you did receive

SIMPONI while you were

pregnant as your baby may be at

higher risk for getting an infection.

It is important to tell your baby's

doctor and other health care

professionals about your

SIMPONI use before the baby

receives any vaccines as certain

vaccines may put your baby at

higher risk for infection.

Your doctor will also advise you

not to breastfeed.

Keep all of your doctor's

appointments so that your progress

can be checked.

Things you must not do

Do not shake the solution of

SIMPONI.

Do not give SIMPONI to anyone

else even if they have the same

condition as you.

Do not stop using SIMPONI, or

lower the dose, unless your doctor

tells you to.

Things to be careful of

Be careful driving or operating

machinery until you know how

SIMPONI affects you.

SIMPONI should not affect your

ability to drive or use machines.

However, make sure you know how

you react to it before you do anything

that could be dangerous if you feel

dizzy.

Side effects

All medicines may have some

unwanted side effects. Sometimes

they are serious, but most of the time

they are not. Your doctor has

weighed the risks of using this

medicine against the benefits they

expect it will have for you.

Do not be alarmed by the following

list of possible side effects.

You may not get any of them.

Ask your doctor, support nurse or

pharmacist any questions you may

have.

Stop taking SIMPONI and tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital if you have any

signs of an allergic reaction such

as:

wheezing, shortness of breath,

difficulty breathing, or a tight

feeling in your chest

swelling of the face, lips, tongue

or other parts of the body

rash, itching, hives or flushed red

skin

dizziness or light-headedness.

Tell your doctor immediately if

you notice any of the following:

1.

Signs of infection such as:

fever, flu-like symptoms, chills or

night sweats

tiredness, persistent cough or

shortness of breath

weight loss

diarrhoea

wounds not healing, are swollen,

red or have pus

dental problems

burning on urination or a

reduction in the amount of urine

that is passed.

2.

Signs of a kidney infection such

as:

back pain, side pain or severe

abdominal pain

fever or chills

tiredness

need to pass urine more

frequently or pain when urinating

changes in the colour or smell of

urine.

3.

Signs of liver problems such as:

yellowing of the skin and eyes

dark coloured urine or pale stools

stomach pains or severe pain in

the abdomen

tiredness or fever

feeling sick or being sick.

4.

Signs of new or worsening heart

failure such as:

shortness of breath

swelling of your feet.

5.

Signs of blood disorders such

as:

persistent fever

sore throat

bruising or bleeding

paleness.

Tell your doctor if you notice

problems at the injection site such

as:

swelling, pain or bruising

itching or redness

Tell your doctor if you notice any

of the following:

headache

dizziness

numbness or tingling

difficulty sleeping

depression

constipation or indigestion

hair loss

symptoms of upper respiratory

tract infections such as runny

nose, blocked sinus or sore throat

lower respiratory tract infections

such as bronchitis or pneumonia

chest discomfort

flu, cold sores or fever

hoarseness

infection of the skin or soft tissue

high blood pressure

pain or swelling of the joints

pain or swelling of the elbow or

shoulder

feeling weak.

This is not a complete list of all

possible side effects. Other may

occur in some people and there

SIMPONI

(160902) ACMI

may be some side effects not yet

known.

Tell your doctor if you do not feel

well or if you notice any other

effects, even if they are not on this

list.

In clinical studies, certain kinds of

cancers, such as cancers that affect

the lymph system (lymphomas),

occurred more frequently in patients

who received medicines that block

TNF, including SIMPONI, than

patients who did not receive these

treatments.

Cancers, other than lymphoma, have

also been reported. There have also

been cases of cancers, including

unusual types, in children and

teenage patients taking medicines

that block TNF.

For children and adults taking TNF

blockers, the chances of getting

lymphoma or others cancers may

increase.

Talk to your doctor if you are

concerned about this.

Skin cancers (including melanoma )

have been reported rarely in patients

treated with TNF-blockers, including

SIMPONI.

Tell your doctor if you notice any

new skin lesions during or after

therapy or if existing lesions

change appearance.

Some side effects may develop even

after you stop taking SIMPONI.

Talk to your doctor, support nurse

or pharmacist if you notice

anything unusual even after you

stop using SIMPONI.

How to store SIMPONI

Storage

Keep SIMPONI in the outer carton

until it is time to use it.

This helps protect it from light.

Keep SIMPONI in a refrigerator

where the temperature stays

between 2°C and 8°C. Do not

freeze. Do not shake.

Keep SIMPONI in a refrigerator

in a way children cannot get to it.

After using SIMPONI

Disposal

After injecting SIMPONI, place

the injection device immediately

into a sharps container. Do not put

the used injection device into your

normal household or recycling

waste.

If your doctor tells you to stop

taking SIMPONI or it has passed

its expiry date, ask your

pharmacist what to do with any

that is left over.

Product description

What it looks like

SIMPONI is a clear to slightly

opalescent, colourless to light yellow

solution which may contain a few

small translucent or white particles.

Do not use SIMPONI if the

solution is discoloured, cloudy, or

you can see foreign particles in it.

SIMPONI is available in the

following presentations for

subcutaneous injection:

SIMPONI pre-filled syringe: a

single-use pre-filled syringe in a

carton pack.

SIMPONI SmartJect injector pen:

a single-use injector pen in a

carton pack. A pre-filled syringe

is contained in this single-use

injector pen.

SIMPONI pre-filled syringes and

pre-filled injector pens are supplied

in containers of 1 unit.

An instruction leaflet explaining how

to self-administer the product is

included in the pack.

Ingredients

Active ingredient:

golimumab (rmc) 50 mg or 100

Inactive ingredients:

sorbitol

histidine

histidine hydrochloride

monohydrate

polysorbate 80

water for injections

Supplier/Manufacturer

JANSSEN-CILAG Pty Ltd

1-5 Khartoum Road

Macquarie Park NSW 2113 Australia

Telephone: 1800 226 334

NZ Office: Auckland New Zealand

Telephone: 0800 800 806

Australian Registration

Number

Pre-filled syringe 50mg: AUST R

153767

SmartJect Injector pen 50mg: AUST

R 153181

Pre-filled syringe 100mg: AUST R

208278

SmartJect Injector pen 100mg:

AUST R 208279

Date of Preparation

13 September 2017

Nurse and educational

support

The SIMPONI patient support

program is available to patients

prescribed Simponi and offers;

home visits from a qualified

Simponi nurse to provide self

injection education

injection SMS reminders

SIMPONI

(160902) ACMI

educational resources

Call 1800-MONTHLY

(1800 666 845)

4-7-2018

Simponi (Janssen Biologics B.V.)

Simponi (Janssen Biologics B.V.)

Simponi (Active substance: golimumab) - Centralised - 2-Monthly update - Commission Decision (2018) 4350 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/992/II/79

Europe -DG Health and Food Safety