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 INFLECTRA?
INFLECTRA contains the active ingredient infliximab. INFLECTRA is used to reduce the
signs and symptoms of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis
and ulcerative colitis. INFLECTRA is also used to treat moderate to severe psoriasis
and Crohn's disease.
2. What should I know before I use INFLECTRA?
Do not use if you have ever had an allergic reaction to 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, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with INFLECTRA and affect how it works.
4. How do I use INFLECTRA?
INFLECTRA 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 INFLECTRA 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.
5. What should I know while using INFLECTRA?
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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 INFLECTRA
before you undergo any surgical procedures or receive any vaccinations.
Tell your doctor, nurse or pharmacist if the medicine starts to upset you or your
symptoms become worse.
Tell your doctor 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 pregnancy.
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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
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INFLECTRA 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?
INFLECTRA 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.
Active ingredient:
Infliximab
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using INFLECTRA. 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 INFLECTRA.
Where to find information in this leaflet:
1. Why am I using INFLECTRA?
INFLECTRA contains the active ingredient infliximab.
INFLECTRA is an approved biosimilar medicine. Comparability in safety, efficacy and
quality between INFLECTRA and the reference product has been established.
Infliximab is a monoclonal antibody that is produced from human and mouse proteins
by recombinant technology. Monoclonal antibodies are proteins that recognise and bind
to certain special proteins in the body.
Infliximab acts by binding to a special protein in the body called tumour necrosis
factor alpha (TNFα).
In people with diseases such as, rheumatoid arthritis, ankylosing spondylitis, psoriatic
arthritis and psoriasis, the body produces too much TNFα, which can cause the body's
immune system to attack normal healthy parts of the body.
INFLECTRA can block the damage caused by too much TNFα.
Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease of the joints. INFLECTRA is used to
reduce the signs and symptoms of rheumatoid arthritis and to prevent damage to the
joints. You will also be given a disease-modifying medicine called methotrexate.
Ankylosing Spondylitis
Ankylosing spondylitis is an inflammatory disease of the spine. INFLECTRA can reduce
the signs and symptoms of ankylosing spondylitis, thereby improving physical function.
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. INFLECTRA is used to reduce the signs and
symptoms of psoriatic arthritis and improve the physical function in adults who have
not responded well enough to previous treatments with other disease-modifying anti-rheumatic
drugs (DMARDS). INFLECTRA may be given alone or in combination with methotrexate.
Psoriasis
Psoriasis is an inflammatory disease of the skin. INFLECTRA is used to treat patients
with moderate to severe psoriasis who have not responded well enough to treatments
such as phototherapy or conventional systemic treatments, or when these treatments
are not appropriate.
Crohn's disease
Crohn's disease is a chronic inflammatory disease of the bowel. It may also affect
any part of the gut. INFLECTRA is used to treat moderate to severe Crohn's disease
in adult patients and in children and adolescent patients (6 to 17 years old) who
have not responded well enough to other treatments.
INFLECTRA can also reduce the number of abnormal openings from the bowel through the
skin (called draining enterocutaneous fistula), a common complication of Crohn's disease.
Ulcerative Colitis
Ulcerative colitis is an inflammatory disease of the bowel. INFLECTRA is used to treat
the signs and symptoms of ulcerative colitis in adult patients and in children and
adolescent patients (6 to 17 years old) who have not responded well enough to other
treatments.
Do not give INFLECTRA to children with Crohn's disease or ulcerative colitis who are
younger than 6 years.
Do not give INFLECTRA to children and adolescents with any other disease.
Your doctor, however, may prescribe INFLECTRA for another purpose.
Ask your doctor if you have any questions about why INFLECTRA has been prescribed
for you.
2. What should I know before I use INFLECTRA?
Warnings
Do not use INFLECTRA if:
you have an allergy to mouse proteins or any of the ingredients listed at the end
of this leaflet.
Some of the symptoms of an allergic reaction to INFLECTRA may include skin rash, hives,
fatigue, wheezing, difficulty in breathing, and/or low blood pressure.
you have severe infections such as tuberculosis and infected abscesses, a repeating
infection or have had repeating infections.
you are already taking another medicine for arthritis, which contains the substance
called anakinra.
If you have never been given INFLECTRA and have congestive heart failure, you should
not use it.
Check with your doctor if you:
currently have an infection, or if you are prone to infections, or if you have a history
of infections
INFLECTRA may affect the normal immune response. You might get infections more easily.
Some cases of serious infections, including tuberculosis (TB) and sepsis have been
reported in patients treated with INFLECTRA.
have ever had or been in close contact with TB, even if you were treated for it.
have ever had or had been in close contact with hepatitis B
Reactivation of hepatitis B have been reported in people treated with TNFα 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 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 INFLECTRA.
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
INFLECTRA.
have ongoing blood disorders or a history of blood disorders.
are scheduled to receive any vaccines
Patients receiving INFLECTRA should not receive some types of vaccines. If possible,
you should have all of your vaccines brought up to date before starting treatment
with INFLECTRA.
