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 IXIFI?
IXIFI contains the active ingredient infliximab. It is used in people with diseases
such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis,
psoriatic arthritis and psoriasis.
IXIFI blocks the damage caused by too much TNFα, a chemical produced by the body in
people with certain diseases, causing the body’ immune system to attack normal healthy
parts of the body.
2. What should I know before I use IXIFI?
Do not use if you have ever had an allergic reaction to infliximab, history of allergies
to some 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 IXIFI and affect how it works.
4. How do I use IXIFI?
IXIF is given by a healthcare professional through a needle placed in a vein in your
arm via a drip (called an infusion) over at least 2 hours (may be less based on previous
use).
Your doctor may ask you to take other medicines along with IXIFI.
5. What should I know while using IXIFI?
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Things you should do
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Contact your doctor immediately if you develop new or worsening symptoms.
Tell your doctor or dentist that you are being treated with IXIFI before you undergo
any surgical procedures.
You should continue to take adequate contraceptive measures to avoid pregnancy.
Tell your doctor that you are taking IXIFI before receiving any vaccinations.
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Driving or using machines
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IXIFI is unlikely to make you drowsy. If you are tired, do not drive a car or work
with machinery.
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Looking after your medicine
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IXIFI will be is stored in its original package in the refrigerator at 2° to 8° Celsius
(Refrigerate. Do not Freeze) before use.
Unopened IXIFI can also be stored in the original carton outside of the refrigerator
up to a maximum of 30°C for a single period of up to 6 months; but not beyond the
expiration date.
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6. Are there any side effects?
Fever or chills, itchiness or hives on the skin, upset stomach or diarrhoea, symptoms
of a cold or aches and pains. More serious side effects include severe allergic reactions,
impacts on the liver or nervous system, infections or some cancers. For more information,
including what to do if you have any side effects, see Section
6. Are there any side effects?
Active ingredient(s):
Infliximab)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using IXIFI. 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 IXIFI.
Where to find information in this leaflet:
1. Why am I using IXIFI?
IXIFI contains the active ingredient infliximab.
Infliximab is a monoclonal antibody - a type of protein that recognises and binds
to certain special proteins 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 normal healthy parts of the
body. IXIFI can block the damage caused by too much TNFα.
IXIFI is a biosimilar medicine.
IXIFI is a medicine used in people with the following diseases:
Rheumatoid arthritis: an inflammatory disease of the joints. IXIFI is used to reduce the signs and symptoms
of rheumatoid arthritis and to prevent damage to the joints. You will also be given
with IXIFI a disease-modifying medicine called methotrexate.
Ankylosing Spondylitis: an inflammatory disease of the spine. IXIFI can reduce the signs and symptoms of
ankylosing spondylitis, thereby improving physical function.
Psoriatic arthritis: an inflammatory disease of the joints in which psoriasis (inflammatory disease of
the skin) usually occurs in association with arthritis. Often the fingers and toes
are affected, although it may occur in other parts of the body. IXIFI 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). IXIFI may be given alone in this case, or in combination
with methotrexate.
Psoriasis: an inflammatory disease of the skin. IXIFI is used to treat patients with moderate
to severe psoriasis who have not responded well enough to treatments such as phototherapy
(treatment with ultraviolet light or sunlight along with a medicine to make your skin
sensitive to light) or conventional treatments, or when these treatments are not appropriate.
Crohn’s disease: a chronic inflammatory disease of the bowel. It may also affect any part of the
gut. IXIFI 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. IXIFI 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: an inflammatory disease of the bowel. IXIFI 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.
IXIFI is not to be given to children with Crohn’s disease or ulcerative colitis who
are younger than 6 years.
Use in children and adolescents is reserved only for Crohn’s disease or ulcerative
colitis in those aged 6 to 17 years old, who have not responded well enough to other
treatments.
IXIFI is not to be given to children and adolescents with any other disease.
Your doctor, however, may prescribe IXIFI for another purpose.
Ask your doctor if you have any questions about why IXIFI has been prescribed for
you.
IXIFI is a medicine that affects your immune system.
2. What should I know before I use IXIFI?
Warnings
Do not use IXIFI if:
You are allergic to infliximab, or any of the ingredients listed at the end of this
leaflet, or if you have a history of allergies to mouse proteins (what infliximab
may be made of).
Some of the symptoms of an allergic reaction may include skin rash, hives, fatigue,
wheezing, difficulty in breathing, and/or low blood pressure.
Always check the ingredients to make sure you can use this medicine.
You have a severe infection, such as tuberculosis and infected abscesses (infection
commonly found in the lungs), sepsis (an infection in the bloodstream), a repeating
infection, or you have had repeating infections in the past.
You have heart failure that is moderate or severe.
You are already taking another medicine for arthritis, which contains the substance
called anakinra.
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.
