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 MONOFER?
MONOFER contains the active ingredient ferric derisomaltose. MONOFER is used to treat
adults with iron deficiency when oral iron preparations are ineffective or cannot
be used, or when there is a need to deliver iron rapidly.
2. What should I know before I use MONOFER?
Do not use if you have ever had an allergic reaction to MONOFER 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 MONOFER and affect how it works.
4. How do I use MONOFER?
Your doctor will use a blood test to determine your iron levels and calculate the
dose of MONOFER you need.
You will usually be given MONOFER in a clinical setting either by a slow injection
directly from the syringe into the vein, by infusion over a longer period, or during
a haemodialysis session (if you are receiving dialysis treatment).
5. What should I know while using MONOFER?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are being treated with
MONOFER.
Tell your doctor straight away if you do not feel well while being treated with MONOFER.
Tell your doctor or visit the Emergency Department immediately if you experience signs
of a severe allergic reaction.
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Things you should not do
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Do not continue treatment with MONOFER if there is leakage around the injection site.
If a leak occurs the treatment must be stopped by your doctor.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how MONOFER
affects you.
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Looking after your medicine
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MONOFER should be stored below 30°C.
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6. Are there any side effects?
Common side effects include nausea, rash and reactions at the site of injection/infusion.
Seek medical attention immediately if you experience any of the following: seizure,
loss of consciousness or a severe allergic reaction. Signs of a serious allergic reaction
involve: persistent low blood pressure; swelling of the tongue/airway, difficulty
swallowing; symptoms involving multiple parts of the body, such as heart (drop in
blood pressure, chest pains), skin (itching, hives or swelling such as the face, lips
or other parts of the body), breathing (shortness of breath, wheezing, troubled breathing)
or stomach (vomiting or pain in and around the stomach).
Active ingredient:
ferric derisomaltose
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using MONOFER. 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 MONOFER.
Where to find information in this leaflet:
1. Why am I using MONOFER?
MONOFER contains the active ingredient ferric derisomaltose.
MONOFER is used to treat iron deficiency in adults when oral iron preparations are
ineffective or cannot be used, or when there is a need to deliver iron rapidly.
The medicine contains iron in the form of ferric derisomaltose.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you. Your doctor may have prescribed it for another purpose.
MONOFER is only available with a doctor’s prescription. It is not addictive.
2. What should I know before I use MONOFER?
Warnings
Do not use MONOFER if:
you are allergic to ferric derisomaltose, or any of the ingredients listed at the
end of this leaflet.
always check the ingredients to make sure you can use this medicine.
you have anaemia that is not caused by iron deficiency.
you have too much iron (overload) or a problem with the way your body uses iron.
There is not enough information to recommend the use of MONOFER in children.
Check with your doctor if you:
have any other medical conditions: liver problems; systemic lupus erythematosus (SLE)
or a related disease; rheumatoid arthritis or other immune or inflammatory conditions;
severe asthma, eczema or other allergies; ongoing bacterial infection in your blood;
or acute or chronic infection.
take any medicines for any other condition.
are allergic to any other medicines, foods, dyes or preservatives.
are prone to allergies.
are older than 65 years of age.
If you are not sure whether any of the above conditions apply to you, ask your doctor.
Your doctor may want to take special precautions if you have any of these conditions.
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, intend to become pregnant, or become pregnant
during treatment. Your doctor will evaluate the risks and benefits of treatment with
MONOFER during pregnancy.
MONOFER may slow the heart rate of your unborn baby for a short time if you have an
allergic reaction to MONOFER. Your doctor will carefully monitor your unborn baby
while you are being given MONOFER while pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is unlikely that MONOFER represents a risk to 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.
MONOFER given together with oral iron preparations can reduce the absorption of oral
iron.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while you are receiving MONOFER.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect MONOFER.
4. How do I use MONOFER?
How much to use
your doctor will perform a blood test to determine the iron levels in your body.
this will then help your doctor calculate the dose of MONOFER you require.
When to use MONOFER
How it is given:
MONOFER should be given by your doctor or nurse in a setting where possible allergic
reactions can be appropriately and promptly treated.
the solution in the vial may be diluted with 0.9% sodium chloride, but never to concentrations
less than 1 mg iron/mL and never diluted in more than 500 mL.
MONOFER can be given by slow injection directly from the syringe into a vein, up to
three times a week.