Your doctor will discuss with you the benefits of using INFLECTRA 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 INFLECTRA is not recommended while you are pregnant. INFLECTRA crosses
the placenta and has been detected in the bloodstream of infants for up to 12 months
following birth.
You must use adequate contraception for at least 6 months after receiving the last
INFLECTRA infusion to avoid falling pregnant.
are breast-feeding
INFLECTRA has been detected in breast milk. Your doctor will discuss with you if
the benefit of INFLECTRA treatment for you outweighs the potential risk to your infant
while breast feeding.
3. What if I am taking other medicines?
Tell your doctor 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 INFLECTRA 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 or ulcerative colitis
to prevent rejection in organ transplantation.
Tell your doctor you are taking INFLECTRA before receiving any vaccinations.
Some vaccinations should not be given while you are being treated with INFLECTRA.
Your doctor or pharmacist will be able to tell you what to do when being given INFLECTRA
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 INFLECTRA.
4. How do I use INFLECTRA?
How INFLECTRA is given
INFLECTRA 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 INFLECTRA 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.
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, then every 8 weeks after
that.
INFLECTRA 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.
If you miss a dose
As INFLECTRA 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 INFLECTRA, make
another appointment as soon as possible.
Your doctor will decide when and how much your next dose of INFLECTRA will be.
If you are given too much
As INFLECTRA 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 INFLECTRA, you should immediately:
tell your doctor, or
phone the Poisons Information Centre
(by calling
13 11 26), 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 INFLECTRA?
Things you should do
Tell your doctor or nurse straight away if:
the medicine starts to upset you or your symptoms become worse.
you are being treated with INFLECTRA before you undergo any surgical procedures.
you have symptoms of TB (persistent cough, weight loss, listlessness, fever), or any
other infection appear. Do this immediately.
you have symptoms of hepatitis B (upset stomach, loss of appetite, vomiting, tiredness,
dark yellow or brown urine, and yellow eyes or skin) appear. Do this immediately.
you are taking INFLECTRA before receiving any vaccinations.
Some vaccinations should not be given while you are being treated with INFLECTRA.
If you are receiving therapeutic infectious agents for the treatment of cancer.
Patients receiving INFLECTRA 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.
Your doctor will also advise you not to breastfeed.
If you have a baby while you are using INFLECTRA, tell your doctor about your INFLECTRA
use before your baby receives any vaccinations. A 12-month waiting period is recommended
before administering live vaccines to your baby.
Things you should be careful of
Tell your doctor if you think you have an infection.
INFLECTRA 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 INFLECTRA 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
INFLECTRA 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 INFLECTRA.
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 INFLECTRA 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.
Serious side effects
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Serious side effects
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What to do
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Aches and pains:
pain or tenderness in chest, muscles, joints or jaw
muscle pains
joint pains
Skin related symptoms:
rash
itching
Swelling or numbness:
swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause
difficulty in swallowing or breathing
numbness or paralysis in the face, leg, or arm, most likely on just one side of the
body
blurred or darkened vision
Heart and chest related symptoms:
abnormal chest sounds
symptoms that may indicate heart failure, e.g. shortness of breath, especially with
exercise or lying down, or swelling of your feet.
Other:
fever
tiredness
Liver related symptoms:
There have been very rare cases where people taking INFLECTRA have developed liver
problems. Signs that you could be having a problem include:
jaundice (skin and eyes turning
yellow)
dark-brown coloured urine
right-sided abdominal pain
fever
severe fatigue (tiredness).
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Tell your doctor or nurse immediately or go straight to the Emergency Department at
your nearest hospital if you notice any of these serious side effects.
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Tell your doctor or nurse 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 above may also occur in some patients. 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 INFLECTRA, 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 INFLECTRA. All of these patients were also receiving drugs known
as azathioprine or 6-mercaptopurine. No cases of HSTCL have been reported in patients
receiving INFLECTRA 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 (melanoma, Merkel cell carcinoma, basal cell carcinoma, mycosis fungoides
and squamous cell carcinoma) have been reported rarely in patients treated with TNF-blockers,
including INFLECTRA.
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 INFLECTRA. Periodic
screening of women treated with INFLECTRA 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 INFLECTRA.
After INFLECTRA 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 INFLECTRA.
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.
These symptoms may appear several months after your last INFLECTRA treatment.
You should continue to take adequate contraceptive measures to avoid pregnancy for
at least 6 months after the last infusion of INFLECTRA.
Tell your doctor if you wish to breastfeed your infant after your last INFLECTRA treatment.
Your doctor will discuss the risks and benefits with you.
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 INFLECTRA contains
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Active ingredient
(main ingredient)
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Infliximab [rmc] 100mg 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 use this medicine if you are allergic to any of these ingredients.
What INFLECTRA looks like
INFLECTRA comes as a white powder in a glass vial
(AUST R 217066).
Storage
INFLECTRA should be stored at 2°C to 8°C (Refrigerate. Do not freeze.) Do not use
beyond the expiry date.
INFLECTRA vials are for single use only. Any unused portion should be discarded.
Who distributes INFLECTRA
INFLECTRA is supplied in Australia by:
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free number: 1800 675 229
This leaflet was prepared in April 2024.