IXIFI may affect the normal immune response. You might get infections more easily.
Some cases of serious infections, including tuberculosis and sepsis have been reported
in patients treated with IXIFI.
Ever had or been in close contact with Tuberculosis, even if you were treated for
it.
Have ever had or had been in close contact with hepatitis B. Reactivation of hepatitis
B has 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 moderate to severe chronic obstructive pulmonary disease (COPD). Lung, head,
neck and other cancers have been reported in patients with COPD 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 defenses. You
may be more likely to develop infections and lymphomas than people in general, even
without receiving TNF blockers such as IXIFI.
Are pregnant or plan to become pregnant. IXIFI is not recommended in pregnancy. Please
see Section 2 - Pregnancy and breastfeeding
Are breast-feeding. IXIFI is not recommended while breastfeeding. Please see Section
2 - Pregnancy and breastfeeding.
Have or have had a disease that affects the nervous system such as multiple sclerosis,
Guillain-Barré syndrome 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 IXIFI.
Have ongoing blood disorders or a history of blood disorders.
Have recently received or are scheduled to receive any vaccines. Patients receiving
IXIFI should not receive ‘live’ vaccines. If possible, you should have all of your
vaccines brought up to date before starting treatment with IXIFI.
have recently received or are scheduled to receive treatment with a therapeutic infectious
agent (such as BCG instillation used for the treatment of cancer).
Take any medicines for any other condition
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.
If you are being treated with IXIFI, you must avoid becoming pregnant by using adequate
contraception during your treatment and for at least 6 months after your last IXIFI
injection.
It is not known if IXIFI can affect your ability to have children in the future.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Breast feeding is not recommended during treatment and for 6 months after the last
dose of IXIFI. Your doctor will help you decide whether or not to use IXIFI.
Severely decreased numbers of white blood cells have also been reported in infants
born to women treated with infliximab for injection during pregnancy. If your baby
has continual fevers or infections, contact your baby’s doctor immediately.
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 interfere with IXIFI and affect how it works.
Tell your doctor if you take a medicine for arthritis containing the ingredient anakinra.
IXIFI should not be taken together with anakinra.
Tell your doctor if you are already taking another medicine for arthritis, which contains
the substance called abatacept.
Tell your doctor about all medicines that you have recently taken or are taking during
your treatment with IXIFI. These include any other medicines to treat rheumatoid arthritis,
ankylosing spondylitis, psoriatic arthritis, psoriasis (such as phototherapy or other
treatments), Crohn’s disease, ulcerative colitis.
Tell your doctor if you take medicines to prevent rejection in organ transplantation.
Tell your doctor you are taking IXIFI before receiving any vaccinations.
While using IXIFI you should not receive live vaccines. If possible, you should have all of your vaccines brought up to date before starting
treatment with IXIFI.
Live vaccines should not be given to your baby while you are breast-feeding unless
your baby’s doctor recommends otherwise. If you have a baby or if you are breast-feeding while you are using IXIFI, tell your
baby’s doctor about your IXIFI use before the baby receives any vaccines, including
live vaccines such as the BCG vaccine (used to prevent tuberculosis) and rotavirus
vaccine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect IXIFI.
4. How do I use IXIFI?
How IXIFI will be given to you
IXIFI is only available on prescription.
IXIF is given by a healthcare professional through a needle placed in a vein in your
arm via a drip (called an infusion) over at least 2 hours.
When IXIFI will be given to you
If you were able to tolerate the first 3 two-hour infusions, your doctor may decide
to give your next IXIFI infusions over a period of not less than 1 hour.
For children and adolescents (6-17 years) with Crohn’s disease or ulcerative colitis,
the infusion is given over a period of not less than 2 hours.
A period of observation to watch for any reactions to the medicine follows treatment.
How much will be given
Your doctor may ask you to take other medicines along with IXIFI.
Rheumatoid Arthritis:
The recommended dose of IXIFI is 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 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 5mg/kg at 2 and 6 weeks after your first infusion, then every 8 weeks after
that.
IXIFI may be given alone or in combination with methotrexate.
Psoriasis:
The recommended 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.
Crohn’s Disease and Fistulising 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 forget to use IXIFI
If you forget or miss an appointment to receive IXIFI, make another appointment as
soon as possible to find out when to receive your next dose.
If you use too much IXIFI
As IXIFI is being 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 IXIFI, you may need urgent
medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
Australia: 13 11 26, or New Zealand: 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 IXIFI?
Things you should do
Contact your doctor immediately if you develop new or worsening symptoms.
Tell your doctor or dentist that you are being treated with IXIFI before you undergo
any surgical procedures.
You should continue to take adequate contraceptive measures to avoid pregnancy.
Be watchful for signs of immediate allergic reaction such as hives, difficulty breathing,
chest pain or low blood pressure, or delayed allergic reaction (up to 12 days after
injection) such as muscle or joint pain with fever or rash.
