Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using REMICADE?
REMICADE contains the active ingredient infliximab. REMICADE is used to reduce the
signs and symptoms of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis,
ulcerative colitis, psoriasis and Crohn's disease.
For more information, see Section
1. Why am I using REMICADE? in the full CMI.
2. What should I know before I use REMICADE?
Do not use if you have ever had an allergic reaction to infliximab, to other murine
(mouse) proteins or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions (including, but not limited
to infections or heart failure), take any other medicines, or are pregnant or plan
to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I use REMICADE? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with REMICADE and affect how it works, or cannot be taken
simultaneously. Discuss with your doctor if any of the other medications you take
impact your treatment with REMICADE. Also tell your doctor if you have had any recent
vaccinations or are planning to be vaccinated.
A list of these medicines is in Section
3. What if I am taking other medicines? in the full CMI.
4. How REMICADE is given?
REMICADE is given in a drip into a vein (called an infusion) over at least 2 hours.
If you were able to tolerate the first 3 two-hour infusions, your doctor may decide
to give your next REMICADE infusions over a period of not less than 1 hour.
For children and adolescents (6-17 years) the infusion is given over at least 2 hours.
A period of observation follows treatment.
5. What should I know while using REMICADE?
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Things you should do
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Remind any doctor, nurse, dentist or pharmacist you visit that you are using REMICADE
before you undergo any surgical procedures or receive any vaccinations.
Tell your doctor, nurse or pharmacist if you do not feel well, the medicine starts
to upset you or your symptoms become worse.
Tell your doctor immediately if symptoms of tuberculosis, hepatitis B or any other
infection appears.
Tell your doctor if you are receiving therapeutic infectious agents for the treatment
of cancer. Continue to take adequate contraceptive measures to avoid falling pregnant.
Tell your doctor if you are planning to become pregnant.
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Things you should be careful of
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Tell your doctor if you think you have an infection.
Tell your doctor immediately if you develop a skin rash or hives.
If you suffer from congestive heart failure, tell your doctor immediately if your
condition worsens.
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Driving or using machines
|
REMICADE is unlikely to make you drowsy. If you are tired, do not drive a car or work
with machinery.
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6. Are there any side effects?
REMICADE may cause side effects, including but not limited to propensity to viral
infections, fever, headache, dizziness, flushing, bronchitis, pneumonia, difficulty
to breathe, sinusitis, nausea, diarrhoea, abdominal pain, rash, urticaria, increased
sweating, dry skin, fatigue, chest pain and infusion-related reactions.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
Infliximab
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using REMICADE. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using REMICADE.
Where to find information in this leaflet:
1. Why am I using REMICADE?
REMICADE contains the active ingredient infliximab. Infliximab is a monoclonal antibody (proteins that recognize and bind to other proteins)
that is produced from human and mouse proteins
Infliximab acts by binding to a special protein in the body called tumour necrosis
factor alpha (TNFα). In people with diseases such as, Crohn's disease, ulcerative
colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis,
the body produces too much TNFα, which can cause the body's immune system to attack
healthy tissue and result in inflammation. Blocking TNFα with REMICADE can reduce
inflammation, but can also reduce your immune system's ability to fight off infections.
REMICADE is used to:
Reduce the signs and symptoms of rheumatoid arthritis (an inflammatory disease of
the joints) and to prevent damage to the joints and improve your physical function.
REMICADE will also be given with a disease-modifying medicine called methotrexate.
Reduce the signs and symptoms of ankylosing spondylitis (an inflammatory disease of
the spine) improve the physical function and the quality of life if you have not responded
to other medicines.
Reduce the signs and symptoms of psoriatic arthritis (an inflammatory disease of the
joints usually accompanied by psoriasis) including reduction of pain and swelling
in and around your joints and improve the physical function and quality of life if
you have not responded to other medications.
Reduce the signs and symptoms and improve the quality of life in patients with moderate
to severe plaque psoriasis (an inflammatory disease of the skin) who have not responded
well enough to treatments such as phototherapy or conventional systemic treatments,
or when these treatments are not appropriate.
Treat active moderate to severe Crohn's disease (a chronic inflammatory disease of
the bowel) in adult patients and in children and adolescent patients (6 to 17 years
old) who have not responded well enough to other treatments. REMICADE will reduce
the symptoms and improves the quality of life. It can also reduce the number of draining
fistulas, a common complication of Crohn's disease.
Treat moderate to severe active ulcerative colitis (an inflammatory disease of the
bowel) in adult patients and in children and adolescent patients (6 to 17 years old)
who have not responded well enough to other treatments.
Your doctor, however, may have prescribed REMICADE for another purpose.
