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FERINJECT 50MG IRON/ML SOLUTION FOR INJECTION/INFUSION

Active substance(s): FERRIC CARBOXYMALTOSE

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Package leaflet: Information for the patient
Ferinject 50 mg iron/mL solution for injection/infusion
Ferric carboxymaltose
medicine is subject to additional moni   This
toring. This will allow quick identification of

new safety information. You can help by
reporting any side effects you may get. See
the end of section 4 for how to report side
effects.

Read all of this leaflet carefully before you are
given this medicine because it contains
important information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor.
– If you get any side effects, talk to your doctor.
This includes any possible side effects not listed
in this leaflet. See section 4.
What is in this leaflet
1. What Ferinject is and what it is used for
2. What you need to know before you receive Ferinject
3. How Ferinject is given
4. Possible side effects
5. How to store Ferinject
6. Contents of the pack and other information

1. What Ferinject is and what it is used for

Ferinject is an antianaemic preparation, a medicine that is used to treat anaemia. It contains iron
in the form of an iron carbohydrate. 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 is
involved in many other functions necessary for
maintenance of life in the human body.
Ferinject is used for the treatment of patients with
iron deficiency, 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 lack of red blood cells due to iron deficiency.
Before administration, your doctor will perform a
blood test to determine the dose of Ferinject you
require.

2. What you need to know before you
receive Ferinject

You must not receive Ferinject
– if you are allergic (hypersensitive) to the product
or any of the other ingredients of this medicine
(listed in section 6).
– if you have experienced serious allergic (hypersensitive) reactions to other injectable iron
preparations.
– if you have anaemia not caused by iron defi­
ciency.
– if you have an iron overload (too much iron in
your body) or disturbances in the utilisation of
iron.
Warnings and Precautions
Talk to your doctor or nurse before receiving Fer­
inject:
– if you have a history of medicine allergy
– if you have systemic lupus erythematosus
– if you have rheumatoid arthritis
– if you have severe asthma, eczema or other
allergies
– if you have an infection
– if you have liver disorders
– Ferinject should not be given to children under
14 years.
– Incorrect administration of Ferinject may cause
leakage of the product at the injection site,
which may lead to irritation of the skin and
potentially long lasting brown discolouration at
the site of injection. The administration must be
stopped immediately when this occurs.
How Ferinject is given
Your doctor or nurse will administer Ferinject undiluted by injection, during dialysis, or diluted by infusion. Ferinject will be administered in a structure
where immunoallergic events can receive appropriate and prompt treatment.
You will be observed for at least 30 minutes by your
doctor or nurse after each administration.
Other medicines and Ferinject
Tell your doctor if you are using, have recently
used or might use any other medicines, including
medicines obtained without prescription. If Fer­
inject is given together with oral iron preparations,
then these oral preparations could be less efficient.
Pregnancy
Ferinject has not been tested in pregnant women.
It is important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to
have a baby.
If you become pregnant during treatment, you
must ask your doctor for advice. Your doctor will
decide whether or not you should be given this
medicine.
Breast feeding
If you are breast-feeding, ask your doctor for
advice before you are given Ferinject. It is unlikely
that Ferinject represents a risk to the nursing child.

F.1/xxxxxxx

Driving and using machines
Ferinject is unlikely to impair the ability to drive or
operate machines.
Important information about some of the
ingredients of Ferinject
This medicinal product contains 0.24 mmol (or
5.5  mg) sodium per millilitre of undiluted solution.
This has to be taken into account by patients on a
sodium-controlled diet.

3. How Ferinject is administered

Your doctor can administer Ferinject by three possible routes: undiluted by injection, during dialysis,
or diluted by infusion.
– By injection, you may receive up to 20 mL of Ferinject, corresponding to 1,000 mg of iron, once a
week directly into the vein.
– If you are on dialysis, you may receive Ferinject
during a haemodialysis session via the dialyser.
– By infusion, you may receive up to 20 mL of Ferinject, corresponding to 1,000 mg of iron, once a
week directly into the vein. Because Ferinject 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 you receive more Ferinject than you should
Your doctor will take responsibility for determining
the appropriate dose and choosing the route, frequency and duration of your treatment.
Overdose can cause accumulation of iron in storage sites. Your doctor will monitor iron parameters
such as serum ferritin and transferrin to avoid iron
accumulation.

4. Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Serious side effects:
Tell your doctor immediately if you experience any
of the following signs and symptoms that may indicate a serious allergic reaction: Rash (e.g. hives),
itching, difficulty breathing, wheezing and/or
swelling of the lips, tongue, throat or body.
In some patients these allergic reactions (affecting
less than 1 in 1,000 people) may become severe or
life-threatening (known as anaphylactoid reactions) and can be associated with heart and circulation problems and loss of consciousness.
Your doctor is aware of these possible side effects
and will monitor you during and after the administration of Ferinject.
Other side effects that you should tell your
doctor about if they become serious:
Common side effects (may affect up to 1 in 10 people): headache, dizziness, high blood pressure,
nausea and injection site reactions (also see section 2).
Uncommon side effects (may affect up to 1 in 100
people): numbness, tingling or prickling sensation
on the skin, a change in your taste sensation, high
heart rate, low blood pressure, redness in the face,
difficulty breathing, vomiting, indigestion, stomach
pain, constipation, diahorrea, itching, hives, redness of the skin, rash, muscle-, joint -and/or back
pain, muscle spasms, fever, tiredness, chest pain,
swelling of the hands and/or the feet, and chills.
Rare side effects (may affect up to 1 in 1,000 people): inflammation of a vein, shivering and a general feeling of discomfort, loss of consciousness,
anxiety, fainting, feeling faint, wheeze, excessive
wind (flatulence), rapid swelling of the deep layers
of the skin, paleness and swelling of the face, and
flu-like symptoms like fever, headache and/or feeling ill (influenza-like illness).
Some blood parameters may change temporarily,
which could be detected in laboratory tests.
The following changes in blood parameters are
common: decrease in blood phosphorus and
increase of a certain liver enzyme called alanine
aminotransferase.
The following changes in blood parameters are
uncommon: increase in certain liver enzymes
called aspartate aminotransferase, gamma-glutamyltransferase and alkaline phosphatase, and
increase in an enzyme called lactate dehydrogenase.
Ask your doctor for more information.
Reporting of side effects
If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
Pf UK MT

By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Ferinject

Keep Ferinject out of the sight and reach of children.
Do not use Ferinject after the expiry date which is
stated on the label. The expiry date refers to the
last day of that month.
Store in the original package in order to protect
from light. Do not store above 30 °C. Do not freeze.
Once the Ferinject vials have been opened, they
should be used immediately. After dilution with
sodium chloride solution, the diluted solution
should be used immediately.
Ferinject will normally be stored for you by your
doctor or the hospital.

6. Contents of the pack and other
information

What Ferinject contains
The active substance is iron (as ferric carboxymaltose, an iron carbohydrate compound). The
concentration of iron present in the product is
50  mg per millilitre. The other ingredients are so­dium hydroxide (for pH adjustment), hydrochloric
acid (for pH adjustment), and water for injection.
What Ferinject looks like and contents of the
pack
Ferinject is a dark brown, non-transparent solution
for injection/infusion.
Ferinject is supplied in glass vials containing:
– 2 mL solution corresponding to 100 mg iron.
Available in pack sizes of 1, 2 and 5 vials.
– 10 mL solution corresponding to 500 mg iron.
Available in pack sizes of 1, 2 and 5 vials.
– 20 mL solution corresponding to 1,000 mg iron.
Available in a pack size of 1 vial.
Not all pack sizes may be marketed.

The following information is intended for
healthcare professionals only:

Monitor patients carefully for signs and symptoms
of hypersensitivity reactions during and following
each administration of Ferinject. Ferinject should
only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. The patient
should be observed for adverse effects for at least
30 minutes following each Ferinject injection.
Determination of the iron need
The individual iron need for repletion using Fer­
inject is determined based on the patient’s body
weight and haemoglobin (Hb) level (see Table 1):
Table 1: Determination of the iron need

Hb
g/dL
<10
10 to 14
>14

Patient body weight
below 35 kg
70 kg
35 kg to <70 kg and over
<6.2
500 mg 1,500 mg 2,000 mg
6.2 to 8.7 500 mg 1,000 mg 1,500 mg
>8.7
500 mg 500 mg 500 mg

mmol/L

Iron deficiency must be confirmed by laboratory
tests.
Calculation and administration of the maximum
individual iron dose(s)
Based on the iron need determined above the
appropriate dose(s) of Ferinject should be administered taking into consideration the following:
A single Ferinject administration should not exceed:
• 15 mg iron/kg body weight (intravenous injection) or 20 mg iron/kg body weight (intravenous
infusion)
• 1,000 mg of iron (20 mL Ferinject)
The maximum recommended cumulative dose of
Ferinject is 1,000 mg of iron (20 mL Ferinject) per
week.
A single maximum daily injection dose of 200 mg
iron should not be exceeded in haemodialysisdependent chronic kidney disease patients.
The use of Ferinject has not been studied in children, and therefore is not recommended in children under 14 years.

