Golimumab (rmc)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about SIMPONI/SIMPONI IV. 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/SIMPONI IV is used for
SIMPONI/SIMPONI IV 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/SIMPONI
IV 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.
SIMPONI IV is used to treat:
rheumatoid arthritis
psoriatic arthritis
ankylosing spondylitis.
Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease of the joints.
SIMPONI/SIMPONI IV is used in patients who have not responded well enough to previous
treatments with other disease-modifying medicines.
SIMPONI/SIMPONI IV 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/SIMPONI IV is used in patients who have not responded well enough to previous
treatments with other disease-modifying medicines.
SIMPONI/SIMPONI IV can be used with or without a disease-modifying medicine called
methotrexate.
Ankylosing Spondylitis and non-radiographic axial spondyloarthritis
SIMPONI IV should not be used in patients with 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
SIMPONI IV should not be used in patients with 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/SIMPONI IV
When you must not use it
Do not use SIMPONI/SIMPONI IV if:
1. You have an allergy to SIMPONI/SIMPONI IV 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/SIMPONI IV can affect your body's ability to fight a serious infection.
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/SIMPONI IV in children.
There is not enough information at present to recommend use of SIMPONI/SIMPONI IV
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/SIMPONI IV 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/SIMPONI
IV and for at least 6 months after the last dose.
3. You are breastfeeding or plan to breastfeed.
It is not known whether SIMPONI/SIMPONI IV 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/SIMPONI IV 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/SIMPONI
IV.
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/SIMPONI IV 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/SIMPONI IV.
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/SIMPONI IV 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/SIMPONI IV 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 IV.
How to use SIMPONI/SIMPONI IV
SIMPONI is available on prescription for subcutaneous administration (as a pre-filled
syringe or a SmartJect injector pen).
SIMPONI IV is available on prescription for intravenous use.
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
Subcutaneous 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 Janssen Immunology PSP on 1800 666 845.
Intravenous infusion
SIMPONI IV should be diluted before administration.
SIMPONI IV is given in a drip into a vein (called an infusion) over a period of about
30 min.
How much is given
Rheumatoid Arthritis, Psoriatic Arthritis or Ankylosing
Spondylitis
Your doctor will decide your dose (in mg) based on your weight. The dose is 2 mg for
every kg of body weight. The list below shows how often you will usually have this
medicine.
1st treatment - Initial treatment
2nd treatment - 4 weeks after your 1st treatment
Further treatments - Every 8 weeks
How long to use it
Continue injecting SIMPONI for as long as your doctor has told you to.
Do not stop using SIMPONI/SIMPONI IV because you are feeling better, unless your doctor
tells you to.
Your condition may flare up if you stop using SIMPONI/SIMPONI IV.
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/SIMPONI IV.
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/SIMPONI IV
Things you must do
Tell any other doctors, dentists and pharmacists who are treating you that you are
using SIMPONI/SIMPONI IV.
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
IV.
Use appropriate contraception to avoid becoming pregnant while using SIMPONI/SIMPONI
IV and for at least 6 months after the last dose.
Tell your doctor if you did receive SIMPONI/SIMPONI IV 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/SIMPONI
IV 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/SIMPONI IV affects
you.
SIMPONI/SIMPONI IV 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/SIMPONI IV 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 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/SIMPONI IV, 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/SIMPONI IV.
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/SIMPONI IV.
Talk to your doctor, support nurse or pharmacist if you notice anything unusual even
after you stop using SIMPONI/SIMPONI IV.
How to store SIMPONI/SIMPONI IV
Storage
Keep SIMPONI/SIMPONI IV in the outer carton until it is time to use it.
This helps protect it from light.
Keep SIMPONI/SIMPONI IV 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.
If needed, you may store SIMPONI/SIMPONI IV at room temperature up to 25°C for one
period of time up to 30 days.
Write the date on the carton, on which SIMPONI/SIMPONI IV is removed from the refrigerator.
If SIMPONI/SIMPONI IV has reached room temperature, do not put it back in the refrigerator.
Throw away SIMPONI/SIMPONI IV if it has been kept at room temperature for 30 days
and has not been used.
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:
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 IV vial: a single use vial in a carton pack
SIMPONI pre-filled syringes, pre-filled injector pens and SIMPONI IV vials are supplied
in containers of 1 unit.
For pre-filled syringe and SmartJect autoinjector pen an instruction leaflet explaining
how to self-administer the product is included in the pack.
Ingredients
Active ingredient:
golimumab (rmc) 50 mg or 100 mg
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
Vial 50 mg: AUST R 311990
Date of Preparation
June 2022
Nurse and educational support
The Janssen Immunology Patient Support Program is available to patients prescribed
SIMPONI. It offers:
starter kit
one-to-one nurse support
reminder service
ongoing education
wellbeing support
Call 1800 666 845