2. What should I know before I use FERRIC CARBOXYMALTOSE-TEVA?
Do not use if you have ever had an allergic reaction to ferric carboxymaltose 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 FERRIC CARBOXYMALTOSE-TEVA and affect how it works.
If FERRIC CARBOXYMALTOSE-TEVA is given together with oral iron preparations, then
these oral preparations will be less effective.
4. How do I use FERRIC CARBOXYMALTOSE-TEVA?
Your doctor can administer FERRIC CARBOXYMALTOSE-TEVA by three possible routes: undiluted
by injection, during haemodialysis, or diluted by infusion.
5. What should I know while using FERRIC CARBOXYMALTOSE-TEVA?
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Things you should do
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Intravenous iron preparations can cause severe allergic reactions. These allergic
reactions may include chest pain. Tell your doctor immediately if you experience it.
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Things you should not do
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Do not use this medicine if you have anaemia not caused by iron deficiency.
Do not use this medicine if you have iron overload (too much iron in your body) or
disturbances in utilisation of iron.
Do not give this medicine to children under 1 year.
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Looking after your medicine
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FERRIC CARBOXYMALTOSE-TEVA will normally be stored for you by your doctor or the hospital.
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6. Are there any side effects?
Common side effects include headache, dizziness, high blood pressure, flushing, nausea,
and injection/infusion site reactions. Persistent bone pain and joint pain may be
a sign of low blood phosphate levels. Serious but rare side effects include allergic
reactions which are sometimes life threatening, such as breathing difficulty, swelling,
lightheadedness, fast heartbeat, sweating, and nausea (anaphylactic reactions).
Solution for injection
Active ingredient(s): Ferric Carboxymaltose (fer-rik car-boxy-malt-ose)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using FERRIC CARBOXYMALTOSE-TEVA.
You should also speak to your doctor, nurse or pharmacist if you would like further
information or if you have any concerns or questions about using FERRIC CARBOXYMALTOSE-TEVA.
Where to find information in this leaflet:
1. Why am I using FERRIC CARBOXYMALTOSE-TEVA?
FERRIC CARBOXYMALTOSE-TEVA contains the active ingredient ferric carboxymaltose. FERRIC CARBOXYMALTOSE-TEVA is an intravenous iron preparation, a medicine that is
given in the treatment of iron deficiency conditions. It contains ferric carboxymaltose,
a carbohydrate complex containing iron. Iron is an essential element required for
the oxygen- carrying capacity of haemoglobin in red blood cells and of myoglobin in
muscle tissue. Moreover, iron plays an important role in many other vital processes
in the human body.
FERRIC CARBOXYMALTOSE-TEVA is given for treatment of adults as well as adolescents aged 14 years and older with
iron deficiency when oral iron preparations are ineffective or cannot be used. FERRIC
CARBOXYMALTOSE-TEVA is also used in children 1 to 13 years old with iron deficiency
anaemia when oral iron preparations are ineffective or cannot be used. The aim of
the therapy is to replenish body iron stores and to remedy anaemia, a reduced level
of haemoglobin due to iron deficiency. It is also used when there is a clinical need
to deliver iron rapidly.
Before administration, your doctor will perform a blood test to calculate the dose
of FERRIC CARBOXYMALTOSE-TEVA you require.
All medicines have risks and benefits. Your doctor has weighed the risks of using
FERRIC CARBOXYMALTOSE-TEVA against the benefits this medicine is expected to have
for you.
2. What should I know before I use FERRIC CARBOXYMALTOSE-TEVA?
Warnings
Do not use FERRIC CARBOXYMALTOSE-TEVA if:
you are allergic to ferric carboxymaltose, or any of the ingredients listed at the
end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
if you have anaemia not caused by iron deficiency.
if you have iron overload (too much iron in your body) or disturbances in utilisation
of iron.
Check with your doctor if you:
take any medicines for any other condition
have an infection, asthma, eczemas, allergies or liver disorders.
you are pregnant or breastfeeding.
if your doctor has told you that you have, or have had low levels of phosphate in
the blood.