Tell your doctor:
That you are taking IXIFI before receiving any vaccinations. Some vaccinations should
not be given while you are being treated with IXIFI.
If you are receiving other medicines for the treatment of cancer. Patients receiving
IXIFI should not receive some medicines used for the treatment of cancer.
If you think you have an infection. IXIFI 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.
If you have had phototherapy for psoriasis.
If you have a baby or if you are breastfeeding while you are using IXIFI 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’s doctor recommends otherwise.
If your baby has continual fevers or infections. Severely decreased numbers of white
blood cells have been reported in infants born to women treated with IXIFI during
pregnancy.
Call your doctor straight away if you:
Develop symptoms of Tuberculosis (persistent cough, weight loss, loss of interest
in doing anything, fever), or any other infection appear. Do this immediately.
Develop symptoms of hepatitis B (upset stomach, loss of appetite, vomiting, tiredness,
dark yellow or brown urine, and yellow eyes or skin). You must do this immediately.
Develop a skin rash or hives. Your doctor may discontinue IXIFI until the symptoms
go away and then begin giving the medicine again. Symptoms will resolve with appropriate
treatment.
Suffer from congestive heart failure and your condition worsens.
Notice symptoms signal liver injury such as jaundice (skin and eyes turning yellow),
dark brown-colored urine, right-sided abdominal pain, fever, and severe fatigue (tiredness).
You have symptoms of a stroke 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.
After IXIFI is stopped
Tell your doctor immediately if you notice any of the following side effects, even
if they occur several weeks after stopping treatment:
skin rash or hives
frequent infections
symptoms of Tuberculosis or any other infection (persistent cough, weight loss, listlessness,
fever).
symptoms of hepatitis B (upset stomach, loss of appetite, vomiting, tiredness, dark
yellow or brown urine, and yellow eyes or skin).
These symptoms may appear several months after your last IXIFI treatment.
You should continue to take adequate contraceptive measures to avoid pregnancy for
at least 6 months after the last infusion of IXIFI.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how IXIFI
affects you.
IXIFI is unlikely to make you drowsy. If you are tired, do not drive a car or work
with machinery.
Looking after your medicine
IXIFI will be is stored in its original package in the refrigerator at 2° to 8° Celsius
(Refrigerate. Do not Freeze) before use.
If removed from the fridge, store unopened IXIFI in its original carton up to a single
period of 6 months at a maximum temperature of 30°C; but not more than the expiration
date already shown on the carton. The new expiry date should now be written on the
carton and IXIFI cannot be returned to the fridge.
It will be kept where young children cannot reach it.
Discard this medicine if not used by the new expiry date or the expiry date printed
on the carton, whichever is earlier.
The vial must be kept sealed. Only a healthcare professional should prepare the medicine
before use and administer it to you. IXIFI vials are for single use only. Any unused
portion should be discarded.
Getting rid of any unwanted medicine
The practice where IXIFI is kept will safely dispose of this medicine per local guidelines
and regulations.
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 IXIFI.
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.
Reactions more likely to occur during the first and second infusion (but may also
appear up to six months after the last infusion):
Fever or chills
Itchiness or hives
Chest pain
Low blood pressure
High blood pressure
Shortness of breath
More common side effects
Serious side effects
Some patients had side effects that caused them to stop infliximab for injection treatment.
The most common reasons were shortness of breath, rash, and headache.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
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 IXIFI, 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
in adolescents and young adults with Crohn’s disease or ulcerative colitis who have
received IXIFI. All of these patients were also receiving drugs known as azathioprine
or 6-mercaptopurine. No cases of HSTCL have been reported in patients receiving IXIFI
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 and Merkel cell carcinoma) have been reported in patients treated
with TNF-blockers, including IXIFI. Tell your doctor if you notice any new skin changes
during or after therapy or if existing skin marks change appearance.
Some women being treated for rheumatoid arthritis with infliximab for injection have
developed cervical cancer. For women taking IXIFI, including those over 60 years of
age, your doctor may recommend that you continue to be regularly screened for cervical
cancer.
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 IXIFI.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to TGA at
http://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 IXIFI contains
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Active ingredient
(main ingredient)
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Infliximab
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Other ingredients
(inactive ingredients)
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Disodium succinate hexahydrate, succinic acid, sucrose, polysorbate 80.
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Do not use this medicine if you are allergic to any of these ingredients.
IXIFI does not contain any preservative.
What IXIFI looks like
IXIFI is supplied as a powder for intravenous infusion, in single-use vials containing
100 mg of infliximab (AUST R 422316).
Who distributes IXIFI
Pfizer Australia Pty Ltd
Level 17, 151 Clarence Street
Sydney NSW 2000
Toll Free Number: 1800 675 229
This leaflet was prepared in September 2024