Children and adolescents
Do not give REMICADE to children with Crohn's disease or ulcerative colitis who are
younger than 6 years.
Do not give REMICADE to children and adolescents with any other disease.
2. What should I know before I use REMICADE?
Warnings
Do not use REMICADE if:
you have an allergy to murine (mouse) proteins or any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic reaction to REMICADE may include skin rash, hives,
fatigue, wheezing, difficulty in breathing, and/or low blood pressure.
you have an infection that you are being treated for. If you have or think you may
have an infection, ask your doctor if it is the kind of infection that could put you
at risk for serious side effects from REMICADE.
you are already taking another medicine for arthritis, which contains the substance
called anakinra.
you have congestive heart failure.
you may not be a candidate for treatment with REMICADE. Your doctor will decide if
you should receive REMICADE.
Check with your doctor if you:
have an infection that won’t go away or a history of infection that keeps coming back.
have had tuberculosis (TB), or if you have recently been with anyone who might have
TB. Your doctor will evaluate you for TB and perform a skin test. If your doctor feels
that you are at risk for TB, he or she may start treating you for TB before you begin
REMICADE therapy.
have ever had or had been in close contact with hepatitis B
Reactivation of hepatitis B have been reported in people treated with TNF blockers.
However, these reports are very rare.
have lived in or travelled to an area where fungal infections called histoplasmosis,
coccidioidomycosis, or blastomycosis are common.
Ask your doctor if you don't know if these infections are common in the area in which
you have lived in or travelled to.
These infections are caused by fungus that can affect the lungs or other parts of
your body.
have had 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.
have moderate to severe chronic obstructive pulmonary disease (COPD)
Lung, head, neck and other cancers have been reported in patients with a history of
heavy smoking.
have a long history of Crohn's disease rheumatoid arthritis, ankylosing spondylitis
or psoriatic arthritis, especially if you have a highly active disease and/or have
been taking medicine that reduces the activity of the body's natural defences.
You may be more likely to develop infections and lymphomas than people in general,
even without receiving TNF-blockers such as REMICADE.
have or have had a disease that affects the nervous system such as multiple sclerosis
and seizures, or if you experience any numbness, weakness, tingling, or sight disturbances.
suffer from congestive heart failure.
Steps must be taken to monitor any changes to your condition during treatment with
REMICADE.
have ongoing blood disorders or a history of blood disorders.
have recently received or are scheduled to receive any vaccines
Patients receiving REMICADE should not receive live vaccines. If possible, you should
have all of your vaccines brought up to date before starting treatment with REMICADE.
have recently received or are scheduled to receive treatment with a therapeutic infectious
agent (such as BCG instillation used for the treatment of cancer).
have any surgery planned
Your doctor may delay treatment with REMICADE
Your doctor will discuss with you the benefits of using REMICADE against the potential
risks.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you:
• are pregnant or intend to become pregnant.
Treatment with REMICADE is not recommended while you are pregnant.
You must use adequate contraception to avoid falling pregnant during REMICADE treatment
and for at least 6 months after the last infusion.
• are breast-feeding
REMICADE passes into breastmilk. Talk to your doctor about the best way to feed your
baby.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may affect the way other medicines work.
Do not use REMICADE if you are already taking another medicine for arthritis, which
contains the substance anakinra.
Tell your doctor if you are already taking another medicine for arthritis which contains
the substance abatacept.
Tell your doctor if you are receiving other treatments:
for rheumatoid arthritis
for ankylosing spondylitis
for psoriatic arthritis
for psoriasis, such as phototherapy or other treatments
for Crohn’s disease
for ulcerative colitis
to prevent rejection in organ transplantation.
Tell your doctor you are taking REMICADE before receiving any vaccinations.
While using REMICADE you should not receive live vaccines. If possible, you should
have all of your vaccines brought up to date before starting treatment with REMICADE.
If you have a baby or if you are breast-feeding while you are using REMICADE, tell
your baby’s doctor about your REMICADE use before the baby receives any vaccines,
including live vaccines such as the BCG vaccine (used to prevent tuberculosis) and
rotavirus vaccine. Live vaccines should not be given to your baby while you are breast-feeding
unless your baby doctor recommends otherwise.
Your doctor or pharmacist will be able to tell you what to do when being given REMICADE
with other medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect REMICADE.
4. How REMICADE is given?
How much is given
REMICADE is only available on prescription and given in a drip into a vein (called
an infusion) over at least 2 hours.
If you were able to tolerate the first 3 two-hour infusions, your doctor may decide
to give your next REMICADE infusion over a period of not less than 1 hour.