Intravenous iron preparations can cause severe allergic reactions. These allergic
reactions may include chest pain. Tell your doctor immediately if you experience it.
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.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
There is no efficacy or safety data on the use of FERRIC CARBOXYMALTOSE-TEVA in pregnancy
before 16 weeks’ gestation. Iron deficiency occurring in the first trimester of pregnancy
can in many cases be treated with oral iron.
There is limited experience with the use of FERRIC CARBOXYMALTOSE-TEVA in women in
pregnancy from 16 weeks’ gestation). If iron treatment is needed in pregnancy, oral
iron should be used where possible and FERRIC CARBOXYMALTOSE-TEVA only used where
the benefit outweighs the risk.
Slow heartbeat may occur in unborn babies whose mothers have been administered intravenous
iron due to allergic reactions in the mother.
Iron treatment including FERRIC CARBOXYMALTOSE-TEVA may worsen infection.
3. What if I am taking other medicines?
Tell your doctor, nurse 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.
If FERRIC CARBOXYMALTOSE-TEVA is given together with oral iron preparations, then
these oral preparations will be less effective.
Important information about some of the ingredients of FERRIC CARBOXYMALTOSE-TEVA:
This medicinal product contains 4.6 mg sodium per millilitre of undiluted solution
and is to be taken into consideration by patients on a controlled sodium diet.
Check with your doctor, nurse or pharmacist if you are not sure about what medicines,
vitamins or supplements you are taking and if these affect FERRIC CARBOXYMALTOSE-TEVA.
4. How do I use FERRIC CARBOXYMALTOSE-TEVA?
FERRIC CARBOXYMALTOSE-TEVA will be administered in a setting where possible allergic
reactions can receive appropriate and prompt treatment.
Your doctor will take responsibility for determining the appropriate dose and choosing
the method, frequency, and duration of your treatment. You may be re-assessed after
4 weeks to determine whether you need more FERRIC CARBOXYMALTOSE-TEVA injections.
How much to take
Adults and adolescents aged 14 years and older:
Your doctor can administer FERRIC CARBOXYMALTOSE-TEVA by three possible routes: undiluted
by injection, during haemodialysis, or diluted by infusion.
by injection, you may receive up to 20 mL of FERRIC CARBOXYMALTOSE-TEVA, corresponding
to 1000 mg of iron, once a week directly into the vein.
if you are on dialysis, you may receive FERRIC CARBOXYMALTOSE-TEVA during a haemodialysis
session via the dialyser. The maximum dose of FERRIC CARBOXYMALTOSE-TEVA during haemodialysis
is 200 mg (4 mL).
by infusion, you may receive up to 20 mL of FERRIC CARBOXYMALTOSE-TEVA, corresponding
to 1000 mg of iron, once a week directly into the vein. Because FERRIC CARBOXYMALTOSE-TEVA
is diluted with sodium chloride solution for the infusion, it may have a volume of
up to 250 mL and appear as a brown solution.
Children and adolescents aged 1 to 13 years:
Your doctor can administer FERRIC CARBOXYMALTOSE-TEVA undiluted by injection or diluted
by infusion.
by injection, your child may receive up to 15 mL of FERRIC CARBOXYMALTOSE-TEVA, corresponding
to 750 mg of iron, once a week directly into the vein.
by infusion, your child may receive up to 15 mL of FERRIC CARBOXYMALTOSE-TEVA, corresponding
to 750 mg of iron, once a week directly into the vein. Because FERRIC CARBOXYMALTOSE-TEVA
is diluted with sodium chloride solution for the infusion, it may have a volume of
up to 250 mL and appear as a brown solution.
If your child is on dialysis, FERRIC CARBOXYMALTOSE-TEVA should not be administered.
FERRIC CARBOXYMALTOSE-TEVA should not be given to children under 1 year.