MONOFER can also be given by infusion over a longer period. The dose may be split
into weekly infusions.
MONOFER can be given during a haemodialysis session if you are receiving dialysis
treatment.
your doctor or nurse will observe you for at least 30 minutes after your MONOFER administration.
How long your treatment will last:
your doctor will determine how long you will need to receive treatment with MONOFER.
you may receive a single MONOFER administration, or several administrations over several
weeks.
If you use too much MONOFER
Overdose may lead to 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.
If you think that you have used too much MONOFER, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), 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 MONOFER?
Things you should do
Before having any surgery or emergency treatment, tell the doctor or dentist that
you are using MONOFER.
Remind any doctor, dentist or pharmacist you visit that you are using MONOFER.
Tell your doctor straight away if you:
do not feel well while you are receiving treatment with MONOFER.
Intravenous iron preparations can cause severe allergic reactions. Tell your doctor
or visit the Emergency Department immediately if you experience itching or hives on
the skin, swelling of the face, lips, tongue or other parts of the body, difficulty
swallowing, shortness of breath, wheezing or troubled breathing, chest pains.
Things you should not do
Do not continue treatment with MONOFER if there is leakage around the injection site.
Your doctor will need to be careful during treatment to avoid any leakage into your
skin around the injection site. If a leak occurs the treatment must be stopped.
If there is any leak of MONOFER at the injection site it may cause irritation of the
skin or a brown discolouration. Discolouration in other areas can also occur.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how MONOFER
affects you.
Looking after your medicine
MONOFER should be stored below 30°C.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, MONOFER will be disposed
of by your doctor or the hospital.
Do not use this medicine after the expiry date.
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 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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Skin related:
rash
soreness and swelling near the administration site
skin discolouration (may occur at the administration site or in other areas of the
body)
Stomach related:
nausea or vomiting
pain in and around the stomach or stomach cramps
indigestion, constipation or diarrhoea
Head related:
headache
blurred vision
dizziness or light headedness
altered mental status
distorted sense of taste
Muscle and joint related:
acute chest and/or back pain
muscle or joint pain or muscle spasm
tremor
Breathing related:
acute chest tightness sometimes with shortness of breath
Heart related:
fast or irregular heartbeats
low or high blood pressure
Allergy related:
tingling or numbness
itchiness or hives on the skin
General:
flushing or sweating
generally feeling unwell
flu-like symptoms
fever or feeling cold/shivering
infection
fatigue
hoarseness or a sore throat
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Head related:
seizure
loss of consciousness
Allergy related:
rare but serious allergic reactions (anaphylactic reactions), which can involve:
persistent low blood pressure
swelling of the tongue/airway, difficulty swallowing
symptoms involving multiple parts of the body such as:
heart (drop in blood pressure or chest pains)
skin (itching, hives or swelling of the face, lips or other parts of the body)
breathing (shortness of breath, wheezing or troubled breathing)
stomach (vomiting or pain in and around the stomach)
Chest related:
chest pain, which could be a sign of a potentially serious allergic reaction called
Kounis syndrome
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Call your doctor straight away, 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 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 of these side effects
(abnormal blood test results including low level of phosphate in the blood and/or
high levels of liver enzymes) can only be found when your doctor does tests from time
to time to check your progress.
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 MONOFER contains
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Active ingredient
(main ingredient)
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Each 1 mL of MONOFER contains 100 mg of iron as ferric derisomaltose
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Other ingredients
(inactive ingredients)
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water for injections
sodium hydroxide (to adjust pH)
hydrochloric acid (to adjust pH)
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Do not use this medicine if you are allergic to any of these ingredients.
What MONOFER looks like
MONOFER is a dark brown, non-transparent solution supplied in a clear glass vial.
It contains the active ingredient, ferric derisomaltose, as a sterile solution for
injection/infusion.
MONOFER 100 mg/1 mL vial (AUST R 280666)
MONOFER 200 mg/2 mL vial (AUST R 290832)
MONOFER 500 mg/5 mL vial (AUST R 290833)
MONOFER 1000 mg/10 mL vial (AUST R 290834)
Not all presentations may be marketed.
Who distributes MONOFER
A. Menarini Australia Pty Ltd
Sydney, Australia
Medical Information: 1800 644 542
® = Registered Trademark
This leaflet was prepared in November 2024.
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