For children and adolescents (6-17 years) the infusion is given over at least 2 hours.
A period of observation follows treatment.
Your doctor may delay treatment with REMICADE if you have any surgery planned.
Rheumatoid arthritis
The recommended starting dose is an infusion of 3 mg/kg. You will get additional doses
of 3 mg/kg at 2 and 6 weeks after your first infusion and then every 8 weeks after
that.
If, after 12 weeks of treatment, your arthritis does not respond well enough to the
3 mg/kg dose, your doctor may decide to gradually increase your dose to a maximum
of 7.5 mg/kg every 8 weeks.
You will also be taking methotrexate as part of your treatment.
Ankylosing Spondylitis
The recommended starting dose is an infusion of 5 mg/kg. You will get additional doses
of 5 mg/kg at 2 and 6 weeks after your first infusion and then every 6 weeks after
that.
Psoriatic arthritis
The recommended starting dose is an infusion of 5 mg/kg. You will receive additional
doses of 5 mg/kg at 2 and 6 weeks after your first infusion and then every 8 weeks
after that.
REMICADE may be given alone or in combination with methotrexate.
Psoriasis
The recommended starting dose is an infusion of 5 mg/kg. You will get additional doses
of 5 mg/kg at 2 and 6 weeks after your first infusion, and then every 8 weeks after
that.
Crohn’s disease
The recommended starting dose for Crohn's disease in adults and in children and adolescents
(6 to 17 years); and for closure of fistula in adult patients is an initial infusion
of 5 mg/kg followed by additional doses of 5 mg/kg at 2 and 6 weeks after your first
infusion, and then every 8 weeks after that. In some cases, your doctor may decide
to increase your dose up to 10 mg/kg.
Ulcerative colitis
The recommended starting dose for ulcerative colitis in adults and in children and
adolescents (6 to 17 years) is an infusion of 5 mg/kg. You will get additional doses
of 5 mg/kg at 2 and 6 weeks after your first infusion, and then every 8 weeks after
that. Your doctor will monitor your response to REMICADE and may adjust your dose.
If you miss a dose
As REMICADE is given under the supervision of your doctor, you are unlikely to miss
a dose. However, if you forget or miss your appointment to receive REMICADE, make
another appointment as soon as possible.
Your doctor will decide when and how much your next dose of REMICADE will be.
If you are given too much REMICADE
As REMICADE is given to you under the supervision of your doctor it is very unlikely
you will receive too much. If you think you or anybody else has been given too much REMICADE, you may need urgent
medical attention.
You should immediately:
phone the Poisons Information Centre (in Australia telephone 13 11 26. In New Zealand telephone 0800 POISON or 0800 764 766), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using REMICADE?
Things you should do
Tell your doctor, nurse or pharmacist if the medicine starts to upset you or your
symptoms become worse.
Tell your doctor, nurse or dentist that you are being treated with REMICADE before
you undergo any surgical procedures.
Tell your doctor or nurse:
if symptoms of TB (persistent cough, weight loss, listlessness, fever), or any other
infection appear.
Do this immediately.
if symptoms of hepatitis B (upset stomach, loss of appetite, vomiting, tiredness,
dark yellow or brown urine, and yellow eyes or skin) appear.
You must do this immediately.
that you are taking REMICADE before receiving any vaccinations.
Live vaccines should not be given while you are being treated with REMICADE.
if you are receiving therapeutic infectious agents for the treatment of cancer.
Patients receiving REMICADE should not receive some medicines, such as live attenuated
bacteria used for the treatment of cancer.
You should continue to take adequate contraceptive measures to avoid pregnancy.
If you have a baby or if you are breast-feeding while you are using REMICADE, tell
your baby's doctor about your REMICADE use before the baby receives any vaccines,
including live vaccines. Live vaccines should not be given to your baby while you
are breast-feeding unless your baby doctor recommends otherwise.
Severely decreased numbers of white blood cells have also been reported in infants
born to women treated with REMICADE during pregnancy. If your baby has continual fevers
or infections, contact your baby’s doctor immediately.
Things you should be careful of
Tell your doctor if you think you have an infection. REMICADE may affect the normal
immune response.
There is a possibility that you may be more prone to infections. You will be watched
closely for signs of infection.
Tell your doctor immediately if you develop a skin rash or hives.
Your doctor may discontinue REMICADE until the symptoms go away and then begin giving
the medicine again. Symptoms will resolve with appropriate treatment.
If you suffer from congestive heart failure, tell your doctor immediately if your
condition worsens.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how REMICADE
affects you.
REMICADE is unlikely to make you drowsy. If you are tired, do not drive a car or work
with machinery.