Your or your child may receive two doses of FERRIC CARBOXYMALTOSE-TEVA with an interval
of at least 7 days directly into the vein.
You will be observed for about 30 minutes by your doctor or nurse after each administration.
Overdose
Overdose can cause accumulation of iron in storage sites. Your doctor will monitor
iron parameters such as serum ferritin and transferrin saturation to avoid iron accumulation.
The risk of accidental overdosing is minimal.
5. What should I know while using FERRIC CARBOXYMALTOSE-TEVA?
Things you should do
You should be aware that:
Intravenous iron preparations can cause severe allergic reactions. These allergic
reactions may include chest pain. Tell your doctor immediately if you experience it.
Remind any doctor, nurse, dentist or pharmacist you visit that you are using FERRIC
CARBOXYMALTOSE-TEVA.
In patients with liver disorders, iron status will be carefully monitored by the doctor
to avoid iron overload.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how FERRIC
CARBOXYMALTOSE-TEVA affects you.
Looking after your medicine
FERRIC CARBOXYMALTOSE-TEVA will normally be stored for you by your doctor or the hospital.
However, if you need to store FERRIC CARBOXYMALTOSE-TEVA,
FERRIC CARBOXYMALTOSE-TEVA should be stored below 25°C.
Once a FERRIC CARBOXYMALTOSE-TEVA vial has been opened, it should be given immediately.
After dilution with sodium chloride solution, the diluted solution should be given
as soon as possible, if storage is necessary hold at 2 - 8°C for not more than 12
hours.
6. Are there any side effects?
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.
See the information below and, if you need to, ask your doctor, nurse or pharmacist
if you have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Head related:
headache
dizziness
flushing
taste disturbance
pallor
anxiety
Skin related:
injection/infusion site reactions
long-lasting brown discoloration of the skin may occur due to leakage of the drug
at the injection site
redness of skin (erythema)
rash
dermatitis
Blood related
low blood phosphate levels which might cause your bones to become soft (hypophosphateamic
osteomalacia)
increase of the liver enzyme alanine aminotransferase, increase of the liver enzymes
aspartate aminotransferase, gamma-glutamyltransferase, blood lactate dehydrogenase
and blood alkaline phosphatase
Stomach related
nausea
vomiting
indigestion
wind
stomach pain
diarrhoea
constipation
Allergy related
generally feeling unwell
tingling or numbness of the hands or feet
itchiness
hives (urticaria)
swelling of hands, ankles or feet
Heart related
fast heart rate (tachycardia),
high blood pressure
low blood pressure
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Speak to your doctor or nurse if you have any of these less serious side effects and
they worry you.
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Serious side effects
Tell your doctor, nurse 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.
If any of the side effects becomes serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or nurse.
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, nurse 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 FERRIC CARBOXYMALTOSE-TEVA contains
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Active ingredient
(main ingredient)
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iron (as ferric carboxymaltose, an iron carbohydrate compound). The concentration
of iron present in the product is 50 mg per milliliter.
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Other ingredients
(inactive ingredients)
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sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water
for injection.
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Do not take this medicine if you are allergic to any of these ingredients.
What FERRIC CARBOXYMALTOSE-TEVA looks like
FERRIC CARBOXYMALTOSE-TEVA, solution for injection/infusion is a dark brown, non-transparent
solution.
FERRIC CARBOXYMALTOSE-TEVA is supplied in the following presentations:
2 mL of solution in a glass vial with green cap containing the equivalent of 100 mg
of iron (AUST R: 450247),
10 mL of solution in a glass vial with purple cap containing the equivalent of 500
mg of iron (AUST R: 450249), or
20 mL of solution in a glass vial with blue cap containing the equivalent of 1000
mg of iron (AUST R: 450248).
Not all presentations may be marketed.
Who distributes FERRIC CARBOXYMALTOSE-TEVA
Teva Pharma Australia Pty Ltd
Level 1, 37 Epping Road
Macquarie Park NSW 2113
Ph: 1800 288 382
This leaflet was prepared in September 2025.