Marketing Authorisation Holder and
Manufacturer
Vifor France SA
7–13, Bd Paul Emile Victor
92200 Neuilly-sur-Seine
France
Tel.a+33 (0)1 41 06 58 90
Faxa+33 (0)1 41 06 58 99
e-mail: contact-fr@viforpharma.com
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria, Bulgaria, Croatia, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovak Republic, Spain, Sweden, United Kingdom: Ferinject. Belgium, Luxembourg: Injectafer. Slovenia: Iroprem.
This leaflet was last revised in April 2015.
For any information about this medicine, please
contact the local representative of the Marketing
Authorisation Holder.
Vifor Pharma UK Limited
The Old Stables, Bagshot Park · Bagshot Surrey
GU19 5PJ UK

Method of administration
Ferinject must only be administered by the intravenous route: by injection, by infusion, or during a
haemodialysis session undiluted directly into the
venous limb of the dialyser. Ferinject must not be
administered by the subcutaneous or intramuscular route.
Caution should be exercised to avoid paravenous
leakage when administering Ferinject. Paravenous
leakage of Ferinject at the injection site may lead to
irritation of the skin and potentially long lasting
brown discolouration at the site of injection. In
case of paravenous leakage, the administration of
Ferinject must be stopped immediately.
Intravenous injection
Ferinject may be administered by intravenous
injection using undiluted solution. The maximum
single dose is 15 mg iron/kg body weight but should
not exceed 1,000 mg iron. The administration rates
are as shown in Table 2:

Table 2: Administration rates for intravenous injection of Ferinject
Volume of Ferinject required

Equivalent iron dose

2 to 4 mL
> 4 to 10 mL
>10 to 20 mL

100 to 200 mg
> 200 to 500 mg
> 500 to 1,000 mg

Administration rate / 
Minimum administration time
No minimal prescribed time
100 mg iron / min
15 minutes

Intravenous infusion
Ferinject may administered by intravenous infusion, in which case it must be diluted. The maximum single
dose is 20 mg iron/kg body weight but should not exceed 1,000 mg iron. Ferinject must only be diluted in
sterile 0.9% m/V sodium chloride solution as shown in Table 3. Note: for stability reasons, Ferinject should
not be diluted to concentrations less than 2 mg iron/mL (not including the volume of the ferric carboxymaltose solution).
Table 3: Dilution plan of Ferinject for intravenous infusion
Volume of Ferinject Equivalent iron dose Maximum amount of sterile
Minimum
required
0.9% m/V sodium chloride solution administration time
2 to 4 mL
> 4 to 10 mL
>10 to 20 mL

100 to 200 mg
> 200 to 500 mg
> 500 to 1,000 mg

50 mL
100 mL
250 mL

Monitoring measures
Post-iron repletion, regular assessments should be
performed to ensure that iron levels are corrected
and maintained. Studies have shown that a sui­
table time point for reassessing iron need is at
least 4 weeks post final Ferinject administration. In
the event the patient requires further iron repletion, the iron need should be recalculated using
Table 1 above.
Incompatibilities
The absorption of oral iron is reduced when administered concomitantly with parenteral iron preparations. Therefore, if required, oral iron therapy
should not be started for at least 5 days after the
last injection of Ferinject.

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6 minutes
15 minutes
Overdose
Administration of Ferinject in quantities exceeding
the amount needed to correct iron deficit at the
time of administration may lead to accumulation of
iron in storage sites eventually leading to haemosiderosis. Monitoring of iron parameters such as
serum ferritin and transferrin saturation may assist
in recognising iron accumulation. If iron accumulation has occurred, treat according to standard
medical practice, e. g. consider the use of an iron
chelator.

Pf UK MT

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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