6. Are there any side effects?
Tell your doctor, nurse, or pharmacist as soon as possible if you do not feel well
while you are being given REMICADE.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
Generally, patients with rheumatoid arthritis, Crohn's disease, ankylosing spondylitis,
psoriatic arthritis, or psoriasis already take several medicines to treat their disease.
These medicines may themselves cause side effects.
If you get additional side effects or any new symptoms, please tell your doctor.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Do not be alarmed by the following list of possible side effects. You may not experience
any of them.
During the infusion of REMICADE the following reactions may occur:
fever or chills
itchiness or hives
chest pain
low blood pressure
high blood pressure
shortness of breath.
These reactions are more likely to occur during the first and second infusion but
may also appear up to six months after the last infusion.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Most of the side effects are mild to moderate in severity. Other side effects not
listed here may occur in some people. Some side effects may appear up to six months
after the last infusion.
Cancers
In clinical studies, more cancers were seen in patients who received TNF-blockers,
including REMICADE, than patients who did not receive these treatments.
In children and adults being treated with TNF-blockers, the chances of getting lymphoma
or other cancers may increase. It should be noted, however, that patients with longstanding
and active rheumatoid arthritis or Crohn's disease may already have a higher risk
for developing cancers even without TNF-blockers, making it difficult to estimate
the risk of developing cancers in these patients. Nevertheless, the role of TNF-blockers
in the development of cancers cannot be excluded.
A rare type of cancer called Hepatosplenic T-cell Lymphoma (HSTCL) has been reported
rarely in adolescents and young adults with Crohn's disease or ulcerative colitis
who have received REMICADE. All of these patients were also receiving drugs known
as azathioprine or 6-mercaptopurine.
No cases of HSTCL have been reported in patients receiving REMICADE only. HSTCL often
results in death. The role of TNF blockers in the development of cancers in children
and adolescents remain unclear.
Talk to your doctor if you are concerned about this.
Skin cancers (T cell lymphoma, mycosis fungoides, melanoma and Merkel cell carcinoma)
have been reported rarely in patients treated with TNF-blockers, including REMICADE.
Tell your doctor if you notice any new skin lesions during or after therapy or if
existing lesions change appearance.
Cervical cancer may occur more frequently in women treated with REMICADE. Periodic
screening of women treated with REMICADE should continue.
Patients with a lung disease called Chronic Obstructive Pulmonary Disease and who
have a history of heavy smoking may have an increased risk for getting cancer while
being treated with REMICADE.
After REMICADE has been stopped
Tell your doctor immediately if:
you notice any of the following side effects, even if they occur several weeks after
stopping treatment with REMICADE.
− skin rash or hives
− frequent infections
symptoms of TB (persistent cough, weight loss, listlessness, fever), or any other
infection appear.
symptoms of hepatitis B (upset stomach, loss of appetite, vomiting, tiredness, dark
yellow or brown urine, and yellow eyes or skin) appear.
• symptoms of a stroke appear which may include numbness or weakness of the face,
arm or leg, especially on one side of the body; sudden confusion, trouble speaking
or understanding; sudden trouble seeing in one or both eyes, sudden trouble walking,
dizziness, loss of balance or coordination or a sudden, severe headache.
These symptoms may appear several months after your last REMICADE treatment.
You should continue to take adequate contraceptive measures to avoid pregnancy for
at least 6 months after the last infusion of REMICADE.
Tell your doctor if you notice any other effects.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What REMICADE contains
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Active ingredient (main ingredient)
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Infliximab (recombinant) 100 mg per vial
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Other ingredients
(inactive ingredients)
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monobasic sodium phosphate monohydrate
dibasic sodium phosphate dihydrate
sucrose
polysorbate 80
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Do not take this medicine if you are allergic to any of these ingredients.
What REMICADE looks like
REMICADE comes as a white powder in a glass vial
(AUST R 73827).
Storage
REMICADE should be stored at 2°C to 8°C (Refrigerate.)
Do not use beyond the expiry date.
REMICADE may be stored at temperatures up to a maximum of 30°C for a single period
of up to 12 months; but not exceeding the original expiration date. The new expiration
date should be written on the carton.
Upon removal from refrigerated storage, REMICADE cannot be returned to refrigerated
storage.
REMICADE vials are for single use only. Any unused portion should be discarded.
Who distributes REMICADE?
JANSSEN-CILAG Pty Ltd
1-5 Khartoum Rd
Macquarie Park NSW 2113 Australia
Telephone: 1800 226 334
NZ Office: Auckland New Zealand
Telephone: 0800 800 806
This leaflet was prepared in May 2025.